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510(k) Data Aggregation
(186 days)
ARTHREX BIO-SUTURE
The Arthrex Bio-Suture is intended for use in soft tissue approximation and or ligation. These sutures may be incorporated, as components, into surgeries where constructs including those with allograft or autograft tissues are used for repair.
The Arthrex Bio-Suture is a dyed or non-dyed braided polyester suture construct coated with type 1 bovine collagen. The suture construct is made of UHMWPE and polyester braided over a UHMWPE core. The suture tape construct is a flat suture construct composed of UHMWPE and polyester yarns braided over a FiberWire suture core and UHMWPE yarns. Arthrex Bio-Suture strands that are dyed black are made of nylon. The suture ends are stiffened with cyanoacrylate. The Arthrex Bio-Suture will be supplied in pre-cut lengths with or without various swaged needles. The Arthrex Bio-Suture constructs meet USP standards for suture, except for diameter.
Here's an analysis of the provided text regarding the Arthrex Bio-Suture, focusing on the acceptance criteria and supporting studies.
Important Note: The provided document is a 510(k) Summary for a medical device (suture). It primarily focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a detailed clinical study for novel performance claims. As such, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set details) are not applicable or not present in this type of regulatory submission. The assessment relies on a comparison to established standards and predicate devices.
Acceptance Criteria and Study Details for Arthrex Bio-Suture
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied by Regulatory Pathway & Standards) | Reported Device Performance (Arthrex Bio-Suture) |
|---|---|
| Biocompatibility: No adverse biological reactions | Biocompatibility testing performed and determined to be substantially equivalent to predicate devices. |
| Tensile Strength: Meets or exceeds performance of predicate devices and relevant USP standards (where applicable). | Tensile testing performed and determined to be substantially equivalent to predicate devices. The device meets USP standards for suture, "except for diameter." (This exception is noted with the understanding that the overall performance is still equivalent or acceptable based on testing). |
| Material Composition: Consistent with known safe and effective materials for sutures (UHMWPE, polyester, bovine collagen coating). | Device is made of UHMWPE and polyester braided over a UHMWPE core, coated with type 1 bovine collagen. Dyed strands use nylon. |
| Physical Characteristics: Consistent with intended function (braided, stiffened ends). | Described as a dyed or non-dyed braided polyester suture construct. Suture ends are stiffened with cyanoacrylate. |
| Sterility: (Implied, standard for medical devices) | Not explicitly detailed in the summary, but presumed to meet regulatory requirements for sterile medical devices. |
| Freedom from Pyrogens: (Implied, standard for medical devices) | Not explicitly detailed in the summary, but presumed to meet regulatory requirements. |
| Toxicity: (Implied by biocompatibility) | Addressed via biocompatibility testing. |
| Intended Use: Safe and effective for soft tissue approximation and/or ligation, and as components in constructs with allograft or autograft tissues. | Stated intended use matches the device description and is considered substantially equivalent to predicate devices with identical intended uses. |
| USP Standards for Suture: Meets general USP standards. | "The Arthrex Bio-Suture constructs meet USP standards for suture, except for diameter." |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not explicitly stated as this is a 510(k) summary focusing on substantial equivalence. The document indicates that "biocompatibility and tensile testing" were performed. The specific number of samples for these tests is not provided in this summary.
- Data Provenance: Not specified, but generally, such testing would be conducted in a controlled laboratory setting (e.g., in-house or by a contract lab). The document does not indicate human trial data (retrospective or prospective) for this submission given its nature as a device comparison.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. For this type of device (suture) and regulatory submission (510(k) for substantial equivalence), the "ground truth" is established through standardized laboratory testing (e.g., mechanical tensile tests, biocompatibility assays) and comparison to predicate devices, rather than expert interpretation of clinical data in a test set. There isn't "ground truth" in the sense of expert consensus on qualitative observations.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. See point 3. Adjudication methods are typically associated with human-interpreted clinical or image-based studies.
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 physical medical device (suture), not an AI-powered diagnostic or assistive tool. MRMC studies are not relevant here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For Biocompatibility: The ground truth is established by standardized biological assays and tests (e.g., ISO 10993 series for medical devices), which determine if the material elicits an acceptable biological response.
- For Tensile Strength: The ground truth is established by objective, quantitative measurements of mechanical properties according to recognized standards (e.g., ASTM, USP, or manufacturer's internal validated methods).
- For Substantial Equivalence: The ultimate "ground truth" for regulatory clearance is that the device is shown to be as safe and effective as a legally marketed predicate device, as determined by the FDA.
8. The sample size for the training set
- Not Applicable. There is no "training set" in the context of this device and submission, as it does not involve machine learning or AI.
9. How the ground truth for the training set was established
- Not Applicable. As there is no training set, this question is not relevant.
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