TALIDERM™ is indicated for the management of wounds including: Diabetic ulcers Venous ulcers Pressure wounds Ulcers caused by mixed vascular etiologies Full thickness and partial thickness wounds Second degree burns Surgical wounds-donor sites/grafts, post-mohr's surgery, and other bleeding surface wounds Abrasions Traumatic wounds healing by secondary intention Dehisced surgical wounds.

Device Description

TALIDERM™ is a sterile primary wound dressing comprised of shortened fibers of poly-N-acetyl glucosamine, isolated from microalgae.

AI/ML Overview

This document is a 510(k) summary for a medical device called TALIDERM™, a wound dressing. It declares substantial equivalence to predicate devices based on biocompatibility and performance characteristics. However, it does not include detailed acceptance criteria or a study that proves the device meets those criteria, as typically found in clinical trial reports for devices that require them.

Here's an analysis of why the requested information cannot be fully provided based solely on the provided text, and what can be inferred:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not provide a specific table of acceptance criteria or quantitative performance metrics for TALIDERM™. Instead, it states:

"Results of scientific testing have ensured that the material is biocompatible, no new adverse effects were introduced and physical properties are appropriate for the intended use."
"Non-clinical testing was conducted. Animal testing was performed to simulate clinical conditions with no adverse effects noted."
"Clinical evidence further supported the safety and performance of TALIDERM™."

These are general statements affirming that testing was done and the outcomes were positive, but they do not define specific, measurable acceptance criteria (e.g., "wound closure rate > X%", "infection rate < Y%") or provide the actual numerical results against such criteria.

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

The document mentions "Clinical evidence further supported the safety and performance of TALIDERM™" but does not specify the sample size for any clinical or test set. It also does not mention the data provenance (e.g., country of origin, retrospective or prospective).

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

The document does not mention the use of experts to establish ground truth. It refers to "clinical evidence," but the specifics of how that evidence was generated, reviewed, or validated by experts are absent.

4. Adjudication Method:

Since there's no mention of experts or a formal review of test set data, there is no information on adjudication methods such as 2+1 or 3+1.

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

A MRMC study involves multiple human readers evaluating cases, often with and without AI assistance, to measure the impact of the AI. This document pertains to a wound dressing, not an AI/diagnostic device. Therefore, it is highly unlikely and not mentioned that an MRMC comparative effectiveness study was done for TALIDERM™.

6. Standalone Performance Study (Algorithm Only):

TALIDERM™ is a physical wound dressing, not an algorithm or software. Therefore, the concept of a "standalone algorithm only performance" study is not applicable to this device.

7. Type of Ground Truth Used:

The document vaguely refers to "Clinical evidence" and "Animal testing." For a wound dressing, the ground truth for safety and performance would typically involve clinical outcomes data (e.g., wound healing rates, infection rates, adverse events) and observed effects in animal models. However, the specific methodology for establishing this ground truth is not detailed.

8. Sample Size for the Training Set:

Since this is a physical wound dressing and not an AI/machine learning device, the concept of a "training set" in the context of statistical model development is not applicable. The document does not provide sample sizes for any studies that would be analogous to a training set.

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

Again, as this is not an AI/machine learning device, the concept of establishing ground truth for a training set is not applicable.

Summary of what can be extracted and what is missing:

This 510(k) summary explains that TALIDERM™ is a sterile primary wound dressing. The claim for substantial equivalence is based on "indication for use, biocompatibility and performance characteristics."

Acceptance Criteria & Performance: Not explicitly stated with quantitative metrics. General statements indicate biocompatibility, appropriate physical properties, and safety/performance supported by non-clinical (animal) and clinical evidence, with "no new adverse effects" and "no adverse effects noted" in animal testing.
Sample Size (Test Set): Not provided.
Data Provenance: Not provided.
Experts for Ground Truth: Not mentioned.
Adjudication Method: Not applicable/mentioned.
MRMC Study: Not applicable/mentioned.
Standalone Performance Study: Not applicable/mentioned.
Type of Ground Truth: Implied to be clinical outcomes and animal model observations, but not detailed.
Sample Size (Training Set): Not applicable/mentioned.
Ground Truth Establishment (Training Set): Not applicable/mentioned.

In conclusion, this 510(k) summary is a regulatory document affirming substantial equivalence based on a high-level review of various tests. It does not contain the detailed study information (specific acceptance criteria, sample sizes, expert involvement, or ground truth methodologies) one would expect from a clinical trial report or a submission for an AI-powered device.

Summary

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KO70557

Marine Polymer Technologies, Inc. TALIDERM Confidential

VIII. 510(k) Summary

MAY 2 3 2007

A. Sponsor/Submitter:

Marine Polymer Technologies, Inc. 107 Water Street Danvers, MA 01923 Phone: 781-270-3200 Fax: 781-270-1133

B. Contact Person

Sergio Finkielsztein President Phone: 781-270-3200 x 13

C. Date of Submission:

February 15, 2007

TALIDERM™

D. Trade (Brand) Name:

E. Common Name:

Dressing, Wound Hydrophilic

F. Classification Number/ Name:

Unclassified

G. Regulatory Class:

H. Product Code:

I. Predicate Devices:

Marine Polymer Technologies, Inc .- SyvekPatch (K984177) and SyvekNT(K022673) Marine Polymer Technologies, Inc. - RDH Bandage (K002550) Tissue Technologies Holdings LLC - TT101 Wound Care Dressing (K061060) TEI Biosciences Inc. Dress Skin (K023778) J&J Medical Ltd .- PROMOGRAN Matrix Wound Dressing (K014129)

FRO

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J. Intended Use:

TALIDERM™ is intended for use under the direction of a healthcare professional.

K. Device Description:

TALIDERM™ is a sterile primary wound dressing comprised of shortened fibers of poly-N-acetyl glucosamine, isolated from microalgae.

L. Summary of Substantial Equivalence:

Marine Polymer Technologies has submitted information on indication for use, biocompatibility and performance characteristics to establish that TALIDERMM is substantially equivalent to currently marketed predicate devices. TALIDERMIM has essentially the same intended use as the predicate devices. Results of scientific testing have ensured that the material is biocompatible, no new adverse effects were introduced and physical properties are appropriate for the intended use. Non-clinical testing was conducted. Animal testing was performed to simulate clinical conditions with no adverse effects noted. Clinical evidence further supported the safety and performance of TALIDERM™

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three overlapping wing segments. The eagle is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA", which is arranged in a circular fashion around the left side of the logo.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Marine Polymer Technologies % Mr. Sergio Finkielsztein President 107 Water Street Danvers, Massachusetts 01923

MAY 2 3 2007

Re: K070557

Trade/Device Name: Taliderm™ Regulatory Class: Unclassified Product Code: FRO Dated: April 12, 2007 Received: April 13, 2007

Dear Mr. Finkielsztein:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally

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Page 2 - Mr. Sergio Finkielsztein

marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115 Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Mellon

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Appendix 2:

Indications for Use Statement

INDICATIONS FOR USE

510(k) Number (if known) K 070557

Device Name TALIDERM™M

TALIDERMIM is indicated for the management of wounds including:

Diabetic ulcers

Venous ulcers

Pressure wounds

Ulcers caused by mixed vascular etiologies

Full thickness and partial thickness wounds

Second degree burns

Surgical wounds-donor sites/grafts, post-molu's surgery, and other bleeding surface wounds Abrasions

Traumatic wounds healing by secondary intention

Dehisced surgical wounds.

TALIDERM™ is intended for use under the direction of a healthcare professional.

Prescription Use (Per 21 C.F.R. 801.109) OR

Over-The-Counter Use (Optional Format 1-2-96)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH. Office of Bevice Evaluation (ODE)

(Division Sign-Off Division of General, Restorative, and Neurological Devices

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510(k) Number 10

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Regulation Number and Section

N/A