(57 days)
Peri-Strips Staple Line Reinforcement is intended for use as a prosthesis for the surgical repair of soft tissue deficiencies using surgical staplers when staple line reinforcement is needed.
Peri-Strips can be used for reinforcement of staple lines during lung and bronchus resections and during bariatric surgical procedures.
Peri-Strips can also be used for reinforcement of staple lines during gastric, small bowel, mesentery, colon, and colorectal procedures.
An implantable surgical patch comprised of crosslinked bovine pericardium
The provided document is a 510(k) summary for the Peri-Strips Staple Line Reinforcement device. It states that the device is "substantially equivalent to the predicate device in terms of testing and indications for use." However, it does not contain specific details about acceptance criteria or a study that proves the device meets those criteria in the typical sense of a performance study with detailed metrics.
Instead, the submission for this type of device (surgical mesh) primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device. This often involves showing that the new device has the same technological characteristics and intended use as the predicate, rather than conducting a separate clinical or performance study with defined acceptance criteria and statistical analysis as one might find for diagnostic AI/ML devices.
Therefore, many of the requested elements for describing a study proving the device meets acceptance criteria cannot be extracted from this document, as such a study is not detailed here.
Here's what can be inferred or stated based on the provided text:
1. Table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated in this document as quantitative performance metrics. The underlying acceptance criterion for a 510(k) submission is "substantial equivalence" to a predicate device.
- Reported Device Performance: The document states, "Peri-Strips® Staple Line Reinforcement is substantially equivalent to the predicate device in term of testing and indications for use." This is the primary "performance" metric reported in the context of a 510(k) for this type of device. Specific quantitative performance data from a clinical trial or a standalone study are not provided.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Not Applicable / Not Provided: The document does not describe a test set or data provenance for a performance study. Demonstrating substantial equivalence for this device likely relied on bench testing, material characterization, and comparison to the predicate, rather than a clinical study with a "test set" in the context of AI/ML or diagnostic devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable / Not Provided: No such information is present, as there's no mention of a performance study involving expert assessment or ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable / Not Provided: No such information is present.
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 / Not Provided: This device is a surgical mesh for staple line reinforcement, not an AI/ML diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant or described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable / Not Provided: This is a physical surgical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Applicable / Not Provided: This concept of "ground truth" as it pertains to diagnostic performance is not relevant for this type of device submission. The "truth" in this context revolves around material properties, biocompatibility, and functional equivalence to the predicate.
8. The sample size for the training set:
- Not Applicable / Not Provided: No "training set" is mentioned as this is not an AI/ML device.
9. How the ground truth for the training set was established:
- Not Applicable / Not Provided: No "training set" or "ground truth" establishment for training is mentioned.
Summary based on the document:
The provided document describes a 510(k) submission for a surgical device. The "acceptance criteria" for such a submission are primarily based on demonstrating "substantial equivalence" to a legally marketed predicate device. The study proving this substantial equivalence would have involved comparing the new device's technological characteristics, materials, and intended use to the predicate device, likely through bench testing and material characterization, rather than a clinical performance study with defined acceptance criteria and statistical analysis as one might find for AI/ML or diagnostic devices.
The document explicitly states: "Peri-Strips® Staple Line Reinforcement is substantially equivalent to the predicate device in term of testing and indications for use." This statement, along with the detailed comparison of intended use, is the core of the "study" proving the device meets the regulatory acceptance criteria for 510(k) clearance.
§ 878.3300 Surgical mesh.
(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.