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The FasTouch Absorbable Fixation System is intended for fixation of prosthetic material to soft tissues in various minimally invasive and open surgical procedures such as hernia repairs.

Device Description

The FasTouch Absorbable Fixation System is a disposable, sterile single-use system designed to deliver absorbable fastener into tissue and prosthesis during general surgery procedures such as hernia repair. The Via Surgical FasTouch Absorbable Fixation System, is designed to be inserted through a 5mm or larger laparoscopic port sleeve. The fasteners two ends are designed to be locked together in the tissue by the Fas Touch firing mechanism, thus forming a closed locked loop into the tissue affixing the surgical mesh to the tissue. The fasteners are absorbable and made of PURASORB PLG 8218 dye with D&C violet No. 2.

AI/ML Overview

This document describes a 510(k) premarket notification for the FasTouch Absorbable Fixation System. It details the device's indications for use, comparison to predicate devices, and performance data used to establish substantial equivalence.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that "All tests met the predefined acceptance criteria" for various performance evaluations. However, it does not explicitly list the quantitative acceptance criteria for each test. Instead, it reports either success or compliance with standards.

Test Category	Specific Test / Standard	Reported Device Performance
Risk Analysis	ISO 14971:2012	Performed
Biocompatibility	Cytotoxicity Study (ISO 10993-5: 2009)	Completed with passing results
	Irritation - ISO Intracutaneous Study (ISO 10993-10: 2010)	Completed with passing results
	Systemic Toxicity Study (ISO 10993:11:2010)	Completed with passing results
	ISO Maximization Sensitization Test (ISO 10993-10: 2010)	Completed with passing results
	Pyrogen Study - Material Mediated (ISO 10993-11: 2010)	Completed with passing results
	Implantation/Toxicity (ISO 10993-6, ISO 10993-11)	Completed with passing results
Sterilization, Packaging, and Shelf Life	Sterilization validation (ISO 11135-1)	Performed, demonstrated compliance
	Shelf life and packaging testing	Performed, successfully completed to support labeled shelf life
Bench Testing	Fixation Strength Evaluation (BT-212)	Met predefined acceptance criteria
	Mesh compatibility and Integrity (BT-213)	Met predefined acceptance criteria
	Performance Evaluation (BT-214)	Met predefined acceptance criteria
Animal Study	Functionality and Usability Assessment	No adverse events, devices performed well, users satisfied
	Histopathology evaluation (up to 3 months)	Met predefined acceptance criteria

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

Sample Size: The document does not specify the exact sample sizes for the bench tests or the animal study.
Data Provenance:
- Bench Testing: The origin of the data is not explicitly stated, but it is implied to be from the manufacturer's internal testing or a contract lab.
- Animal Study: Performed at the Institute of Animal Research in Kibbutz Lahav in Israel.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Animal Study: "Several trained surgeons" evaluated the device. Specific number and qualifications (e.g., years of experience, specialization) are not provided beyond "trained surgeons."
Other Tests: For bench and biocompatibility tests, the ground truth is established by meeting predefined criteria or compliance with international standards, not by expert consensus in the same way clinical ground truth is established.

4. Adjudication method for the test set

The document does not describe any formal adjudication method (e.g., 2+1, 3+1) for the test sets. For the animal study, the assessment was based on the performance observed by "trained surgeons" and histopathology evaluation.

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

No, a multi-reader, multi-case comparative effectiveness study was not done. This device is a surgical fixation system, not an AI-powered diagnostic or assistive tool for human readers. Therefore, the concept of "human readers improve with AI" does not apply.

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

No, this device is a physical surgical tool. The concept of an "algorithm only" or "standalone" performance without human interaction is not applicable. The device's performance is inherently linked to its use by a surgeon.

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

Biocompatibility: Ground truth is established by adherence to and passing results from recognized international standards (ISO 10993 series).
Sterilization, Packaging, Shelf Life: Ground truth is established by adherence to and passing results from recognized international standards (ISO 11135-1) and successful completion of internal testing.
Bench Testing: Ground truth is established by predefined acceptance criteria, which likely relate to mechanical properties, material integrity, and functionality.
Animal Study: Ground truth is based on:
- Direct observation and assessment by "trained surgeons" (functionality and usability).
- Histopathology evaluation (biological response to implantation).

8. The sample size for the training set

This information is not applicable. This device is a physical surgical product and does not involve AI/machine learning models that require a "training set" in the conventional sense.

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

This information is not applicable, as there is no training set for this type of device.

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