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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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Restrata® is intended for use in the management of wounds, including: Partial and full thickness wounds, pressure sores/ ulcers, diabetic ulcers, chronic vascular ulcers, tunneled / undermined wounds, surgical wound (e.g., donor site/ grafts, post-Mohs surgery, podiatric wounds, dehisced wounds), trauma wounds (e.g., abrasions, partial thickness burns, skin tears), and draining wounds.

Restrata® is a sterile, single use device intended for use in local management of wounds. Restrata® is a soft, white, conformable, non-friable, absorbable matrix that provides a moist environment for the body's natural healing process to occur. Restrata® is made from synthetic biocompatible materials and was designed to include a fibrous structure with high porosity, similar to native extracellular matrix. Restrata® is a porous matrix with a defined rate of resorption that provides a scaffold for cellular infiltration and vascularization before completely degrading via hydrolysis. The device permits the ingress of cells and soft tissue formation in the defect space / wound bed. The device does not contain any human or animal materials or tissues. Restrata® is terminally sterilized, in a single use double peel package in a variety of sizes in non-meshed and meshed configurations. Contents of the package are guaranteed sterile and non-pyrogenic unless the package has been opened or damaged. The subject device is a modification of the predicate device to include updated product labeling, a change in product size offerings, and a change in product design offerings.

The provided text is a 510(k) Summary for the Acera Surgical Restrata® wound matrix, seeking substantial equivalence to a predicate device. This type of document focuses on demonstrating that a new medical device is as safe and effective as a legally marketed device and does not typically include detailed studies with acceptance criteria, sample sizes, expert qualifications, or MRMC studies, as would be expected for an AI/ML powered device.

The "study" in this context is the submission and review process for substantial equivalence (510(k)), which primarily relies on demonstrating that the technological characteristics and performance of the new device are equivalent to a predicate device.

Here's an attempt to answer your questions based on the provided text, while acknowledging that many of your points are not directly addressed because this is not an AI/ML device submission:

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

The document doesn't explicitly state "acceptance criteria" in the way one might for a diagnostic performance study. Instead, the "acceptance criteria" can be inferred as demonstrating substantial equivalence to the predicate device (Restrata® Wound Matrix K170300) and the reference device (PriMatrix® Dermal Repair Scaffold K153690) across various technological characteristics. The reported device performance is presented as direct equivalence.

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

The document does not describe a "test set" in the context of a statistical study for device performance. It refers to the predicate device (Restrata® Wound Matrix K170300) and a reference device (PriMatrix® Dermal Repair Scaffold K153690). The "data" provenance for asserting equivalence comes from prior approvals and testing related to these predicate and reference devices, not new patient data or a specific test set for the subject device. The submission focuses on changes to the predicate device (updated labeling, new smaller size, and meshed design options) and argues these changes do not alter fundamental safety and effectiveness.

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. The ground truth here is the established safety and effectiveness of the predicate device, as determined by its original 510(k) clearance process. No new expert adjudication for a test set is reported for this specific submission, as it relies on equivalence to existing devices.

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

Not applicable. No new test set requiring expert 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

Not applicable. This device is a wound matrix, not an AI/ML-powered diagnostic or assistive tool.

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

Not applicable. This device is a wound matrix, not an AI/ML algorithm.

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

For this 510(k) submission, the "ground truth" is that the predicate device is safe and effective. The subject device demonstrates substantial equivalence by showing that its technological characteristics are the same or adequately similar to the predicate, and any differences (like new sizes or meshed configuration) do not raise new questions of safety or effectiveness. This is supported by relying on previously submitted and reviewed non-clinical testing (mechanical, biocompatibility) for the predicate device.

8. The sample size for the training set

Not applicable. No training set is involved as this is not an AI/ML device.

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

Not applicable. No training set is involved.

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The Phoenix Wound Matrix is intended for use in the management of wounds. Wound types include: Partial and fullthickness wounds, pressure ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/undermined wounds, surgical wounds (donor sites/grafts, post-Moh's surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, second degree burns, skin tears) and draining wounds.

The Phoenix Wound Matrix is a sterile, single use device intended for the management of wounds. The Phoenix Wound Matrix is a conformable, non-woven, fibrous, three-dimensional matrix. The Phoenix Wound Matrix is made from two types of polymer fibers: Poly(lactide-co-caprolactone) and Polyglycolic acid, which are bioabsorbed after degrading via hydrolysis.

This response is based on the provided text, which is a 510(k) submission summary for the Phoenix Wound Matrix. It's important to note that a 510(k) submission primarily focuses on demonstrating substantial equivalence to a predicate device, rather than proving the safety and effectiveness of new technology through a comprehensive clinical study with acceptance criteria and a detailed study design. Therefore, much of the requested information regarding detailed acceptance criteria, specific study designs (like MRMC), and ground truth establishment for AI/algorithm performance cannot be extracted from this document, as it pertains to a different type of regulatory submission (most often for novel AI/ML medical devices).

The document is a declaration of substantial equivalence for a wound matrix, not an AI/ML device. Therefore, the questions about acceptance criteria for AI algorithms, sample sizes for test and training sets, expert consensus, MRMC studies, and ground truth establishment are not applicable in this context.

However, I can extract information related to the device's performance testing from the "Performance Data" section.

Device: Phoenix Wound Matrix
Regulatory Pathway: 510(k) (seeking substantial equivalence to predicate devices)

1. Acceptance Criteria and Reported Device Performance

Since this is a traditional medical device (wound matrix) and not an AI/ML device, the "acceptance criteria" are not defined as statistical metrics for an algorithm's performance (e.g., sensitivity, specificity, AUC). Instead, they relate to biocompatibility, mechanical properties, and non-inferiority in wound healing.

2. Sample Size and Data Provenance for the Test Set

• Sample Size for Test Set: Not explicitly stated in terms of number of wounds or animals. The text only mentions "an animal wound healing study in a porcine model."
• Data Provenance: The study was an "animal wound healing study in a porcine model." This implies a controlled laboratory setting, likely in the US given the FDA submission. It is by nature a prospective experiment in an animal model, not retrospective human data.

3. Number of Experts and Qualifications for Ground Truth

• Not applicable. This device is a wound dressing, not an AI/ML diagnostic device requiring expert interpretation for ground truth establishment. The performance data is based on direct biological and mechanical testing.

4. Adjudication Method for the Test Set

• Not applicable. As above, no human expert adjudication is described for the performance testing of this physical device.

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

• No. This is not an AI/ML diagnostic or image-based device. An MRMC study is not relevant for evaluating the performance of a wound matrix.

6. Standalone (Algorithm Only) Performance

• Not applicable. There is no algorithm associated with this physical wound matrix device for standalone performance evaluation.

7. Type of Ground Truth Used

• Biological and Physical Measurements: For biocompatibility, the ground truth is established by standard ISO 10993 biological assays (e.g., cell viability for cytotoxicity, skin reaction for irritation/sensitization, histological examination for implantation studies). For mechanical properties, it's defined by laboratory stress/strain measurements. For wound healing, it's based on observed healing progression in the animal model.

8. Sample Size for the Training Set

• Not applicable. This device does not use machine learning or AI models, so there is no concept of a "training set."

9. How Ground Truth for Training Set was Established

• Not applicable. As there is no training set, this question is irrelevant.

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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 SupraSDRM Biodegradable Matrix Wound Dressing is indicated for use in the management of:

• Partial and full thickness wounds
• Pressure (stage I and IV) and venous ulcers
• Ulcers caused by mixed vascular etiologies
• Venous stasis and diabetic ulcers
• 1st and 2nd degree burns
• Partial thickness burns
• Cuts and abrasions
• Acute wounds
• Trauma wounds
• Surgical wounds
• Superficial wounds
• Grafted wounds and donor sites

The SupraSDRM Biodegradable Matrix Wound Dressing is a tri-polymer, Biodegradable dermal covering that is provided in a flat sheet. The SupraSDRM Biodegradable Matrix Wound Dressing can be cut with scissors to the desired shape and size. The SupraSDRM Biodegradable Matrix Wound Dressing is fully malleable at room temperature and becomes more pliable at body temperature and thus can be conformed three dimensionally to most any anatomical orientation. The SupraSDRM Biodegradable Matrix Wound Dressing can be used either alone or in conjunction with a petroleum jelly and/or gauze wound and burn dressing which can also serve to further secure the SupraSDRM Biodegradable Matrix Wound Dressing and prevent dislocation. The PolyMedics Innovations (PMI) SupraSDRM Biodegradable Matrix Wound Dressing is provided in various shapes such as rectangles, ovals, and circles and will be provided in other shapes and sizes as needed for particular wound and burn-care applications. The PolyMedics Innovations (PMI) SupraSDRM Biodegradable Matrix Wound Dressing is provided in sheets of 50mm x 50mm to 180mm to 230mm and will be provided in other shapes and sizes as needed for particular burn and wound-care applications. The thickness of the PolyMedics (PMI) SupraSDRM Biodegradable Matrix Wound Dressing ranges from 1,500um to 2,100um according to the region to be treated. The PolyMedics Innovations (PMI) SupraSDRM Biodegradable Matrix Wound Dressing is provided in solid sheets that contain micropores that range in size from 13um to 300um.

This document is a 510(k) premarket notification for the SupraSDRM Biodegradable Matrix Wound Dressing. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than undergoing a new, independent evaluation of safety and effectiveness, which would involve acceptance criteria and a study design as typically understood for new medical devices.

Therefore, the provided text does not contain the information requested regarding acceptance criteria and a study demonstrating the device meets those criteria, largely because it's a submission for substantial equivalence.

Instead, the document highlights the device's equivalence to predicate and reference devices based on:

1. Indications for Use: The SupraSDRM dressing has the same indications as the predicate and reference devices for managing various wounds and burns.
2. Design and Materials: Similarities in physical form (sterile, single-use, flat, thin, rectangular sheets, flexible, semi-rigid, cuttable), dimensions (thickness, size), porosity, mass per unit area, and material composition are noted. Specifically, it mentions the SupraSDRM and Suprathel devices are fabricated from the same tri-polymer, and the SupraSDRM and Iodophor Foam Dressing are fabricated from the same polyvinyl alcohol material.
3. In Vitro Testing: Mechanical tensile strength, inherent viscosity, biocompatibility (ISO 10993-5 and -10), sterilization validations (EN ISO 11137-1), and package seal integrity tests were performed. These tests compare the SupraSDRM to the predicate device under specific in vitro conditions, not a clinical study to prove acceptance criteria for device performance in patients.
4. Chemical and Physical Characteristics Comparison: A comparison was made for material composition, percentages of specific polymers, inherent viscosity, glass transition temperature, porosity, product thickness, and manufacturing process between SupraSDRM and the predicate device.

To directly answer your questions based only on the provided text, while noting the limitations of a 510(k) submission:

1. Table of acceptance criteria and reported device performance:
   The document does not explicitly list "acceptance criteria" and "reported device performance" in the typical sense of a clinical trial demonstrating efficacy endpoints. Instead, it details characteristics and in-vitro test results used to demonstrate equivalence to predicate devices.

   Characteristic/Test	SupraSDRM Biodegradable Matrix Wound Dressing Performance / Specification	Predicate/Reference Device Performance / Specification
   Indications for Use	Management of partial/full thickness wounds, pressure/venous/diabetic ulcers, 1st/2nd degree burns, cuts, abrasions, acute/trauma/surgical/superficial/grafted wounds and donor sites.	Same as SupraSDRM
   Design Features	Sterile, single use, flat, thin, rectangular, flexible, semi-rigid, cuttable.	Same as SupraSDRM
   Thickness	1,500um to 2,100um (sheets), 50um - 2100um (general)	50um - 2100um
   Size	50mm x 50mm to 180mm x 230mm	50mm x 50mm to 180mm x 230mm
   Pore Size	13um to 300um (solid sheets with micropores), 5um - 300um (general)	5um - 300um
   Porosity	Not explicitly stated as a single value for SupraSDRM; general equivalence to range of 85-98%.	85-98%
   Mass per unit area	Not explicitly stated as a single value for SupraSDRM; general equivalence to range of 45-150 g/m2.	45-150 g/m2
   Material Composition	Tri-polymer of polylactide, trimethylene carbonate, ε-caprolactone and polyvinyl alcohol. Specifically poly(DL-lactide-co-trimethylene carbonate-co-ε-caprolactone) (same as Suprathel) and polyvinyl alcohol (same as Iodophor Foam Dressing).	Suprathel: poly(DL-lactide-co-trimethylene carbonate-co-ε-caprolactone). Iodophor Foam Dressing: polyvinyl alcohol.
   Mechanical Tensile Strength	Performed and compared to predicate device in saline conditions (37℃, various times).	Data for predicate device used for comparison. No specific numeric criteria or results provided.
   Inherent Viscosity	Performed and compared to predicate device in saline conditions (37℃, various times).	Data for predicate device used for comparison. No specific numeric criteria or results provided.
   Biocompatibility	Tested successfully per ISO 10993-5 (Cytotoxicity) and ISO 10993-10 (Irritation and Skin Sensitization).	Implied predicate devices are biocompatible.
   Sterilization Validation	Validated per EN ISO 11137-1.	Implied predicate devices are sterilized.
   Package Seal Integrity	Evaluated per ANSI/AAMI/ISO 11607-1 and 11607-2.	Implied predicate devices have validated packaging.
   Stability	Evaluated for inherent viscosity, product thickness, glass transition temperature, residual monomer, and residual excipients.	Not detailed, but implied to be acceptable for predicate devices.

2. Sample size used for the test set and the data provenance: Not applicable. This document describes a 510(k) submission, not a clinical trial with a "test set" in the context of device performance in patients. The "tests" mentioned (in-vitro, physical/chemical comparisons) would have their own sample sizes for laboratory specimens, but these are not provided in the summary. Data provenance is not specified beyond "in vitro" testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth, in the sense of clinical outcomes or expert consensus for a clinical study, is not part of this 510(k) documentation.

4. Adjudication method: Not applicable. There is no clinical study with adjudication described.

5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable. This is not an AI-assisted diagnostic device, and no MRMC study is mentioned.

6. Standalone performance (algorithm only without human-in-the-loop performance): Not applicable. This is a wound dressing, not an algorithm or AI device.

7. The type of ground truth used: Not applicable in the clinical trial sense. The "ground truth" for the 510(k) was the performance and characteristics of the legally marketed predicate devices, against which the new device was compared using physical, chemical, and in-vitro biological testing.

8. The sample size for the training set: Not applicable. This is not an AI/ML device where a "training set" would be relevant.

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

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Restrata™ Wound Matrix is intended for use in the management of wounds, including: Partial and full thickness wounds, pressure sores/ ulcers, diabetic ulcers, chronic vascular ulcers, tunneled / undermined wounds, surgical wound (e.g., donor site/ grafts, post-Mohs surgery, podiatric wounds, wound dehiscence), trauma wounds (e.g., abrasions, partial thickness burns, skin tears), and draining wounds.

The Restrata™ Wound Matrix is a sterile, single use device intended for use in local management of wounds. The Restrata™ Wound Matrix is a soft, white, conformable, non-friable, absorbable matrix that acts as a protective covering for wound defects, providing a moist environment for the body's natural healing process to occur. Restrata™ is made from synthetic biocompatible materials and was designed to include a fibrous structure with high porosity, similar to native extracellular matrix. Restrata™ is a porous matrix with a defined rate of resorption that provides a scaffold for cellular infiltration and vascularization before completely degrading via hydrolysis. The device permits the ingress of cells and soft tissue formation in the defect space / wound bed. The device does not contain any human or animal materials or tissues. Restrata™ Wound Matrix is supplied terminally sterile, in a single use double peel package in a variety of sizes. Contents of the package are guaranteed sterile and non-pyrogenic unless the package has been opened or damaged.

The provided text is a 510(k) Summary for the Acera Surgical Restrata™ Wound Matrix. This document describes the device, its intended use, and its technological characteristics as part of a premarket notification to the FDA to demonstrate substantial equivalence to an already legally marketed predicate device.

Key takeaway: This document is not a study proving a device meets acceptance criteria, but rather a submission to the FDA demonstrating substantial equivalence. Therefore, much of the requested information about acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment will not be found in this type of regulatory submission. The 510(k) process focuses on demonstrating similarity to an existing device, rather than proving a device meets specific, predefined performance metrics through a clinical study with acceptance criteria.

However, I can extract the information that is present and explain why other information is not available:

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

The document does not present a table of specific, numeric acceptance criteria with corresponding device performance metrics. Instead, it demonstrates equivalence through comparative tables of characteristics and references to performance data.

From the "Technological Characteristics" section, a comparative table is provided:

Performance Data Summary:

• "The subject device has mechanical properties (tensile strength and suture pull-out strength) equivalent or superior to the reference device." (No specific numerical values or acceptance criteria are stated).
• "The subject device was also tested against a commercially available wound dressing with the same intended use in a clinically relevant full thickness porcine wound model. Analysis included an assessment of biocompatibility, along with macroscopic assessment of wound healing, planimetric measurement of wound closure, and histopathology. Test results showed that the subject device had an equivalent wound healing response compared to the control article, and exhibited no adverse tissue responses." (Again, no specific numerical outcomes or acceptance criteria are provided; the finding is "equivalent").

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

• Sample size: Not explicitly stated. The "Performance Data" section mentions a "clinically relevant full thickness porcine wound model," implying animal testing, but the number of animals or wounds tested is not specified.
• Data provenance: The performance data comes from non-clinical testing (mechanical properties and a porcine wound model). The country of origin for the data is not specified, nor is whether the study was retrospective or prospective (though animal model studies are inherently prospective).

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

• This information is not provided. Since the described tests are primarily non-clinical (mechanical and animal model), the concept of "experts establishing ground truth for a test set" in the context of human data (e.g., radiologists for imaging) does not directly apply. For the animal study, the assessment of "equivalent wound healing response" and "no adverse tissue responses" would have been made by researchers/veterinarians/pathologists, but their number and specific qualifications are not detailed in this summary.

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

• This information is not provided and is generally not applicable to the non-clinical tests described in this 510(k) summary. Adjudication methods are typically used in clinical studies involving interpretation of human data.

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 study was performed or described. This document is for a physical medical device (wound matrix), not an AI/software device that assists human readers.

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

• Not applicable, as this is a physical medical device, not an algorithm.

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

• For the mechanical properties, the "ground truth" would be established by standardized mechanical testing methods.
• For the porcine wound model, the "ground truth" was established through "macroscopic assessment of wound healing, planimetric measurement of wound closure, and histopathology." This is effectively a combination of direct observation, quantitative measurement, and microscopic pathology, as assessed by the researchers of that study.

8. The sample size for the training set

• Not applicable. This is a physical device being submitted via 510(k), not an AI/machine learning algorithm that requires a training set. The "testing" referred to is for device performance, not algorithm training.

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

• Not applicable, as there is no training set for a physical device.

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The Mirragen™ Advanced Wound Matrix is intended for use in the management of wounds. Wound types include: Partial and full-thickness wounds, pressure ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/undermined wounds (donor sites/grafts, post-Moh's surgery, post laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, first and second degree burns, skin tears) and draining wounds.

The Mirragen™ Advanced Wound Matrix is composed solely of biocompatible and resorbable borate glass fibers and particulate. The borate glass constituent is medical-grade. The device is a resorbable fiber dressing that covers the wound. It may be used for a period of 3 to 7 days. The porosity of the device allows for absorption of fluid.

This document describes the Mirragen™ Advanced Wound Matrix and its substantial equivalence to predicate devices, but it does not provide specific acceptance criteria or a study designed to prove the device meets such criteria in the format requested.

The document is a 510(k) summary for the device, which aims to demonstrate that a new medical device is at least as safe and effective as a legally marketed predicate device. This is different from a performance study demonstrating a device meets predefined numerical acceptance criteria for, for example, diagnostic accuracy.

Therefore, most of the requested information cannot be directly extracted from the provided text.

Here's an attempt to answer based on the information available, highlighting what is not provided:

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

This information is not provided in a quantified, tabular format within the document. The document states that the device "meets its specifications" and "functioned as intended," and showed "similar wound healing response" to predicate devices, but no specific numerical acceptance criteria or performance metrics are given.

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

• Sample Size for Test Set: Not explicitly stated as a numerical sample size for a test set. The document refers to "samples of the Mirragen™ dressing" for characterization and states, "The dressing was also tested against the predicate devices in full and partial thickness wounds in a clinically relevant porcine model." The number of porcine subjects or wounds is not specified.
• Data Provenance: The document does not specify the country of origin for the data. The porcine model study would be considered prospective for that specific animal study.

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/provided. The studies described are preclinical (bench testing and animal studies), not clinical studies involving human expert assessment for ground truth.

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

This information is not applicable/provided. The studies described are preclinical.

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/provided. The device is a wound matrix, not an AI-powered diagnostic device, and no MRMC study is mentioned.

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

This information is not applicable/provided. The device is a wound matrix, not an algorithm.

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

• For the preclinical characterization tests, the "ground truth" would be the direct measurements and observations of the physical and chemical properties of the device (e.g., mass, density, composition, dissolution time, fluid absorption capacity).
• For the porcine wound healing study, the "ground truth" was established through:
  • Macroscopic assessment of wound healing
  • Planimetric measurement of wound closure
  • Histopathology
  • Histomorphometry
    These are objective measurements and histological examinations rather than expert consensus on subjective findings.

8. The sample size for the training set

This information is not applicable/provided. The device is a physical wound matrix, not a machine learning model that requires a training set.

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

This information is not applicable/provided. The device is a physical wound matrix, not a machine learning model.

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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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