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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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For over-the-counter use, Exufiber Ag+ may be used for:

• · Abrasions
• · Lacerations
• Minor cuts
• · Minor scalds and burns

Under the supervision of a healthcare professional, Exufiber Ag+ is intended to be used on the following medium to high exuding wounds:

• · Leg ulcers (venous stasis ulcers and ulcers and ulcers of mixed etiology) and diabetic foot ulcers
• · Pressure ulcers (partial and full thickness)
• Partial thickness burns
• · Donor sites and other wounds that are prone to bleeding, such as debrided wounds
• Traumatic wounds
• Surgical wounds that heal by primary intention, such as dermatological incisions (e.g. orthopaedic and vascular), and surgical wounds left to heal by secondary intention, such as dehisced surgical incisions
• · Oncology wounds with exudate, such as fungoides-cutaneous tumours, fungating carcinoma, cutaneous metastasis, Kaposi's sarcoma and angiosarcoma

Exufiber Ag+ may be used for management of wounds as an effective barrier to bacterial penetration of the dressing, as this may help to reduce the risk of infection.

Indicated wear time: up to seven (7) days.

Exufiber Ag+ Antimicrobial Gelling Fibre Dressing is a highly absorbent and gel-forming wound dressing that is intended to be used on medium to high exuding wound fluid, creating a soft gel and maintaining a moist wound healing environment. The dressing consists of a polyvinyl alcohol (PVA) pad or ribbon, coated on both sides with silver sulfate to act as a preservative in the dressing to inhibit or reduce microbial growth.

The provided document is a 510(k) Summary for the "Exufiber Ag+ Antimicrobial Gelling Fibre Dressing" and mainly focuses on demonstrating substantial equivalence to a predicate device ("Aquacel Ag Extra Hydrofiber Dressing with Silver and Strengthening Fiber"). It does not include detailed information about specific acceptance criteria and a study proving the device meets those criteria, as one would expect for a performance study with detailed metrics.

Instead, the document states: "In vitro and in vivo methods have been used to demonstrate the safety and effectiveness of the Exufiber Ag+ Antimicrobial Gelling Fibre Dressing with regards to the following parameters: Cytotoxicity, Irritation, Sensitization, Wound healing model, Antimicrobial efficacy against 11 strains, Silver release kinetics, Minimum effective concentration." It also explicitly states: "No clinical data was required to support substantial equivalence."

Therefore, I cannot provide the requested information in the format of a table of acceptance criteria and reported device performance based on the input text. The information is not present in this regulatory submission.

However, I can extract the general categories of performance data mentioned:

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

The document does not provide a table with specific acceptance criteria (e.g., "cytotoxicity level must be below X") or detailed quantitative reported device performance for these criteria. It only lists the types of tests performed to demonstrate safety and effectiveness.

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

This information is not provided in the document. The studies mentioned are described as "in vitro and in vivo methods," which typically refer to laboratory and animal studies, not human clinical trials in this context.

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 provided in the document. Ground truth as typically understood in AI/imaging studies (e.g., expert consensus on image interpretation) is not relevant for the types of in vitro and in vivo safety/effectiveness studies mentioned in this 510(k) summary.

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

This information is not provided in the document, as it's not applicable to the types of studies described (laboratory and animal studies for safety and effectiveness).

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

A multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned and is not applicable to an antimicrobial gelling fibre dressing. The document explicitly states "No clinical data was required to support substantial equivalence."

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

This concept is not applicable to a medical device like a wound dressing. This device does not involve an algorithm or AI.

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

For the mentioned studies:

• Cytotoxicity, Irritation, Sensitization: Likely based on standardized biological assay results (e.g., cell viability, skin reactions) compared against established safety thresholds.
• Wound healing model: Likely based on observable physiological changes and measurements in an animal model, compared to controls.
• Antimicrobial efficacy: Likely based on laboratory measurements of bacterial count reduction (e.g., colony-forming units) after exposure to the dressing, compared to specified acceptance criteria.
• Silver release kinetics: Likely based on analytical chemistry measurements of silver concentration over time.
• Minimum effective concentration: Likely based on microbiology experiments to determine the lowest concentration of silver needed to inhibit microbial growth.

8. The sample size for the training set

This is not applicable as the device is a physical wound dressing and does not involve a training set or AI model.

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

This is not applicable as the device is a physical wound dressing and does not involve a training set or AI model.

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