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VERAFEYE Imaging Catheter: The VERAFEYE Imaging Catheter is intended for intra-luminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart of adult patients. The catheter is intended for imaging guidance only, not treatment delivery, during cardiac interventional percutaneous procedures.

VERAFEYE Imaging System: The VERAFEYE Imaging System is intended for cardiac applications. The system transmits ultrasound energy into adult patients creating 2D (B-mode), & 3D images of the heart, cardiac valves, great vessels, and surrounding anatomical structures to evaluate the presence or absence of pathology. The system also provides the ability to indicate scale with respect to anatomical structures, which provides information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes. The system utilizes catheters which are intended for intra-cardiac and intraluminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart of adult patients is intended for imaging guidance only, not treatment delivery, during cardiac interventional percutaneous procedures.

The VERAFEYE System is intended to be used for live, minimally-invasive guidance of several different intracardiac procedures including, but not limited to, atrial ablation procedures and transseptal punctures. The system will provide image information of cardiovascular anatomic features, spatial relationships of other devices within the heart and great vessels, physiological information of cardiovascular structures and features. In doing so we expect to provide an imaging system capable of improving the safety, expediency, cost-effectiveness and patient tolerance of the aforementioned procedures compared to the same procedures using the existing technologies and methodologies. The system will be comprised of a catheter and an ultrasound imaging system with a console and computer screen. The VERAFEYE Imaging System includes the System Console (SC) for image display and manipulation as well as the Catheter Interface Unit (CIU) which the catheter connects to. The SC will have two monitors to allow for ease of image view and review for both the technician and physician user. The technician user will be able to control the system software via a graphical user interface using multiple methods of input including a mouse and keyboard. Caster wheels on the SC will allow easy movement of the system throughout the cardiac interventional lab which can have a small footprint as well as small obstacles to cross. The catheter will be a 11Fr single use, sterile device, which will be able to perform intracardiac and intraluminal ultrasound imaging of adults. The catheter will be capable of live 2D side viewing imaging, as well as live 3D rendered images. The imaging system will be able to resolve and measure features such as the inferior and superior vena cava, ascending and descending aorta, left and right atria, left and right ventric valve, mitral valve and tricuspid valve. The physician user will have easy steering maneuverability of the catheter via deflection and rotation, facilitating control over the position of the transducer to allow for multiple angles of images.

This appears to be a 510(k) Pre-market Notification document for the VERAFEYE System. It describes the device's intended use and compares it to predicate devices to establish substantial equivalence, rather than detailing a study used to prove the device meets specific acceptance criteria in the context of an AI/ML study.

Therefore, the requested information points (1-9) which are typically associated with performance evaluations of AI/ML devices, are not directly addressed in this document. The document focuses on regulatory comparison and safety/effectiveness based on non-clinical data and equivalence to existing devices.

Specifically:

• Acceptance Criteria and Reported Device Performance: This document doesn't provide a table of acceptance criteria for AI performance or reported device performance in that context. It focuses on functional and technological comparisons with predicate devices.
• Sample Size and Data Provenance (Test Set): Not applicable as this is not an AI/ML performance study.
• Number of Experts and Qualifications (Ground Truth): Not applicable.
• Adjudication Method: Not applicable.
• Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable. The document states, "No clinical testing is included in the submission. Determination of substantial equivalence is based on an assessment of non-clinical data."
• Standalone Performance Study (Algorithm Only): Not applicable.
• Type of Ground Truth Used: Not applicable.
• Sample Size for Training Set: Not applicable.
• How Ground Truth for Training Set was Established: Not applicable.

The document primarily makes a case for substantial equivalence based on technical characteristics, intended use, and non-clinical performance data, rather than reporting on an AI/ML specific performance study. It lists various safety and performance standards (e.g., UL 60601-1, IEC 60601-2-37, ISO 10993-1) that the device was tested against to demonstrate safety and effectiveness for regulatory clearance.

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The Sleepnet Mojo Full Face Vented Mask, Veraseal 2 Full Face Vented Mask, Innova Full Face Vented Mask and Ascend Full Face Vented Mask are intended to be used with positive airway pressure devices, such as CPAP or bilevel, operating at or above 3 cm H2O. The masks are to be used on adult patients (>30kg) for whom positive airway pressure therapy has been prescribed.

Mojo is intended for Single patient, multi-use in the home or hospital/institutional environment.

Veraseal 2 is intended for Short Term Single Patient use (maximum of 7 days) in the hospital institutional environment.

Innova is intended for Single patient, multi-use in the home or hospital/institutional environment.

Ascend is intended for Single patient, multi-use in the home or hospital/institutional environment.

The Sleepnet Mojo Vented Full Face Mask, Veraseal 2 Full Face Vented Mask, Innova Full Face Vented Mask and Ascend Full Face Vented Mask are used with positive pressure devices, such as CPAP and Bi-level.

The modifications to the cleared Mojo Full Face mask (K120463) are:

• Addition of contraindication and updated warning related to presence of magnets
• Change to the headgear material
• Addition of an XL size

The modifications to the cleared Veraseal Full Face mask (K120463) are:

• Modified design, now called the Veraseal 2 Full Face Vented Mask
• . Addition of an XL size

Other modifications include:

• Addition of the Innova Full Face Vented Mask version
• Addition of the Ascend Full Face Vented Mask version

This document does not describe an AI/ML device or a comparative effectiveness study. It is a 510(k) summary for several full face vented masks (Mojo, Veraseal 2, Innova, Ascend) and compares them to a predicate device (Mojo Full Face Mask and Veraseal Full Face Mask, K120463).

The summary focuses on demonstrating substantial equivalence to a previously cleared device through comparisons of indications for use, patient population, environment of use, and technological characteristics. This typically involves performance testing, biocompatibility, transportation, shelf-life, and reprocessing.

Therefore, many of the requested elements for an AI/ML device evaluation (e.g., sample size for test/training sets, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance) are not applicable to this document.

However, I can extract the acceptance criteria and reported device performance from the provided "Table of Comparison to Predicate" and "Non-Clinical Testing Summary" as they relate to these medical masks.

1. Table of Acceptance Criteria and the Reported Device Performance (as applicable to a physical medical device, not AI/ML):

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The Sleepnet Mojo 2 Full Face Vented Mask, Veraseal 3 Full Face Vented Mask, and V3 Full Face Vented Mask are intended to be used with positive airway pressure devices, such as CPAP or bi-level, operating at or above 3 cm H2O.

The masks are to be used on adult patients (>30 kg.) for whom positive airway pressure therapy has been prescribed.

Veraseal 3 -Disposable single use (hospital/institutional) Single patient, multi-use up to 7 days (hospital/institutional)

V3 -Single patient, multi-use (home)

Mojo 2 -Single patient, multi-use (home or hospital/institutional)

The Sleepnet Veraseal 3, V3 and Mojo 2 Full Face Vented masks are identical to the predicate Veraseal 3, V3, and Mojo 2 Full Face Vented masks (K190254).

The subject of this submission is:

• Addition of a contraindication related to magnets on the Mojo 2 Full Face Vented mask .
• . Update to the warning related to magnets on the Mojo 2 Full Face Vented mask

The provided text describes a 510(k) premarket notification for a medical device, specifically full face vented masks (Mojo 2, Veraseal 3, V3 Full Face Vented Mask). This submission seeks to establish substantial equivalence to a predicate device (K190254). Crucially, the document explicitly states that no performance testing was conducted on the subject device because its design is identical to the predicate device. The only changes are the addition of a contraindication and an updated warning related to magnets, prompted by a prior recall.

Therefore, the information required to answer your query regarding acceptance criteria and the study proving the device meets those criteria (e.g., test set sample size, expert ground truth establishment, MRMC studies, standalone performance, ground truth type for training/test sets) is not present in the provided document. This document primarily focuses on demonstrating substantial equivalence based on identical design and leveraged predicate data, rather than new performance studies.

However, I can extract the specifications and comparison tables, which can be interpreted as the implicit "acceptance criteria" through their demonstration of identical characteristics to the predicate device. The "reported device performance" is then the stated performance of these identical characteristics.

Here's a breakdown of what can be inferred from the document, acknowledging the missing information about new performance studies:

A. Acceptance Criteria and Reported Device Performance (Inferred from Predicate Equivalence)

Since the subject device is identical to the predicate device (K190254) in design and performance, the "acceptance criteria" are effectively that the subject device's specifications match those of the predicate. The "reported device performance" is therefore the reported performance of the predicate device, which the subject device is stated to replicate.

B. Study Details (Not Applicable/Information Not Provided)

1. Sample size used for the test set and the data provenance: Not applicable. No new performance testing was conducted for this submission. The device design is identical to the predicate.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No new performance testing was conducted.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No new performance testing was conducted.
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: Not applicable. This device is a face mask, not an AI-powered diagnostic tool.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a face mask, not an algorithm.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. No new performance testing was conducted.
7. The sample size for the training set: Not applicable. No new performance testing was conducted, and this is a physical device, not a machine learning model requiring a training set.
8. How the ground truth for the training set was established: Not applicable.

Summary of the Study Proving Acceptance Criteria:

The "study" proving the device meets the acceptance criteria is the demonstration of substantial equivalence to a previously cleared predicate device (K190254). The manufacturer asserts that the subject devices (Mojo 2, Veraseal 3, V3 Full Face Vented Mask) are identical in design, indications for use, technology, principle of operation, environment of use, patient population, and performance characteristics to the predicate.

The only modifications are to the labeling, specifically the addition of a new contraindication and an updated warning statement for the Mojo 2 mask related to magnets. These changes were a proactive measure following a voluntary recall and information from post-market surveillance.

Therefore, the evidence for meeting acceptance criteria relies entirely on the prior clearance of the predicate device (K190254) and the assertion that the new device is functionally identical, with only labeling changes to address safety information not present in the original predicate's labeling. No new performance data, clinical trials, or expert consensus studies were performed or presented for this specific 510(k) submission.

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The Sleepnet Mojo 2 and Veraseal 3 Full Face Non-Vented and AAV Non-Vented Masks are intended to provide a patient interface for application of noninvasive ventilation. The mask is to be used as an accessory to ventilators that have adequate alarms and safety systems for ventilator failure, and which are intended to administer positive pressure ventilation. The mask will be offered in a disposable version and a multi-use version. It is intended for use on adult patients (>30 kg), who are appropriate candidates for noninvasive ventilation.

Veraseal 3 - Disposable single use (hospital/institutional) Single patient, multi-use up to 7 days (hospital/institutional)

Mojo 2 -Single patient, multi-use (home or hospital/institutional)

The Sleepnet Mojo 2 and Veraseal 3 are full face mask used with non0invasive ventilation. They are available in multiple sizes and in a Non-Vented style with an elbow and Non-Vented with elbow and anti-asphyxia (AAV) valve.

The subject of this submission is:

• The Mojo 2 subject devices include a new contradiction and warning, which was not . included in the predicate device - K190533.
  Veraseal 3 is intended as a Disposable single use (hospital/institutional) and as a Single patient, multi-use up to 7 days (hospital/institutional)

Mojo 2 is intended as a Single patient, multi-use (home or hospital/institutional)

The provided text describes a 510(k) premarket notification for Sleepnet Corporation's Mojo 2 and Veraseal 3 Full Face Masks. This submission primarily focuses on changes to contraindications and warnings due to a previous recall, rather than new device performance data.

Therefore, the document explicitly states: "No new performance testing was conducted on the subject device, since the device designs are identical to the predicates." This means there is no study described that proves the device meets new acceptance criteria. The acceptance criteria and reported device performance are based on the predicate device (K190533) and its original clearance.

However, I can extract the information related to the device and the comparison to its predicate as requested in your format, noting the absence of new performance data.

Here's the information based on the provided text:

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

Since no new performance testing was conducted, there are no new specific acceptance criteria or reported performance data for the subject devices presented in this summary beyond the fact that their design is identical to the predicate. The "acceptance criteria" for this specific 510(k) submission revolve around demonstrating substantial equivalence, especially concerning the updated labeling.

The following table summarizes the key attributes and their comparison to the predicate device, implying that the acceptance for these attributes is "identical" to the predicate, which had presumably met its own performance acceptance criteria during its original clearance (K190533).

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

There is no new test set or data provenance information provided in this submission, as "No new performance testing was conducted." The basis of this submission is the identical design to a predicate device and updated labeling.

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. No new test set and no ground truth establishment for a test set are described. The updated contraindications and warnings were established due to information from post-market surveillance related to a voluntary recall (Event 94169).

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

Not applicable. No new test set 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

Not applicable. This device is a patient interface for ventilation, not an AI-assisted diagnostic or therapeutic device. No MRMC study was performed or is relevant.

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

Not applicable. This device is a mechanical patient interface, not an algorithm.

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

Not applicable for new data. The primary "ground truth" for the new contraindication/warning was post-market surveillance data leading to a voluntary recall (Event 94169), which indicated potential risks from magnets interacting with medical implants. This implicitly relies on real-world outcomes and expert clinical judgment regarding patient safety.

8. The sample size for the training set

Not applicable. This device is a mechanical patient interface, not an AI/ML device that requires a training set.

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

Not applicable. This device is a mechanical patient interface, not an AI/ML device.

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The VERABAND™ is a compact, lightweight, body-worn activity monitoring device designed to document physical movement associated with applications in physiological monitoring. The device is intended to monitor limb or body movements during daily living and sleep for a limited time interval (up to 30- days).

The VERABAND™ can be used to assess activity in any instance where quantifiable analysis of physical motion is desired. VERABAND™ is not intended for diagnostic purposes.

The VERABANDTM is a compact, wrist-worn battery-operated wearable device intended for collecting a patient's motion data for assessing patient activity. VERABANDTM is intended to acquire and store data while being worn during normal activities and/or during sleep. The device consists of a wearable band with compact housing for battery-powered on-board electronics with an accelerometer. The recorded activity data is timestamped and stored in non- volatile memory for later retrieval. Downloaded VERABANDTM data can be post-processed based on the timestamp and magnitude of acceleration for reporting.

Here's a breakdown of the acceptance criteria and study information for the Veraband™ device based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

• Accelerometer shall meet static calibration point accuracy requirement.
• Accelerometer shall meet repeatability and reproducibility requirement. | Pass |
  | Activation Trigger | - Device shall activate at the required light level.
• Device shall not activate while in the packaging. | Pass |
  | Device Donning/Doffing | Device shall be able to survive the required donning and doffing. | Pass |
  | Device Band Separation and Elongation Forces | - Device shall meet force requirements for elongation.
• Device shall meet force requirements for separation. | Pass |
  | Battery Life for Duration of Use | Device shall meet the battery life requirements for Expected Device Life. | Pass |
  | User Cleaning | Device shall maintain function after a required minimum number of cleanings. | Pass |
  | Device Sampling Rate and Full-Scale Dynamic Range | Device shall have a sampling rate and full-scale dynamic range that meets the requirements. | Pass |
  | Device Frequency Response | Device shall be within the requirement of the predicate's bandwidth. | Pass |
  | VERABAND™ Intended Use | Device shall meet repeatability and reproducibility requirements for activity levels. | Pass |
  | VERABAND™ Report Generation Comparison | Device output metrics shall meet the predicate comparison requirements. | Pass |
  | Usability | Device shall meet the related usability requirement survey scores. | Pass |
  | Packaging Testing | Device shall maintain function per requirements after shipping. | Pass |
  | EMC | Device shall meet the related EMC requirements. | Pass |
  | Electrical Basic Safety | Device shall meet the related electrical basic safety requirements. | Pass |
  | Biocompatibility Testing | Device shall meet the related biocompatibility requirements. | Pass |
  | Firmware Verification and Validation Testing | Device shall meet the related Firmware requirements. | Pass |
  | Software Verification and Validation Testing | Device shall meet the related Software requirements. | Pass |

2. Sample Size and Data Provenance (for test set, if applicable)

The document primarily describes non-clinical engineering and performance testing. It does not explicitly state a "test set" in the context of clinical data. For the "VERABAND™ intended use" test, it states "Simulated users wearing the device perform activities at different intensities of motion and wear compliance times." While it implies subjects, no specific sample size is provided. The data is non-clinical/simulated.

3. Number of Experts for Ground Truth and Qualifications (for test set, if applicable)

Not applicable, as the provided data focuses on non-clinical and simulated testing for performance validation rather than expert-derived ground truth for a test set of patient data.

4. Adjudication Method (for test set, if applicable)

Not applicable. The reported tests are primarily objective engineering and performance validations against predefined criteria, not subjective human evaluations requiring adjudication.

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

No. The document explicitly states: "The VERABAND™ did not require clinical studies to support substantial equivalence to the primary predicate device." Therefore, no MRMC study was conducted or reported.

6. Standalone (Algorithm Only) Performance Study

Yes, the majority of the reported testing falls under standalone performance. The "non-clinical testing summary" details various tests (e.g., accelerometer accuracy, battery life, sampling rate, frequency response, report generation comparison) that evaluate the device's technical functionality and performance in isolation or in comparison to a predicate device's output, without human-in-the-loop performance measurement.

7. Type of Ground Truth Used

For the non-clinical tests, the ground truth was based on:

• Established engineering specifications and requirements (e.g., full-range accuracy, required light level, expected device life, minimum number of cleanings, sampling rate, full-scale dynamic range, predicate's bandwidth, repeatability and reproducibility for activity levels, predicate comparison requirements for output metrics).
• Recognized consensus standards (e.g., IEC, ISO, ASTM).
• Simulated motions and user activities.

8. Sample Size for the Training Set

The document does not mention a "training set" in the context of machine learning or AI. The device is described as an activity monitoring device with an accelerometer to acquire and store data, which is then post-processed. It doesn't appear to be an AI/ML-driven diagnostic device that would typically involve a training set for model development.

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

Not applicable, as there is no mention of a "training set" for an AI/ML model. The device's operation relies on sensor data acquisition and processing based on established algorithms and engineering principles, not on a trained machine learning model.

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The Tono-Vera® Tonometer and Ocu-Dot® Tonometer Probes is intended to be used for the measurement of intraocular pressure of the human eye.

The Reichert Tono-Vera® Tonometer is a hand-held, battery powered instrument that utilizes rebound methodology to measure the intraocular pressure (IOP) of the eye. The tonometer propels a small, plastic-tipped measurement probe in a controlled manner against a patient's unanesthetized eye in order to calculate IOP. The device has a simple, four-button control system and an LCD that provides information to the operator and displays measurement results.

There are two Tono-Vera Tonometer models:
· Tono-Vera Tonometer Starter Kit, AA Battery, Model 16305; and
• Tono-Vera Tonometer Starter Kit, Rechargeable, Model 16306.

Both models of the Tono-Vera Tonometer have a required accessory, the Ocu-Dot® Tonometer Probe, model 16318. The Ocu-Dot Tonometer Probe is a sterile, single-use, disposable accessory.

The Tono-Vera Tonometer utilizes a camera-based alignment system, called ActiView™ to improve alignment with the apex of the cornea and reduce measurement variability caused by operator technique. The measuring process starts automatically once alignment conditions are fulfilled.

The device has two measurement options: 3+ (Quick) Measurement Option and 6 Measurement Option. Both the 3+ (Quick) Measurement Option and 6 Measurement Option use the same calculation for the IOP result. The 3+ (Quick) Option can calculate a final IOP result with as few as three measurements. The 6 Measurement Option always uses six measurements to calculate the final IOP result.

The Tono-Vera Tonometer can be connected to a computer with ReichertSync® installed on it. Data from ReichertSync can be imported by an EMR system.

The Tono-Vera Tonometer determines IOP by detecting and analyzing the motion of the measurement probe as it briefly contacts the cornea.

Here's an analysis of the acceptance criteria and the study proving the device meets it, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text primarily focuses on demonstrating substantial equivalence to a predicate device (Icare Ic100) and meeting an industry standard (ANSI Z80.10-2014) for tonometry. Specific numerical acceptance criteria for a direct comparison study between the Tono-Vera Tonometer and the Goldmann Applanation Tonometer are not explicitly stated as a table within the document. However, the performance metrics reported against the predicate device give us an indication of the performance expected and validated.

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The glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. Gloves have been tested for use with chemotherapy drugs and Fentanyl Citrate using ASTM D6978-05(2019)

Aloe Vera Nitrile Examination Gloves (Green) Tested for Use with Chemotherapy Drugs and Fentanyl Citrate are Class I Patient Examination Gloves and Specialty Chemotherapy Gloves. They are ambidextrous and come in different sizes - Extra Small, Small, Medium, Large, Extra Large and XXL. Gloves meet the specification of ASTM D6319-19 and have been tested for resistance to permeation by chemotherapy drugs and Fentanyl Citrate as per ASTM D6978-05(2019). The gloves are single use, disposable, and provided non-sterile.

The provided document describes the acceptance criteria and study results for the "Aloe Vera Nitrile Examination Gloves (Green) Tested for Use with Chemotherapy Drugs and Fentanyl Citrate" (K240080).

Here's the breakdown:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the gloves are based on various physical characteristics, chemical permeation resistance (as per ASTM D6978-05(2019)), and biocompatibility tests (as per ISO 10993 standards). The reported device performance is compared to these criteria and, in some cases, to a predicate device (K200671).

Physical and Design Characteristics (Meeting ASTM D6319-19):

Chemotherapy Permeation Resistance (ASTM D6978-05(2019)):

Fentanyl Citrate Permeation Resistance (ASTM D6978-05(2019)):

Biocompatibility (ISO 10993 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 explicitly state the specific sample sizes used for each test. However, it indicates that tests were conducted according to recognized international standards such as ASTM D6319-19 (Standard Specification for Nitrile Examination Gloves for Medical Application), ASTM D6978-05(2019) (Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs), and ISO 10993 series for biocompatibility. These standards typically specify the number of samples required for testing.

The data provenance is not explicitly stated as 'country of origin' in that format, but the applicant is "Syntex Healthcare Products Co., Ltd" from "Xinji, Hebei, China," indicating the testing likely occurred under their purview or by contracted labs. The studies appear to be prospective testing conducted specifically for this premarket notification.

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)

This information is not applicable as the document describes performance testing of a physical medical device (gloves) against established engineering and biocompatibility standards. It does not involve interpretation of medical images or patient data by human experts for ground truth establishment.

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

This information is not applicable for the same reason as point 3. Testing involves objective measurements against predefined standards.

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 information is not applicable as the device is a medical glove, not an AI-powered diagnostic or assistive tool.

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

This information is not applicable as the device is a medical glove, not an algorithm.

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

The "ground truth" for this device's performance is based on established international and national standards for medical gloves:

• ASTM D6319-19: for physical dimensions and integrity (e.g., freedom from holes, tensile strength).
• ASTM D6978-05(2019): for resistance to permeation by chemotherapy drugs and Fentanyl Citrate, where "breakthrough detection time" is the key metric.
• ISO 10993 series (ISO 10993-5, -10, -11, -23): for biocompatibility assessments like cytotoxicity, sensitization, irritation, and systemic toxicity.

8. The sample size for the training set

This information is not applicable as the device is a physical product and does not involve machine learning or AI models with training sets.

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

This information is not applicable as the device is a physical product and does not involve machine learning or AI models.

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The 3M™ V.A.C. Veraflo Cleanse Choice™ Dressing Kit is used as part of an integrated wound management system that provides 3M™ Veraflo™ Therapy, which consists of negative pressure wound therapy (3M™ V.A.C.® Therapy) with an instillation option.

· 3M™ V.A.C.® Therapy in the absence of instillation is intended to create an environment that promotes wound healing by secondary or tertiary (delayed primary) intention by preparing the wound bed for closure, promoting granulation tissue formation and perfusion, and by removing exudate and infectious material.

· The instillation option is indicated for patients who would benefit from vacuum assisted drainage and controlled delivery of topical wound treatment solutions and suspensions over the wound bed. It provides hydromechanical removal of infectious materials, non-viable tissue and wound debris which reduces the number of surgical debridements required, while promoting granulation tissue formation, creating an environment that promotes wound healing.

The 3M™ V.A.C. Veraflo Cleanse Choice™ Dressing Kit with and without instillation is indicated for patients with chronic, acute, traumatic, sub-acute and dehisced wounds, partial- thickness burns, ulcers (such as diabetic, pressure and venous insufficiency), flaps and grafts.

The 3M™ Veraflo™ Cleanse Choice Complete™ Dressing Kit is used as part of an integrated wound management system that provides 3M™ Veraflo™ Therapy, which consists of negative pressure wound therapy (3M™ V.A.C.® Therapy) with an instillation option.

· 3M™ V.A.C.® Therapy in the absence of instillation is intended to create an environment that promotes wound healing by secondary or tertiary (delayed primary) intention by preparing the wound bed for closure, reducing edema, promoting granulation tissue formation and perfusion, and by removing exudate and infectious material.

· The instillation option is indicated for patients who would benefit from vacuum assisted drainage and controlled delivery of topical wound treatment solutions and suspensions over the wound bed. It provides hydromechanical removal of infectious materials, non-viable tissue and wound debris which reduces the number of surgical debridements required, while promoting granulation tissue formation, creating an environment that promotes wound healing.

The 3M™ Veraflo™ Cleanse Choice Complete™ Dressing Kit with and without instillation is indicated for patients with chronic, acute, traumatic, sub-acute and dehised wounds, partial- thickness burns, ulcers (such as diabetic, pressure and venous insufficiency), flaps and grafts.

Both dressing kits are intended to be used with the 3M™ V.A.C.® Ulta Therapy Unit and its associated canisters and cassette for the delivery of 3M™ Veraflo™ Therapy that provides Negative Pressure Wound Therapy coupled with controlled delivery and drainage of topical wound treatment solutions and suspensions over the wound bed. The dressing kits provide sterile disposable components needed for delivery of 3MTM VerafloTM Therapy.

Each kit contains a wound dressing with 10 mm diameter holes specifically designed for use with 3M™ Veraflo™ Therapy (either the 3M™ V.A.C. Veraflo™ Cleanse Choice™ or the 3MTM Veraflo™ Cleanse Choice Complete™ Dressing), an occlusive drape covering the dressing (either the 3MTM V.A.C. Advanced Drape or the V.A.C. Dermatac™ Drape), a tubing set for connecting the dressing to the negative pressure and instillation pumps (either the 3M™ V.A.C. VeraT.R.A.C.TM Pad or the 3M™ VeraT.R.A.C. Duo™ Tube Set, depending on dressing size) and a wound measuring ruler.

The subject dressings differ only in the number of dressing pieces provided in the kit, in the drape materials of construction and in the method of sterilization:

• . The 3M™ V.A.C. Veraflo™ Cleanse Choice™ Dressing Kit is gray in color, has three dressing layers (one with holes, one thin cover layer and one thick cover layer without holes), has a drape constructed of a polyurethane film with acrylic adhesive and is sterilized by irradiation.
• The 3M™ Veraflo™ Cleanse Choice Complete™ Dressing Kit is blue in color, has only one ● dressing piece (which consists of a combination of the layer with holes and the thin cover layer without holes in the 3M™ V.A.C. Veraflo™ Cleanse Choice™ Dressing), has a drape constructed of a polyurethane film with acrylic adhesive and a perforated silicone layer, and is sterilized by ethylene oxide (ETO).

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided FDA 510(k) summary for the 3M™ V.A.C. Veraflo Cleanse Choice™ Dressing Kit and 3M™ Veraflo™ Cleanse Choice Complete™ Dressing Kit.

It's important to note that this document is an FDA 510(k) summary for a medical device (dressing kit), not an AI/ML powered device. Therefore, many of the typical questions for AI/ML device studies regarding ground truth establishment, expert adjudication, MRMC studies, and training sets are not applicable to this type of submission. The performance described here relates to the physical and functional characteristics of dressings in wound care, not algorithmic performance.

Acceptance Criteria and Device Performance (Not applicable for AI/ML specific criteria)

The document primarily focuses on demonstrating substantial equivalence to predicate devices for a dressing kit. The "acceptance criteria" here are implied by the claim of substantial equivalence and are met through comparative analysis and leveraging existing clinical data for the predicate device, rather than new, large-scale clinical trials with pre-defined statistical endpoints for novel performance metrics.

Implicit Acceptance Criteria (Met by comparison and leveraging existing data):

• Functional Equivalence: The subject dressings perform the intended functions (negative pressure wound therapy, instillation, hydromechanical removal of infectious materials, non-viable tissue, and wound debris) comparably to the predicate devices.
• Material Equivalence/Safety: The materials of construction, physical properties, and sterilization methods are either identical or demonstrably safe and effective.
• Shelf-Life: The device maintains its stability and performance over the proposed shelf-life.
• Biocompatibility & Sterility: Meets all relevant FDA biocompatibility requirements and is sterile at a SAL of 10^-6.
• Clinical Efficacy (Leveraged): The device, in conjunction with the therapy unit, effectively promotes wound healing, granulation tissue formation, and removal of undesirable wound materials, as demonstrated by prior clinical data for the predicate device.

Table of Acceptance Criteria and Reported Device Performance (as inferred from the document):

Study Details (As applicable to a medical device, not an AI/ML device):

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

   • Test Set (for Functional Equivalence/Bench Testing): Not explicitly stated numbers of devices tested. The "test set" here refers to samples subjected to bench tests (material comparisons, physical properties, finite element modeling, foam changes under negative pressure). The document states "production equivalent samples accelerated aged to the proposed shelf life" for shelf-life testing.
   • Clinical Data Provenance: The clinical data leveraged is from "literature-reported clinical data" from "21 retrieved reference publications" including "177 patients." This implies retrospective data from various clinical settings and possibly multiple countries, given it's a literature search. It is "real-world clinical evidence."

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

   • Not applicable in the typical AI/ML sense. For this medical device, "ground truth" for the bench tests would be established by validated measurement techniques and engineering specifications. For the clinical data, the "truth" is based on the reported clinical outcomes in the published literature (e.g., reduction in non-viable tissue, granulation tissue formation), which were assessed by the authors of those papers (presumably clinicians). The 510(k) relies on the validity of these published clinical observations.

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

   • Not applicable in the typical AI/ML sense. There was no human expert adjudication of model outputs or image interpretations. The "adjudication" for the bench tests would be through standard laboratory procedures and data analysis. For the clinical literature, the FDA reviews the cited publications for their relevance and applicability.

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:

   • Not applicable. This is not an AI-powered device. No MRMC study was performed.

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

   • Not applicable. This is not an AI-powered device/algorithm.

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

   • Bench Testing: Engineering specifications, validated measurement results, and comparative physical/mechanical properties.
   • Clinical "Ground Truth": For the clinical claims, the "ground truth" is based on the reported clinical outcomes data from the cited literature, specifically "evidence of reduction in non-viable wound tissue" and "impact on granulation tissue formation." Indirect endpoints included "decrease in the need for surgical debridement or visible evidence of reduction of nonviable tissue in photographs."

7. The sample size for the training set:

   • Not applicable. This is not an AI/ML device that requires a training set.

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

   • Not applicable. This is not an AI/ML device that requires a training set or its associated ground truth establishment.

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The 3M™ Veraflo™ Cleanse Choice Complete™ Dressing Kit is used as part of an integrated wound management system that provides 3M™ Veraflo™ Therapy, which consists of negative pressure wound therapy (3M™ V.A.C.® Therapy) with an instillation option.

• 3M™ V.A.C.® Therapy in the absence of instillation is intended to create an environment that promotes wound healing by secondary or tertiary (delayed primary) intention by preparing the wound bed for closure, reducing edema, promoting granulation tissue formation and perfusion. and by removing exudate and infectious material.

• The instillation option is indicated for patients who would benefit from vacuum assisted drainage and controlled delivery of topical wound treatment solutions and suspensions over the wound bed.

The 3M™ Veraflo™ Cleanse Choice Complete™ Dressing Kit with and without is indicated for patients with chronic, acute, traumatic, sub-acute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic, pressure and venous insufficiency), flaps and grafts.

The Veraflo™ Cleanse Choice Complete Dressing Kit is intended to be used with the separately provided V.A.C.® Ulta Therapy Unit and its associated canisters and cassette for the delivery of Veraflo Therapy that provides V.A.C.® Therapy Negative Pressure Wound Therapy with an instillation option. The system kit provides sterile disposable components needed for delivery of Veraflo Therapy. The kit contains the wound dressing (Veraflo Cleanse Choice Complete Dressing), drape (V.A.C. Dermatac Drape), tubing set (3M™ V.A.C. VeraT.R.A.C.™ Pad or 3M™ V.A.C. VeraT.R.A.C. Duo™ Tube Set) and a wound measuring ruler. The kit components are intended to simplify wound dressing applications by replacing the multiple grey foam dressing pieces in the predicate kit with a single blue foam piece and to provide the V.A.C. Dermatac Drape in the same package with the dressing. Because V.A.C. Dermatac Drape can only be sterilized by ethylene oxide, the kit must also be sterilized by this method.

The provided text describes the 3M™ Veraflo™ Cleanse Choice Complete™ Dressing Kit, which is a component of a powered suction pump system for wound therapy. The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device and does not involve an AI/ML algorithm or a study comparing AI performance against human readers. Therefore, many of the requested categories are not applicable.

Here's an analysis based on the provided text:

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

The document does not explicitly state quantitative "acceptance criteria" in the typical sense for an AI/ML device (e.g., AUC > X, sensitivity > Y). Instead, it focuses on verifying that the modified device performs as expected and meets existing predicate design requirements.

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

Not applicable for this type of device (medical device, not AI/ML). The "tests" performed were physical and biological evaluations of the dressing kit, not a test set of data.

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

Not applicable. Ground truth for the device's function (e.g., maintaining negative pressure) would be established through engineering and biological testing standards, not expert consensus on data interpretation.

4. Adjudication method 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 device is a dressing kit for wound therapy, not an AI diagnostic or assistive tool.

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

Not applicable. This is not an algorithm.

7. The type of ground truth used

The "ground truth" for this device's performance is established by:

• Compliance with biological safety standards (ISO 10993-1).
• Demonstration of physical functionality (maintaining negative pressure, fluid removal) under simulated use conditions.
• Usability assessment against existing predicate device's usability profile.

8. The sample size for the training set

Not applicable. This is not an AI/ML device.

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

Not applicable.

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