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NovoSorb BTM is indicated for use in the management of wounds including: partial and full thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic and vascular ulcers, surgical wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, second-degree burns, and skin tears) and draining wounds.

The NovoSorb BTM device has been modified to expand the available thickness of the foam component from 2 mm to 2-6 mm. Sizes are limited to a maximum volume of 160 cm³. The device continues to be a porous, biodegradable, polyurethane foam, adhered to a fenestrated transparent sealing membrane. The sealing membrane is designed to physiologically close the wound limiting evaporative moisture loss during integration of the foam. The sealing membrane is to be removed and discarded when appropriate, leaving only the foam layer to biodegrade in patients.

NovoSorb BTM is a terminally sterilized, single use device intended for deep partial and full thickness wounds. Each NovoSorb BTM is packed in a transparent polymer pouch, enclosed in an aluminized pouch. A product label is placed on the pouch. The aluminized pouch together with an instruction for use is individually packaged in a cardboard envelope and a product label is placed on the envelope.

It appears there might be a misunderstanding of the provided FDA 510(k) clearance letter. The document is for a medical device called "NovoSorb BTM," which is a wound dressing. This device is a physical medical device (a porous, biodegradable, polyurethane foam), not an AI/software-based medical device.

Therefore, the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of AI (e.g., sample size for test/training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone algorithm performance) is not applicable to this submission.

The 510(k) summary clearly states:

• "No clinical tests were performed; determination of substantial equivalence was not based on an evaluation of clinical performance data."
• "PolyNovo believes the modified NovoSorb BTM device is substantially equivalent to the legally marketed predicate devices NovoSorb BTM (K172140) and NovoSorb MTX (K242149), because no differences in technological characteristics exist between different foam thicknesses as there is no change to the foam density for different foam thicknesses."

The "acceptance criteria" for this device, as described in the non-clinical tests section, relate to physical and mechanical properties of the wound dressing, not diagnostic performance based on AI.

Below is a brief summary of how the device met its acceptance criteria, based only on the provided document, without attempting to fit it into an AI study framework:

Acceptance Criteria and Study for NovoSorb BTM (Physical Medical Device)

The NovoSorb BTM is a physical wound dressing device, not an AI or software-based diagnostic tool. Therefore, the acceptance criteria and supporting studies are based on the physical, mechanical, and biological properties of the material and its substantial equivalence to previously cleared predicate devices, rather than AI performance metrics.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated. The verification testing would involve a sufficient number of device samples to demonstrate consistency in manufacturing and material properties.
• Data Provenance: The data are from non-clinical bench testing. No geographical or temporal provenance is specified, as the tests are against material and mechanical standards for the device itself rather than patient data. The tests are prospective in the sense that they are performed on newly manufactured devices to demonstrate compliance.

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

• This concept is not applicable. "Ground truth" for this device relates to established engineering and material science standards for physical device properties (e.g., material composition confirmed by analytical chemistry, mechanical properties confirmed by engineering tests). It does not involve expert consensus on medical image interpretation or clinical outcomes.

4. Adjudication Method for the Test Set

• Not applicable. Adjudication methods are typically used in clinical studies or AI evaluations to resolve discrepancies among human readers or algorithm outputs. For physical device testing, the results are objective measurements against predefined specifications.

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

• No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation (often with AI assistance). The submission explicitly states: "No clinical tests were performed; determination of substantial equivalence was not based on an evaluation of clinical performance data."

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done

• Not applicable. This device is not an algorithm or software. It is a physical wound dressing.

7. The Type of Ground Truth Used

• The "ground truth" for this device's acceptance is based on established engineering specifications, material science standards, and performance characteristics of the predicate devices. This includes:
  • Chemical composition (e.g., polyurethane).
  • Physical properties (e.g., density, porosity, pore size).
  • Mechanical properties (e.g., strength, durability).
  • Sterility assurance level (SAL).
  • Packaging integrity.

8. The Sample Size for the Training Set

• Not applicable. This device is not an AI model, and therefore, there is no "training set."

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

• Not applicable. As there is no AI model or training set, the concept of establishing ground truth for it does not apply.

In summary, the FDA 510(k) for NovoSorb BTM is a clearance based on substantial equivalence to existing predicate devices, supported by non-clinical bench testing that confirms the modified device maintains the same physical, material, and performance characteristics. The detailed questions about AI study methodologies are not relevant to this specific device submission.

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NovoSorb® MTX is indicated for the management of wounds including: partial and full thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic and vascular ulcers, tunneled/ undermined wounds, surgical wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, second-degree burns, and skin tears) and draining wounds. The device is intended for single use only.

NovoSorb® MTX is a fully synthetic biodegradable device that is composed of a single foam layer. The foam is a 2-6 mm thick, white, open cell degradable foam with a high degree of porosity (>90%) providing a scaffold for dermal tissue integration. NovoSorb® MTX will be supplied in sizes ranging from 4 cm2 to 800 cm2 with a maximum volume of 160 cm³.

NovoSorb® MTX is a terminally sterilized, single use device intended for deep partial and full thickness wounds. It is intended for use by qualified healthcare professionals in a hospital/clinical environment and is not intended for use at home.

Each NovoSorb® MTX is packed in a transparent polymer pouch, enclosed in an aluminized pouch. A product label is placed on the pouch. The aluminized pouch together with an instruction for use is individually packaged in a cardboard envelope and a product label is placed on the envelope.

The provided FDA 510(k) summary for NovoSorb® MTX (K242149) does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria in the context of an AI/algorithm-driven device.

This submission is for a medical device that is a wound dressing, not an AI or algorithm-based diagnostic or prognostic tool. Therefore, the concepts of "acceptance criteria" related to algorithm performance (like sensitivity, specificity, AUC), sample sizes for test sets, data provenance, expert ground truth establishment, MRMC studies, or standalone performance studies, and training set details are not applicable as described in your request.

The submission focuses on demonstrating substantial equivalence to a predicate wound dressing based on material properties, physical characteristics, mechanical strength, durability, and biocompatibility.

Here's a breakdown of why your specific questions cannot be answered from this document:

• 1. A table of acceptance criteria and the reported device performance: This document discusses performance in terms of physical characteristics, mechanical strength, durability, and a hydrolytic degradation study, as well as biocompatibility. These are typical for a physical medical product, not for an algorithm's diagnostic performance. There are no explicit "acceptance criteria" listed in a tabular format for algorithm performance.
• 2. Sample size used for the test set and the data provenance: Not applicable. There is no "test set" in the context of an AI algorithm evaluation. The document mentions testing of the device itself (e.g., hydrolytic degradation, mechanical properties) but not a dataset for an AI.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. There is no AI test set requiring expert-established ground truth.
• 4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
• 5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI-assisted device.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
• 8. The sample size for the training set: Not applicable. There is no AI training set.
• 9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document is a 510(k) summary for a physical medical device (a wound dressing) and does not contain any information about an AI or algorithm-based component.

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NovoSorb® Matrix is indicated for use in the management of wounds including: partial and full thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic and vascular ulcers, surgical wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, partial thickness burns, and skin tears) and draining wounds.

Not Found

I am sorry, but the provided text from the FDA 510(k) clearance letters for the NovoSorb® Matrix does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria.

The letters primarily address the administrative aspects of the 510(k) submission, confirming the device's substantial equivalence to a legally marketed predicate device and detailing regulatory guidelines for its marketing. They do not include details about:

• A table of acceptance criteria or reported device performance metrics.
• Sample sizes, data provenance, or details about test and training sets.
• Information on expert panels, ground truth establishment, or adjudication methods.
• Any multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.

Therefore, I cannot fulfill your request for this information based on the provided document. The 510(k) clearance process focuses on substantial equivalence, which often relies on comparison to existing devices rather than new performance studies demonstrating specific numerical acceptance criteria in the way described for an AI/ML medical device.

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The NovoSorb™ BTM Wound Dressing is indicated for use in the management of wounds including: partial and full thickness wounds, pressure ulcers, diabetic ulcers, chronic and vascular ulcers, surgical wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, second-degree burns, and skin tears) and draining wounds. The device is for single use only.

The NovoSorb™ BTM Wound Dressing device is a 2mm thick, porous, white biodegradable polyurethane foam bonded with a polyurethane adhesive layer to a fenestrated one-sided transparent sealing membrane. The sealing membrane is designed to physiologically close the wound limiting evaporative water loss during integration of the foam. The adhesive layer and sealing membrane are to be removed and discarded when appropriate leaving only the foam layer to biodegrade in patients.

NovoSorb™ BTM Wound Dressing device is supplied in various sizes, ranging from 4cm² to 800cm². The NovoSorb™ BTM Wound Dressing is a single use, terminally sterilized device, individually packed in a transparent polymer pouch enclosed in a white aluminized pouch contained in a cardboard envelope.

This FDA 510(k) letter ([K172140](https://510k.innolitics.com/search/K172140)) is a notification of an administrative change in product code for the NovoSorb™ BTM Wound Dressing and explicitly states that the submission was not re-reviewed (referencing document {0} and {1}). The original substantial equivalence determination was made on August 11, 2017.

The 510(k) summary (documents {4} and {5}) states that no clinical tests were performed, and the determination of substantial equivalence was not based on an evaluation of clinical performance data. Therefore, the provided documents do not contain information related to acceptance criteria, device performance, sample sizes, ground truth establishment, expert adjudication, or comparative effectiveness studies that would be typically associated with clinical studies for AI/ML devices.

The NovoSorb™ BTM Wound Dressing is described as a medical device for wound management, not an AI/ML device. The provided text refers to it as a "2mm thick, porous, white biodegradable polyurethane foam bonded with a polyurethane adhesive layer to a fenestrated one-sided transparent sealing membrane." (document {5}). The core of the 510(k) submission was a comparison to a predicate device (BTM Wound Dressing, [K142879](https://510k.innolitics.com/search/K142879)) based on technological characteristics and mechanical testing.

Thus, none of the requested information regarding acceptance criteria, study details, sample sizes, expert ground truth, or multi-reader studies can be extracted from the provided text for an AI/ML device, as this is a traditional medical device submission.

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The BTM Wound Dressing is indicated for the management of wounds including: partial and full thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic and vascular ulcers, surgical wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, second-degree burns, and skin tears) and draining wounds. The device is intended for one-time use.

The BTM Wound dressing is a biodegradable dermal covering that is comprised of three layers: Biodegradable Layer: 1. Foam A wound-facing, 2mm thick, white, open cell degradable foam with a high degree of porosity (>90%) designed to subsequently biodegrade. The foam is a biocompatible, biodegradable polyurethane material. Removable Layer: 2. Adhesive (bonding) layer A polyurethane bonding layer which bonds the Foam and Sealing Membrane together. 3. Sealing Membrane A transparent polyurethane membrane designed to physiologically close the wound and limit evaporative water loss. The sealing membrane is designed to remain attached to the dermal foam, if required, for at least 30 days in vivo. The BTM Wound dressing is supplied in various sizes, ranging from 10cm x 10cm, up to 20cm x 40cm. The dressings are single use, terminally sterilized devices, individually packed in a polymer pouch within an aluminized envelope.

The provided text describes a 510(k) summary for the BTM Wound Dressing (K142879), which seeks to demonstrate substantial equivalence to predicate devices rather than fulfilling specific acceptance criteria in the manner of a new device approval or AI/software device. Therefore, much of the requested information regarding acceptance criteria, specific device performance metrics, sample sizes for test sets, expert involvement, and ground truth establishment, which are typical for AI/software device evaluations, is not directly stated in this document.

However, I can extract and infer information relevant to the study of the BTM Wound Dressing as it relates to establishing substantial equivalence.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not present a table of specific acceptance criteria (e.g., sensitivity, specificity, accuracy targets) for the BTM Wound Dressing's performance against a quantifiable benchmark. Instead, it relies on demonstrating substantial equivalence to predicate devices in terms of indications for use, design, materials, mechanical properties, and non-clinical/clinical performance. The "performance" reported is related to biocompatibility and clinical safety.

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

• Test Set (Clinical Study): 14 patients
• Data Provenance: Clinical studies were conducted. The location (country of origin) is not explicitly stated, but the company is based in Australia. The studies appear to be prospective clinical studies, as they involve "patients requiring free flap surgery" and "patients undergoing BTM application at donor harvest sites," indicating active treatment and observation.

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

• This information is not provided. For a medical device like a wound dressing, the "ground truth" for clinical outcomes (e.g., graft failure, hematoma, LFTs) would typically be established by the treating physicians and clinical investigators involved in the study. Their qualifications are not detailed.

4. Adjudication Method for the Test Set

• This information is not provided. Clinical studies generally involve independent review or consensus among clinicians, but a specific adjudication method (like 2+1 or 3+1) is not mentioned. The adverse events were "deemed 'possibly related' to the BTM by the investigators," suggesting internal assessment among the study investigators.

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

• No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging or AI-assisted interpretation, which is not applicable to a physical wound dressing device. This device is not an AI or software device.

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

• No, a standalone algorithm performance study was not done. This device is a physical wound dressing, not an algorithm or AI.

7. The Type of Ground Truth Used

• For the clinical studies, the "ground truth" was based on clinical observation and patient outcomes data as assessed by the investigators, including reports of adverse events like graft failure, hematoma, and laboratory test results (LFTs). Comparison was made against published literature and control cohorts for similar procedures.

8. The Sample Size for the Training Set

• This concept is not applicable as this is a physical medical device (wound dressing), not an AI/machine learning model that requires a training set.

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

• This concept is not applicable as this is a physical medical device.

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NovoPore™ is intended to be used as part of a Negative Pressure Wound Therapy (NPWT) system. When used in conjunction with a NPWT system, it is intended to remove excess exudate, infectious material, and tissue debris from wounds which may promote wound healing. NPWT systems are indicated for use on chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), explored fistulas, flaps, and grafts.

The NovoPore™ Dressing is a polyurethane foam wound dressing used as an accessory to powered suction pumps. The single-use dressing is packaged in a peelable oriented polyamide / polyethylene bag and is sterilized by gamma irradiation. The NovoPore™ Dressing is available in one size: medium.

The NovoPore™ Dressing is a polyurethane foam wound dressing intended for use with Negative Pressure Wound Therapy (NPWT) systems. The study provided focuses on establishing substantial equivalence to predicate devices (KCI GranuFoam® and Genadyne A4-XLR8 Foam Dressing) through non-clinical performance data and does not involve human clinical trials for efficacy or effectiveness.

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

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally implied by demonstrating performance that is "substantially equivalent" or comparable to the predicate devices. For mechanical properties, the device aimed to show similar or better performance compared to the predicates.

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