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The BubbleView™ Single-Use Digital Flexible Cystoscope is a sterile, single-use, flexible endoscope intended to be used for endoscopic access to and examination of the lower urinary tract. The BubbleView™ is intended to provide visualization via ViewHub® video processor and can be used with endoscopic accessories.

BubbleView™ is intended for use in a hospital environment or medical office environment. BubbleView™ is designed for use in adults.

ViewHub® is designed to display live imaging data from compatible MACROLUX™ endoscopes.

The Single-Use Digital Flexible Cystoscope System consists of BubbleView™ Single-Use Digital Flexible Cystoscope (consists of a handle with control lever, endoscope cable and access port for accessories, and a flexible body portion) and ViewHub® Video Processor with itsaccessories including power cables. The BubbleView™ is provided sterile (sterilized by EQ) and intended to be single-use. The ViewHub® is a reusable multi-patient use device. The built-in LED at the Distal tip of the BubbleView™ Single-Use Digital Flexible Cystoscope provides a light source, the lens module captures the light signal, then the CMOS module converts the light signal into an electrical signal: the endoscope cable connects the BubbleView™ to the ViewHub®, which provides power and processes video signal from the endoscope; the control lever on the handleconnected to the controllable portion by a wire rope controls the bending direction and angle of the controllable portion: the instrument channel delivers water and other instruments. The ViewHub® Video Processor is a video imaging system that receives video signals from the connected endoscope, controls the lightat the endoscope tip and outputs this signal including a graphical user interface to a connected external video monitor.

The provided text is a 510(k) summary for the BubbleView™ Single-Use Digital Flexible Cystoscope and ViewHub® Video Processor. This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria for an AI/ML-driven device. As such, it does not contain the detailed information requested regarding acceptance criteria, study methodologies for AI/ML performance, ground truth establishment, or multi-reader multi-case studies.

The document primarily describes:

• The device and its intended use.
• A comparison to a legally marketed predicate device (Pusen Single Use Flexible Video Cystoscope System K222602) to establish substantial equivalence based on indications for use and technological characteristics.
• Non-clinical performance tests for mechanical and optical characteristics. These tests are to support the safety and effectiveness of the hardware (the cystoscope and video processor) itself, not an AI component.

Therefore, I cannot extract the information requested about acceptance criteria and study data for an AI/ML device from this specific FDA submission document. The questions you posed are highly relevant for AI/ML medical devices, but this document appears to be for a traditional medical imaging device without an explicitly stated AI/ML component.

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C50 is intended for clinical practice of general dentistry, as an aid in the diagnosis of pit and fissure caries, as an aid to highlight dental plaque and gingival inflammations (restricted to gingival inflammations which lead to bleeding upon probing) and as intra-oral camera to visualize anatomical details invisible to the naked eye or with a mirror (thanks to magnification).

The C50 is an intraoral video camera equipped with LEDs to illuminate the inspection site. The C50 optics and its complementary metal oxide semiconductor (CMOS) sensor capture the natural fluorescence of the site under observation and convert the images into a video signal that is sent to the computer via a USB interface. The dental practitioner can use the images displayed on the computer screen as an aid in diagnosis. A USB Type-C (camera) to USB-A cable is provided to connect the C50 to a computer. The C50 provides the following functions: Aid in the detection of pit and fissure caries Information about patient dental hygiene Highlighting of dental plaque Highlighting of gingival inflammations (restricted to gingival inflammation that leads to bleeding upon probing) Showing the difference between "before" and "after" care (follow-up). In CARIO mode (blue mode), the camera assists the dental practitioner by highlighting potential carious areas in pits and fissures on the occlusal surface of the teeth. In DAYLIGHT mode (white mode), the camera enables visualization of anatomical details invisible to the naked eye or with a mirror (thanks to its magnification). DAYLIGHT+ mode (white mode) is a shortcut version of DAYLIGHT mode where the contrast has been pushed from 20 to 70. In PERIO mode (yellow mode), the camera helps the dental practitioner to visualize dental plaque, in addition to highlighting areas of gingival inflammation (restricted to gingival inflammation that leads to bleeding upon probing).

The C50 is an intraoral camera intended for use in general dentistry. Its indications for use include aid in the diagnosis of pit and fissure caries, highlighting dental plaque and gingival inflammations (restricted to those leading to bleeding upon probing), and functioning as an intra-oral camera for magnified visualization of anatomical details.

Here's the breakdown of acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document describes comparison testing and other verification and validation tests rather than specific quantitative acceptance criteria for clinical performance metrics (e.g., sensitivity, specificity for caries detection). Instead, the performance testing focuses on demonstrating substantial equivalence to the predicate device and compliance with relevant safety and technical standards.

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

The document does not explicitly state a test set in the traditional sense of a clinical diagnostic study with patient data used for accuracy evaluation. Instead, it refers to "comparison testing of image quality" and "mechanical performance testing" conducted on the device and its accessories (C50, C50TIPS, protective sheath, USB cable).

• Sample Size: Not specified in terms of number of patients or cases. The testing appears to have been performed on the devices themselves and associated accessories.
• Data Provenance: Not applicable in the context of device performance testing. The "data" generated comes from direct laboratory and safety testing of the device hardware and software. No patient or human subject data is mentioned for performance evaluation.

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

Not applicable. As described above, the testing performed was focused on device characteristics and substantial equivalence to a predicate, not on a diagnostic accuracy study requiring expert ground truth establishment for patient cases.

4. Adjudication Method for the Test Set

Not applicable, as no clinical diagnostic test set with multiple reader interpretations requiring adjudication is described.

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 MRMC comparative effectiveness study is described. The C50 is an intraoral camera and not an AI-powered diagnostic algorithm that assists human readers in interpretation. It provides visual information to the dental practitioner.

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

The C50 is a hardware device (intraoral camera with different illumination modes) that provides visual information. It is not an algorithm, and therefore, a standalone algorithm performance study is not applicable. The device's "diagnosis aid" function relies on the visual information it provides to the human practitioner.

7. The Type of Ground Truth Used

The ground truth used for relevant testing was based on:

• Comparison to a predicate device (SOPROCARE): Many aspects of the C50's performance (image quality, temperature elevation, functional modes) were evaluated against the known performance of the predicate device to establish substantial equivalence.
• Compliance with established standards: Electrical safety, EMC, photobiological safety, software validation, reprocessing validation, and biocompatibility were evaluated against recognized international and FDA standards.
• Engineering specifications/functional requirements: Mechanical tests ensured specific physical functionalities like the fit of accessories and light blocking.

8. The Sample Size for the Training Set

Not applicable. The C50 is a medical device, not an AI/machine learning model that requires a training set.

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

Not applicable, as there is no training set for this device.

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The Capenergy C equipments RF System - C25, C50, C100, C200, C300, C400, C500 are intended to provide topical heating for the purpose of elevating tissue temperature for treatment of selected medical conditions such as: relief of pain, muscle spasms, increase in local circulation The massage device provided is intended to provide a temporary reduction in the appearance of cellulite.

Capenergy C equipments RF System - C25, C50, C100, C200, C300, C400, C500 are indicated for use in dermatological and general surgical procedures for electrocoagulation and hemostasis.

Capenergy C equipment's RF System - C25, C50, C100, C200, C300, C400, C500, including the hand piece, is a system generating RF energy with integral temperature and impedance feedback mechanism for procedures that require elevating tissue temperature. The Capenergy System constantly monitors the temperature and impedance of the target treatment tissue, automatically adjusting energy delivery to maintain effective and safe tissue heating.

Capenergy C equipment's RF System - C25, C50, C100, C200, C300, C400, C500 consists of an AC/DC power supply unit, RF generator, controller and user interface. The RF hand piece is connected to the console via a cable and a switch activates the energy delivery to the hand piece. The hand piece is comprised of conductive and capacitive electrodes.

The provided document, a 510(k) Premarket Notification Submission for the Capenergy C Equipment RF System, does not describe the acceptance criteria and a study proving the device meets those criteria in the typical format of a clinical study assessing diagnostic accuracy or comparative effectiveness.

Instead, this document focuses on demonstrating substantial equivalence to existing predicate devices based on non-clinical performance testing and conformance to voluntary standards. The "acceptance criteria" here are primarily functional specifications and regulatory compliance rather than statistical performance metrics from a human-in-the-loop or standalone study.

Here's a breakdown of the information that can be extracted, and where the requested information is not applicable or not provided in this specific document:

1. Table of Acceptance Criteria and Reported Device Performance

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

This document primarily describes non-clinical, bench testing, and compliance with standards. There is no mention of a clinical "test set" in the context of patient data or clinical images for evaluating diagnostic performance. The "test set" implicitly refers to the physical devices themselves and their components undergoing various performance and safety assessments.

• Sample Size: Not applicable in the context of clinical data. For bench testing, typically multiple units or components are tested, but the exact count is not specified.
• Data Provenance: Not applicable in the context of clinical data. The testing is reported as "Functional laboratory testing performed in foreseeable operating conditions." This suggests internal laboratory testing rather than external clinical data.

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

This is not applicable to this type of submission. Ground truth, in the context of diagnostic or AI-based devices, refers to a definitive diagnosis or finding against which the device's performance is measured (e.g., pathology report, expert consensus on images). This submission pertains to an energy-based therapeutic device and its safety/functional performance, not a diagnostic AI system requiring expert-adjudicated ground truth.

4. Adjudication Method for the Test Set

This is not applicable for the same reasons as point 3. There is no diagnostic "test set" of cases requiring adjudication.

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

This is not applicable. The Capenergy C equipment RF System is a therapeutic device intended for "topical heating for the purpose of elevating tissue temperature for treatment of selected medical conditions" and "electrocoagulation and hemostasis." It is not an AI-assisted diagnostic device, and therefore, no MRMC study or assessment of human reader improvement with AI assistance would be relevant or performed for this product.

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

This is not applicable. As a therapeutic RF energy system, the device's primary function is to deliver energy for heating and coagulation. It's not an "algorithm-only" or "standalone" diagnostic system. Its performance relates to its physical outputs (RF power, temperature control, etc.), which were evaluated through bench testing.

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

This is not applicable in the sense of clinical ground truth for diagnostic purposes. The "ground truth" for this device's performance relies on:

• Engineering specifications and standards: Conformance to electrical safety, EMC, software, and biocompatibility standards (e.g., IEC 60601 series, IEC 62304, ISO 10993-1).
• Physical measurements: The ability to achieve and maintain specific temperatures (40-45°C) and power outputs.
• Comparison to predicate devices: Establishing substantial equivalence by showing that the subject device operates safely and effectively within similar parameters as legally marketed devices.

8. The sample size for the training set

This is not applicable. This device is a hardware-based therapeutic system, not an AI/machine learning model that undergoes "training." Its "software" (evaluated to IEC 62304) controls the device's functions, but this is a traditional software development and validation process, not machine learning.

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

This is not applicable for the same reasons as point 8.

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The DigitalDiagnost C50 system is intended for use in generating radiographic images of human anatomy by qualified/ trained doctor or technician. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. This device is not intended for mammographic applications.

The DigitalDiagnost C50 Digital Radiography System (DigitalDiagnost C50) is a flexible digital radiography (DR) system that is designed to provide fast and smooth radiography examinations of sitting, standing or lying patients. The DigitalDiagnost C50 consist of the following components: ceiling suspension with X-ray assembly, wall stand with detector carrier, patient table with detector carrier and floating table top, high voltage generator, and an acquisition and reviewing workstation for post-processing, storage and viewing of images. Images may be transferred via a DICOM network for printing, storage and detailed review.

Here's a breakdown of the acceptance criteria and study information for the DigitalDiagnost C50, based on the provided text.

1. Table of Acceptance Criteria & Reported Device Performance:

Study Proving Acceptance Criteria:

The document states that a non-clinical verification/validation study was performed. The basis for substantial equivalence is that the DigitalDiagnost C50 is considered equivalent to the predicate DigitalDiagnost C50 (K163410) based on:

• Identical Indications for Use.
• Fundamental scientific technology (including largely identical components or components identical to other cleared reference devices).
• Non-clinical performance testing (demonstrating compliance with standards).
• Safety and effectiveness (as supported by the non-clinical testing).

The non-clinical verification and validation tests demonstrated that the DigitalDiagnost C50:

• Complies with the aforementioned international and FDA-recognized consensus standards and FDA guidance documents.
• Meets the acceptance criteria and is adequate for its intended use.

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

The document explicitly states: "The DigitalDiagnost C50 does not require clinical study..." and "Summary of Clinical Data: Based on the information provided above, the DigitalDiagnost C50 is considered substantially equivalent to the currently marketed and predicate DigitalDiagnost C50 (K163410, January 4, 2017) in terms of fundamental scientific technology."

Therefore, there appears to be no clinical test set, sample size, or specific data provenance for a clinical study as part of this 510(k) submission. The evaluation relies on non-clinical performance data and equivalence to predicate/reference devices.

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

Since no clinical study with a test set was performed, this information is not applicable and not provided in the document.

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

Since no clinical study with a test set was performed, this information is not applicable and not provided in the document.

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 MRMC comparative effectiveness study was mentioned. The device described, DigitalDiagnost C50, is an X-ray system, not an AI-assisted diagnostic device. Therefore, this information is not applicable and not provided in the document.

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

The DigitalDiagnost C50 is an X-ray imaging system. There is no mention of a standalone algorithm-only performance study, as it's not a standalone diagnostic algorithm. Therefore, this information is not applicable and not provided in the document.

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

For the non-clinical verification and validation tests, the "acceptance criteria" were derived from international and FDA-recognized consensus standards and FDA guidance documents (listed on pages 11-12). These standards themselves implicitly define the "ground truth" or acceptable performance ranges for device characteristics, image quality, electrical safety, radiation protection, software lifecycle, usability, and risk management. No other forms of expert consensus, pathology, or outcomes data are mentioned for establishing ground truth for the device's technical specifications.

8. The sample size for the training set:

Since no clinical study or AI algorithm training is described for this device, this information is not applicable and not provided in the document.

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

Since no clinical study or AI algorithm training is described for this device, this information is not applicable and not provided in the document.

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The CAPENERGY C Devices - C100, C200, C300, C400, C50 are intended to provide topical heating for the purpose of elevating tissue temperature for treatment of selected medical conditions such as: relief of pain, muscle spasms, increase in local circulation. The massage device provided is intended to provide a temporary reduction in the appearance of cellulite.

The proposed device is an equipment for diathermy by energy transfer using radio frequency alternating electrical currents applied to the patient by using electrodes or plates. The RF current is coupled to the human body by means of an insulated or non-insulated electrode -the active accessory-, which together with the body and the return electrode -the passive plate- forms an electric circuit, which allows the passage of RF current through the body areas situated between the two electrodes. The number of available channels on the different models of the CAPENERGY product range varies from one to four. When a model has several channels, these operate independently. Each channel has a keyboard that lets you manage the parameters of frequency and channel power. It also has two light columns that report the selected power level and a qualitative indication of the power delivered by the channel. The user interface has a screen and a keyboard that allows you to manage several functions: timer, connected accessories management, state management, energy and temperature measurements and alarms. The user interface is organized in a menu system that makes it possible to choose between the different features available on the equipment.

The provided text is a 510(k) Premarket Notification for the CAPENERGY C Devices (C100, C200, C300, C400, C50). This document is primarily focused on demonstrating substantial equivalence to predicate devices, rather than presenting a detailed clinical study for the device itself. Therefore, much of the requested information regarding acceptance criteria and a study proving the device meets them, particularly in the context of AI/ML performance, is not present in this document.

However, based on the non-clinical data section, we can infer some information about performance testing.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not specified. The document states "bench testing" and "functional laboratory testing," which typically refers to testing of the device itself rather than human or image data. No patient or image test set is mentioned.
• Data Provenance: Not applicable, as no human or image data test set is described. The testing appears to be primarily laboratory-based device performance testing.

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. No ground truth based on expert review of patient data is mentioned.
• Qualifications of Experts: Not applicable.

4. Adjudication method for the test set

• Adjudication Method: Not applicable. No test set requiring adjudication (e.g., image review) is described.

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 comparative effectiveness study was not done. The device description and intended use (diathermy device) do not involve human readers interpreting images or data with or without AI assistance.
• Effect Size of AI Improvement: Not applicable.

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

• Standalone Performance: Not applicable. This document describes a physical medical device (diathermy) and its performance, not an AI algorithm. The software validation mentioned is for the device's operational software, not an AI component making diagnostic or treatment recommendations.

7. The type of ground truth used

• Type of Ground Truth: For the performance tests mentioned (temperature maintenance, electrical safety, EMC, software validation, biocompatibility), the "ground truth" would be established by engineering specifications, relevant international standards (e.g., IEC 60601-1, IEC 60601-1-2, IEC 62304, ISO 10993-1), and internal performance targets.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. This document does not describe the development or testing of an AI/ML algorithm that would require a training set.

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

• How Ground Truth was Established: Not applicable, as no training set for an AI/ML algorithm is mentioned.

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The C50 and C80 patient monitors are intended to be used for monitoring, displaying, reviewing, alarming and storing of multiple physiological parameters as following: ECG (3-lead or 12-lead selectable, arrhythmia detection, heart rate (HR)), Respiration rate (RR), SpO2, pulse rate (PR), non-invasive blood pressure (NIBP), temperature (Temp), invasive blood pressure (IBP), carbon dioxide (CO2), anesthetic gas (AG), cardiac output (C.O.) for single patient. The C80 can also monitor the ICG (impedance cardiography) and BIS (bispectral index).

All the parameters can be monitored on single adult, pediatric, and neonatal patients with the exception of the following:

· The ICG monitoring is applicable to the adult patients of 122229cm in height and 30159Kg (67~341 pounds) in weight only;

· NIBP measurement continual mode is not applicable to neonates;

· Anesthetic depth (BIS) of the multi-parameter patient monitor is not intended for neonatal patients;

The monitors are to be used in general healthcare facilities by clinical physicians or appropriate medical staff under the direction of physicians. The monitors are not intended for home use.

The C50 and C80 patient monitors are intended to be used for monitoring, displaying, reviewing, alarming and storing of multiple physiological parameters as following: ECG (3-lead, 5-lead or 12-lead selectable, arrhythmia detection, heart rate (HR)), Respiration rate (RR), SpO2, pulse rate (PR), non-invasive blood pressure (NIBP), temperature (Temp), invasive blood pressure (IBP), carbon dioxide (CO2), anesthetic gas (AG), cardiac output (C.O.) for single patient. The C80 can also monitor the ICG (impedance cardiography) and BIS (bispectral index).

All the parameters can be monitored on single adult, pediatric, and neonatal patients with the exception of the following:
• The ICG monitoring is applicable to the adult patients of 122229cm in height and 30159Kg (67~341 pounds) in weight only;
• NIBP measurement continual mode is not applicable to neonates;
• Anesthetic depth (BIS) of the multi-parameter patient monitor is not intended for neonatal patients;
Those monitors provide patient monitoring capabilities by using corresponding accessories.
The multi-parameter Patient monitor, model: C50 and C80 have same design principle and technical characteristics:
But the software in the host and modules and components are different.
The differences between C50 and C80 are ICG, BIS and size of monitor.

The provided document describes the acceptance criteria and a study proving the C50 and C80 Multi-parameter Patient Monitor meets these criteria.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally established through adherence to recognized international standards and clinical performance metrics. The document details a comparison with a predicate device (K170876, Passport Series Patient Monitors). While explicit "acceptance criteria" for each parameter are not always separately listed with a single performance value from the new device, the "Comparison" column in the table below infers if the new device meets or exceeds the predicate's performance or if sufficient justification is provided for differences.

Study that Proves the Device Meets Acceptance Criteria

The essential studies to prove the device meets acceptance criteria are divided into Non-Clinical Performance Data and Clinical Studies.

Non-Clinical Performance Data:

• Software Verification and Validation Testing: Conducted in accordance with FDA guidance "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." Risk analysis was performed, and the software was deemed a "major" level of concern.
• Electrical safety and Electromagnetic Compatibility (EMC): Testing conducted according to:
  • ANSI AAMI ES60601-1:2005/(R)2012 And A1:2012 (IEC 60601-1:2005, MOD)
  • IEC 60601-1-2 Edition 4: 2014-02
• Bench Testing: Functional and system-level tests were performed, showing the devices meet specifications and perform equivalently to the predicate.
• Biocompatibility Testing: Performed for patient-contacting components (ECG cable, SpO2 probes, temperature probes) that were not previously cleared. Cytotoxicity, sensitization, and irritation testing were conducted based on ISO 10993-1 and FDA's 2016 biocompatibility guidance.
• Conformance with Applicable Standards: The device demonstrated compliance with numerous recognized consensus standards, in addition to those listed above for specific modules (e.g., ISO 80601-2-55 for Respiratory Gas Monitors, ISO 80601-2-56 for Thermometers, ISO 80601-2-61 for Pulse Oximeter Equipment, ANSI AAMI EC57:2012 for Cardiac Rhythm and ST-Segment measurement algorithms).

Clinical Studies:

1. NIBP Clinical Study - for adults and children

• Device Parameter: Non-invasive Blood Pressure (NIBP)
• Acceptance Criteria/Standard: Complies with ISO 81060-2 Second Edition 2013-05-01 "Non-Invasive Sphygmomanometers - Part 2: Clinical Validation Of Automated Measurement Type."
• Sample Size: 25 patients (19 adults, 6 children).
  • Demographics: 10 men, 15 women. 6 patients aged 3-12, 2 aged 12-40, 10 aged 40-60, 7 above 60.
• Data Provenance: Retrospective or Prospective not explicitly stated, but implies prospective data collection from "The Second Affiliated Hospital of Guangzhou Medical University and The First Affiliated Hospital of Guangzhou Traditional Chinese Medical University" from 2012 to 2013 (China).
• Ground Truth: Implicitly referent method (e.g., auscultation by trained observers) as required by ISO 81060-2.
• Adjudication Method: Not specified, but standard practice for NIBP clinical validation involves multiple observers for reference measurements.
• Results: "The results are accurate and reliable, and the repeated measurement consistency is in good condition, within the measurement range. Moreover, No adverse events and side effects were found in clinical trials."

2. NIBP Clinical Study - for neonate and infants

• Device Parameter: Non-invasive Blood Pressure (NIBP)
• Acceptance Criteria/Standard: Complies with ISO 81060-2 Second Edition 2013-05-01 "Non-Invasive Sphygmomanometers - Part 2: Clinical Validation Of Automated Measurement Type."
• Sample Size: 20 subjects.
  • Demographics: 10 males, 10 females. 13 subjects

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The DigitalDiagnost C50 system is intended for use in generating radiographic images of human anatomy by qualified/ trained doctor or technician. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. This device is not intended for mammographic applications.

The Philips DigitalDiagnost C50 Digital Radiography System (Philips DigitalDiagnost C50) is a flexible digital radiography (DR) system that is designed to provide fast and smooth radiography examinations of sitting, standing or lying patients.

The Philips DigitalDiagnost C50 consists of the following components: ceiling suspension with X-ray assembly, wall stand with detector carrier, patient table with detector carrier and floating table top, high voltage generator, and an acquisition and reviewing workstation for post-processing, storage and viewing of images. Images may be transferred via a DICOM network for printing, storage and detailed review.

Based on the provided text, the device in question, the Philips DigitalDiagnost C50, is a stationary x-ray system cleared through a 510(k) premarket notification. The document does not describe acceptance criteria or a study that proves the device meets acceptance criteria in the context of an AI/algorithm-driven diagnostic aid.

Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (Philips DuraDiagnost K141381) and a reference device for the wireless detector (Varian Nexus DR™ Digital X-ray Imaging System K161459).

Therefore, I cannot provide the requested information about acceptance criteria and a study proving the device meets acceptance criteria related to AI/algorithm performance, a multi-reader multi-case study, standalone algorithm performance, or the ground truth establishment for a training set. The device is a traditional x-ray system, not an AI-powered diagnostic tool as suggested by some of the detailed questions.

However, I can extract information regarding overall device compliance and performance from the text as it relates to demonstrating substantial equivalence for an X-ray system:

Acceptance Criteria and Device Performance for the Philips DigitalDiagnost C50

The provided text on the Philips DigitalDiagnost C50's 510(k) submission does not include acceptance criteria and a study in the context of an AI-driven diagnostic device. Instead, it focuses on demonstrating substantial equivalence to predicate and reference devices for a stationary X-ray system. The "acceptance criteria" mentioned refer to the device meeting the requirements set forth by international and FDA-recognized consensus standards and device-specific guidance documents, as well as the successful completion of non-clinical verification and validation tests.

1. Table of Acceptance Criteria and Reported Device Performance (as related to Substantial Equivalence and Safety/Effectiveness):

The document details a comparison of technological characteristics between the proposed device (DigitalDiagnost C50) and its predicate (Philips DuraDiagnost) and reference device (Varian Nexus DR™ Digital X-ray Imaging System for the wireless detector). The "acceptance criteria" here are implicitly that the proposed device's characteristics are either identical or that any minor differences do not affect the safety or effectiveness, thus demonstrating substantial equivalence (SE).

2. Sample Size and Data Provenance for Test Set (for an AI/Algorithm):

• Not applicable. The submission is for a traditional X-ray system, not an AI/algorithm-driven diagnostic device. The performance data relies on comparing the technical specifications and non-clinical bench testing against established standards and predicate devices.

3. Number of Experts and Qualifications to Establish Ground Truth (for an AI/Algorithm):

• Not applicable. See point 2.

4. Adjudication Method for Test Set (for an AI/Algorithm):

• Not applicable. See point 2.

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

• Not applicable. The document explicitly states: "The DigitalDiagnost C50 did not require a clinical study since substantial equivalence to the primary currently marketed and predicate device was demonstrated with the following attributes: Design features; Indication for use; Fundamental scientific technology; Non-clinical performance testing; and Safety and effectiveness." There is no mention of an MRMC study or an effect size for human readers with or without AI assistance.

6. Standalone Algorithm Performance:

• Not applicable. The device is an X-ray system, not a standalone algorithm.

7. Type of Ground Truth Used (for an AI/Algorithm):

• Not applicable. For this X-ray system, "ground truth" for performance is established through adherence to recognized standards, technical specifications, and successful non-clinical performance (bench) testing, demonstrating that the images generated are of appropriate quality and the system functions safely and effectively as intended.

8. Sample Size for the Training Set (for an AI/Algorithm):

• Not applicable. See point 2.

9. How the Ground Truth for the Training Set Was Established (for an AI/Algorithm):

• Not applicable. See point 2.

In summary, the Philips DigitalDiagnost C50 is a conventional X-ray system whose acceptance criteria are fundamentally tied to demonstrating substantial equivalence to legally marketed predicate devices through comprehensive non-clinical performance (verification and validation) tests and adherence to established international and FDA-recognized consensus standards. The document does not describe the evaluation of an AI or algorithm.

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