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Synthetic absorbable INSORB™ staples are intended for use in abdominal, thoracic, gynecologic, orthopedic, plastic and reconstructive surgery for the subcuticular closure of skin where an absorbable tissue fastener is desired for temporary tissue approximation.

INSORB™ Absorbable Staples are 5 mm in length, 0.8 mm thick, 3.5 mm wide overall, and have cleat tips that are 0.8 mm apart. They are used in conjunction with a manual surgical stapler from Incisive (Note: Incisive's manual surgical stapler is a Class I exempt device pursuant to 21 CFR 878.4800 and is not the subject of this submission).

The provided text describes a 510(k) premarket notification for the INSORB™ Absorbable Staple. It outlines the device's characteristics, intended use, and a comparison to a predicate device. The core of the submission focuses on specific performance specifications related to staple pull strength.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The text indicates that these are minimum "peak load" pull strength specifications and that the modified staple's design allows for these 25% increases compared to the predicate device. This implies that the reported performance meets or exceeds these new, higher acceptance criteria.

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

The provided text does not specify a sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). The information is presented as a statement of technological comparison and resulting specification changes, implying that internal testing was conducted to verify these new specifications.

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 to this type of submission. The device is a physical medical staple, and its performance is measured by objective mechanical pull strength tests. There is no "ground truth" established by experts in the context of diagnosing or interpreting findings.

4. Adjudication Method for the Test Set

This is not applicable as the information pertains to objective mechanical testing rather than expert review or interpretation.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically used for diagnostic devices involving human interpretation (e.g., radiologists reading images) and comparing performance with and without AI assistance. The INSORB™ Absorbable Staple is a surgical fastener, and its effectiveness is determined by mechanical properties and clinical outcomes, not by human reader interpretation.

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

This is not applicable to the INSORB™ Absorbable Staple, as it is a physical medical device and not an algorithm or AI system.

7. The Type of Ground Truth Used

The "ground truth" in this context is the objective measurement of peak load pull strength under controlled laboratory conditions (dry and after specific durations in buffered saline at 37°C). This is a direct physical measurement, not expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set

This is not applicable. The INSORB™ Absorbable Staple is a physical device, not an AI or machine learning model that requires a training set. The "optimization in the staple shape" likely refers to engineering design and material science improvements, which are validated through physical testing, not a training set.

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

This is not applicable for the same reasons as point 8.

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