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Foundation DRS Solo is indicated for the management of wounds including:

• · Full thickness and partial thickness wounds
• Pressure ulcers
• Venous ulcers
• · Ulcers caused by mixed vascular etiologies
• · Diabetic ulcers
• · First degree burns
• · Partial thickness burns (superficial second-degree burns)
• · Donor sites and other bleeding surface wounds
• · Abrasions
• · Trauma wounds (abrations, lacerations, skin tears)
• · Dehisced wounds
• · Surgical wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence)

Foundation DRS Solo may be cut to size.

Foundation DRS Solo is a highly conformable, advanced wound care device comprising a porous matrix of chitosan derived from shellfish and sodium chondroitin sulfate, a glycosaminoglycan. The chitosan- glycosaminoglycan biodegradable, porous matrix provides a scaffold for cellular invasion and capillary growth. The device is applied on the surface of the wound, and provides a moist wound environment. The dressing may be replaced or may remain in place, acting as a scaffold to promote cellular infiltration and capillary growth as the dressing degrades.

This document, a 510(k) Premarket Notification summary for the Foundation Dermal Regeneration Scaffold (DRS) Solo, does not describe an AI/ML powered medical device or a study involving human readers and AI assistance for diagnostic purposes.

Instead, this document pertains to a medical device that is a dermal regeneration scaffold for wound management. The "acceptance criteria" discussed are related to the safety and performance of this physical wound dressing, not the accuracy or performance of an AI algorithm.

Therefore, I cannot provide the requested information about acceptance criteria for an AI device, sample size for test sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance, as these concepts are not applicable to the device described in the provided text.

The "Summary of Nonclinical Testing" section (page 4-5) lists the studies conducted to demonstrate the safety and performance of the Foundation DRS Solo. These include biocompatibility tests, bacterial endotoxins testing, chemical characterization, sterilization validation, packaging validation, and a Wound Healing Study in a Porcine Model. The document states that "All tests found the device to meet study endpoints and meet acceptance criteria," but it does not specify what those exact acceptance criteria were for each test.

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PELNAC™ Bilayer Wound Matrix is indicated for the management of wounds including:

• · partial and full-thickness wounds,
• · pressure ulcers,
• · venous ulcers,
• · diabetic ulcers,
• · chronic 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 device is intended for one-time use.

PELNAC™ Bilayer Wound Matrix is a collagen-based wound matrix that consists of two layers: a porcine collagen sponge layer and a silicone film layer and is offered in two versions: 1. Meshed Type (i.e., fenestrated) and 2. Non-Meshed Type (i.e., non-fenestrated). The collagen sponge layer should be applied to the wound surface. Both versions of the device also contain a synthetic gauze material to add strength to the silicone film layer. When applied to full-thickness skin defects, PELNAC™ Bilayer Wound Matrix provides a scaffold for cellular invasion and capillary growth. PELNAC™ Bilayer Wound Matrix is offered in sheet form of various sizes and is provided terminally sterilized by ethylene oxide, is for single patient use, and can only be applied to a patient by a qualified doctor in a professional setting for the management of full-thickness skin defects as described in its product labeling.

This document is a 510(k) premarket notification for the PELNAC™ Bilayer Wound Matrix. It primarily focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a study proving that an AI/software device meets specific performance acceptance criteria for diagnostic tasks.

Therefore, most of the requested information regarding acceptance criteria for AI/software, sample sizes for test sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, and training set details are not applicable to this document. This submission is for a material device (wound matrix) and the "study" mentioned is a human repeat insult patch test (HRIPT) and a clinical follow-up for a tissue-based medical device.

However, I can extract information related to the device's safety and performance testing as presented in the document, which serves a similar role to "acceptance criteria" for a physical medical device.

Acceptance Criteria and Study for PELNAC™ Bilayer Wound Matrix

The "acceptance criteria" for this device are established through demonstrating its substantial equivalence to a legally marketed predicate device (AVAGEN Wound Dressing) and conformity to recognized standards and guidance. The "study" refers to non-clinical and clinical testing performed to support this claim.

1. Table of "Acceptance Criteria" and Reported Device Performance

Since this is a physical medical device and not an AI/software, the "acceptance criteria" are not reported as diagnostic performance metrics (e.g., sensitivity, specificity). Instead, they are related to biocompatibility, sterility, physical/chemical properties, and clinical safety/tolerance. The "reported device performance" indicates whether the device met these established safety and performance benchmarks.

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

• Non-Clinical (In vitro/Bench/Animal Studies): The document states "final finished samples of PELNAC™ Bilayer Wound Matrix" were tested, but specific sample sizes for these tests (biocompatibility, physical/chemical, sterility, packaging) are not provided.
• Clinical Data:
  • Human Repeat Insult Patch Test (HRIPT): 56 subjects.
  • Finger Degloving Injuries Pilot Study: 18 subjects.
• Data Provenance: Not explicitly stated for all non-clinical tests. For the clinical studies:
  • The HRIPT and the finger degloving study were likely conducted by or sponsored by the manufacturer (Gunze Limited), which is based in Japan. The document does not specify the country of origin for the clinical data points, nor whether they were retrospective or prospective studies, though the nature of HRIPT and follow-up studies typically implies a prospective design.

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

• This device is a material device, not an AI/software. There is no "ground truth" to be established by experts in the context of image interpretation or diagnostic accuracy. The "ground truth" for the clinical study would be observed physiological responses to the device (irritation, sensitization, healing, lack of adverse immune response), assessed by qualified medical professionals involved in the study (e.g., dermatologists for HRIPT, surgeons for the finger injury study). The number and qualifications of these medical professionals are not specified in the provided text.

4. Adjudication Method for the Test Set:

• Not applicable for this type of medical device submission. Adjudication methods are typically relevant for human reader studies or expert consensus for ground truth establishment in AI/software evaluations. Clinical observations for this device would be direct assessments by the treating/evaluating clinicians.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and effect size:

• No, an MRMC comparative effectiveness study was not conducted. This type of study is relevant for diagnostic imaging AI, not for a wound matrix medical device. The "clinical studies" described (HRIPT, finger degloving) are safety and performance studies for a material device, not diagnostic effectiveness studies comparing human readers with and without AI assistance.

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

• Not applicable. This is not an algorithm or AI device.

7. The Type of Ground Truth Used:

• For Biocompatibility and Physical/Chemical Testing: The "ground truth" is adherence to established international standards (e.g., ISO 10993 series) and internal specifications, derived from scientific understanding of material safety and performance.
• For Clinical Studies (HRIPT, Finger Degloving): The "ground truth" is direct clinical observation and objective measurement of patient responses (e.g., absence of skin irritation/sensitization, absence of specific immune responses, healing progression, histological analysis reports). This is based on outcomes data and clinical assessment by medical professionals.

8. The Sample Size for the Training Set:

• Not applicable. This is not an AI/machine learning device. There is no "training set" in the context of algorithm development.

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

• Not applicable. As there is no training set for an algorithm, there is no ground truth establishment for it.

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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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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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