(142 days)
The OrthoPediatrics ACL Reconstruction System is intended for fixation of tendons and ligaments during orthopedic reconstruction procedures such as Anterior Cruciate Ligament (ACL) Reconstruction.
The OrthoPediatrics ACL Reconstruction System is a two part fixation system for anchoring soft tissue grafts in ACL deficient patients. It is available in diameters of 6mm, 6.5mm, 7mm, 7.5mm, 8mm, 8.5mm, 9mm, & 10mm in order to accommodate differing anatomic requirements. The first system is a screw designed to work in conjunction with a sleeve that has been fitted into the graft tunnel within the bone. Both screw and sleeve components are made entirely of PEEK Optima. The second system consists of a titanium alloy implant intended to hook onto the looped portion of the soft tissue graft and then rest onto the cortex at the end of the graft tunnel.
The OrthoPediatrics ACL Reconstruction System's performance was evaluated through mechanical testing, specifically static pull-out testing and dynamic cyclic loading, to demonstrate substantial equivalence to predicate devices. The document does not provide specific numerical acceptance criteria or detailed device performance metrics beyond stating that the system "demonstrated substantial equivalence to predicate device performance."
Here's an overview of the information you requested, based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated in the provided text, but generally would involve specific thresholds for static pull-out strength and dynamic cyclic loading characteristics to ensure adequate fixation and durability. | The results demonstrated that the OrthoPediatrics ACL Reconstruction System is substantially equivalent to predicate device performance in static pull-out testing and dynamic cyclic loading. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size: Not specified in the provided text.
- Data Provenance: Not specified in the provided text. Mechanical testing is typically laboratory-based, so "country of origin" would refer to the testing facility, which is not mentioned. The data would be prospective in the sense that the tests were specifically conducted for this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
This question is not applicable. The study involved mechanical performance testing of a physical device, not interpretation of data by human experts to establish ground truth.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This question is not applicable as the study involved mechanical testing, not expert interpretation requiring adjudication.
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
This question is not applicable. The study was a mechanical performance evaluation of a medical device, not a human reader study involving AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. The study was a mechanical performance evaluation of a physical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for mechanical testing is established by standardized test methods (e.g., ASTM standards) that define how force is applied and how displacement/failure is measured. The "ground truth" would be the direct measurements of mechanical properties (e.g., peak load, stiffness, cycles to failure) observed during these tests.
8. The sample size for the training set
This question is not applicable. The study did not involve a training set as it was a mechanical performance evaluation, not a machine learning model.
9. How the ground truth for the training set was established
This question is not applicable for the same reason as above.
§ 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.