(149 days)
To hold a Semi Tendonosus ST (soft tissue) graft in place in the femoral tunnel during the healing period following ACL reconstrution surgery.
Femoral fixation of autograft or allograft ACL soft tissue grafts
The Cross Pin is 1.654 " long by 0.132" dia. with a conical tip by 0.180" long. The Cross Pin is molded from Purac PLA.
The provided text describes a submission for a medical device (Mitek 3.3mm ST Cross Pin) seeking 510(k) clearance. The document focuses on comparing the new device to a predicate device (Acufex EndoButton) to establish substantial equivalence based on non-clinical tests.
Here's an analysis of the acceptance criteria and study information, based only on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Fixation Strength (Bench Tests) | Statistical equivalence (in both strength and stiffness) to the Acufex EndoButton. |
| Bending (Bench Tests) | Statistical equivalence to the Acufex EndoButton. |
| Shear (Bench Tests) | Statistical equivalence to the Acufex EndoButton. |
| Effect of Cross Pin Orientation on Ultimate Strength of Hamstring Grafts | In-vitro evaluation tests were conducted to show this effect. (No specific performance metric or "acceptance" is stated for this; it's a descriptive test.) |
2. Sample size used for the test set and the data provenance
The text mentions "Bench fixation strength tests, bending and shear" and "In-Vitro evaluation tests." However, it does not specify the sample size used for these tests. It also does not mention the country of origin of the data or whether it was retrospective or prospective, as these were bench and in-vitro tests, not human trials.
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 in the document. The "tests" performed were non-clinical bench and in-vitro evaluations of mechanical properties, not diagnostic or clinical assessments requiring expert ground truth establishment in the traditional sense for medical imaging or clinical outcome studies.
4. Adjudication method for the test set
This information is not applicable and not provided. Adjudication methods are typically used in clinical studies or expert reviews where there's a need to resolve discrepancies in observations or diagnoses. Since these were bench tests, an adjudication method for a test set is not relevant.
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
No MRMC study was done. The document explicitly states: "No clinical tests were done." This device is a mechanical implant, and the study was focused on its mechanical properties compared to a predicate device, not on diagnostic accuracy or AI assistance for human readers.
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 device is a physical medical implant (a cross pin), not an algorithm or AI system. Therefore, standalone performance in the context of an algorithm is irrelevant.
7. The type of ground truth used
For the bench fixation strength, bending, and shear tests, the "ground truth" was established by direct measurement of physical properties (strength, stiffness) of the devices under controlled experimental conditions. For the in-vitro evaluation tests, the "ground truth" was the directly measured ultimate strength of the hamstring grafts under various cross pin orientations. This is based on objective, quantifiable physical properties rather than expert consensus or pathology in a biological sense.
8. The sample size for the training set
This information is not applicable and not provided. The assessment was a direct comparison of physical properties of two medical devices. There was no "training set" in the context of machine learning or predictive modeling.
9. How the ground truth for the training set was established
This information is not applicable and not provided for the same reason as point 8. There was no training set.
§ 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.