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The SyntheMed Device is a fragmentable nasal dressing and is indicated for use in patients undergoing nasal/sinus surgery as a space occupying stent to separate and prevent adhesions between mucosal surfaces.

The SyntheMed Device ("the device") is a single use, synthetic, bioresorbable polymeric film composed of polymers used extensively in implantable, absorbable medical devices. The device comprises bis(hydroxyl)-terminated PLA-PEG-PLA triblocks, where PLA = poly(lactic acid) and PEG = poly(ethylenc glycol). These PLA-PEG-PLA triblocks are chain extended to yicld the device's final high molecular weight polymer. This device functions to fill nasal/sinus cavities following surgery or trauma and to keep mucosal surfaces separate during the healing process. The device leaves the site of placement by natural elimination within 4 weeks, or it may be aspirated from the cavity earlier at the discretion of the physician.

This document is a 510(k) Pre-market Notification for the SyntheMed Device, a nasal dressing. It does not describe a study involving the device's performance against specific acceptance criteria in a quantitative manner as one might find for an AI/ML medical device. Instead, the submission focuses on demonstrating substantial equivalence to predicate devices.

Therefore, many of the requested elements for an AI/ML device study will not be applicable or available in this document. I will fill in the available information and explicitly state when information is not provided.

Here's the breakdown:

1. Table of Acceptance Criteria and Reported Device Performance

No explicit acceptance criteria with quantitative performance metrics are provided in this document. The entire submission is built around demonstrating substantial equivalence to predicate devices, rather than meeting novel performance criteria.

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

Not applicable. This is not a study measuring performance against a test set in the context of an AI/ML device. The "test" for this device is the comparison to predicate devices, which involves reviewing their characteristics and demonstrating similarity.

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 context of an AI/ML device performance study is not relevant here. The ground "truth" for substantial equivalence is based on regulatory definitions and comparisons to existing devices.

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

Not applicable. No 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 physical nasal dressing, not an AI/ML diagnostic tool. Therefore, an MRMC study related to human reader performance with or without AI assistance is not relevant.

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

Not applicable. This device is a physical product and does not involve an algorithm.

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

Not applicable. The "truth" in this submission is the regulatory concept of substantial equivalence, established by comparing the device's characteristics (indications, materials, function) to legally marketed predicate devices.

8. The sample size for the training set

Not applicable. This is not an AI/ML device requiring a training set.

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

Not applicable. This is not an AI/ML device requiring a training set with established ground truth.

Summary of the Study that Proves the Device meets the Acceptance Criteria (Substantial Equivalence):

The "study" described in the provided document is a comparative analysis for substantial equivalence as required for a 510(k) pre-market notification. The core of this "study" is outlined in Section 6, "Substantial Equivalence Summary".

• Objective: To demonstrate that the SyntheMed Device is substantially equivalent to legally marketed predicate devices, thereby establishing its safety and effectiveness.
• Methodology: The manufacturer, SyntheMed, Inc., compared the SyntheMed Device to three predicate devices: Polyganics Nasospore (K052099), Genzyme Hylasine (K012532), and Medtronic Xomed Meropack Nasal Dressing (K041381).
• Comparison Areas: The comparison focused on:
  • Indications for Use: The SyntheMed Device's indication for use (fragmentable nasal dressing for patients undergoing nasal/sinus surgery as a space-occupying stent to separate and prevent adhesions between mucosal surfaces) was shown to be shared with all predicate devices.
  • Material Composition: The SyntheMed Device (PLA, PEG) was compared to the materials of the predicate devices. While the exact chemical compositions differ, the document emphasizes that PLA and PEG are FDA-approved GRAS polymers widely used in resorbable medical devices, implying a similar safety profile. It also notes that the SyntheMed Device is a "resorbable, synthetic polymeric material similar to Nasospore, Meropack and Hylasine."
  • Method of Action: The SyntheMed Device's method of action (hygroscopic, fragments in contact with fluids) was directly compared to the predicate devices. Nasopore shares the same method of action, while Hylasine and Meropack are hygroscopic and form a gelatinous mass. The document implicitly argues that these mechanisms achieve a similar clinical function.
  • Biocompatibility: All devices, including the SyntheMed Device, adhere to ISO 10993 standards for biocompatibility. Animal studies were also performed on the SyntheMed Device under GLP and ISO 10993/USP guidelines to support safety and biocompatibility.
  • Sterility: All devices are sterile.
• Conclusion: SyntheMed, Inc. concluded that the SyntheMed Device is substantially equivalent to the predicates based on design, indications, and intended use, and shares similar indications for use language. The FDA's letter (K082276) confirms this substantial equivalence determination.

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