(33 days)
BioFiber Suture is indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological tissues, microsurgery or ophthalmic surgery.
Tornier, Inc. BioFiber Suture is an absorbable, braided, sterile, surgical suture composed of poly(4-hydrobutyrate) (P4HB). BioFiber Suture is braided for optimal handling properties and is available either dyed (D&C Violet No. 2) or un-dyed (natural), with and without pre-attached needles.
This document describes the 510(k) summary for the Tornier BioFiber Suture (K122487). It focuses on demonstrating substantial equivalence to a predicate device, TephaFLEX™ Poly(4-hydroxybutyrate) Suture, rather than presenting a study to prove the device meets pre-defined acceptance criteria in the manner of a clinical trial for diagnostic devices. Therefore, many of the typical acceptance criteria and study design elements you asked for are not directly applicable or available in this type of submission.
Here's an attempt to extract and interpret the information based on the provided text, while acknowledging the limitations of this type of regulatory submission:
Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied by the USP (United States Pharmacopeia) standards for absorbable surgical sutures and ISO 10993-1 for biocompatibility. The performance is reported as compliance with these standards.
| Feature | Acceptance Criteria (Implied by Predicate/Standards) | Reported Device Performance (Tornier BioFiber Suture) |
|---|---|---|
| USP Suture diameter | Compliant for specified USP size | Compliant for Size 2, "except that the diameter is slightly larger" |
| USP Suture Needle Attachment | Compliant for specified USP size | Compliant for Size 2 |
| USP Tensile Strength | Compliant for specified USP size | Compliant for Size 2 |
| Biocompatibility | ISO 10993-1 compliant for permanent implant materials | Performed, results led to conclusion of substantial equivalence |
| Resorption/Degradation | Studied and evaluated | Performed, results led to conclusion of substantial equivalence |
| Packaging Evaluation | Studied and evaluated | Performed, results led to conclusion of substantial equivalence |
Note on "Slightly Larger Diameter": This deviation from the predicate's exact specification for USP size 2 diameter is noted but must have been deemed acceptable by the FDA for the device to achieve substantial equivalence. The overall USP compliance for "Size 2" likely means it falls within the permitted range despite being on the larger side of that range.
Study Details
This submission describes non-clinical testing to support substantial equivalence, not a clinical study on human subjects with a diagnostic device. Therefore, questions 2-6 and 8-9 are not directly applicable in the way they would be for a clinical trial of a diagnostic algorithm.
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated. For mechanical and material testing, sample sizes would typically be determined by statistical requirements for engineering tests, but these are not provided in this summary.
- Data Provenance: The testing was "performed in accordance with FDA's Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Absorbable Poly(hydroxybutyrate) Surgical Suture Produced by Recombinant DNA Technology." The tests are laboratory-based (mechanical, chemical, biological compatibility), not patient data-based.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as this is not a diagnostic device involving expert interpretation of data. The "ground truth" here is compliance with established engineering and biocompatibility standards measured through standardized laboratory tests.
4. Adjudication method for the test set:
- Not applicable. Results are quantitative measurements against objective standards, not subjective interpretations requiring adjudication.
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 is a surgical suture, not an AI-assisted diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device (suture), not an algorithm.
7. The type of ground truth used:
- The "ground truth" consists of established, objective engineering standards (e.g., USP for diameter, for needle attachment, for tensile strength) and biocompatibility standards (ISO 10993-1). These are quantitative benchmarks against which the device's performance is measured.
8. The sample size for the training set:
- Not applicable. This is not an AI/machine learning device requiring a training set.
9. How the ground truth for the training set was established:
- Not applicable. This is not an AI/machine learning device.
§ 878.4494 Absorbable poly(hydroxybutyrate) surgical suture produced by recombinant DNA technology.
(a)
Identification. An absorbable poly(hydroxybutyrate) surgical suture is an absorbable surgical suture made of material isolated from prokaryotic cells produced by recombinant deoxyribonucleic acid (DNA) technology. The device is intended for use in general soft tissue approximation and ligation.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Absorbable Poly(hydroxybutyrate) Surgical Suture Produced by Recombinant DNA Technology.” For the availability of this guidance document see § 878.1(e).