(63 days)
Silkam® sutures are intended for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.
The subject device is a nonabsorbable, sterile, flexible, braided multifilament thread composed of an organic protein called fibroin. It is derived from the domesticated silkworm species Bombyx mori, of the family Bombicidae, and is indicated for general soft tissue approximation and/or ligation. It meets all applicable requirements of the U. S. Pharmacopeia Official Monograph for Nonabsorbable Surgical Sutures (Class I). It will be offered undyed, and dyed with the FDA listed colorant Logwood extract in accordance with Title 21 CFR, §73.1410. It will be offered uncoated, or with a coating to enhance certain characteristics. It will be available with and without standard needles attached.
Here's an analysis of the provided text regarding the acceptance criteria and study for the AESCULAP® Silkam® Nonabsorbable Silk Surgical Suture:
Key Takeaway: This 510(k) summary focuses on demonstrating substantial equivalence to existing predicate devices rather than establishing novel acceptance criteria for a new device type and proving its performance through distinct studies with defined metrics like sensitivity, specificity, or reader improvement. The device is a conventional surgical suture, and its "performance" is largely defined by its adherence to established USP standards and its similarity to already approved sutures.
1. Table of Acceptance Criteria and Reported Device Performance
Given that this is a 510(k) for a conventional surgical suture demonstrating substantial equivalence, the "acceptance criteria" are intrinsically tied to meeting the requirements of existing U.S. Pharmacopeia (U.S.P.) standards and exhibiting physical properties comparable to predicate devices. The "reported device performance" is its successful demonstration of meeting these standards and equivalency.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Conformance to U.S. Pharmacopeia (U.S.P.) XXIII Official Monograph for Nonabsorbable Surgical Sutures (Class I), including specific sections: | The subject device conforms in all respects to the requirements of the Official Monograph for Nonabsorbable Surgical Suture in U.S.P. XXIII, including Sutures -- Diameter, Sutures -- Needle Attachment, and Tensile Strength. |
| Substantial equivalence in physical properties to predicate devices (Perma-Hand®, Davis & Geck Silk Suture, SOFSILK®). | Physical properties of the subject device are substantially equivalent to those of the predicate devices, including fiber diameter, knot pull tensile strength, knot security, capillarity, and needle attachment strength. |
| Substantial equivalence in manufacturing process. | The subject device is manufactured in the same manner as the predicate devices, from degummed and bleached yarns of natural silk, braided in standard operations. |
| Substantial equivalence in packaging and sterilization. | The subject device is packaged and sterilized in the same or equivalent manner as the predicate devices. |
| Substantial equivalence in labeling claims. | The subject device has the same labeling claims as the predicate devices. |
| Acceptable biosafety profile. | In vitro and in vivo biosafety studies were conducted. (Implied acceptability given the substantial equivalence conclusion). The suture fiber has "essentially the same physical and chemical properties, and hence, biosafety profile and in vivo performance characteristics, as do the predicate devices." |
| Retention of tensile strength over time. | 12 and 24 month implant studies in animals were conducted to demonstrate retention of tensile strength. (Implied acceptability given the substantial equivalence conclusion). |
| Material composition: Nonabsorbable, sterile, flexible, braided multifilament thread, organic protein fibroin, derived from Bombyx mori silkworm. | Confirmed: Composed of "organic protein called fibroin... derived from the domesticated silkworm species Bombyx mori." Identical material as predicate devices. |
| Dye: Undyed or dyed with FDA listed Logwood extract per 21 CFR §73.1410. | Confirmed: Offered undyed, and dyed with FDA listed colorant Logwood extract at ≤1.0% by suture weight in accordance with 21 CFR §73.1410. Identical to predicate devices. |
| Coating: Uncoated or with biocompatible coating to enhance characteristics. | Confirmed: Offered uncoated, or with a coating to enhance certain characteristics. "Treated with a biocompatible coating to enhance its handling properties" (identical to predicate devices). |
| Available with and without standard needles attached. | Confirmed: Available with and without standard needles attached. Identical to predicate devices. |
| Intended Use: General soft tissue approximation and/or ligation, including cardiovascular, ophthalmic and neurological procedures. | This is the stated intended use, found to be substantially equivalent to predicate devices. The FDA clearance letter re-affirms this intended use. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not specify a distinct "test set" sample size in terms of number of sutures or animal subjects used for the non-clinical tests. The testing performed was to demonstrate conformance to USP standards and substantial equivalence by comparing physical properties. The USP outlines testing methodologies, which inherently involve a statistically relevant number of samples for each parameter (e.g., diameter, tensile strength).
- Data Provenance: The studies were internal non-clinical tests ("Non-Clinical testing conducted on the subject device"). The mention of "in vivo biosafety studies, and 12 and 24 month implant studies in animals" indicates prospective animal studies were conducted. The country of origin of the data is implicitly the United States, as the submission is to the FDA for a US market.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not applicable/not mentioned. This device is a physical product (suture) with well-defined physical and material properties measured quantitatively. "Ground truth" is established by adherence to established engineering, material science, and biological testing standards (e.g., USP monographs) rather than expert consensus on subjective interpretations.
- Qualifications of Experts: Not applicable/not mentioned. The assessment relies on laboratory measurements and analytical testing, not human expert interpretation for "ground truth" in the way it would for, for instance, a diagnostic imaging AI.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. There is no mention of an adjudication process, as the tests are for physical properties against defined standards, not subjective assessments requiring multiple experts for consensus.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study Done: No.
- Effect Size of Human Readers: Not applicable. An MRMC study is relevant for diagnostic or interpretive devices (e.g., AI in radiology) where human-in-the-loop performance is assessed. This is a nonabsorbable surgical suture, a physical product, not an AI or interpretive device.
6. Standalone Performance Study
- Standalone Study Done: Yes, in essence. The non-clinical tests (e.g., physical testing for USP conformance, biosafety studies, implant studies) represent the "standalone" performance of the device itself (the suture material, its strength, biocompatibility) when tested against established benchmarks and compared to predicate devices. This is "algorithm only without human-in-the loop performance" in the context of the device's function as a physical object, not an AI algorithm.
7. Type of Ground Truth Used
- Type of Ground Truth: The ground truth used is primarily defined by standardized test methods and quantitative measurements outlined in the U.S. Pharmacopeia (U.S.P.) XXIII, combined with comparative data from predicate devices.
- USP Monograph Requirements: For parameters like diameter, needle attachment, and tensile strength (e.g., , , ).
- In Vitro and In Vivo Biosafety Data: Scientific data from biological studies.
- Animal Implant Study Data: Data on tensile strength retention from animal studies.
- Comparative Data: Performance metrics demonstrated by the legally marketed predicate devices.
8. Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. "Training set" is a concept specific to machine learning and AI development. This product is a physical medical device, not an AI system. The manufacturing process itself (from which "training" for humans might occur) is described as standard in the fiber industry, based on historical knowledge and established techniques, rather than iterative learning from a distinct "training set."
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth for Training Set Was Established: Not applicable, as there is no "training set" in the AI sense. The "ground truth" for suture manufacturing and quality control is established through decades of industrial practice, material science, and regulatory standards (like the USP). The manufacturing process itself is well-understood and governed by established quality assurance protocols to ensure consistency and meet specifications; it does not involve establishing "ground truth" in an AI/ML context.
§ 878.5030 Natural nonabsorbable silk surgical suture.
(a)
Identification. Natural nonabsorbable silk surgical suture is a nonabsorbable, sterile, flexible multifilament thread composed of an organic protein called fibroin. This protein is derived from the domesticated speciesBombyx mori (B. mori ) of the familyBombycidae. Natural nonabsorbable silk surgical suture is indicated for use in soft tissue approximation. Natural nonabsorbable silk surgical suture meets the United States Pharmacopeia (U.S.P.) monograph requirements for Nonabsorbable Surgical Suture (class I). Natural nonabsorbable silk surgical suture may be braided or twisted; it may be provided uncoated or coated; and it may be undyed or dyed with an FDA listed color additive.(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.