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Sorbact® Ribbon Gauze is intended for use in the management of exuding partial to full thickness wounds (including clean, colonized, contaminated or infected wounds). Sorbact® Ribbon Gauze is indicated for shallow cavity wounds and fistulas.

Sorbact® Ribbon Gauze is a sterile (gamma irradiation), single use only, hydrophobic microbe binding wound dressing. It consists of a Sorbact® wound contact layer, which allows passage of wound exudate into a secondary dressing.

Based on the provided text, the device in question is the "Sorbact® Wound Dressing – Ribbon Gauze". However, this document is a 510(k) premarket notification for a modification to an existing device, specifically a change to the color additive. The provided information does not describe a study that uses a test set to prove the device meets performance criteria related to its clinical efficacy or diagnostic performance as an AI/ML device.

The performance data section explicitly states: "The modification addressed by this 510(k) is a change to the color additive in the Sorbact® Ribbon Gauze. As the intended use, device description, wound contact material, instructions for use, mechanism of action, storage conditions, and shelf life of the modified device are the same as that of the predicate device, both devices have the same fundamental scientific technology."

Therefore, the "performance data" presented is entirely focused on non-clinical testing related to the safety and material properties of the new color additive, rather than a clinical performance study involving a test set, ground truth, or human readers, as would be expected for an AI/ML device.

Given this, I cannot fill in the requested table and answer the specific questions (2-9) because the information is not present in the provided document. The document describes a traditional medical device (wound dressing) and a 510(k) submission for a minor change (color additive), not an AI/ML device or its performance evaluation in the context you've outlined.

Here's what I can extract regarding acceptance criteria and performance, as related to the specific modification:

1. Table of Acceptance Criteria and Reported Device Performance (for the color additive change):

Missing Information (as per your prompt's format, because it's not an AI/ML device):

2. Sample sizes used for the test set and data provenance: Not applicable. This was non-clinical material and biocompatibility testing, not a clinical test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No clinical ground truth established.
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.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. Safety and material testing, not clinical diagnosis.
8. The sample size for the training set: Not applicable. No AI/ML training set.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document pertains to a regulatory submission for a minor modification to a non-AI/ML medical device. It does not contain the information required to address your specific questions about AI/ML device performance studies.

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The NewEra REVA Kit is intended to be used with the NewEra pumps. The system 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 formations and by removing exudate and infectious material.

NPWT is appropriate for use on the following wounds:

• · Pressure Ulcers
• · Diabetic/neuropathic ulcers
• · Venous insufficiency ulcers
• · Chronic, Acute, Traumatic, and Subacute wounds
• · Post-operative and dehisced surgical wounds
• · Skin flaps and grafts

The NewEra REVA Kit is a convenience kit offered in three sizes: small, medium, and large. The kit contains individually sterilized and packaged products. All products in the kit are 510(k) approved or exempt, except for the IHT NPWT REVA (REVA). The kit includes a REVA to connect to a waste canister, PhaseOne Skin and Wound Cleanser, SkinTac, a ruler, one or more Cutimed Sorbact Compresses, and one or more transparent film IHT drapes (IHT drape), depending on the size, PhaseOne (K131542, K113820, K081009, K071056) and Cutimed Sorbact (K063059) are 510(k) approved devices. The IHT drape (NAD), SkinTac (KOX) and ruler (FTY) are Class I 510(k) exempt.

The PhaseOne is used to cleanse the wound. SkinTac is used on the 2" surrounding surface area of the wound (peri-wound). The wound is measured, and the REVA drain is cut to a length apropriate for the wound. The REVA drain is wrapped in Cutimed Sorbact, and Cutimed Sorbact is fluffed and filled appropriately into the wound. The REVA skirt is used to cover over and seal the wound. An IHT Drape is provided for additional material if necessary. The NewEra REVA Kit attaches to an exudate canister to carry exudate from the wound. The NewEra REVA Kit interacts with a NPWT pump that applies a negative pressure to the wound via the components of the kit.

The REVA drain and anchor are made of silicone, and the skirt is a clear polyurethane film, which are all common materials currently found in similar wound care products with established biocompatibility.

Here's an analysis of the provided text regarding the NewEra REVA Kit, focusing on answering your questions about acceptance criteria and the study proving it.

First, it's very important to note that this document is a 510(k) Premarket Notification from 2015, which is a submission to the FDA to demonstrate substantial equivalence to a previously legally marketed device (predicate device). It is not a clinical trial report or a detailed stand-alone performance study. Therefore, a lot of the information you've requested regarding AI algorithm performance (like MRMC studies, training set size/ground truth, number of experts for ground truth, etc.) is not applicable to this type of medical device (a physical wound therapy kit) and thus is not present in the document.

The "studies" described here are benchtop performance tests and a usability study, not clinical efficacy trials or AI algorithm performance evaluations.

Acceptance Criteria and Reported Device Performance

For the NewEra REVA Kit, the "acceptance criteria" are implicitly derived from the performance claims of the predicate devices and the physical properties required for a negative pressure wound therapy (NPWT) system. The "performance" is demonstrated through benchtop testing.

Study Details (Based on available information for this type of device)

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

   • Benchtop Testing: The document does not specify a numerical sample size (e.g., how many REVA kits were tested). It simply states "Bench top testing was performed on the device to confirm REVA's ability..."
   • Usability Study: The document states that "individuals who represented actual potential users" were used, but does not specify the number of participants in the usability study.
   • Data Provenance: The testing appears to be prospective (performed for this submission) and conducted by the manufacturer, Integrated Healing Technologies. No country of origin for the data is explicitly stated beyond the company's location in Franklin, Tennessee, USA.

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

   • Not applicable to this type of device and study. Benchtop tests typically rely on measurement instruments and standardized procedures. The usability study would involve user observation and feedback, not "expert ground truth" in the diagnostic sense.

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

   • Not applicable. This method is typically used in diagnostic imaging studies where multiple readers interpret images, and their disagreement is resolved through adjudication. This device is a physical wound therapy kit, and the studies performed (benchtop and usability) do not involve such interpretation.

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

   • No, an MRMC comparative effectiveness study was not done. This type of study relates to AI-powered diagnostic systems, which is not what the NewEra REVA Kit is. The device is a physical negative pressure wound therapy kit.

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

   • Not applicable. This device does not involve an AI algorithm.

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

   • Not applicable/Implicit:
     • For benchtop tests, the "ground truth" is the physical laws and engineering specifications that dictate how the device should perform (e.g., if it's set to -125 mmHg, it should deliver -125 mmHg). This is measured by calibrated equipment.
     • For the usability study, the "ground truth" is whether participants could successfully complete the tasks (applying the kit to a wound model) and potentially their subjective feedback on ease of use.

7. The sample size for the training set:

   • Not applicable. This device does not use a "training set" as it is not an AI/machine learning model.

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

   • Not applicable. (See point 7).

In summary: The document details a 510(k) submission for a physical medical device (NPWT kit). The "studies" involve benchtop engineering tests and a usability observation, designed to demonstrate that the device functions as intended and is substantially equivalent to existing predicate devices. Concepts like AI algorithms, training sets, expert ground truth for image interpretation, and MRMC studies are not relevant to this type of submission or device.

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The NewEra Dome Kit is intended to be used with the NewEra I and II pumps. The system 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 formations and by removing exudate and infectious material. NPWT is appropriate for use on the following wounds: Pressure Ulcers, Diabetic/neuropathic ulcers, Venous insufficiency ulcers, Chronic, Acute, Traumatic, and Subacute wounds, Post-operative and dehisced surgical wounds, Explored fistulas, Skin flaps and grafts.

The NewEra Dome Kit is a convenience kit offered in three sizes: small, medium, and large. The kit contains individually sterilized and packaged products, except PhaseOne which is not sterile. All products in the kit are 510(k) approved or exempt, except for the IHT NPWT dome (IHT dome). The kit includes an IHT dome to connect to a waste canister, PhaseOne Skin and Wound Cleanser, SkinTac, a ruler, one or more Cutimed Sorbact Compresses, and one or more transparent film IHT drapes (IHT drape), depending on the size. PhaseOne (K131542, K113820, K071056) and Cutimed Sorbact (K063059) are 510(k) approved devices. The IHT drape, SkinTac and ruler are Class I 510(k) exempt. The PhaseOne is used to cleanse the wound. Cutimed Sorbact is then fluffed and filled into the wound. SkinTac is used on the border of the wound. The IHT Drape is applied to seal the wound. A hole is cut in the drape and the IHT NPWT dome is placed over the hole to allow suction. The NewEra Dome Kit attaches to an exudate canister to carry exudate from the wound and encourage wound closure. The IHT dome and tubing are made of a medical grade thermoplastic elastomer, and the drapes and dome skirt are clear polyurethane films which are all common materials currently found in similar wound care products with established biocompatibility.

The provided text describes the NewEra Dome Kit, a Negative Pressure Wound Therapy (NPWT) system. Here's a breakdown of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Bench top performance and pressure testing: No specific sample size is mentioned for this testing. It's implied to be conducted in a laboratory setting (benchtop). Data provenance is not specified beyond being "bench top."
• Usability study: No specific sample size is mentioned for the usability study, only "individuals who represented actual potential users." The data is prospective, generated from the usability study.
• No specific details on countries of origin are provided.

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

There is no mention of experts being used to establish ground truth for the benchtop tests or the usability study in the provided text. The tests appear to be objective measurements (pressure, exudate removal, alarm function) and user performance.

4. Adjudication Method for the Test Set

No adjudication method is described for either the benchtop or usability testing. The benchtop tests likely involved direct measurement and observation. The usability study involved users applying the kit, and the "successful application" suggests a pass/fail outcome based on predefined criteria, not expert 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

The document does not describe an MRMC comparative effectiveness study or any involvement of AI. The device is a physical NPWT kit, 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 question is not applicable as the NewEra Dome Kit is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

• For the benchtop tests, the ground truth was based on objective physical measurements (e.g., pressure readings, observation of exudate removal, alarm activation) against predefined performance specifications.
• For the usability study, the ground truth was based on the successful completion of predefined tasks by representative users.

8. The Sample Size for the Training Set

The document does not describe a "training set" as the device is a physical product and not an AI/machine learning model that requires training data.

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

This question is not applicable for the reasons stated in point 8.

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