(32 days)
The biocomposite suture anchor is intended to reattach soft tissue to bone in orthopedic surgical procedures. The Argo Knotless® GENESYS™ Anchor may be used in either arthroscopic or open surgical procedures. After the suture is anchored to the bone, it may be used to reattach soft tissue, such as ligaments, tendons, or joint capsules to the bone. The suture anchor system thereby stabilizes the damaged soft tissue, in conjunction with appropriate postoperative immobilization throughout the healing period.
The Argo Knotless® GENESYS™ Anchor is an implantable bone anchor, that is supplied single use, sterilized via ethylene oxide (ETO) to a SAL of 10 °. The threaded anchor is manufactured of bioabsorbable material, and the suture eyelet is manufactured of PEEK Optima material. The device features a single use driver, a threaded anchor, a PEEK-Optima eyelet, a #2 UHMWPE, non-absorbable retention suture, and loader tab. The retention suture holds the PEEK eyelet in place on the driver and can be incorporated into the repair if desired. The suture eyelet can hold up to six (6) sutures or one (1) bioresorbable reinforced implant. These anchor configurations require a pre-prepared bone hole which can be created with Class I, Exempt instrumentation.
The provided text is a 510(k) Summary for the Argo Knotless® GENESYS™ Anchor, a medical device. This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and study results in the format typically found in clinical trial reports for software devices.
Based on the information provided, here's what can be extracted and what is not present:
Missing Information:
The document does not describe acceptance criteria in the typical statistical sense (e.g., specific thresholds for sensitivity, specificity, or other performance metrics). It also does not describe a study that proves the device meets these types of acceptance criteria. The performance data mentioned refers to mechanical testing and user validation, not a clinical study to establish analytical or clinical performance of an AI/software device.
Therefore, the following points cannot be answered from the provided text:
- A table of acceptance criteria and the reported device performance: Not provided in terms of statistical performance metrics.
- Sample sized used for the test set and the data provenance: Not applicable in the context of AI/software performance. The "test set" here refers to mechanical testing or cadaveric validation.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method for the test set: Not applicable.
- 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: This device is a physical bone anchor, not an AI/software product that assists human readers.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used: Not applicable for an AI/software performance study. For the mechanical and user validation tests, the "ground truth" would be the physical properties or user feedback.
- The sample size for the training set: Not applicable as this is not an AI/software device.
- How the ground truth for the training set was established: Not applicable.
What is present in the document about performance and validation:
The document briefly mentions "performance data" in Section VII, but this refers to mechanical and user validation for a physical medical device.
1. Acceptance Criteria and Reported Device Performance (As implied for a physical device, not statistical AI performance):
While not explicitly stated as "acceptance criteria," the document indicates that the device's performance was evaluated to demonstrate substantial equivalence to its predicate. The implied acceptance criterion is that the new device performs as intended and similarly to the predicate device in terms of mechanical properties and user experience.
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Performance as intended (mechanical stability, insertion, pull-out) | Performance Testing (Insertion, Cyclic and Ultimate Pull Displacement Resistance) completed. |
| User validation for surgical procedures | User Validation (Cadaver Medial Collateral Ligament/Lateral Ligament) completed. |
| Packaging and labeling suitability | Packaging and Labeling User Validation completed. |
2. Study that proves the device meets the (implied) acceptance criteria:
The study refers to a variety of tests and validations performed:
- Performance Testing: This would typically involve laboratory tests to measure parameters like insertion force, resistance to cyclic loading, and ultimate pull-out strength. The document doesn't provide specific quantitative results but states these tests were "completed."
- User Validation (Cadaver Medial Collateral Ligament/Lateral Ligament): This indicates hands-on testing of the device's usability and effectiveness in a cadaveric model, simulating surgical conditions for the intended use (reattaching soft tissue to bone).
- Packaging and Labeling User Validation: This would involve confirming that the packaging maintains sterility and integrity, and that the labeling is clear and accurate for users.
Data Provenance and Sample Size for Test Set:
- Sample Size: The specific sample sizes for these tests (e.g., number of anchors tested, number of cadavers, number of users for validation) are not provided in this summary.
- Data Provenance: Not specified, but generally, such performance and cadaveric testing would be conducted in a laboratory or simulated surgical environment. It is not "data" in the sense of patient records from a specific country.
In summary, the provided document is a regulatory submission for a physical medical device. It does not contain the specific information requested about acceptance criteria and study design as it pertains to the performance validation of an AI/software device.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.