Search Results

The TissueStat PTFE (polytetrafluroethylene) Suture and Delivery Device is indicated for use in all types of soft tissue approximation and / or ligation, including cardiovascular, dental, general surgical procedures and repair of the dura mater. TissueStat PTFE Sutures are not indicated for use in microsurgery, ophthalmic procedures, or peripheral neural tissues. TissueStat PTFE Sutures are provided sterile as a single use device.

The TissueStat PTFE surgical sutures are monofilament surgical sutures composed from expanded polytetrafluoroethylene (ePTFE) material. They are available uncoated and undyed in USP size 2/0. The sutures are attached to standard stainless steel surgical needles. The TissueStat Suture Delivery Device is a Class I Manual Surgical Instrument that assists with suture placement. The PTFE suture is loaded into the Suture Delivery Device and is delivered to the desired location through the device tip by pressing the actuation button on the device handle.

The provided documentation is a 510(k) premarket notification for a medical device called "TissueStat PTFE Suture and Delivery Device." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through a standalone clinical study with defined performance metrics.

Therefore, many of the requested details about acceptance criteria, specific study designs, sample sizes for test sets, expert ground truth establishment, adjudication methods, or MRMC studies are not applicable to this type of regulatory submission and are not present in the provided text.

The "Performance Data" section outlines verification and validation testing conducted to support substantial equivalence, not a comparative effectiveness study or a study to meet specific clinical acceptance criteria in the way typically expected for an AI/ML device.

Here's the information that can be extracted or inferred from the provided text, and where the requested information is not available:

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

The document does not present a table of acceptance criteria and reported device performance in terms of clinical outcomes or diagnostic accuracy. Instead, it lists the types of performance testing conducted to verify that the device meets engineering and material standards for substantial equivalence.

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

Not applicable or not mentioned. The document primarily focuses on mechanical and biocompatibility testing for substantial equivalence, not a clinical study with a "test set" in the context of AI/ML or diagnostic performance. Therefore, there is no information about data provenance or sample sizes for such a clinical test set.

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)

Not applicable or not mentioned. The concept of "ground truth" established by experts is typically relevant for diagnostic or AI/ML device evaluations. This document describes a surgical suture and delivery device, where "ground truth" would relate to material properties and mechanical performance, established through standardized testing, not expert consensus on interpretations.

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

Not applicable or not mentioned. Adjudication methods are relevant for expert consensus in clinical studies, which is not the type of study described here.

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. The "TissueStat PTFE Suture and Delivery Device" is a physical medical device (suture and delivery system), not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study comparing human reader performance with and without AI assistance is irrelevant to this device and was not performed.

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

Not applicable. This is a physical medical device, not an algorithm.

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

For the mechanical and biocompatibility testing mentioned, the "ground truth" or reference would be established by:

• USP standards: For Suture Diameter (USP ), Suture Tensile Testing (USP ), and Needle Attachment Testing (USP ). These are standardized testing protocols.
• ISO 10993 and FDA Guidance: For Biocompatibility Risk Assessment, adherence to these standards forms the basis for demonstrating safety.

8. The sample size for the training set

Not applicable. The device is not an AI/ML product developed using training data.

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

Not applicable. The device is not an AI/ML product.

Summary of Relevant Information from the Document:

While the document does not present acceptance criteria and performance in the format of an AI/ML device evaluation, it does outline the type of performance data collected to demonstrate substantial equivalence:

Verification and Validation Testing Conducted:

• Mechanical Testing:
  • Suture Diameter Testing per USP
  • Suture Tensile Testing per USP
  • Needle Attachment Testing per USP
• Biocompatibility Testing:
  • Conducted a Biocompatibility Risk Assessment in accordance with ISO 10993-1 (2018) and FDA Guidance (2020).
  • The PTFE suture is an implant with permanent (>30 days) contact with tissue.

Conclusion:

The submission concludes that, based on the indications for use, technological characteristics, and performance testing in comparison to the predicate device, the TissueStat PTFE Suture and Delivery Device has been shown to be substantially equivalent to the legally marketed predicate device for its intended use. This means the testing demonstrated that the device meets the established engineering and safety standards equivalent to the predicate, and therefore, does not raise new questions of safety or effectiveness.

Ask a specific question about this device