The iCare App is intended for use in the home and clinical settings as and their healthcare professionals to view test results which are measured by iHealth devices to better manage user's health and get feedback from their professional care team.

The iCare App can also connect to medical devices and or non-medical devices and get data from devices during measurement or from the data stored in memory of the device for enhanced data managements. Data can be transmitted, displayed, and stored in the App.

The iCare APP is a mobile application on both Android and iOS platforms.iCare allows users to better manage their own health by enabling them to measure their vital signs, access their results and relevant health information with just their smart device and internet connection, and receive feedback from their professional care team.

iCare includes a patient darshboard featuring the Home, Health, Plus, Education, and Profile tabs. Accessory devices can be connected to the system to allow for collection of blood sugar, blood pressure, blood oxygen, and/or weight measurements. The patient darshboard functionality includes the ability to start measuring, allows users to view and track measurements, and export testing schedules for blood sugar, blood pressure, blood oxygen, and weight measurements; send messages to their professional care team; view previous appointment history information; view medication instructions; add entries to the food diary and review feedback from their registered dietician; set timers; and access articles and videos about health knowledge.

The provided text is a 510(k) Summary for the iCare App, focusing on its substantial equivalence to a predicate device. It primarily details regulatory information, device description, and non-clinical test summaries. It does not contain information about a study that proves the device meets specific performance acceptance criteria for a medical diagnostic or screening function.

The iCare App is classified as a "Medical Device Data System" (MDDS) that transmits, displays, and stores data from connected medical devices. Its function is to aid users and healthcare professionals in viewing test results for health management. It explicitly states: "Both devices make no interpretation, evaluation, medical judgments, or recommendations for treatment." This means the app itself doesn't perform diagnostic functions that would require specific performance metrics like sensitivity, specificity, or AUC against a ground truth.

Therefore, many of the requested criteria, such as acceptance criteria for diagnostic performance, a test set, expert ground truth establishment, MRMC studies, or standalone algorithm performance, are not applicable or not provided in this document because the device is a data management system, not a diagnostic algorithm.

Here's a breakdown of the applicable information based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not present a table of quantitative performance acceptance criteria for diagnostic accuracy, sensitivity, or specificity, because the iCare App is an MDDS for data management, not a diagnostic tool. Instead, acceptance criteria are implied through the successful completion of non-clinical tests that demonstrate the basic functionality, safety, and effectiveness for its intended use as a data display and storage system.

2. Sample sized used for the test set and the data provenance

• Sample Size for Test Set: Not applicable for diagnostic performance as the device is not a diagnostic algorithm. The document mentions non-clinical testing (software, wireless, cybersecurity, usability) but does not specify "test set" sizes in the context of clinical data for diagnostic performance.
• Data Provenance: Not applicable in the context of clinical diagnostic data. The document focuses on the technical aspects of the software.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Number of Experts: Not applicable, as the device does not perform diagnostic interpretations requiring expert-established ground truth for clinical cases.
• Qualifications of Experts: Not applicable.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Adjudication Method: Not applicable, as there is no clinical test set requiring ground truth adjudication for diagnostic performance.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• MRMC Study: No, an MRMC study was not done. The iCare App is an MDDS and does not involve AI assistance for human readers in a diagnostic capacity. It makes "no interpretation, evaluation, medical judgments, or recommendations for treatment."
• Effect Size: Not applicable.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Standalone Performance: No, a standalone performance study in the context of diagnostic accuracy was not done. The device's function is data transmission, display, and storage, not diagnostic algorithm performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Type of Ground Truth: Not applicable for clinical diagnostic performance. For the software verification and validation, the "ground truth" would be the successful execution against specified requirements and accepted software engineering practices and FDA guidance.

8. The sample size for the training set

• Training Set Sample Size: Not applicable. This document does not describe a machine learning model that was trained on a dataset. The iCare App is a software application for data management, not an AI/ML algorithm requiring a training set of clinical data for diagnostic purposes.

9. How the ground truth for the training set was established

• Ground Truth Establishment for Training Set: Not applicable, as there is no mention of a training set for an AI/ML algorithm.

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The Vios Monitoring System (VMS) is intended for use by medically qualified personnel for physiological vital signs monitoring of adult (18+) patients in healthcare facilities. It is indicated for use in monitoring of 7-Lead ECG, heart rate, respiratory rate, pulse rate, functional oxygen saturation of arterial hemoglobin, non-invasive blood pressure (NIBP) continuously, and patient posture and activity. VMS allows for the input of non-invasive blood pressure and body temperature and can display data from peripheral devices. VMS can generate alerts when rate-based cardiac arrhythmias are detected and when physiological vital signs fall outside of selected parameters.

The non-invasive Blood Pressure Tracking feature is based on Pulse Arrival Time (PAT), which is obtained utilizing ECG and PPG signals following a calibration process using an FDA-cleared oscillometric blood pressure monitor. This feature is not intended for use in critical care environment.

The Vios Central Station Monitor (CSM) and Central Server (CS) Software (SW) is indicated for use by healthcare professionals for the purpose of centralized monitoring of patient data within a healthcare facility. The Vios CSM SW and CS SW receives, stores, manages, and displays patient physiological and waveform data and alarms generated by Vios proprietary patient vitals monitoring software.

The Vios Monitoring System (VMS) Model 2050 is a wireless mobile medical device platform that allows caregivers in healthcare settings to monitor patient vitals.

The VMS includes a proprietary monitoring software, Chest Sensor, Finger Adapter and Central Server and Central Monitoring Station.

The VMS BSM SW Model B2050 is stand-alone software that can receive, analyze, and display physiological vitals data from one or more patient-worn sensors via standard communication protocols (Bluetooth™). It runs on a commercial IT platform and is intended to be used in conjunction with the Vios Chest Sensor and Vios Lead Adapters and can support peripheral, medical grade, Bluetooth™-enabled devices.

The VMS Chest Sensor Model CS2050 is a small, patient-worn, non-sterile multiple use, and rechargeable sensor that acquires 3-channel ECG, bioimpedance, 2-channel pulse oximetry, and tri-axial accelerometer data. The sensor contains signal acquisition firmware (embedded software) and wirelessly communicates acquired data via standard communication protocols (Bluetooth™) to the BSM SW for analysis and display. The Chest Sensor has a button that, when pressed, sends a patient call alert to the BSM SW.

VMS Chest Sensor Adapter Models L2050F (Pulse Ox Finger Adapter) are plastic, non-sterile, patient-worn, multiple use pulse oxygenation sensors that connect to the Vios Chest Sensor and are secured to the patient via medical grade ECG electrodes.

The provided text describes a 510(k) clearance for the Vios Monitoring System Model 2050, focusing on the addition of a blood pressure tracking feature. Here's an analysis of the acceptance criteria and the study details based solely on the provided document:

Missing Information: It's important to note that the provided FDA 510(k) clearance letter is a summary document and does not contain the detailed clinical study report or the specific acceptance criteria with numerical performance targets. It states that the device meets "all consensus standards requirement" and that "results were within the acceptance criteria," but it does not define those criteria or present detailed performance data in a table format. Therefore, I will have to make assumptions about the typical acceptance criteria for Non-Invasive Blood Pressure (NIBP) devices based on the mentioned standards (ISO 81060-2, IEEE 1708, ISO 81060-3) and then state the general reported outcome from the document.

1. Table of Acceptance Criteria and Reported Device Performance

Given the lack of specific numerical acceptance criteria and performance data in the provided document, the table below will broadly reflect typical NIBP acceptance criteria based on the mentioned standards and the general statement of performance from the text.

• Mean difference $\le \text{5 mmHg}$
• Standard deviation $\le \text{8 mmHg}$
  (Requirements per ISO 81060-2) | "The results were within the acceptance criteria, similar to the predicate device." |

Explanation of Assumption: The document explicitly states that "The clinical testing and analysis is performed according to applicable clauses from ISO 81060-2, IEEE 1708, and ISO 81060-3 for validation using reference invasive blood pressure measurement on the radial artery." ISO 81060-2 is the primary standard for non-invasive sphygmomanometers, which outlines specific statistical accuracy requirements (mean difference and standard deviation). Therefore, the acceptance criteria are assumed to be those specified in ISO 81060-2. The document does not provide numerical results for the Vios Monitoring System.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: Not explicitly stated in the provided document. The text mentions "a range of subjects, representative of the intended population."
• Data Provenance: Not explicitly stated. The document indicates a "clinical study" was performed, but does not specify the country of origin of the data or whether it was retrospective or prospective. Given it's a clinical study for validation, it is most likely prospective.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not provided in the document. The ground truth was established by "reference invasive blood pressure measurement on the radial artery," which is a direct, objective medical measurement, not typically requiring a panel of experts for interpretation in the same way as, for example, image interpretation.

4. Adjudication Method for the Test Set

This information is not applicable/provided as the ground truth for blood pressure measurement (invasive arterial line) is an objective, quantitative measurement that does not require expert adjudication in the same manner as subjective or qualitative assessments.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study (comparing human reader performance with and without AI assistance) is typically performed for diagnostic imaging or similar interpretation tasks where human perception and decision-making are aided by AI. For a vital signs monitor, the primary assessment is of the device's accuracy against a known reference, not its ability to assist human readers in interpretation.

6. If a Standalone (Algorithm Only) Performance Study Was Done

Yes, a standalone performance study was done. The clinical testing described for "Blood Pressure Tracking" assesses the algorithm's accuracy in autonomously generating blood pressure values from PAT (Pulse Arrival Time) against an invasive blood pressure reference. This is an assessment of the algorithm's standalone performance.

7. The Type of Ground Truth Used

The ground truth used for the blood pressure tracking feature was invasive blood pressure measurement on the radial artery. This is considered a gold standard and highly accurate method for blood pressure determination.

8. The Sample Size for the Training Set

The document does not provide information regarding the sample size for a training set. The descriptions focus on the validation study for the blood pressure tracking feature. It is implied that the algorithm was developed (trained) prior to this validation, but the details of that training are not included in this summary.

9. How the Ground Truth for the Training Set Was Established

The document does not provide information on how the ground truth for any training set was established. It only describes the ground truth for the clinical validation study (invasive blood pressure measurement on the radial artery) and the calibration process. The "calibration (initialization)" step uses an "FDA-cleared oscillometric blood pressure monitor" for initial coefficient determination, which is distinct from establishing ground truth for a large-scale training set.

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The Vios Monitoring System (VMS) is intended for use by medically qualified personnel for physiological vital signs monitoring of adult (18+) patients in healthcare facilities. It is indicated for use in monitoring of 7-lead ECG, heart rate, functional oxygen saturation of arterial hemoglobin, non-invasive blood pressure and activity. VMS allows for the input of body temperature, and can display data from peripheral devices. VMS can generate alerts when the physiological vital signs fall outside of selected parameters.

VMS can also generate alerts when cardias arrhythmias (Tachycardia, Asystole, Ventricular Fibrillation and Atrial Fibrillation/ Atrial Flutter) are detected.

The ECG rhythm analysis is intended for use by medified professionals in the identification of arrhythmia events and to aid in clinical review of arrhythmias and medical interventions.

The Vos CSM/CS Software is indicated for use by healthcare professionals for the purpose of centralized monitoring of patient data within a healthcare facility. The Vios CSMCS SW receives, stores, and displays patient physiological and waveform data and alams generated by Vios proprietary patient vitals monitoring software.

The Vios Monitoring System (VMS) Model 2050 is a wireless mobile medical device platform that allows caregivers in healthcare settings to monitor patient vitals. The VMS includes a proprietary monitoring software, Chest Sensor, Finger Adapter and Central Server and Central Monitoring Station. The VMS BSM SW Model B2050 is stand-alone software that can receive, analyze, and display physiological vitals data from one or more patient-worn sensors via standard communication protocols (Bluetooth™). It runs on a commercial IT platform and is intended to be used in conjunction with the Vios Chest Sensor and Vios Lead Adapters and can support peripheral, medical grade, Bluetooth™-enabled devices. The VMS Chest Sensor Model CS2050 is a small, patient-worn, non-sterile multiple use,

The Vios Monitoring System (VMS) Model 2050 was evaluated for its arrhythmia detection features, specifically assessing its performance against the ANSI/AAMI EC57:2012 standard and additional database records.

Here's a breakdown of the acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily references compliance with the ANSI/AAMI EC57:2012 standard for cardiac rhythm and ST-segment measurement algorithms. While specific numerical acceptance criteria (e.g., minimum sensitivity, positive predictivity) for each arrhythmia are not explicitly listed in the provided summary, the study's conclusion of meeting "performance requirements as outlined in the consensus standard ANSI/AAMI EC57:2012" implies that the device achieved the performance thresholds defined within that standard for the tested arrhythmias.

2. Sample Size for the Test Set and Data Provenance:

The document states that the device's performance was evaluated using:

• Records from the ANSI/AAMI EC57 standard. This standard often utilizes a combination of standard ECG databases (e.g., MIT-BIH Arrhythmia Database).
• Additional records from LTAF, AAEL, and VFDB databases.

The specific sample sizes (number of patients or ECG recordings) for each arrhythmia or for the combined test set are not provided in the summary. The provenance of LTAF, AAEL, and VFDB databases is not detailed; however, these are generally recognized public databases of ECG recordings used for algorithm testing, often comprising retrospective data.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

The document does not state the number of experts used or their specific qualifications for establishing the ground truth of the test set. For publicly available and widely used databases like those mentioned (MIT-BIH, LTAF, AAEL, VFDB), the ground truth labels are typically established by multiple expert cardiologists or electrophysiologists using established criteria, often after multiple review rounds. However, this specific information is not in the provided text.

4. Adjudication Method for the Test Set:

The document does not specify the adjudication method used (e.g., 2+1, 3+1). For standard ECG databases, ground truth is usually established via expert consensus, which inherently involves an adjudication process, but the specific mechanics are not described here.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

The document does not indicate that a multi-reader multi-case (MRMC) comparative effectiveness study was done to assess how much human readers improve with AI vs. without AI assistance. The testing described is focused on the standalone performance of the device's arrhythmia detection algorithm.

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance:

Yes, a standalone performance evaluation was done. The summary explicitly states: "The non-clinical tests for evaluation of performance of Vios system with the addition of arrhythmia alarms is based on ANSI/AAMI EC57, showing substantial equivalence to the predicate (K180472). The subject device's performance was also evaluated using additional records from LTAF, AAEL, and VFDB database..." This describes the algorithm's performance without direct human intervention as part of the detection process.

7. Type of Ground Truth Used:

The ground truth for the test was established through expert consensus/annotations from well-known ECG databases (ANSI/AAMI EC57, LTAF, AAEL, and VFDB). These databases contain ECG recordings that have been meticulously reviewed and annotated by medical experts (typically cardiologists or electrophysiologists) to identify and label different cardiac events and arrhythmias,
Pathology and outcomes data are not mentioned as sources for ground truth in this context.

8. Sample Size for the Training Set:

The document does not specify the sample size used for the training set of the Vios Monitoring System's arrhythmia detection algorithm.

9. How the Ground Truth for the Training Set Was Established:

The document does not specify how the ground truth for the training set was established. However, it is common practice for such algorithms to be trained on large, expertly annotated ECG datasets, similar to those used for testing (expert consensus/annotations).

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The Alma Harmony is intended for use in surgical applications requiring the ablation, vaporization, and coagulation of soft tissue in medical specialties including: aesthetic surgery (dermatology and plastic surgery).

Clear Skin Pro 1540nm Applicator:
The ClearSkin Pro 1540nm is indicated for : Use in dermatological procedures requiring fractional skin resurfacing and coagulation of soft tissue.

SupErb 2940nm Applicator:
The 2940 nm Er.Y AG Laser Module handard and scanner accessory tips (with and without contactcooling) is indicated for use in soft tissue (skin, cutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs, and glands.
Dermatology and Plastic Surgery: Skin resurfacing, Treatment of wrinkles, Epidermal nevi, Telangiectasia, Spider veins, Actinic chelitis, Keloids, Verrucae, Skin tags, keratoses, Scar revision (including acne scars), Debulking benign tumors, Debulking cysts, Superficial skin lesions, Diagnostic biopsies, Decubitus ulcers.
General Surgery: Surgical incision, vaporization, ablation, and coagulation of soft tissue where skin incision, tissue dissection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors and lesions, tissue ablation, and/or vessel coagulation may be indicated.
Genitourinary: Treatment of: Lesions of the external genitalia, urethra and anus, penis, scrotum, and urethra (includes condyloma acuminate, giant perineal condyloma, and verrucous carcinoma), vulvar, lesions, polyps, and familiar polyps of the colon.
Gynecology: Treatment of: Cervical intraepithelial neoplasia (CIN), herpes simplex, endometrial adhesions, cysts, and condyloma.
Oral/Maxiofacial: Treatment of: Benign oral tumors, oral and glossal lesions, and gingivectomy.
Otothrynolaringology / Head and Neck (ENT): Treatment of: Ear, nose and throat lesions, polyns, cysts, hyperkeratosis, Excision of carcinogenic tissue and oral leukoplakia.
Ophthalmology : Treatment of: Soft tissue surrounding the eye and orbit.
Podiatry: Treatment of: Warts, plantar verrucae, large mosaic verrucae, Matrixectomy.

Clear Lift Pro Q-Switched Cr: Nd: YAG 1064 / 532 nm Applicator
1064mm mode is indicated for the removal or lightening of unwanted facial or body hair, for skin resurfacing (ablation of epidermal skin layers) in dermatology and aesthetic surgery, benign pigmented lesions (dermal melanocytosis) and tattoo removal for dark and blue inks.
532 nm mode is indicated for tattoo removal including red, blue and green inks, for the treatment of benign vascular lesions including telangiectasias, spider angiomas, spider nevi and the treatment of benign pigmented lesions including Café-au-lait birthmarks, solar lentigines, Becker's nevi, freckles nevus spilus and nevus of ota. 532mm mode is also indicated for incision, ablation and vaporization of soft tissue in general dermatology.

ClearVas Nd:YAG 1064nm
For the coagulation and hemostasis of benign vascular lesions such as, but not limited to, port wine stams, hemangiomas, warts, telangiectasia, rosacea, venus lake, leg veins, and spider veins.
Treatment of wrinkles.
Removal of unwanted hair and for the treatment of pseudofolliculitis barbae (PFB).
The ClearVas Nd: YAG 1064nm is indicated for use on all skin types (Fitzpatrick I-VI), including tanned skin.

Iris VL / PL Applicator:
Intended for use in aesthetic and cosmetic applications requiring selective photothermolysis (photocoagulation or coagulation) and hemostasis of soft tissue in the medical specialties of general and plastic surgery, and dermatology.
The treatment of benign pigmented epidermal lesions including dyschromia, hyperpigmentation, melasma, and ephelides (freckles), lentigines, nevi, melasma, and cafe-au-lait macules.
The treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas, poikiloderma of Civatte, leg veins and venous malformations. Use on all skin types (Fitzpatrick I- VI).

Iris Dye VL / Dye SVL Applicator:
The treatment of benign pigmented lesions including café -au-lait (macules), lentigines (senile and solar), freckles (ephelides), chloasma, nevi, nevus of Ota, and Becker's Nevi. • The treatment of other pigmented cutaneous lesions including verrucae, skin tags, keratosis, and plaques. • The treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations. • Use on skin types (Fitzpatrick I-V).

Iris SHR Applicator:
The Advanced Fluorescence Technology (AFT) 650-950 nm handpiece (with and without contact-cooling) is indicated for: The treatment of tattoos, the treatment of moderate inflammatory acne vulgaris, the treatment of benign pigmented epidermal lesions including dyschromia, hyperpigmentation, melasma, and ephelides (freckles), lentigines, nevi, melasma, and cafe-au-lait, the treatment of cutaneous lesions including warts, scars and striae, the treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations. The removal of unwanted hair and to effect stable long-term or permanent hair reduction. Use on all skin types (Fitzpatrick I-VI), including tanned skin

Iris Acne Applicator:
Intended for use in aesthetic and cosmetic applications requiring selective photothermolysis (photocoagulation or coagulation) and hemostasis of soft tissue in the medical special and plastic surgery and dermatology.
The Advanced Fluorescence Technology (AFT) 420-950 nm Acne Module Applicator (with and without contact-cooling) is indicated for:
The treatment of moderate inflammatory acne vulgaris.
The treatment of benign pigmented epidermal lesions including dyschromia, hyperpigmentation, melasma, and ephelides (freckles).
The treatment of cutaneous lesions including warts, scars and striae.
The treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas, poikiloderma of Civate, leg veins and venous malformations.
Use on all skin types (Fitzpatrick I-VI).

Iris NIR Applicator: Intended to emit energy in the infra-red spectrum to provide topical heating for the purpose of elevating the tissue temperature.
For the temporary relief of minor muscle pain and stiffness, the temporary relief of minor joint pain associated with arthritis, the temporary increase in local circulation where applied, and the relaxation of muscles; may also help muscle spasms, minor sprains and strains, and minor muscular back pain.

Iris Diode Applicator
The Iris diode is intended for use for vascular lesions, spider naevi, teleangiectass, red superficial veins of the legs and face, pigmented lesions (e.g. cafe-au-lait stains, lentigo), hemangiomas, port wine stains, rosacea.

The Alma Harmony is a Class II Medical Device that combines multiple technologies into one platform for use in dermatologic, aesthetic procedures and pain management procedures. The system is comprised of a micro-processor-controlled and user-friendly console that houses the power supply, the electronics, and the user interface. It has 10 applicators that are attached to the console, which can be selected for use in treatment through the user interface.
In addition, this submission will add the Smart Clinic Software that was previously cleared in the Soprano Titanium (K210371).

This document is a 510(k) Premarket Notification from the FDA, evaluating the substantial equivalence of the Alma Harmony device to previously cleared predicate devices. It describes the device, its intended use, and a comparison of its technological characteristics with the predicate devices. The document references performance testing and animal studies. However, it does not describe acceptance criteria for an AI/ML powered medical device, nor does it detail a study proving such a device meets those criteria.

Therefore, I cannot provide the requested information from this document. The document primarily focuses on demonstrating the substantial equivalence of the Alma Harmony, which is a laser and light-based medical device, to existing laser and light-based devices. There is no mention of AI or machine learning components with specific performance criteria or studies in the context of diagnostic accuracy, human-in-the-loop performance, or standalone algorithm performance.

The section titled "Software verification and validation testing was conducted, and documentation provided as recommended by the FDA's 'Guidance for the Content of Premarket Submissions Contained in Medical Devices." is the only mention of software, and it's a general statement about V&V testing, not specific to AI/ML or its performance metrics. The statement "this submission will add the Smart Clinic Software. This software was previously cleared in the Alma Titanium K230371" confirms that any software component is previously cleared, implying it's not a novel AI/ML component being tested for new performance criteria.

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The Revi System is indicated for the treatment of patients with symptoms of urgency incontinence alone or in combination with urinary urgency.

The Revi System is a tibial neuromodulation system that consists of the following four different components:

1. Implant: An implantable wireless neurostimulation component that is implanted in the vicinity of the tibial neurovascular bundle. The implant is battery-less and does not have an internal power source.
2. Rechargeable Wearable Unit: This unit is comprised of a wearable device and leg band. The wearable device contains an electrical circuit board, flexible antenna, and rechargeable battery with dedicated charger. The Rechargeable Wearable Unit, when used by the patient, is designed to be paired to a specific implant. Once paired, the Rechargeable Wearable Device transmits power and can only communicate (through magnetic coupling) with the specific implant to which it is paired.
3. Clinician Programmer (CP): This application is the system's interface used by the healthcare providers for treatment control, status evaluation, parameter programming and data acquisition. Access to the CP is password protected to allow access only to authorized users. The CP transfers data to and from the Rechargeable Wearable Unit via a wireless Bluetooth connection.
4. HealthGo Micro (Hub): The Hub communicates with the Rechargeable Wearable Unit using a Bluetooth connection and acquires and transmits data to the Cloud only during the charging sessions of the Rechargeable Unit. The Hub allows health care providers access to device data logs between visits without the need for in-person visits. The Hub is a Class I 510(k) exempt device (Product code OUG, 21 CFR 880.6310).

Acceptance Criteria and Device Performance for the Revi System

This document outlines the acceptance criteria for the Revi System and details the studies that demonstrate the device meets these criteria.

1. Table of Acceptance Criteria and Reported Device Performance

The Revi System's clinical performance was evaluated against primary and secondary effectiveness endpoints with pre-defined performance goals (PG). The device's safety was assessed by the incidence of adverse events.

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The Soprano Titanium diode laser module is intended for use in dermatology procedures requiring coagulation. The indications for use for the Soprano Trio diode laser module include:

The Super Hair Removal (SHR) Mode is intended for temporary hair reduction.

The Soprano Trio diode laser module HR mode is intended for use in dermatology procedures requiring coagulation. The indications for the Soprano Trio diode laser HR module include: Benign vascular and vascular dependent lesions.

810nm Applicator

Soprano Titanium 810 nm applicator intended use and indications for use:

The indications for use for the 810nm Modified Diode Laser Module 2 cm2 include:

• The Hair Removal (HR) and Super Hair Removal (SHR) Mode are intended for permanent reduction in hair regrowth defined as a long term, stable reduction in the number of hairs re-growing when measured at 6.9 and 12 months after the completion of a treatment regimen.

Use on all skin types (Fitzpatrick I-VI), including tanned skin.(HR, and SHR Modes)

755nm applicator

Soprano Titanium 755 nm applicator intended use and indications for use:

The indications for use for the 755nm Diode Laser Module include:

• The Hair Removal (HR) and Super Hair Removal (SHR) Mode are intended for permanent reduction in hair regrowth defined as a long term, stable reduction in the number of hairs re-growing when measured at 6,9 and 12 months after the completion of a treatment regimen.

· Use on all skin types (Fitzpatrick I-VI), including tanned skin.(HR, SHR Modes)

NIR Applicator

NIR Applicator intended use and indications for use

The Alma Lasers NIR Modules intended use is to emit energy in the near infrared (NIR) spectrum to provide topical heating.

The indications for use for NIR Modules are:

• · Elevating the tissue temperature for the temporary relief of minor muscle pain and stiffness,
• · The temporary relief of minor joint pain associated with arthritis,
• · The temporary increase in local circulation where applied, and
• · The relaxation of muscles; may also help muscle spasms, minor sprains and strains, and minor muscular back pain.

The Alma Lasers Soprano Titanium Laser System consists of:

• System console (contains the laser diodes, the system software, power supply and various other electronic and mechanical parts)
• Operator control panel with touch screen technology (GUI)
• 810 nm applicator ●
• 755 nm applicator
• Small NIR applicator
• Trio 4 cm2 applicator ●
• Trio 2 cm2applicator .

This document is a 510(k) premarket notification from the FDA, asserting the Alma Soprano Titanium device's substantial equivalence to a predicate device (K222064). This means that the device is deemed to be as safe and effective as a previously cleared device. Therefore, a separate study to prove the device meets acceptance criteria is not explicitly provided in this document, as the substantial equivalence framework relies on comparison to an already approved device.

However, based on the provided text, we can infer some information about performance testing and clinical data:

1. A table of acceptance criteria and the reported device performance:

The document does not explicitly state "acceptance criteria" and "reported device performance" in a table format for the newly submitted device. Instead, it refers to performance testing against established safety and essential performance standards for medical electrical equipment and laser products. The implicit "performance" is that the device conforms to these standards.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

The document states, "Based on the similarities in the safety and effectiveness profiles of the subject and the predicate, no clinical studies were deemed needed to support this submission." This indicates that there was no new clinical test set for this specific 510(k) submission. The device's safety and effectiveness are established through its substantial equivalence to the predicate device K222064.

Therefore, questions regarding sample size, data provenance (country of origin, retrospective/prospective), number of experts, and adjudication methods for a test set are not applicable to this submission, as no new clinical test data was generated.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

Not applicable, as no new clinical studies were conducted for this submission.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable, as no new clinical studies were conducted for this submission.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. The Smart Clinic software is classified as an MDDS (Medical Device Data System), which is focused on data management and display, not AI-assisted diagnosis or interpretation requiring MRMC studies.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. The document focuses on hardware (laser modules, applicators) and an MDDS software component. There is no mention of a standalone algorithm for diagnostic or interpretative purposes.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

Not applicable to this 510(k) submission directly, as it relies on substantial equivalence. The "ground truth" for the predicate device (K222064) would have been established through its own clearances and supporting data, which is not detailed here. For the current submission, the "ground truth" is that the device conforms to the relevant performance standards mentioned in Section VII and maintains similar technical characteristics to the predicate.

8. The sample size for the training set:

Not applicable, as no new clinical studies involving training sets for algorithms are mentioned or deemed necessary for this submission. The Smart Clinic software is an MDDS and does not appear to involve a learning algorithm requiring a training set in the context of this document.

9. How the ground truth for the training set was established:

Not applicable, as no new clinical studies involving training sets for algorithms are mentioned or deemed necessary for this submission.

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The THD Procto Software is a software that can be used:

· In endoanal ultrasound (EAUS), in order to help evaluate pelvic floor disorders by processing and recording images of tissue structures in the pelvic region with the aid of a dedicated ultrasound probe. This is done by inserting the probe into the anal canal, acquiring the ultrasound signal and letting the software process the image.

· In Anoscopy exams in order to record images and videos of the anorectal channel, which are acquired through a dedicated video camera that provides images with a resolution greater than 1.1 MPx through USB protocol

The THD Procto Software System, is a diagnostic system intended to be used to investigate pelvic floor disorders, and specifically the THD Procto Software together with its accessories (endoanal probe and video camera), is able to be applied for:

• Endoanal ultrasound (→ trans-rectal ultrasound / echography) -
• -Anoscopy exams,

During Endoanal Ultrasound the THD Procto Software System processes and records images of tissue structures in the pelvic region with the aid of a dedicated ultrasound probe; Durinq Anoscopy exams the THD Procto Software System records and displays images of the anorectal channel with the aid of a dedicated video camera;

The THD Procto Software consists of three macro modules or sub-parts, each one with its own function, as described below:

• Medical Report (Launcher) module, which contains the functions for the management of . the patient database and of the Exams database. Patients and Exams databases support the operation of the remaining macro modules (Endoanal Ultrasound Module and Anoscopy Exams Module) that are listed below
• . Endoanal Ultrasound Module, which manages:
  • The acquisition of the ultrasound signal from the probe and its processing to o transform it into a two-dimensional echographic image / video
  • Any image / video processing (application of notes, zoom, measurements, etc.) in o real-time (during the exam) or post-processing,
  • The examination report (medical history, comments, conclusions) and the printing O
• Anoscopy Exams module, which manages:
  • Capturing images and video from the video camera via standard USB protocol. o Images are then recorded and displayed on the computer screen
  • Any image / video processing (application of notes, zoom, measurements, etc.) in O real-time (during the exam) or post-processing
  • The examination report (medical history, comments, conclusions) and the printing o

Here's a breakdown of the acceptance criteria and study details for the THD Procto Software System, based on the provided document. Please note that the document is a 510(k) summary, which focuses on substantial equivalence to predicate devices rather than detailed performance studies typical for novel AI/ML devices. Therefore, some information, particularly regarding specific performance metrics and AI/ML evaluation methodologies, is not present. The device appears to be primarily an imaging and diagnostic system with software for processing and recording, not an AI/ML diagnostic algorithm that would have specific performance metrics like sensitivity, specificity, or AUC.

Acceptance Criteria and Device Performance

The provided document (a 510(k) summary) doesn't explicitly state quantitative acceptance criteria in the typical sense of a pre-defined performance threshold for an AI/ML algorithm (e.g., "sensitivity must be >X%"). Instead, the "acceptance" in this context is based on demonstrating substantial equivalence to predicate devices for its intended use as an ultrasonic pulsed echo imaging system and for anoscopy exams.

Therefore, the "reported device performance" is largely demonstrated through a comparison of technological characteristics and intended uses with legally marketed predicate devices, rather than through specific performance metrics like accuracy, sensitivity, or specificity.

Table of Acceptance Criteria and Reported Device Performance (based on Substantial Equivalence)

Since the device is cleared via 510(k) substantial equivalence, the "acceptance criteria" revolve around demonstrating that the device is as safe and effective as the predicate. The "reported device performance" is the assertion of meeting these equivalence points.

Study Details (Based on the 510(k) Summary)

It's crucial to understand that a 510(k) summary is not a detailed scientific study report. It summarizes the basis for substantial equivalence to a predicate device. Therefore, explicit information about a "study" in the typical clinical trial sense, especially for AI/ML performance, is not present for this device. The information provided below is a reconstruction based on typical 510(k) submission practices rather than an explicit description of a performance study within the document.

1. Sample size used for the test set and the data provenance:

• Not explicitly stated. For a 510(k) submission based on substantial equivalence of an imaging system rather than a diagnostic AI algorithm, there isn't typically a "test set" in the sense of a dataset used for performance evaluation against ground truth. Equivalence is primarily based on technical characteristics, rather than performance on a clinical dataset.
• The document implies that the device works by acquiring and processing real-time ultrasound signals and camera inputs, suggesting its function is akin to a medical device instrument rather than a standalone AI diagnostic tool evaluated on a pre-defined test set.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable/Not stated. Given the nature of a 510(k) for an imaging system, ground truth establishment by experts for a "test set" is not detailed in this summary. The device's function is to provide images and measurements, not to interpret them autonomously.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

• Not applicable/Not stated. No test set or associated adjudication method is mentioned in this 510(k) summary.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• No evidence. This document does not describe an MRMC study. The THD Procto Software System appears to be an imaging and measurement software rather than an AI-assisted diagnostic tool that would typically undergo such a study.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

• No evidence. The document describes a system involving a human operator (inserting probes, acquiring signals, using the software for processing and recording). There is no mention of a standalone algorithm or its performance.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• Not applicable/Not stated. The document does not describe performance evaluation against a specific type of ground truth in the context of an AI/ML diagnostic claim. The device aims to visually present anatomical structures and allow for measurements, for which the "ground truth" is typically the real-time anatomical structures themselves as visualized by the medical professional.

7. The sample size for the training set:

• Not applicable/Not stated. The document does not describe a training set, suggesting this device is not based on a machine learning model that requires a training set. It appears to be a functional image acquisition, processing, and recording software.

8. How the ground truth for the training set was established:

• Not applicable/Not stated. As no training set is mentioned, ground truth establishment for it is not discussed.

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The intended use of the Philips Patient Information Center iX software application is to:

• Receive, aggregate, process, distribute and display physiologic waves, parameters, alarms and events at locations other than ● at the patient, for multiple patients.
• . Determine alarm conditions and generate alarm signals for Philips approved medical devices, that send physiological data and do not have the ability to determine the alarm condition.
  • Algorithms present in the software are limited to the ST/AR ECG (for arthythmia, ST Segment and QT Segment — Monitoring) and SpO2.
• Generate alarm signals for user notification, based on the alarm signal determined and sent by Philips approved medical devices.
• Perform diagnostic 12-Lead analysis and interpretation based on raw ECG data samples provided from Philips approved ● medical devices. Result may be displayed, printed and/or distributed to Philips approved medical devices.
• Provide review and trend application data, designed to contribute to the screening of patient condition. All information or visual indications provided are intended to support the judgement of a medical professional and are not intended to be the sole source of information for decision making, thus these applications are not intended for diagnoses or active patient monitoring where immediate action is required.
• Provide connection to other systems not associated with active patient monitoring, such as information systems. The software ● performs the action to transfer, store, convert from one format to another according to preset specifications, or to display medical device data.

The Information Center Software is intended for use in professional healthcare professionals. The Information Center Software is not intended for home use.

Indicated for use when monitoring adult and/or specified pediatic subgroups (Newborn (neonate), Infant, Child, Adolescent) patients as indicated by labeling of the medical device providing the data.

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The Philips Information Center uses off-the-shelf Windows PCs and servers, combined with the M3290B Patient Information Center iX software Release C.03 to provide centralized display of physiologic waves, parameters, and trends, format data for strip chart recordings printed reports, and secondary annunciation of alarms from other networked medical devices. The M3290B Patient Information Center iX software Release C.03 provides for the retrospective review of alarms, physiologic waves and parameters from its database.

Additionally, the M3290B Patient Information Center iX software Release C.03 provides primary annunciation of alarms and configuration and control access for networked telemetry monitors.

Compatible Accessories include: Mobile Caregiver - a medical device data system, viewing only, mobile application associated with the Enhanced Web Viewing feature cleared in the predicate device.

The provided text describes the Philips M3290B Patient Information Center iX Release C.03 and its substantial equivalence to a predicate device. However, it explicitly states that no clinical performance testing was performed for the new device. Therefore, the specific information requested regarding acceptance criteria, reported device performance metrics, sample sizes, expert qualifications, and ground truth establishment for a study proving the device meets acceptance criteria cannot be extracted from this document.

The document primarily focuses on non-clinical performance and a comparison of technical characteristics with the predicate device to argue for substantial equivalence.

Here's the breakdown based on the information provided and not provided in the document:

1. Table of acceptance criteria and the reported device performance:

• Acceptance Criteria: Not explicitly stated with quantifiable metrics for clinical performance. The document mentions "Verification, validation, and testing activities, where required to establish the performance, functionality, and reliability characteristics of the new device with respect to the predicate are performed." This suggests internal performance and functionality goals were met, but specific clinical acceptance criteria are not detailed.
• Reported Device Performance: Not reported as no clinical performance testing was done.

2. Sample sized used for the test set and the data provenance:

• Not provided. No clinical test set was used.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not provided. No clinical test set requiring expert ground truth was used.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not provided. No clinical test set requiring adjudication was used.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• No, an MRMC study was NOT done. The document states: "Clinical Performance testing for M3290B Philips Patient Information Center iX software Release C.03 was not performed, as there were no new clinical applications that had hazards or risk mitigations that required a clinical performance testing to support equivalence."

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

• While the device includes algorithms (ST/AR ECG for arrhythmia, ST Segment and QT Segment Monitoring, and SpO2), the document does not detail any standalone performance studies for these algorithms. Its focus is on the overall "Patient Information Center iX software application" and its substantial equivalence to the predicate. The changes primarily relate to a user-adjustable QRS detection threshold, which was a feature already cleared on another Philips product (K014261).

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• Not provided for clinical performance. For internal verification and validation, the ground truth would typically be based on product specifications and risk analysis, but this is not clinical ground truth.

8. The sample size for the training set:

• Not applicable/Not provided. As no new clinical performance testing was performed, details about training sets for algorithms are not discussed in this document.

9. How the ground truth for the training set was established:

• Not applicable/Not provided.

Summary of Device Changes and Justification for No Clinical Study:

The primary change in the M3290B Patient Information Center iX Release C.03 compared to its predicate (Release C.01) is the addition of a user-adjustable minimum QRS detection threshold. This feature was previously cleared on Philips ST/AR, ST and Arrhythmia Algorithm Software (K014261). The manufacturer argues that this, along with other non-significant changes (such as system scalability increases, cybersecurity improvements, and OS updates), does not introduce new clinical features or risks that would necessitate new clinical performance testing. Therefore, "Clinical Performance testing... was not performed, as there were no new clinical applications that had hazards or risk mitigations that required a clinical performance testing to support equivalence."

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PENTAX Medical ENT Video Imaging System consists of PENTAX Medical Video Naso-Pharyngo-Laryngoscopes, PENTAX Medical Video Processor, PENTAX Medical Digital Video Capture Module, PENTAX Medical Laryngeal Strobe and other ancillary equipment.

1. PENTAX Medical Video Naso-Pharyngo-Laryngoscope
   The PENTAX Medical Video Naso-Pharyngo-Laryngoscope VNL-J10 Series (VNL8-J10, VNL11-J10 and VNL15-J10) is intended to be used with a PENTAX Medical Video Processor, PENTAX Medical Laryngeal Strobe, documentation equipment, video monitor, endoscopic device and other ancillary equipment for optical visualization (via a video monitor) of, and, for VNL15-J10 only, therapeutic access to, nasal, pharyngeal, laryngeal and the upper airway anatomy.

2. PENTAX Medical Video Processor
   The PENTAX Medical Video Processor (EPK-i5010) is intended to be used with the PENTAX Medical camera heads, PENTAX Medical VNL-1570STK, VNL8-10, VNL11-J10, and VNL15-J10 endoscopes, PENTAX Medical Laryngeal Strobe, video monitors and other ancillary equipment for ENT endoscopic observation and naso-pharyngo-laryngoscopic (ENT) diagnosis, treatment and video observation with or without stroboscopy.

The PENTAX Medical EPK-i5010 Video Processor includes PENTAX i-Scan™, a digital, post-processing imaging enhancement technology.

PENTAX Medical ENT Video Imaging System is used for ENT endoscopic observation and nasopharyngolaryngoscopic (ENT) diagnosis, treatment, and video observation.

The System functions by receiving image signals from the image sensor in an endoscope, which are processed within a video processor and then output to a monitor. Brightness, color balance, and other properties of the displayed images can be adjusted using the buttons on the system's control panel. The light at the distal end of the endoscope illuminates the body cavities of the patient through the endoscope connected to the video processor.

The primary components of the system include the following:

• PENTAX Medical Video Processor EPK-i5010
• PENTAX Medical Video Naso-Pharyngo-Laryngoscope VNL-1570STK
• PENTAX Medical Video Naso-Pharyngo-Laryngoscope VNL-J10 Series (VNL-J10 Series)
• PENTAX Medical Laryngeal Strobe 9400
• PENTAX Medical Digital Video Capture Modules (two models are available: 9310HD/937HD)

The provided document describes the PENTAX Medical ENT Video Imaging System and its substantial equivalence to a predicate device. Here's a breakdown of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a formal table of specific quantitative acceptance criteria alongside performance data for individual parameters (e.g., specific signal-to-noise ratio values). Instead, it states that "The acceptance criteria have been satisfied for all tests" for system interoperability and that "Based on the tests results, the optical performance of the subject device is substantially equivalent to that of the predicate device."

Here's a summary of the evaluated parameters and the general conclusion:

2. Sample Size Used for the Test Set and the Data Provenance

• Sample Size: The document refers to a "library of images" being captured for evaluation. However, it does not specify the exact number of images or cases used in this "library."
• Data Provenance: The document does not explicitly state the country of origin. It indicates that it was a "non-significant risk clinical study with IRB approval," which suggests a prospective clinical study, though the specifics of the patient population are not provided beyond the scope of image evaluation.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

• Number of Experts: The document states that the images were "evaluated by experienced ENT physicians." The exact number of experts is not specified.
• Qualifications of Experts: They are described as "experienced ENT physicians." Specific details such as years of experience or board certification are not provided.

4. Adjudication Method for the Test Set

The document states that the images were "evaluated by experienced ENT physicians" and that the "subject devices were evaluated as having equivalent ability to visualize vascular structure and/or mucosal surface." This implies a subjective assessment, but it does not detail any specific adjudication method (e.g., 2+1, 3+1 consensus).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

The study described is a comparative visualization study between two imaging systems (subject vs. predicate). It is not an MRMC comparative effectiveness study involving AI assistance. The PENTAX i-Scan™ is a digital, post-processing imaging enhancement technology included in the video processor, but the study focuses on the overall performance of the imaging system and does not specifically measure human reader improvement with or without AI (i-Scan) assistance in the context of an MRMC study.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done

No, a standalone algorithm-only performance study was not explicitly described. The clinical performance data presented involves human interpretation ("evaluated by experienced ENT physicians"). The i-Scan technology is an integrated enhancement, not a separate AI algorithm being evaluated for standalone performance.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The ground truth for the clinical performance evaluation was based on the subjective assessment/evaluation of "experienced ENT physicians" regarding the visualization ability of vascular structure and/or mucosal surfaces. It is not explicitly stated to be an expert consensus of a specific number of experts, nor is it based on pathology or outcomes data from the patients.

8. The Sample Size for the Training Set

This document describes a premarket notification for a medical imaging system, not an AI/ML device that requires a distinct training set for an algorithm. Therefore, no training set sample size is mentioned or applicable in the context of an algorithm. The "library of images" mentioned pertains to the evaluation (test) set for demonstrating equivalence.

9. How the Ground Truth for the Training Set Was Established

As this is not an AI/ML device with a distinct training set for an algorithm, this question is not applicable. The "ground truth" discussed in the performance study relates to the evaluators' assessment of image quality from the captured library of images.

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The Intelli Vue XDS Software is intended for use as an additional, independent display for viewing screens, generated by specified network-connected Philips patient monitors. The IntelliVue XDS Software alone is not intended for remotely monitoring patients without caregivers in vicinity (unattended patients).

It is indicated for local and remote operation of these Philips patient monitors. It is indicated for printing reports as generated by these Philips patient monitors. It is indicated to be used by trained healthcare professionals.

Rx Only: Caution, U.S. Federal Law restricts this device to sale by or on the order of a physician.

The IntelliVue XDS Software (867019) is a bedside information system. The IntelliVue XDS Software provides network services, printing services, patient monitor remote display services, launch pad services, input device sharing services and XDS database services.

The IntelliVue XDS Software can be connected to one or more specified Philips patient monitors and allows the remote viewing of the patient monitor generated data. Depending on the configuration, the remote operation of the network-connected patient monitor with standard off-the shelf information technology equipment input devices (touch screen, keyboard, and mouse) is also supported.

The IntelliVue XDS software does not modify or alter the Philips specified patient monitor. nor does it generate any data on its own. It is solely displaying the patient monitor generated data. It also displays the current alarm and INOP states for the patient, but does not provide an auditory alarm signal announciation function. The IntelliVue XDS Software is not a primary monitoring or alarming device.

The IntelliVue XDS Software is a software only product. It is intended to be installed on customer supplied compatible off-the shelf information technology equipment that meet the technical requirements as specified by Philips.

The provided text describes a 510(k) submission for the Philips IntelliVue XDS Software. It focuses on the substantial equivalence of the modified software (Rev. M.1) to a previously cleared version. However, it does not contain the detailed acceptance criteria and a specific study proving the device meets those criteria, as typically found in a clinical study report.

Here's an analysis based on the information provided, highlighting what is present and what is missing, and making inferences where possible:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a table of acceptance criteria with corresponding performance metrics. It generally states:

• "Pass/Fail criteria were based on the specifications cleared for the predicate device and all test results showed substantial equivalence."
• "The results demonstrate that the Philips IntelliVue XDS Software (SW Rev.M.1) meets all safety and reliability requirements and performance claims."

This indicates that the acceptance criteria were likely related to maintaining the functionality, safety, and reliability of the predicate device. Specific performance metrics (e.g., accuracy, latency, resolution) are not detailed.

2. Sample Size Used for the Test Set and Data Provenance

The document states:

• "Testing involved software testing on integration level (functional testing and regression testing) and software testing on system level (hazard analysis testing and dedicated software performance testing)."

This refers to software engineering testing rather than a clinical study with a "test set" of patient data. Therefore, the concept of sample size for a test set of patient data and data provenance (country of origin, retrospective/prospective) is not applicable to the type of testing described. The testing focused on the software itself rather than its performance on a dataset of patient cases.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

As the testing described is not a clinical study on patient data but rather software verification and validation, there is no mention of experts establishing ground truth for a test set in the context of medical image or signal interpretation.

4. Adjudication Method

Given the nature of the testing described (software verification and validation), an adjudication method (like 2+1 or 3+1) for a test set is not applicable.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

An MRMC study compares human reader performance with and without AI assistance. The provided document describes software that acts as an "additional, independent display" and allows "remote operation" of patient monitors. It explicitly states:

• "The IntelliVue XDS Software alone is not intended for remotely monitoring patients without caregivers in vicinity (unattended patients)."
• "The IntelliVue XDS Software is not a primary monitoring or alarming device."

This indicates the device is an accessory display/control system, not an AI interpreting data or aiding human readers in diagnosis. Therefore, an MRMC comparative effectiveness study is not applicable and was not performed.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

The described device is software that displays and allows remote operation of patient monitor data. It "does not modify or alter the Philips specified patient monitor, nor does it generate any data on its own." It "solely displays the patient monitor generated data."

While software verification and validation were performed on the algorithm itself, this is not a "standalone performance study" in the sense of an AI algorithm producing diagnostic outputs without human intervention. The software's function is to mirror existing monitor data and enable control, not to independently interpret or diagnose.

7. Type of Ground Truth Used

For the software verification and validation, the "ground truth" would be the expected functional behavior and performance defined by the software's specifications and the predicate device's characteristics. It is not based on expert consensus, pathology, or outcomes data related to patient conditions.

8. Sample Size for the Training Set

The document pertains to the verification and validation of a software application for displaying and interacting with patient monitor data, not an AI/ML algorithm that is "trained" on a dataset. Therefore, there is no concept of a "training set" as understood in AI/ML, and thus no sample size for a training set is provided or applicable.

9. How the Ground Truth for the Training Set Was Established

As there is no training set for an AI/ML algorithm, this question is not applicable.

Summary of what is present and missing:

• Acceptance Criteria/Performance: General statements about meeting safety, reliability, and performance claims, and substantial equivalence to the predicate device. Specific quantitative criteria are not provided.
• Study Details (Test Set, Experts, Adjudication, MRMC, Standalone, Ground Truth): Not applicable or not performed in the context of a clinical study or AI performance evaluation, as the device is a display/control software, not an AI diagnostic tool.
• Training Set: Not applicable, as the device is not an AI/ML algorithm that requires training.

The provided document describes a software verification and validation process to ensure the new software version maintains the same functionality, safety, and performance as its predicate, rather than a clinical study to establish new performance claims against a defined ground truth for medical interpretation.

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