(77 days)
Safil® Synthetic Absorbable Surgical Sutures are indicated for use in all types of general soft tissue approximation and ligation, including use in ophthalmic surgery, but not in cardiovascular surgery, microsurgery or in neural tissue.
The subject device is an absorbable, flexible multifilament or monofilament suture thread which is supplied sterile. It is composed of synthetic polyglycolic acid polymer, and is indicated for soft tissue approximation and/or ligation. It will be offered undyed, and dyed with the FDA approved colorant D&C Green No. 6 in accordance with Title 21 CFR, §74.3206. It will be available uncoated, and coated with an absorbable magnesium stearate-based coating. It will be available with and without standard needles attached.
This 510(k) summary describes a traditional medical device (surgical sutures), not an AI/ML powered device. As such, many of the requested categories related to AI/ML device studies (e.g., sample sizes for test/training sets, expert ground truth, MRMC studies) are not applicable.
However, I can extract the information relevant to the acceptance criteria and the study that proves the device meets those criteria, based on the provided text.
Acceptance Criteria and Device Performance for Safil® Synthetic Absorbable Surgical Suture
The study described is a non-clinical study demonstrating substantial equivalence to predicate devices, rather than a prospective clinical trial with specific performance metrics against an established ground truth in the context of AI.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Criteria (from USP XXIII or manufacturing standards) | Reported Device Performance / Method of Proof |
|---|---|---|
| Material Composition | - Composed of 100% polyglycolic acid polymer | - Demonstrated: FTIR spectroscopy to show substantial equivalence of identity and purity to predicate DEXON® suture. |
| Colorant | - Undyed, or dyed with FDA approved D&C Green No. 6 (21 CFR §74.3206) | - Demonstrated: Offered undyed and dyed with D&C Green No. 6 at compliant concentration. |
| Design | - Sterile, flexible multifilament (sizes 8-0 and larger) or monofilament (sizes 9-0 and smaller) thread. - Offered uncoated or coated with absorbable magnesium stearate-based coating. - With or without standard needles attached. | - Demonstrated: Same design as predicate devices (DEXON®, POLYSORB®, VICRYL®). Conforms to USP XXIII requirements for absorbable surgical suture. |
| Physical Properties | - Conformance to U.S. Pharmacopeia (U.S.P.) XXIII, including: - Sutures --Diameter - Sutures -- Needle Attachment - Tensile Strength - Other properties: fiber diameter, knot pull tensile strength, straight pull tensile strength, elongation at break, knot security, and needle attachment strength. | - Demonstrated: Extensive physical testing to prove conformance to U.S.P. XXIII requirements and substantial equivalence to predicate devices for all listed physical properties. |
| Biocompatibility | - Safe for in vivo use. | - Demonstrated: In vitro and in vivo biosafety studies. |
| In Vivo Performance | - Appropriate rates of tensile strength and mass loss (absorption). | - Demonstrated: Implant studies in animals. |
| Manufacturing Process | - Typical industry processes for polymer synthesis, extrusion, spinning, drawing, braiding/cutting, coating, and attachment to needles. | - Demonstrated: Manufacturing process described as identical to DEXON® and equivalent to POLYSORB® and VICRYL® predicate devices. |
| Packaging & Sterilization | - Same or equivalent methods as predicate devices. | - Demonstrated: Sterilization validation and evaluation of sterilant residues. Shelf-life testing. |
| Labeling Claims | - Same or equivalent indications, contraindications, warnings, cautions, and precautions as predicate devices. | - Demonstrated: Labeling claims are same or equivalent to predicate devices. |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not explicitly stated as a single "test set" analogous to an AI/ML validation data set. The non-clinical tests involved various samples of the Safil® suture for physical, chemical, and biological testing. The specific number of sutures or batches tested for each parameter is not provided in this summary.
- Data Provenance: The data comes from internal non-clinical testing conducted by Aesculap®, the manufacturer, and potentially third-party labs for specific tests (e.g., sterilization validation). The country of origin for the data is not specified beyond it being conducted by the manufacturer. The data is retrospective in the sense that it's generated as part of product development and submission, not a prospective study on a patient population.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. For this traditional medical device (suture), "ground truth" is established by adherence to recognized standards (e.g., USP XXIII, FDA CFR) and established scientific/engineering principles for material properties and performance. There isn't an "expert consensus" model for interpreting results in the way there would be for image-based diagnostic AI. The experts involved would be materials scientists, engineers, and regulatory specialists designing and evaluating the tests against these standards.
4. Adjudication method for the test set:
- Not Applicable. Without "experts" establishing a "ground truth" in the context of subjective interpretation, there is no adjudication method like 2+1 or 3+1. Testing results are objective measurements against established specifications or comparisons to predicate device measurements.
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 not an AI-powered device, and thus no MRMC study comparing human readers with and without AI assistance was conducted.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not Applicable. This is not an AI-powered device.
7. The type of ground truth used:
- The "ground truth" (or more accurately, the reference standard) used for this device is primarily:
- Regulatory Standards/Specifications: U.S. Pharmacopeia (U.S.P.) XXIII monographs for absorbable surgical sutures, and Title 21 CFR regulations (e.g., for colorants).
- Predicate Device Performance: The performance characteristics (physical, mechanical, chemical properties) of the legally marketed predicate devices (DEXON®, VICRYL®, POLYSORB®). The goal was to demonstrate "substantial equivalence" to these devices.
- Biological Response: In vitro and in vivo biosafety studies, and animal implant studies, to assess biological compatibility and degradation, referenced against established safety profiles for similar materials.
8. The sample size for the training set:
- Not Applicable. This is not an AI-powered device, so there is no "training set."
9. How the ground truth for the training set was established:
- Not Applicable. No training set exists for this traditional medical device.
§ 878.4493 Absorbable poly(glycolide/l-lactide) surgical suture.
(a)
Identification. An absorbable poly(glycolide/l-lactide) surgical suture (PGL suture) is an absorbable sterile, flexible strand as prepared and synthesized from homopolymers of glycolide and copolymers made from 90 percent glycolide and 10 percent l-lactide, and is indicated for use in soft tissue approximation. A PGL suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. “Monograph for Absorbable Surgical Sutures;” it may be monofilament or multifilament (braided) in form; it may be uncoated or coated; and it may be undyed or dyed with an FDA-approved color additive. Also, the suture may be provided with or without a standard needle attached.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See § 878.1(e) for the availability of this guidance document.