Search Results

Ask a specific question about this device

Ask a specific question about this device

The silk nonabsorbable sutures, USP are indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures .

Silk nonabsorbable surgical sutures, USP, manufactured by R. K. Medical L. L. C. are equivalent to silk nonabsorbable surgical sutures manufactured by Davis + Geck. The silk sutures manufactured by R. K. Medical and D+G can be twisted, or braided, coated with silicone, or wax, or uncoated, dyed black (Logwood) or undyed.

The provided text describes a 510(k) summary for R. K. Medical's Silk Nonabsorbable Surgical Sutures. This document aims to demonstrate the device's substantial equivalence to a predicate device (silk nonabsorbable surgical sutures manufactured by Davis + Geck).

However, the questions you've asked are typically relevant to the evaluation of AI/ML-based medical devices, where an algorithm's performance is assessed against established ground truth. The document provided describes a traditional medical device (surgical sutures) and its conformity to performance specifications rather than statistical performance metrics against a ground truth.

Therefore, many of your questions, such as those related to "acceptance criteria and reported device performance" in the context of AI, sample sizes for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, types of ground truth, and training sets, are not applicable to this document.

Instead, the document details the acceptance criteria and the study (testing) that proves the device meets those criteria in the context of traditional medical device substantial equivalence.

Here's how to reframe the information from the document to answer what parts are applicable:

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

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

• Sample Size: Not specified in the document. The document states "Testing...demonstrates that R. K. Medical silk sutures meet or exceed U. S. P. specifications." The USP (United States Pharmacopeia) outlines testing methodologies, which would include sample sizes (e.g., number of sutures to test for each parameter). However, the specific number of samples tested by R. K. Medical is not provided in this summary.
• Data Provenance: Not explicitly stated, but assumed to be internal testing conducted by R. K. Medical L. L. C. in Danbury, CT, U.S.A. (as per the applicant's address). The testing methods are "according to methods outlined in USP XXIII," which are internationally recognized standards.
• Retrospective or Prospective: This distinction is not applicable to the physical testing of sutures. The testing is performed on manufactured products to ensure they meet specifications.

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)

• Not Applicable. For this type of device, "ground truth" is defined by the objective, measurable specifications outlined in USP XXIII. Expert interpretation is not used to establish these physical characteristics.

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

• Not Applicable. Adjudication methods are used in scenarios where human interpretation or consensus is required to establish a gold standard, typically in diagnostic imaging or clinical trials. Here, physical measurements are objective.

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 traditional medical device (sutures), not an AI-assisted diagnostic tool.

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

• Not Applicable. This is a physical medical device, not an algorithm.

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

• The "ground truth" (or more accurately, the performance standard) used is the United States Pharmacopeia (USP XXIII) specifications for silk nonabsorbable surgical sutures. These are objective, quantitative criteria for suture diameter, length, tensile strength, and needle attachment.

8. The sample size for the training set

• Not Applicable. There is no "training set" for physical testing of sutures to meet specifications. This concept is relevant to machine learning where an algorithm learns from data.

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

• Not Applicable. As there is no training set, this question is not relevant.

In summary, the document demonstrates that R. K. Medical's silk sutures meet the established physical and mechanical performance standards set by USP XXIII, thereby establishing their equivalence to a predicate device. The nature of the device (surgical sutures) means that the questions posed about AI/ML device evaluation are not directly applicable.

Ask a specific question about this device