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The SuturTek Surgical Steel Suture is intended for use in sternal closure.

The SuturTek Surgical Steel Suture is a sterile, single-use, non absorbable, stainless steel monofilament suture. It is designed to remain inside the patient. It may or may not be attached to a stainless steel needle. The needle and any unused portions of suture are disposables.

The provided text describes a 510(k) summary for a surgical steel suture and does not contain detailed information about acceptance criteria, device performance, or a study proving its conformance beyond general bench testing. The document is primarily focused on demonstrating substantial equivalence to predicate devices for regulatory approval.

Therefore, many of the requested details cannot be extracted from the given input.

Here's a breakdown of what can be inferred or directly stated from the provided text, and what is missing:

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

• Acceptance Criteria: Not explicitly stated. The document mentions "Bench testing was performed to demonstrate that the SuturTek Surgical Steel Suture would perform as intended." without listing specific performance metrics or thresholds.
• Reported Device Performance: Not explicitly stated. The document indicates that bench testing was performed and implies successful performance ("would perform as intended"), but no quantitative results are provided.

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

• Sample Size for Test Set: Not mentioned.
• Data Provenance (e.g., country of origin of the data, retrospective or prospective): Not mentioned. It's bench testing, so "country of origin" of data wouldn't typically apply in the same way as clinical data.

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

• This information is not applicable as the testing described is bench testing, not a clinical study involving expert interpretation or ground truth establishment in a diagnostic sense.

4. Adjudication method for the test set

• Not applicable as the testing described is bench testing.

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

• No, a MRMC comparative effectiveness study was not done. The device is a surgical suture, not an AI or imaging diagnostic device.

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

• Not applicable. The device is a surgical suture, not an algorithm.

7. The type of ground truth used

• Not applicable in the conventional sense. For bench testing of a physical device, the "ground truth" would be the engineering specifications and performance standards against which the device is tested. These specifics are not detailed in the provided text.

8. The sample size for the training set

• Not applicable, as this is a physical medical device, not an AI/ML algorithm requiring a training set.

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

• Not applicable, as this is a physical medical device.

Summary of available information:

• Study Type: Bench testing.
• Purpose of Study: To demonstrate that the SuturTek Surgical Steel Suture would perform as intended.
• Conclusion of Study (implied): The bench testing was successful, as the FDA granted 510(k) clearance based on substantial equivalence.
• Device Intended Use: For use in sternal closure during thoracic surgery.
• Comparison Basis: Substantial equivalence to predicate devices (Aesculap: Steelex Sternum Set; K023411 and CP Medical: Surgical Steel Monofilament Stainless Steel; K030351). The operating principle, materials, intended use, and design of construction are stated to be the same as predicate devices.

Missing Information (critical for your request): Detailed acceptance criteria, specific performance results, sample sizes, and expert involvement (as the study was bench testing).

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