(90 days)
The EndoANCHOR Fixation Device is intended for fixation of prosthetic material to and approximation of soft tissue in various minimally invasive and open general surgical procedures, such as hernia repair.
The OpenANCHOR Fixation Device is intended for fixation of prosthetic material to and approximation of soft tissue in various open general surgical procedures, such as hernia repair.
The EndoANCHOR and OpenANCHOR Fixation Devices are sterile, single patient use instruments that deploy nitinol anchors into prosthetic material and soft tissue for fixation and approximation applications. The nitinol anchors are 5.9 mm long and 6.7 mm wide. The EndoANCHOR fixation device is designed for endoscopic surgical use with a trocar or for oven surgical use. Two sizes of the EndoANCHOR Fixation Device are offered: a 3 mm and 5 mm diameter shaft. Both instrument shafts are 301 mm long and contain 20 nitinol anchors. The OpenANCHOR Fixation Device is designed for open surgical use. The instrument has a 132mm long, 3 mm diameter shaft and contains 10 nitinol anchors.
Here's an analysis of the provided text regarding the EndoANCHOR and OpenANCHOR fixation devices' acceptance criteria and supporting study, formatted as requested:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Inferred) | Reported Device Performance | Study Type |
|---|---|---|---|
| Safety | Safe for intended use | "Preclinical testing was performed to ensure the device performs as intended" and "demonstrated satisfactory according to the EndoANCHOR and OpenANCHOR Fixation Devices during surgical procedures." | Bench and animal testing |
| Effectiveness/Functionality | Performs as intended | "Preclinical testing was performed to ensure the device performs as intended when used I roomling to the instructions for use." and "demonstrated satisfactory according to the EndoANCHOR and OpenANCHOR Fixation Devices during surgical procedures." | Bench and animal testing |
| Material Compatibility | Biocompatible (implied by material type and intended use) | Nitinol anchors used; no adverse events reported, suggesting compatibility. | N/A (implied by general safety) |
| Sterility | Sterile for single patient use | "The EndoANCHOR and OpenANCHOR Fixation Devices are sterile, single patient use instruments." | N/A (implied by device description) |
| Fixation/Approximation | Achieves fixation of prosthetic material and approximation of soft tissue | "deploy nitinol anchors into prosthetic material and soft tissue for fixation and approximation applications." and "demonstrated satisfactory according to the EndoANCHOR and OpenANCHOR Fixation Devices during surgical procedures." | Bench and animal testing |
Explanation of Inferred Criteria: The document is a 510(k) summary, which often focuses on substantial equivalence rather than explicit, quantified acceptance criteria. Therefore, the "specific criteria" are inferred from the stated purpose of the preclinical testing and the nature of medical device approval for devices of this type. The statement "ensure the device performs as intended" broadly encapsulates these inferred criteria.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size (Test Set): Not explicitly stated. The document refers to "bench and animal testing" but does not provide specific numbers of animals or test configurations.
- Data Provenance: Not explicitly stated regarding country of origin. The study appears to be retrospective relative to the 510(k) submission, as the testing was already completed when the summary was prepared.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This information is not provided in the document. The summary focuses on preclinical performance data rather than human expert evaluation of test results.
4. Adjudication Method for the Test Set
- Adjudication method is not applicable and therefore not mentioned, as the study involves bench and animal testing, not human readers interpreting data that would require adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, a MRMC comparative effectiveness study was not done. The preclinical testing comprised bench and animal studies to assess the device's performance, not to evaluate human reader improvement with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. The device is a mechanical surgical instrument, not an algorithm or AI. Therefore, a standalone algorithm performance study is irrelevant.
7. The Type of Ground Truth Used
- The ground truth for the preclinical testing was established through direct observation and measurement of device function and biological response in bench and animal models. This would include:
- Mechanical performance: (e.g., anchor deployment success, tensile strength of fixation)
- Biological response: (e.g., tissue integration, inflammatory response, absence of adverse events in animal models)
- Clinical outcomes in animal models: (e.g., successful approximation of tissue, durable fixation over time).
8. The Sample Size for the Training Set
- Not applicable. The device is a physical surgical instrument, not an AI or machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As the device is not an AI/ML model, there is no training set or associated ground truth establishment method.
§ 878.4750 Implantable staple.
(a)
Identification. An implantable staple is a staple-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.