(79 days)
The Arthrex Tibial GraftBolt is intended to be used for fixation of tissue including ligament or tendon to bone and bone tendon during cruciate ligament reconstruction procedures
The Arthrex Tibial GraftBolt consists of a pre-packaged mating sheath and a screw pair offered in two new sizes which extend the current size range.
The Arthrex Tibial GraftBolt is a medical device for fixing tissue to bone during cruciate ligament reconstruction. The provided text describes the device and its substantial equivalence to a predicate device, but it does not contain acceptance criteria or detailed study results that prove the device meets specific performance criteria beyond general statements about "ultimate load strength."
Therefore, I cannot provide a table of acceptance criteria and reported device performance or information about sample sizes, ground truth establishment, expert qualifications, or MRMC studies for this specific device from the provided text.
Here's what can be extracted based on the limited information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated in the document. The document mentions "minimum acceptance criteria" but does not define them. | "the submitted mechanical testing data demonstrated that the ultimate load strength of the proposed devices meets or exceeds the minimum acceptance criteria." |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified in the provided text.
- Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective or prospective). The study is described as "mechanical testing data."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not applicable. The "ground truth" for mechanical testing would typically refer to established engineering standards or physical measurements, not expert consensus on medical images or diagnoses.
- Qualifications of Experts: Not applicable.
4. Adjudication method for the test set:
- Adjudication Method: Not applicable. Mechanical testing typically involves objective measurement against pre-defined standards, not human 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:
- MRMC Study Done: No. This device is a mechanical implant, not an AI-powered diagnostic or assistive tool. MRMC studies are not relevant here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone Study: The "mechanical testing data" can be considered a form of standalone testing, as it evaluates the device's physical properties independently. However, this is not an "algorithm only" study.
7. The type of ground truth used:
- Type of Ground Truth: Mechanical testing standards and physical measurements of "ultimate load strength."
8. The sample size for the training set:
- Sample Size: Not applicable. This is a physical device undergoing mechanical testing, not a machine learning model requiring a training set.
9. How the ground truth for the training set was established:
- How Ground Truth Established: Not applicable.
Summary of what is known from the provided text:
- The device is "Arthrex Tibial GraftBolt."
- It is intended for fixation of tissue during cruciate ligament reconstruction.
- It was compared for substantial equivalence to a predicate device (K093912: Arthrex Tibial GraftBolt).
- Mechanical testing was performed to demonstrate that its ultimate load strength "meets or exceeds the minimum acceptance criteria." The specific criteria are not detailed.
- The mechanical testing is the "study" that supports the device meeting its performance claims for substantial equivalence in terms of strength.
§ 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.