(182 days)
The BioLok® Screw is indicated for use in anterior cruciate ligament (ACL) reconstruction procedures where the surgeon:
- places the graft in tibial and/or femoral tunnels; and .
- inserts screws between the tunnel wall and graft to hold the graft in place. .
The BioLok® Screw is used to provide interference fixation of patellar bone-tendon-bone grafts in ACL reconstruction.
The BioLok® Screw is used to provide interference fixation during femoral and/or tibial fixation in ACL reconstruction using a soft tissue graft (semi-tendonosis gracilis).
The BioLok® Screw is a cannulated, sterile, single-use bone screw made of an absorbable polymer similar to that used in bioabsorbable suture and will gradually be absorbed into the body. The BioLok® Screw is manufactured from a mixture of Tri-Calcium Phosphate (TCP and poly (L-lactide) (PLLA).
The provided document is a 510(k) summary for the BioLok® Screw, a medical device. This type of document is a pre-market notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device. It does not typically include information about clinical trials, extensive performance studies, or AI-related aspects like multi-reader multi-case studies, ground truth establishment for training data, or sample sizes related to AI model development.
Based on the provided information, I can answer the following:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state numerical acceptance criteria in the format typically seen for rigorous performance metrics (e.g., specific thresholds for strength, pull-out force, etc.). Instead, the performance data provided is comparative.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Requisite strength over time for early and sustained graft fixation. | Test results confirm this. |
| Favorable pull-out test results compared to predicate devices. | Pull-out test results compare favorably with predicate devices. |
| Equivalence in design, materials, and indications to predicate devices. | The BioLok® Screw is equivalent in design, materials, and indications to the predicate devices. |
2. Sample size used for the test set and the data provenance
The document does not specify the sample size used for any mechanical or performance tests. It also does not mention data provenance (e.g., country of origin, retrospective/prospective) for any test data.
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 and not provided. The device is a bone fixation screw; its performance is evaluated through mechanical testing, not by expert interpretation of images or data requiring ground truth establishment in the way an AI diagnostic device would.
4. Adjudication method for the test set
This information is not applicable and not provided. The evaluation of mechanical test results does not typically involve adjudication methods like those used for expert consensus in clinical trials or diagnostic studies.
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
An MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic devices where human readers interpret medical images. The BioLok® Screw is a physical surgical implant, not an AI diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This information is not applicable and not provided. The BioLok® Screw is a physical device, not an algorithm.
7. The type of ground truth used
The concept of "ground truth" as typically applied to diagnostic algorithms (e.g., pathology, outcomes data, expert consensus on images) is not directly applicable here. The "ground truth" for a mechanical device like the BioLok® Screw would be the objective measurements of its physical and mechanical properties and its performance in specific tests (e.g., force required for pull-out, material degradation rates). The document states "Test results confirm that this composite has the requisite strength over time" and "Pull out test results compare favorably with the predicate devices," implying these mechanical test outcomes are the basis for evaluation.
8. The sample size for the training set
This information is not applicable and not provided. There is no mention of a "training set" as the device is not an AI model.
9. How the ground truth for the training set was established
This information is not applicable and not provided, as there is no training set for an AI model.
§ 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.