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JMOON NouvelleSkin facial toning device is intended for facial stimulation and indicated for overthe-counter cosmetic use.
JMOON NouvelleSkin facial toning device is an over-the-counter device that emits energy in the red and near-infrared spectrum, designed for the treatment of facial wrinkles.

Jmoon NouvelleSkin Facial Toning device is an at-home handled device that provides an advanced, easy-to-use and efficient solution for better facial wellness. This device includes microcurrent, red and infra-red light LED, which allow you to customize your treatments according to your face skin. The device provides indicator lights and beeps feedback to guide the user during the treatment cycle.
The microcurrent therapy will deliver 3 different low-level electrical microcurrent impulses on face within a few minutes to complete facial stimulation. The red light and infra-red therapy is a treatment that uses red light to reportedly improve your skin's appearance, like reducing wrinkles.

The provided text describes a 510(k) premarket notification for the JMOON NouvelleSkin Facial Toning Device. The submission aims to demonstrate substantial equivalence to predicate devices, rather than proving performance against specific acceptance criteria through a clinical study with real-world data and expert adjudication. Therefore, much of the requested information (like sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, and ground truth for training set) is not applicable or not present in the provided document.

However, the document does contain "acceptance criteria" in the form of conformance to various safety and performance standards for non-clinical testing.

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

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

The acceptance criteria for this device are its conformance to recognized safety and performance standards. The reported 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 explicitly states: "No clinical test data was used to support the decision of substantial equivalence."
The testing performed was non-clinical (lab bench testing). Therefore, there is no "sample size for the test set" in the context of human subjects or clinical data, nor is there data provenance in terms of country of origin or retrospective/prospective studies.

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 clinical test data was used, no experts were needed to establish ground truth for a test set based on human subjects. The acceptance criteria were based on adherence to international technical standards, which are established by expert consensus in regulatory and technical bodies.

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

Not applicable. No clinical test set with human subject data 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

Not applicable. No MRMC study was conducted, as the device is not an AI-assisted diagnostic or interpretive tool, and no clinical studies were performed.

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

This concept is not directly applicable to this device, which is a physical facial toning device. However, the non-clinical testing evaluates the device's standalone physical, electrical, and biocompatibility performance against specified standards. The results indicate that the device "Conforms" to these standards in a standalone capacity.

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

The "ground truth" for the non-clinical testing is compliance with the specified international standards (e.g., IEC 60601-1, ISO 10993 series). These standards represent an expert consensus on safety and performance requirements for medical devices.

8. The sample size for the training set

Not applicable. The device is not based on a machine learning algorithm; therefore, there is no "training set" in the conventional sense of AI/ML development.

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

Not applicable. There is no training set for this device.

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Wearable Breast Pump (ABP-1508PRO, ABP-1306, ABP-1306, ABP-1306 PRO, M1, M3, M8, M5, M6, K1, K2, K3, K5, ABP-1306PLUS, ABP-1308, M2) is a powered breast pump to be used by lactating women to express and collect milk from their breasts. The device is intended for a single user.

The Wearable Breast Pump (ABP-1508PRO, ABP-1506, ABP-1306 PRO, M1, M3, M8, M5, M6, K1, K2, K3, K5, ABP-1306PLUS, ABP-1308, M2) is an electrically powered breast pump to be used in a home environment by a single user. The device is provided non-sterile and can be used on one breast (single pumping) or on both breasts at the same time (double pumping). The subject devices are capable of expression, stimulation, and auto modes with nine associated suction levels for each. The subject devices feature various combinations of on/off buttons, level up/down buttons, mode selection buttons, suction level/time indicators, battery visual indicator displays. The pumps are powered by internal, non-replaceable, rechargeable lithium-ion batteries which are charged using the included AC power supply and cable. The subject device can be operated while plugged into AC power. The breast pumps use cyclic negative pressure (suction) to mimic the suckling patterns of a feeding infant. A DC motor drives a membrane vacuum pump to generate the suction required to stimulate and express breast milk. The timing of this pattern is dependent upon the suction/speed settings selected by the user and is preprogrammed in the devices. The devices are capable of producing peak suction levels between -60 and -240 mmHg at speeds between 26 and 108 cycles per minute. There available pumping modes with 9 distinct levels of vacuum and cycle speed. The subject device ensures backflow protection between the breast shield and the electronic components via a physical barrier (silicone diaphragm) mechanism. All other components (i.e., motor unit) of the subject device are not in contact with the breast. All milk contacting components are compliant with 21 CFR 174-179.

The provided text describes a 510(k) premarket notification for a Wearable Breast Pump and does not include information about a study that proves the device meets specific acceptance criteria for AI/ML performance. The document focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing.

Therefore, I cannot provide the requested information regarding:

• A table of acceptance criteria and reported device performance for AI/ML.
• Sample size and data provenance for a test set.
• Number and qualifications of experts for ground truth establishment.
• Adjudication method for a test set.
• Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done, or its effect size.
• Whether a standalone (algorithm only) performance study was done.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
• The sample size for the training set.
• How the ground truth for the training set was established.

The document mentions "Software" and states it was "evaluated at the Basic Documentation level as recommended in the 2023 FDA guidance document 'Content of Premarket Submissions for Device Software Functions.'" This level of documentation suggests that the software in question is likely not an AI/ML algorithm that requires rigorous clinical validation with ground truth for diagnostic or prognostic purposes, but rather controls basic device functions (e.g., suction settings, modes, battery indicators).

The performance testing listed in Section 9 ("Summary of Non-Clinical Performance Testing") includes:

• Vacuum level verification testing
• Backflow protection testing
• Use life testing
• Battery performance testing
• Battery status indicator testing

These are standard engineering and safety tests for a powered breast pump, not the type of studies typically conducted to evaluate AI/ML performance against acceptance criteria for a diagnostic or decision-support system.

In summary, the provided FDA 510(k) clearance letter and summary do not contain information related to AI/ML device performance or the study details requested in your prompt.

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The Infinity CentralStation (ICS) is intended for use by trained healthcare professionals for the purpose of centralized monitoring of adult, pediatric and neonatal patient data within the hospital or clinical environment. Centralized monitoring involves the display and management of data from networked patient monitors including the annunciation of visual and audible physiologic parameter alarms at a central monitoring workstation.

Infinity CentralStation with Rest ECG is intended for the production of diagnostic electrocardiograms for adult and pediatric patients when connected to a monitor with diagnostic 12-Lead ECG monitoring enabled.

The Infinity M300/M300+ is intended for use with the ICS to monitor ECG and pulse oximetry and nonambulatory adult and pediatric patients using wireless communication over the Infinity patient monitoring network.

The Infinity M300/M300+ with TruST is intended for 12-Lead ECG monitoring with a reduced set of electrodes. Reconstructed leads are intended for real-time assessment of ST segment changes.

The Infinity® CentralStation (ICS) Wide (or widescreen) is a Central monitoring station capable of real-time display and storage of multi-parameter physiological patient data and alarm annunciation for networked devices including but not limited to ambulatory and non-ambulatory wireless telemetry monitoring.

The Infinity M300/M300+ is a wireless telemetry, patient-worn device with rechargeable lithiumion battery which monitors ECG and SpO2 physiological data and features a color display, local alarm alerts and keypad interface. ECG functions include heart rate, arrhythmia detection and ST segment analysis and SpO2 functions include pulse plethysmogram and pulse rate. Infinity M300/M300+ with TruST allows for 12-lead ECG monitoring with a reduced set of electrodes by deriving values for missing leads.

The provided text is a 510(k) premarket notification summary for the Draeger Medical Systems Infinity CentralStation Wide, Infinity M300, and Infinity M300+ devices. It details the device's indications for use, technological characteristics, and performance data to demonstrate substantial equivalence to predicate devices. However, it does not explicitly contain detailed acceptance criteria tables with reported device performance or specific study details regarding sample sizes, ground truth establishment for test sets, expert qualifications, or adjudication methods for this specific submission's changes.

The document states that the changes related to cybersecurity and M300+ swappable battery were evaluated through verification and validation testing. It emphasizes that these modifications do not raise new issues of safety and effectiveness and do not change the fundamental scientific technology of the cleared devices, meaning the previous performance characteristics are considered to remain valid.

The key performance data described pertains to compliance with various standards related to electrical safety, EMC, alarm systems, electrocardiographic monitoring, and pulse oximetry. These standards implicitly contain acceptance criteria.

Based on the provided information, I can extract the following, though some requested details related to individual device performance metrics and specific study designs for this particular 510(k) are not explicitly stated in this summary.

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

The document doesn't provide a table of performance acceptance criteria directly. Instead, it refers to compliance with established international and national standards for medical electrical equipment. The "reported device performance" is implicitly that the device meets 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 does not detail specific sample sizes for test sets for the verification and validation of the changes in this submission. The testing done refers to internal company verification and validation efforts rather than clinical studies with patient data for assessing core performance metrics like arrhythmia detection accuracy. Data provenance is not specified.

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/Not provided. The document summarizes the regulatory submission for changes to existing devices, focusing on technical compliance and safety/effectiveness equivalence, not new clinical performance evaluation requiring external expert ground truth establishment for a diagnostic output. The modifications are for cybersecurity and hardware components (swappable battery).

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

Not applicable/Not provided. Adjudication methods are typically used in clinical studies involving interpretation of medical data, which is not the focus of the performance data section for this specific submission's changes.

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. This submission is for modifications (primarily cybersecurity and a new battery component) to existing patient monitoring devices, not for a new AI/CAD system. Therefore, an MRMC study is not relevant to the described changes.

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

The performance data focuses on compliance with technical standards for the device's functions (e.g., ECG monitoring, pulse oximetry, alarm systems) and validation of the cybersecurity and hardware changes. These are "standalone" in the sense that the device's technical functions are tested against defined standards. However, it's not "algorithm only" in the context of a new diagnostic algorithm. The monitoring functions (like arrhythmia detection, ST-segment measurement for 12-lead ECG) are inherent to the device and would have been evaluated in prior clearances against ANSI/AAMI EC57.

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

For the specific changes in this submission (cybersecurity, swappable battery), the "ground truth" would be the successful implementation and verification of design requirements and risk mitigations, as tested internally by Dräger. For the underlying physiological monitoring capabilities (ECG, SpO2, arrhythmia, ST-segment), the ground truth for performance evaluation in predicate devices would typically be established through recognized test databases (e.g., MIT-BIH Arrhythmia Database for arrhythmia detection, or similar validated datasets for ST-segment analysis) or expert review against reference standards, as per standards like ANSI/AAMI EC57. The document for this submission does not detail these for the underlying performance.

8. The sample size for the training set:

Not applicable. The described changes and performance data do not relate to machine learning model training.

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

Not applicable. Not a machine learning submission.

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The LUX-Dx Insertable Cardiac Monitor (ICM) is intended to monitor and record subcutaneous electrocardiogram (S-ECG). The recorded S-ECG is used for the clinical evaluation and diagnosis of cardiac arrhythmias. The LUX-Dx is indicated for use in patients that have a known heart condition and are at risk of developing an abnormal heart rhythm, or have symptoms that may suggest a cardiac arrhythmia such as dizziness, palpitations, syncope, chest pain, and/or shortness of breath. The LUX-Dx has not been tested specifically for pediatric use.

The LUX-Dx II (M302) and LUX-Dx II+ (M312) ICM devices evaluate S-ECG waveform data for indications of cardiac arrhythmias and "marks" the S-ECG signal for clinical presentation and evaluation when the algorithm criteria are met. The ICM device is inserted into the subcutaneous layer of the fourth intercostal space of the left chest wall. The ICM device is powered by an integrated battery. The electrodes used for detecting the S-ECG signal are located on each end of the ICM device, in the header and at the base of the battery. The LUX-Dx system includes the following main components:

• ICM Device - a subcutaneously-implanted cardiac monitor device for cardiac arrhythmia event data collection and transmission. In addition, symptom events are collected and transmitted from the device.
• . Mobile Monitor (MM) - mobile applications (myLUX™ Patient app and LUX-Dx™ Clinic Assistant app) running on an OTS mobile device that communicates with the ICM device (using Bluetooth Low Energy (BLE)) and the LATITUDE Clarity™ server (using cellular/Wi-Fi) for collection and transmission of event, patient, and device data.
• . LATITUDE Clarity™ server - a server that communicates with the Mobile Monitor for bidirectional data transmission and provides web access for clinicians to perform remote monitoring activities and manage general patient and system parameters and workflow activities.
• . System Accessories- for insertion of the ICM device, an insertion tool and incision tool are provided. In addition, a magnet is provided to initiate ICM/MM app communication.

The provided text describes the LUX-Dx II (M302) and LUX-Dx II+ (M312) Insertable Cardiac Monitors (ICM) and their substantial equivalence to a predicate device. However, the text does not contain detailed acceptance criteria or the specific results of a study demonstrating the device meets those criteria, nor does it provide information about the test set, experts, adjudication, or training set as requested in points 2-9 of your prompt.

The document primarily focuses on establishing substantial equivalence to a predicate device (LUX-Dx ICM M301, K193473) for FDA 510(k) clearance. It mentions "algorithm validation" as part of design validation testing but does not elaborate on the specifics of this validation study to the extent requested.

Here's a breakdown of what can be extracted from the provided text, and what is missing:

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

What is provided: The document states that the new device models (M302, M312) include "new and enhanced detection algorithms, bring-your-own-device (BYOD) capability, and additional changes for sustaining/maintenance and continuous improvement." Specifically, they feature a PVC detection algorithm and enhancements to the Pause algorithm (M302, M312) and AF algorithm (M312 only) to reduce false positives.

What is missing: The text does not provide specific quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy targets) for these algorithms, nor does it present the reported performance against such criteria. The "Summary of Performance Testing" section broadly mentions "algorithm validation" but gives no results.

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

Missing. The text mentions "algorithm validation" but does not provide any details about the test set used for this validation, including its size or provenance.

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)

Missing. There is no information in the document regarding experts or their qualifications for establishing ground truth.

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

Missing. The document does not describe any adjudication methods used for the test set.

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

Missing. The document does not mention an MRMC study or any assessment of human reader improvement with AI assistance. The device is an Insertable Cardiac Monitor, which automatically detects and records arrhythmias, implying less focus on real-time human interpretation with AI assistance in the same way an imaging AI might.

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

What is suggested: The mention of "algorithm validation" implies that the standalone performance of the algorithms was tested. The device's nature as an ICM that "marks" S-ECG signal when algorithm criteria are met suggests a primary focus on standalone algorithmic detection.

What is missing: Specific results or details of a standalone performance study.

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

Missing. The document does not specify how ground truth was established for "algorithm validation."

8. The sample size for the training set

Missing. No information about a training set is provided.

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

Missing. No information about a training set or its ground truth establishment is provided.

In summary, while the document confirms the device features new and enhanced algorithms for detecting cardiac arrhythmias, it fundamentally lacks the detailed performance study information, acceptance criteria, and ground truth methodologies that your prompt requests. The focus of this FDA 510(k) summary is on demonstrating substantial equivalence rather than providing a detailed performance study report.

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The product (FineCross M3) is intended to be percutaneously into blood vessels and support a guide wire while performing PCI (percutaneous coronary intervention). The product is also intended for injection of radiopaque contrast media for angiography. The product should not be used in cerebral and peripheral vessels.

FineCross M3 is a single use, ethylene oxide sterilized device that is intended to be percutaneously introduced into blood vessels and support a guide wire while performing PCI (percutaneous coronary intervention). The product is also intended for injection of radiopaque contrast media for angiography. FineCross M3 features a three-layer construction, which consists of a stainless steel mesh braid sandwiched between an outer layer of polyester elastomer and an inner layer of polytetrafluoroethylene. The outer surface of the catheter is coated with hydrophilic polymer.

Here's an analysis of the provided text regarding the acceptance criteria and study for the FineCross M3 device, structured to answer your specific questions.

1. Table of Acceptance Criteria and Reported Device Performance

The document provides a list of performance tests conducted on the FineCross M3 device. For each test, it states that "Performance testing met the predetermined acceptance criteria and is acceptable for clinical use throughout its shelf life." However, it does not provide specific numerical or qualitative values for the acceptance criteria, nor does it detail the specific reported device performance values for each test. Instead, it offers a general statement of compliance.

Biocompatibility Testing:

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

The document does not specify the sample sizes used for each of the performance or biocompatibility tests. It only states that tests were performed on "non-aged and accelerated aged samples" for performance testing (except Radio-detectability and Simulated Use Usability) and on "non-aged, sterile, whole device" and "accelerated-aged (2 years), sterile, whole device" for biocompatibility.

The data provenance is industrial (manufacturer-conducted testing) and likely combines both novel testing for this specific device and potentially established testing protocols based on industry standards. It is not patient or clinical data, so terms like "retrospective" or "prospective" are not applicable in this context. The country of origin for the manufacturing and testing is Japan (Ashitaka Factory of Terumo Corporation).

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

This document describes non-clinical performance and biocompatibility testing of a medical device (a microcatheter). It does not involve diagnostic interpretation or patient data where "ground truth" would typically be established by human experts like radiologists. Therefore, this information is not applicable to the provided document. The ground truth for these tests is based on objective, measurable physical and chemical properties and engineering standards.

4. Adjudication Method for the Test Set

As this document describes non-clinical performance and biocompatibility testing, an "adjudication method" in the context of expert consensus (like 2+1 or 3+1 for clinical interpretations) is not applicable. The results of these tests are determined by adherence to pre-defined scientific and engineering protocols and acceptance criteria.

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

There was no MRMC comparative effectiveness study and no AI component mentioned in this 510(k) submission. This K-submission is for a medical device (microcatheter), not an AI/software-as-a-medical-device.

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

This is not applicable as the device is a physical medical instrument (microcatheter), not an algorithm or AI system.

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

For the performance tests, the "ground truth" is defined by engineering specifications, material science principles, and established industry standards. For example, the freedom from leakage is tested against a standard preventing fluid escape, and material biocompatibility is tested against ISO 10993 standards and FDA guidance. This is not a "ground truth" derived from expert consensus, pathology, or outcomes data in a clinical sense.

8. The Sample Size for the Training Set

There is no training set in this context. This is a physical medical device, not a machine learning model.

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

This is not applicable as there is no training set mentioned in the document.

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The Bladder Scanner (Models: M3, M4, M4-HD) is B-mode pulsed-echo ultrasound device. It intended as a handheld battery-operated device. The M3, M3-HD, M4, M4-HD Bladder Scanner projects ultrasound energy through the lower abdomen of the patient to obtain images of the bladder which is used to calculate bladder Volume noninvasively. The M3, M3-HD, M4, M4-HD Bladder Scanner is intended to be used only by qualified medical professionals.

The M Series Bladder Scanner is a handheld battery-operated device, which is developed by SUZHOU PEAKSONIC MEDICAL TECHNOLOGY CO., LTD., and manufactured by Suzhou Lischka Medtech Co., Ltd., it provides non-invasive bladder volume measurement utilizing real-time ultrasound imaging. The device consists of the main unit, 3D probe (M4, M4-HD)/2D probe (M3, M3-HD), Data processing and storage modules, APP software, battery and Charger.

Here's a breakdown of the acceptance criteria and the study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria in an "acceptance criteria" section. However, it does list the "Volume measurement accuracy" and implicitly sets the predicate device's performance as the benchmark for substantial equivalence.

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

The document explicitly states: "Clinical testing is not required." This implies that no clinical test set with human patients was used to prove the device meets these specific performance metrics. The performance metrics are likely derived from non-clinical phantom studies or internal validation processes that are not detailed in this summary. Therefore, there is no information on sample size or data provenance (country of origin, retrospective/prospective) for a clinical test set.

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

Since clinical testing was not required, there is no mention of experts being used to establish ground truth for a test set in the context of human patient data.

4. Adjudication Method

Not applicable, as no clinical test set with human data was used requiring expert adjudication.

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

No. The document clearly states that clinical testing was not required. Therefore, no MRMC study comparing human readers with and without AI assistance was performed.

6. Standalone (Algorithm Only) Performance Study

The document focuses on the device performance and states that "The M3,M3-HD,M4,M4-HD Bladder Scanner was evaluated with safety, EMC and Acoustic Output." It provides performance accuracy figures for volume measurement. This suggests that the algorithm's performance, as integrated into the device, was evaluated to achieve these accuracy figures. While the term "standalone study" in the context of an algorithm might imply a specific type of evaluation (e.g., using a separate dataset to test the algorithm's output without the full device), the volume measurement accuracy directly reflects the algorithm's capability.

7. Type of Ground Truth Used

Based on the lack of clinical testing, the ground truth for the stated performance accuracy (bladder volume measurement) was likely established through:

• Phantom studies: Using calibrated phantoms with known volumes. This is a common method for validating ultrasound device accuracy.
• Engineering measurements: Direct measurements of physical models.

The document does not specify the exact method for establishing ground truth for the performance metrics, but it is implied to be non-clinical.

8. Sample Size for the Training Set

The document does not provide any information regarding the training set size for the device's algorithms.

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

The document does not provide any information regarding how the ground truth for the training set (if any, as it could be rule-based or trained on phantom data) was established.

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The Infinity M300 is intended for use with the ICS to monitor ECG and pulse oximetry on ambulatory and nonambulatory adult and pediatric patients using wireless communication over the Infinity patient monitoring network.

The Infinity M300 with TruST is intended for 12-Lead ECG monitoring with a reduced set of electrodes. Reconstructed leads are intended for real-time assessment of ST segment changes.

The Infinity M300 is a wireless telemetry, patient-worn device with rechargeable lithium-ion battery which monitors ECG and SpO2 physiological data and features a color display, local alarm alerts and keypad interface. ECG functions include heart rate, arrhythmia detection and ST segment analysis and SpO2 functions include pulse plethysmogram and pulse rate. Infinity M300 with TruST allows for 12-lead ECG monitoring with a reduced set of electrodes by deriving values for missing leads.

The provided text is a 510(k) summary from the FDA, detailing the premarket notification for the Draeger Medical Systems' Infinity M300 device. While it mentions "Verification Testing" and "Validation Testing" and refers to meeting criteria and supporting substantial equivalence, it does not provide the specific acceptance criteria, method, or results in a detailed, quantifiable manner that would allow for a comprehensive answer to your request.

The document is a regulatory communication, not a scientific study report. It states that "The results of Verification testing confirm the modified device continues to meet the criteria for substantial equivalence to the predicate device" and that "Validation test results support substantial equivalence to the predicate device." However, it does not disclose what those criteria are or the specific performance metrics achieved.

Therefore, I cannot provide a table of acceptance criteria and reported device performance or details on sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, or ground truth establishment based on the provided text. This information would typically be found in the full submission to the FDA, which is not included here.

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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.

Rx only.

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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JUSHA-M350G/JUSHA-M350/M350 LCD Monitor is intended to be used in displaying and viewing digital images for diagnosis of X-ray or MRI, etc. by trained medical practitioners. The device does not support the display of mammography images for diagnosis.

JUSHA-M350G/JUSHA-M350/M350G/M350 LCD Monitor is the display system with the high resolution (2048*1560), high luminance (1000 cd/m²), and 16-bit grayscale (65536 level), built-in DICOM standard LUT. In particular, JUSHA-M350G has ambient brightness adapting, real-time DICOM automatic calibration, full-screen brightness equalization, presence induction and focusview function, with these this display can automatic adjustment according to different requirements in order to achieve the best results.
The product is consisted of the following components:

• 21.3" Mono-TFT LCD Panel
• DMX0704AR0/main board/REV1.1
• JUSHA-M350G LCD Monitor software
• Power Adapter
• Data Cable.

The provided text describes the 510(k) premarket notification for the JUSHA-M350G/JUSHA-M350/M350G/M350 LCD Monitor. This device is a diagnostic display monitor, not an AI/ML-driven medical device. Therefore, the information requested in the prompt regarding acceptance criteria and study data for AI/ML performance (e.g., sample size for test/training sets, expert ground truth, MRMC studies) is not applicable to this submission.

The document focuses on demonstrating substantial equivalence to a predicate device (JUSHA-M33C) based on technical characteristics, performance specifications (luminance, resolution, contrast, etc.), applicable standards (electrical safety, EMC), and intended use.

Here's a breakdown of the relevant information provided:

1. Acceptance Criteria and Reported Device Performance:

The "acceptance criteria" for this type of device are primarily compliance with recognized standards and demonstration of comparable performance to a predicate device. The performance data is presented as a comparison table between the proposed device and the predicate.

Bench testing was conducted to demonstrate the proposed device meets certain performance standards, including:

• Measurement of the angular dependency of luminance response (horizontal, vertical, diagonal)
• Measurement of the luminance non-uniformity characteristics (per TG18 guideline)
• Measurement of the chromaticity non-uniformity characteristics (per TG18 guideline)
• Measurement of small-spot contrast ratio
• Measurement of temporal response
• Performance data on luminance stability

Electrical safety and electromagnetic compatibility (EMC) testing also showed compliance with IEC 60601-1 and IEC 60601-1-2.

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

This is a hardware device (LCD monitor), not an AI/ML diagnostic algorithm. Therefore, there are no "test sets" of patient data in the context of diagnostic accuracy. The "testing" refers to bench testing of the monitor's technical specifications and compliance with electrical/EMC standards. The document does not specify a "sample size" for these bench tests, as it typically involves testing a representative number of units or prototypes to ensure compliance. Data provenance is not applicable in the context of patient data here.

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

Not applicable. Ground truth and expert adjudication are relevant for diagnostic algorithms assessing medical images, not for a display monitor.

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

Not applicable.

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. This is not an AI-assisted device.

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

Not applicable. This is a display device.

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

Not applicable. The "ground truth" for a monitor is its adherence to specified optical and electrical performance parameters, as measured by calibrated equipment, and its compliance with relevant industry standards (e.g., DICOM, IEC).

8. The sample size for the training set:

Not applicable. There is no AI/ML model being trained.

9. How the ground truth for the training set was established:
Not applicable.

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