Search Results

Sofsilk™ Coated Braided Silk Sutures are indicated for use in soft tissue approximation and/or ligation.

Sofsilk™ 6/0 and 7/0 black braided silk sutures are nonabsorbable, sterile, non-mutagenic surgical sutures composed of natural proteinaceous silk fibers called fibroin. This protein is derived from the domesticated silkworm species Bombyx mori of the family bombycidae. The silk fibers are treated to remove the naturally-occurring sericin gum and braided to produce Sofsilk™ surgical silk sutures. The braided sutures are coated uniformly with silicone to reduce capillarity and to increase surface lubricity, which enhances handling characteristics, ease of passage through tissue, and knot run-down properties. Sofsilk™ sutures are colored black with Logwood extract (21CFR73.1410). Sofsilk™ sutures meet all requirements established by the United States Pharmacopeia (USP) and the European Pharmacopeia (EP) for nonabsorbable surgical sutures, Sofsilk™ Coated Braided Silk Suture. Sofsilk™ sutures are indicated for use in soft tissue approximation and/or ligation.

The provided text is a 510(k) summary for the Sofsilk™ Coated Braided Silk Suture. It details the device's characteristics, indications for use, and a comparison to a predicate device. However, it does not contain information about an AI/ML-based device or its performance criteria.

Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, ground truth, or MRMC studies, as these aspects are not discussed in the provided document. The document describes a traditional medical device (surgical sutures) and its regulatory clearance based on substantial equivalence, primarily through bench testing for physical and mechanical performance, and biocompatibility.

The "study" mentioned refers to mechanical and physical bench tests of the suture, not a clinical or AI performance study.

Here's what the document does provide regarding the device's performance evaluation:

• Acceptance Criteria (implied standards compliance):

  • Meets or exceeds requirements of U.S.P. (United States Pharmacopeia) for nonabsorbable surgical sutures.
  • Meets or exceeds requirements of E.P. (European Pharmacopeia) for nonabsorbable surgical sutures.
  • Compliant with ISO 10993-1:2018 "Biological evaluation of medical devices-Part 1: Evaluation and testing" for biocompatibility.
  • Sterility Assurance Level (SAL) of 10^-6 for ETO sterilization.

• Reported Device Performance (bench tests):

  • USP/EP diameter: Tested, found equivalent to predicate.
  • USP needle attachment: Tested, found equivalent to predicate.
  • USP tensile strength: Tested, found equivalent to predicate.
  • Biocompatibility: Evaluated and confirmed compliant with ISO 10993-1 for its intended patient contact profile.
  • Shelf life: Stability studies conducted, proposed 5-year shelf life demonstrated.

The document explicitly states: "This premarket submission did not rely on the assessment of clinical performance data to demonstrate substantial equivalence." This further confirms that there was no clinical study, let alone one involving AI/ML performance.

Ask a specific question about this device

Ask a specific question about this device

Modified Sofsilk* Suture has indications for use in general soft tissue approximation and/or ligation, including cardiovascular, ophthalmic, microsurgery and neural tissue.

Modified Sofsilk * Suture is a nonabsorbable, sterile, flexible multifilament thread, prepared from silk fiber produced from the species Bombyx mori. The primary component of silk is the high molecular weight fibrous polymer fibroin.

The provided text is a 510(k) summary for the Modified Sofsilk Suture and does not describe a study involving an AI/CAD/software device, therefore most of the requested information is not applicable. The document focuses on establishing substantial equivalence of a physical medical device (suture) to a predicate device.

Here's an analysis based on the information available:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" in the way it would for a performance study of a device like AI. Instead, it refers to the device being "substantially equivalent" to a predicate device, Sofsilk* (K964581). This implies that the Modified Sofsilk Suture met the same performance characteristics as the predicate device, which would include physical properties relevant to sutures (e.g., tensile strength, knot security, biocompatibility).

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not applicable as the document describes a physical medical device (suture) and not a software/AI device that would involve a test set of data. The "test set" in this context would refer to the samples of the Modified Sofsilk Suture manufactured for testing physical properties to demonstrate equivalence. The document does not specify the number of suture samples tested or the provenance of any data beyond the general manufacturing and testing processes that would occur for such a device.

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)

This is not applicable. Ground truth, in the context of AI/software devices, refers to expert labeling of data. For a physical device like a suture, "ground truth" would relate to objective measurements of its physical and biological properties against established standards, not expert interpretations of data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable. Adjudication methods are typically used in studies involving human interpretation of data, often in the context of AI performance evaluation, to resolve discrepancies in expert opinions.

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

This is not applicable. MRMC studies are used to evaluate the performance of human readers, with or without AI assistance, on a collection of cases. This document concerns a physical surgical suture.

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

This is not applicable. This question pertains to the performance of an algorithm without human intervention, which is not relevant to a physical medical device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

As explained in point 3, the concept of "ground truth" as typically defined for AI/software devices is not applicable. For this physical medical device, demonstrating compliance with "ground truth" would involve proving that the suture meets established physical, chemical, and biological standards through laboratory testing (e.g., tensile strength, biocompatibility, sterility).

8. The sample size for the training set

This is not applicable. There is no "training set" for a physical medical device like a suture as there is no algorithm being trained.

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

This is not applicable for the reasons stated above; there is no training set for this type of device.

Ask a specific question about this device

SOFSILK* suture is intended for the approximation of tissues where prolonged retention of tensile strength is required.

SOFSILK* suture is a nonabsorbable, sterile, flexible multifilament thread, prepared from silk fiber produced by the species Bombyx mori. The primary component of silk is the high molecular weight fibrous polymer fibroin.

This document does not describe a medical device that uses AI/ML with a testing framework and outcomes. Instead, it is a 510(k) premarket notification for a *surgical suture (SOFSILK)**.

Therefore, most of the requested information (acceptance criteria for AI performance, sample sizes for test/training sets, expert qualifications, MRMC studies, standalone performance, etc.) is not applicable to this type of device.

Here's how I can address the parts of your request that are relevant, based on the provided text:

1. A table of acceptance criteria and the reported device performance

The provided text does not include specific quantitative acceptance criteria or performance metrics typical for AI/ML devices (e.g., accuracy, sensitivity, specificity). For a surgical suture, performance is typically assessed through biocompatibility, tensile strength, knot security, and sterility, often against recognized standards like USP (United States Pharmacopeia) or ISO. This document only states:

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not applicable as it's a physical device, not a data-driven AI/ML system. There are no "test sets" of data in the context of AI. Testing for sutures would involve material science evaluations, animal studies (historically), and clinical experience, none of which are detailed here.

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)

This is not applicable. "Ground truth" in the AI sense does not exist for a surgical suture. The performance of the suture is determined by physical and biological properties.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable.

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

This is not applicable. MRMC studies are for evaluating interpretative tasks, not for physical medical devices like sutures.

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

This is not applicable. This device is a physical product and does not involve an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This is not applicable. The "truth" for a suture is its physical and biological properties and its ability to perform its intended function in vivo, which is established through various testing methods and adherence to material standards (like ISO 10993-1 for biocompatibility).

8. The sample size for the training set

This is not applicable. There is no "training set" for a physical suture device.

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

This is not applicable.

In summary: The provided document is for a traditional surgical suture. The questions posed in the prompt are designed for AI/ML-driven medical devices, and as such, most are not relevant to this product. The key information provided relates to the device's identity, intended use, and material compliance with an ISO standard for biocompatibility.

Ask a specific question about this device