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Stainless Steel Surgical Suture is indicated for use in abdominal wound closure, hernia repair, sternal closure and certain orthopedic procedures including cerclage and tendon repair.

The CP Medical Stainless Steel Surgical Suture, monofilament, manufactured by C.P. Medical is equivalent to Nonabsorbable Surgical Sutures, Monofilament Stainless Steel manufactured by: Davis-Geck US Surgical Danbury, CT 06810 and Ethicon, Inc. P O BOX 151 Somerville. NJ 08876-0151. C.P. Medical's proposed device is packaged as four (4) individual sutures inside one suture card. The four-unit suture card is placed into Tyvek and twelve Tyvek packs are inserted into a suture box. The suture may also be supplied in bulk on an OEM basis as requested via customer specifications. The suture is supplied sterile or non-sterile and is either Gamma Irradiated or EtO sterilized to the SAL of 10°. The shelf life/expiration date is validated to five years from date of manufacture. USP Size 5 (metric 7.0), 6 and 7 (length 18") are primarily intended to be used for sternal closures. Additional sizes and lengths may be available in the future. All product is tested to USP standards prior to market release. The proposed device meets the requirements of ASTM F138-00 Gr.2 (Reg. Melt).

This summarization is for a 510(k) Premarket Notification for a Class II medical device, specifically a Stainless Steel Surgical Suture. These submissions primarily focus on demonstrating substantial equivalence to already legally marketed devices, rather than establishing de novo performance criteria against clinical outcomes.

Therefore, the requested information on acceptance criteria and a study proving the device meets them will be interpreted within the context of a 510(k) submission, meaning the "acceptance criteria" are typically USP standards and equivalence to predicate devices, and the "study" is often bench testing to confirm these standards are met.

Here's the breakdown:

Acceptance Criteria and Device Performance

Study Details to Prove Acceptance Criteria (Substantial Equivalence)

1. Sample sizes used for the test set and the data provenance:

   • Test Set Description: The provided text indicates "Physical testing was performed on the predicate and proposed surgical sutures." While specific sample sizes for each test (suture diameter, length, tensile strength, needle attachment strength) are not explicitly stated, the implication is that sufficient samples were tested to demonstrate compliance with USP standards for each.
   • Data Provenance: The testing was performed internally by CP Medical, Inc. or by a certified laboratory on their behalf, demonstrating compliance with USP standards. It appears to be prospective testing conducted for the purpose of this 510(k) submission. No country of origin for patient data is relevant as this is bench testing, not clinical data.

2. 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 a stainless steel surgical suture, "ground truth" is established by adherence to recognized regulatory standards (e.g., USP, ASTM) and physical test methods. There are no human experts "adjudicating" diagnostic or clinical "ground truth" in this context. The "truth" is whether the physical properties of the suture meet the predefined specifications.

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

   • Not Applicable. As this involves physical bench testing against objective standards, there is no need for expert adjudication methods like 2+1 or 3+1, which are common in clinical image interpretation studies. The results are quantitative measurements compared against a numerical threshold set by the USP.

4. 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 device is a surgical suture, not a diagnostic imaging AI algorithm. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is entirely irrelevant to this submission.

5. 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.

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

   • The "ground truth" for this device's performance is objective, quantitative data obtained from physical and mechanical bench testing (e.g., measuring diameter, length, tensile strength, needle attachment strength) against established industry standards, specifically United States Pharmacopeia (USP) standards and ASTM F138-00 Gr.2.

7. The sample size for the training set:

   • Not Applicable. This device is a physical product and does not involve AI or machine learning algorithms that require a "training set."

8. How the ground truth for the training set was established:

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

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