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510(k) Data Aggregation
(130 days)
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.
INSORBTM Absorbable Staples are 5.1mm in length, 0.79mm thick, 3.48mm wide overall, and have barb tips that are 0.66mm 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). INSORB™ staples are made from an absorbable copolymer which is a synthetic polyester derived from lactic and glycolic acids. It is chemically similar to other surgical glycolide/lactide-based copolymers. Polyglycolic/polylactic acid copolymers degrade in vivo by hydrolysis to glycolic acid and lactic acid which are then absorbed and metabolized by the body.
This document describes the INSORB™ Absorbable Staple, a medical device, and the study supporting its 510(k) clearance.
Here's an analysis of the provided information against your requested criteria:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Attribute | Acceptance Criteria (from document) | Reported Device Performance (from document) |
|---|---|---|
| Functional Characteristics | Appropriate functional characteristics for a subcuticular skin closure stapling device. | "This testing demonstrates that the INSORB™ Absorbable Staples meet all required specifications." |
| Safety | Safe for use as an implantable absorbable staple for subcuticular skin closure. | "This testing demonstrates that the INSORB™ Absorbable Staples meet all required specifications." |
| Equivalence | Substantially equivalent to legally marketed predicate devices. | The device was found substantially equivalent to the indicated predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly mentions an "animal study" as part of the functional and safety testing. However, it does not specify the sample size for this animal study, nor does it provide details on the data provenance (e.g., country of origin, retrospective or prospective).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not mention the use of human experts to establish ground truth for any test set. The validation appears to be based on an animal study and mechanical performance testing.
4. Adjudication Method for the Test Set
Not applicable, as human expert involvement and a test set requiring adjudication are not described in the provided text.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. The document does not describe a multi-reader multi-case (MRMC) comparative effectiveness study, nor does it refer to human readers improving with or without AI assistance. The device is a surgical stapler, not an AI-powered diagnostic or assistive tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable to the device described. The INSORB™ Absorbable Staple is a physical medical device, not an algorithm or software. Its performance is evaluated through functional, safety, and animal testing, not through algorithmic standalone performance.
7. The Type of Ground Truth Used
Based on the information provided, the ground truth for the device's performance appears to be established through:
- Mechanical performance testing: Assessing physical properties and function against predefined specifications.
- Animal study: Evaluating in-vivo performance, degradation, and tissue reaction in a living model.
8. The Sample Size for the Training Set
Not applicable. The INSORB™ Absorbable Staple is a physical medical device, not a machine learning model, so there is no concept of a "training set" in the context of this submission.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
Summary of Study that Proves Acceptance Criteria:
The study proving the device meets the acceptance criteria is summarized as "FUNCTIONAL & SAFETY TESTING". This testing included:
- An animal study: Designed to verify appropriate functional characteristics and safety in a biological environment.
- Mechanical performance testing: To ensure the staples perform according to engineering specifications.
- Package testing: (Likely to ensure sterility and integrity during storage and transport).
The document states, "This testing demonstrates that the INSORB™ Absorbable Staples meet all required specifications," and concludes that the device is "substantially equivalent" to predicate devices, which is the primary regulatory acceptance criterion for K024117.
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