(72 days)
SILK is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.
SILK is a nonabsorbable, sterile, flexible multifilament thread composed of an organic protein called fibroin. This protein is derived from the domesticated species Bombyx mori (B. mori) of the family Bombycidae.
SILK is offered braided, uncoated or silicon coated, undyed or dyed with an FDA listed color additive, D&C Blue No. 9 (21CFR74.1109), or Logwood extract, C.I. Natural Black 1 (21CFR74.1410). SILK meets the United States Pharmacopeia (U.S.P.) monograph requirements for nonabsorbable silk surgical sutures.
This is a 510(k) summary for a medical device called SILK, which is a nonabsorbable surgical suture. The provided text describes the device, its intended use, and a comparison to a predicate device to establish substantial equivalence. It is important to note that this document is for a surgical suture, not an AI-powered diagnostic device. Therefore, the typical acceptance criteria and study designs associated with AI performance (like accuracy, sensitivity, specificity, MRMC studies, ground truth establishment by experts, etc.) are not applicable to this submission.
The "acceptance criteria" for a surgical suture like SILK are related to its physical properties and biocompatibility, typically established by adherence to recognized standards like the United States Pharmacopeia (USP). The "study" proving it meets these criteria is non-clinical testing.
Here's the information extracted and interpreted in the context of a surgical suture, addressing your points where applicable:
Acceptance Criteria and Device Performance (for a Surgical Suture)
1. A table of acceptance criteria and the reported device performance
For a surgical suture, the "acceptance criteria" are compliance with established industry standards and functional requirements compared to a predicate device. The "device performance" is simply meeting these standards and demonstrating substantial equivalence.
| Acceptance Criteria (for Surgical Suture) | Reported Device Performance (SILK) |
|---|---|
| Intended Use Equivalence: General soft tissue approximation and/or ligation (including cardiovascular, ophthalmic, neurological procedures). | Meets: Indicated for use identical to the predicate device: general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures. |
| Suture Material Equivalence: Natural Organic Protein (Fibroin), Braided or Twisted, White/Dyed. | Meets: Natural Organic Protein (Fibroin) from Bombyx mori. Braided, uncoated or silicon coated, undyed or dyed (D&C Blue No. 9 or Logwood extract). |
| Suture Characteristics Equivalence: Not absorbed, gradual loss of tensile strength in vivo. | Meets: Not absorbed, progressive degradation of proteinaceous silk fiber in vivo may result in gradual loss of all of the suture's tensile strength over time. |
| Sterilization Method Equivalence: Same or equivalent process as predicate. | Meets: Gamma Irradiation. Predicate device uses "Same or equivalent process." |
| How Supplied Equivalence: Sterile, single use, braided, coated/uncoated, undyed/dyed, with/without needle. Meets USP requirements. | Meets: Sterile, single use, braided, uncoated or coated, undyed or dyed with FDA listed color additive. Available with or without surgical needle. Meets U.S.P. Requirements. Predicate is "Same or equivalent manner" and also meets U.S.P. Requirements. |
| Suture Diameter, Suture Length, Knot Pull Tensile Strength, Needle Attachment Strength Equivalence. | Implied Meets: The table includes these categories but the cells are blank. However, the text states "Non-Clinical Testing was conducted on the subject device to prove conformance to the requirements of U.S.P. standards and to demonstrate substantial equivalence to the predicate device. Physical properties and functionality testing assured the safety and effectiveness of the subject device within its intended uses." This implies these specific parameters meet the USP standards and are substantially equivalent. |
| Packaging Equivalence: Similar dry packaging. | Meets: Dry packaged in Aluminum Foil and Polyester tear open packaging. Predicate is "Dry packaged in Tyvek/Mylar." (Considered equivalent as both are dry, tear-open packaging). |
| Labeling Equivalence: Conformance with CDRH instructions and FDA Guidance documents. | Meets: In conformance with CDRH instructions and FDA Guidance documents ("Alternate Suture Labeling"). Predicate is "Same." |
| Conformance to U.S.P. Standards. | Meets: "Results of the non-clinical testing demonstrate conformance with the U.S.P. standards and requirements for Absorbable surgical suture." (Note: The device is nonabsorbable, so this might be a typo in the original text, likely meaning nonabsorbable surgical suture standards). The device description explicitly states SILK "meets the United States Pharmacopeia (U.S.P.) monograph requirements for nonabsorbable silk surgical sutures." |
| Conformance to ISO 9002, EN 46002 & EN 552 Standards. | Meets. |
Study Details (Relevant to a Surgical Suture)
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not explicitly stated as a distinct "test set" in the context of AI. For a surgical suture, non-clinical testing involves mechanical and material tests. The number of samples for these tests would follow USP and ISO testing protocols, but the specific quantity is not provided.
- Data Provenance: Not applicable in the AI sense. This is non-clinical performance and physical property testing of manufactured suture samples.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Number of Experts & Qualifications: Not applicable. Ground truth for a suture is established by objective physical and chemical testing against recognized standards (e.g., USP monographs for tensile strength, diameter, sterility, material composition). It doesn't rely on expert consensus in the same way an AI diagnostic image interpretation would.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable. Performance is measured objectively against standards, not through human interpretation 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
- MRMC Study: No. This is a surgical suture, not an AI diagnostic device. MRMC studies are specific to evaluating AI's impact on human diagnostic performance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. This is a physical device, a suture, not an algorithm. The "standalone performance" is its physical and chemical properties as tested.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of Ground Truth: Established by recognized physical and chemical standards and specifications from regulatory bodies (e.g., United States Pharmacopeia (USP)) and international standards organizations (e.g., ISO, EN). This includes specifications for material composition, dimensions, tensile strength, sterility, and biocompatibility.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. This is not an AI/machine learning device. There is no concept of a "training set" for a surgical suture's regulatory submission outside of potentially manufacturing process validation data, which is not described here in detail.
9. How the ground truth for the training set was established
- Ground Truth for Training Set Establishment: Not applicable as there is no training set for this type of device.
Summary for this specific device (SILK Surgical Suture):
The "acceptance criteria" are adherence to the U.S.P. standards for nonabsorbable silk surgical sutures, ISO 9002, EN 46002, and EN 552 Standards, and substantial equivalence to the predicate device (Davis & Geck Silk Non-Absorbable Surgical Sutures, K930590) in terms of material, characteristics, intended use, manufacturing, and labeling.
The "study that proves the device meets the acceptance criteria" is Non-Clinical Testing. This testing focused on:
- Conformance to U.S.P. standards.
- Physical properties and functionality testing to assure safety and effectiveness.
- Demonstrating substantial equivalence to the predicate device.
No clinical testing was available or required for this 510(k) submission, indicating that the non-clinical data was deemed sufficient for establishing substantial equivalence for this Class II surgical suture.
§ 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.