FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

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.

AI/ML Overview

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:

Indications for Use: The SupraSDRM dressing has the same indications as the predicate and reference devices for managing various wounds and burns.
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.
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.
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:

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.

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.
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.
Adjudication method: Not applicable. There is no clinical study with adjudication described.
Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable. This is not an AI-assisted diagnostic device, and no MRMC study is mentioned.
Standalone performance (algorithm only without human-in-the-loop performance): Not applicable. This is a wound dressing, not an algorithm or AI device.
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.
The sample size for the training set: Not applicable. This is not an AI/ML device where a "training set" would be relevant.
How the ground truth for the training set was established: Not applicable.

Summary

Regulation Number and Section

N/A