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Aurolab nonabsorbable Silk suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.

This Silk suture is a nonabsorbable, sterile, surgical sutures composed of an organic protein called fibroin. This protein is derived from the domesticated species Bombyx mori (B. mori) of the family Bombycidae.Those dyed black are dyed with Hematein (logwood) black and the logwood extract conforms with 21 CFR 73.1410 and does not exceed 1.0% (W/W) of Suture.

This nonabsorbable suture is compossed of silk filaments that are braided or twisted in a suitable construction for the intended size to meet current USP specification.

This suture may be uncoated or have a silicone coating , a paraffin wax coating , or a natural gum coating ( Virgin Silk) . This sutures come with needles attached.

The provided document is a 510(k) summary for Aurolab's nonabsorbable Silk sutures. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with detailed acceptance criteria and performance data as typically seen in AI/ML device submissions.

Here's an analysis based on the provided text, addressing the requested points where information is available:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not explicitly mentioned. The document states that "tests according to methods presented in United States Pharmacopoeia (U.S.P) were conducted for diameter, tensile strength and Suture-needle attachment." USP monographs specify testing methods, which include sample sizes (e.g., 10 suture strands for specific tests), but the exact number of samples tested by Aurolab is not provided in this summary.
• Data Provenance: The tests were conducted internally by Aurolab in India. The data is retrospective in the sense that the summary is presenting results of tests already completed.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This is not applicable to the provided document. The "ground truth" for this medical device (nonabsorbable silk suture) is established by adherence to recognized industrial standards, specifically the United States Pharmacopoeia (USP). Experts in this context would be laboratory technicians and quality control personnel performing the physical and mechanical tests, not clinical experts establishing a medical "ground truth."

4. Adjudication Method

Not applicable. Performance is determined by objective measurements against predefined USP specifications, not by expert adjudication of clinical outcomes or images.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic or AI/ML devices where human interpretation is involved. For a surgical suture, the effectiveness is demonstrated through mechanical and material property testing and clinical use experience (not detailed in this summary).

6. Standalone (Algorithm Only Without Human-in-the Loop Performance) Study

Not applicable. This is a medical device (surgical suture), not an AI algorithm.

7. Type of Ground Truth Used

The "ground truth" for this device is based on United States Pharmacopoeia (USP) standards and specifications for nonabsorbable silk sutures. These are objective, measurable physical and chemical properties.

8. Sample Size for the Training Set

Not applicable, as this is not an AI/ML device.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as this is not an AI/ML device.

Summary of Acceptance Criteria and Study Design for the Suture:

The study conducted to demonstrate the substantial equivalence of the Aurolab nonabsorbable Silk sutures was a bench testing study focused on characterizing the physical and mechanical properties of the suture.

• Acceptance Criteria: The primary acceptance criteria were that the device's diameter, tensile strength, and suture-needle attachment met the specifications outlined in the United States Pharmacopoeia (USP) for nonabsorbable silk sutures.
• Study Design:
  • Objective: To establish technical equivalency with predicate devices (Ethicon silk nonabsorbable sutures).
  • Methodology: Performance tests were conducted in accordance with USP methodologies.
  • Results: The tests performed showed that Aurolab devices meet USP standards and are technically equivalent to the predicate devices.
  • Conclusion: Based on these tests, the device was deemed substantially equivalent to legally marketed predicate devices.

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Silk sutures are indicated for use as nonabsorbable sutures in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, and neural tissue.

Silk Non-Absorbable Surgical Sutures are composed of the organic protein fibroin which is derived from the domesticated species Bombyx mori (B.mori) of the family Bombycidae. Silk sutures are braided or twisted and available in white or dyed (black or blue). Braided sutures (except for size 8/0) are coated with silicone. Silk sutures are also available in various lengths, diameters and quantities with or without surgical needles. SILK sutures are not absorbed, progressive degradation of the proteinaceous silk fiber in-vivo may result in gradual loss of all the suture's tensile strength over time. The proposed Silk suture needle will be manufactured using an automated end stiffening process of applying the medical grade adhesive to a portion of the silk strand which is then cured and cut to length.

The provided text describes a 510(k) submission for a Silk Non-Absorbable Surgical Suture with UV-10 adhesive, focusing on the substantial equivalence to a previously cleared device. The key change is an automated needle-end stiffening process compared to a manual one.

Here's an analysis of the acceptance criteria and study information, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

The document does not specify a "test set" in the context of a typical clinical study or a performance study with a defined sample size for the evaluation of the automated needle-end stiffening process. The primary evidence presented is biocompatibility testing.

• Sample size: Not explicitly stated for biocompatibility tests. It's usually a small number of samples required to demonstrate biological compatibility according to standards.
• Data provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). However, biocompatibility testing is typically conducted in a laboratory setting.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This device submission primarily relies on biocompatibility testing and demonstrating substantial equivalence to a predicate device. There is no "ground truth" derived from expert review of cases in the way that might apply to a diagnostic imaging AI algorithm. The "ground truth" for biocompatibility is established by adherence to recognized standards (ANSI/AAMI 10993 and USP guidelines) and passing the specified tests.

4. Adjudication method for the test set

Not applicable. There is no "test set" that requires adjudication (e.g., clinical cases reviewed by experts).

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 a diagnostic device with an AI component.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a surgical suture, not a diagnostic device with an AI component.

7. The type of ground truth used

For the safety assessment, the "ground truth" is based on:

• Biological standards: Adherence to ANSI/AAMI 10993 and USP guidelines for biocompatibility.
• Predicate device characteristics: The known safety and performance profile of the legally marketed predicate Silk Non-Absorbable Surgical Suture (K930590). The new device is considered "substantially equivalent" if it shares the same safety and effectiveness profile.

8. The sample size for the training set

Not applicable. This is a physical medical device (suture), not a machine learning model.

9. How the ground truth for the training set was established

Not applicable. This is a physical medical device (suture), not a machine learning model.

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