(111 days)
To hold a bone tendon bone graft in place by cross pinning in the femoral tunnel during a period of time following surgery allowing the natural healing process(es) to occur.
Femoral fixation of autograft or allograft ACL Bone Tendon Bone Grafts
The Cross Pin is 1.654″ long by 0.105″ dia with a conical tip by .180 long. The Cross Pin is molded from Purac(PLA). To hold a bone tendon bone graft in place by cross pinning in the femoral tunnel during a period of time following surgery allowing the natural healing process(es) to occur.
Here's an analysis of the provided text regarding acceptance criteria and supporting studies:
This document describes a medical device submission for a Staple, Fixation, Bone, & soft tissue device, specifically the Mitek BTB Absorbable (PLA) Cross Pin. The submission aims to demonstrate substantial equivalence to a predicate device, the Linvatec PLA Bioscrew.
It's important to note that the provided text focuses on non-clinical (benchtop) tests to demonstrate substantial equivalence. No clinical tests were performed or required for this submission. Therefore, questions related to human reader performance, AI assistance, or clinical ground truth are not applicable in this context.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Mitek BTB Absorbable (PLA) Cross Pin were implicitly established by demonstrating comparable performance to the predicate device, the Linvatec PLA Bioscrew, in specific mechanical tests.
| Acceptance Criteria (Implicit) | Reported Device Performance (Mitek Cross Pin) |
|----------------------------------------------------------------+|---------------------------------------------------------------------------------------------------------------------|
| No significant strength difference in bending tests compared to predicate (Bioscrew). | "Bench top Bending and Shear tests were done on the PLA pins [...] The results showed that there was no significant strength difference between the two." (Implied comparison to Bioscrew) |
| No significant strength difference in shear tests compared to predicate (Bioscrew). | "Bench top Bending and Shear tests were done on the PLA pins [...] The results showed that there was no significant strength difference between the two." (Implied comparison to Bioscrew) |
| Comparable pull-out strength to predicate (Bioscrew). | "strength comparisons to the Bioscrew in pull out tests were done to the Bioscrew. The results showed that there was no significant strength difference between the two." |
| Comparable strength after 8 weeks (in-vitro) to "zero" day results (indicating stability). | "Eight week In-vitro tests were also done and found to have results that were comparable to 'zero' day results." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the numerical sample size for the benchtop tests (e.g., number of pins tested for bending, shear, or pull-out). It simply states that "Bench top Bending and Shear tests were done on the PLA pins" and "strength comparisons to the Bioscrew in pull out tests were done to the Bioscrew."
The data provenance is laboratory-based benchtop testing. There is no information about country of origin, as it pertains to manufactured devices and their testing, not patient data. The tests are non-clinical and therefore cannot be classified as retrospective or prospective in the human study sense.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. For this type of non-clinical device submission, ground truth is established through standardized engineering and material science testing methods, not by human expert review of clinical data.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods like 2+1 or 3+1 refer to methodologies used in clinical studies for resolving discrepancies among expert readers. Since this submission relies on benchtop testing, such methods are not relevant.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No MRMC comparative effectiveness study was done. The submission explicitly states: "No clinical tests were done for this product." Therefore, there is no effect size related to human readers improving with or without AI assistance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Not applicable. This device is a physical medical implant, not an AI algorithm. Therefore, there is no "standalone" algorithm performance to assess.
7. The Type of Ground Truth Used
The ground truth used was mechanical performance data obtained from standardized benchtop testing (Bending, Shear, and Pull-out tests) of the device and a predicate device, as well as in-vitro degradation/stability testing.
8. The Sample Size for the Training Set
Not applicable. Clinical training sets for AI algorithms were not used. The manufacturing process of the pins serves as the "training" for the device itself, adhering to design specifications.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no training set in the AI sense for this device. The "ground truth" for manufacturing would be the established design specifications, material properties, and quality control parameters.
§ 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.