(73 days)
Titanium Interference Screws are intended for use in fixation of patellar bone grafts in ACL reconstruction.
Titanium Interference Screws are metallic bone screws used to provide fixation of patellar bone-tendon-bone grafts during anterior cruciate ligament (ACL) repair.
This document is a marketing clearance (510(k)) for a medical device called "Titanium Interference Screws." It establishes substantial equivalence to a predicate device, meaning it's considered as safe and effective as a device already on the market, and therefore does not include detailed studies demonstrating performance against specific acceptance criteria in the way a clinical trial for a novel device would.
The provided document does not contain a study focused on proving the device meets acceptance criteria in a clinical or AI-related context, nor does it provide a table of acceptance criteria and reported device performance relevant to AI/diagnostic efficacy.
Instead, the document focuses on demonstrating substantial equivalence for the Titanium Interference Screws by comparing their characteristics and non-clinical performance to an already legally marketed predicate device. The "acceptance criteria" here refer to the regulatory safety and performance standards for a substantially equivalent device, rather than specific diagnostic metrics.
However, based on the non-clinical tests described, we can infer some "acceptance criteria" as they relate to the mechanical performance of the device.
Here's an analysis based on the information provided, inferring what could be considered "acceptance criteria" for this type of device and what was done to support its clearance:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a 510(k) for a physical medical device (Titanium Interference Screws) and not an AI or diagnostic device, the "acceptance criteria" are related to its mechanical and biological safety, not diagnostic performance. The document states that the test results "indicate the device and the modifications do not introduce any new risks to the device performance" and "the testing indicates that the device performs within the intended use and did not raise any new safety and efficacy issues."
| Acceptance Criteria (Inferred from Non-Clinical Tests) | Reported Device Performance |
|---|---|
| Cyclic Loading Performance: Device withstands cyclic stress without failure or degradation that would introduce new risks. | "The test results indicate the device and the modifications do not introduce any new risks to the device performance." |
| Failure Torque Performance: Device's failure torque meets established safety limits (implies it's strong enough not to fail prematurely during use). | "The test results indicate the device and the modifications do not introduce any new risks to the device performance." |
| Insertion Torque Performance: Device's insertion torque is within acceptable limits for surgical implantation (implies it's easy/safe to implant). | "The test results indicate the device and the modifications do not introduce any new risks to the device performance." |
| Pull Out Strength Performance: Device maintains fixation strength in bone after implantation (implies it won't dislodge prematurely). | "The test results indicate the device and the modifications do not introduce any new risks to the device performance." |
| Bacterial Endotoxin Levels: Device meets sterility and pyrogenicity limits (≤20 EU/Device per USP41-NF36 Chapter ). | "demonstrating that the device meets the limit of ≤20 Endotoxin units (EU)/Device per USP41-NF36 Chapter Medical Devices -Bacterial Endotoxin and Pyrogen Tests." |
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size: Not explicitly stated for each non-clinical test. The document mentions "Cyclic loading testing of Titanium Interference Screws," "Failure torque testing of Titanium Interference Screws," etc., which implies a sample of devices were tested. Typical mechanical testing involves a statistically significant number of samples, but the exact count is not disclosed here.
- Data Provenance: The tests are non-clinical, likely performed in an engineering lab environment. The country of origin of the data is not specified beyond being part of the submission from "Biomet Inc." in "Warsaw, Indiana" to the FDA. The data is prospective in the sense that these tests were conducted specifically for this 510(k) submission to demonstrate performance, but they are in vitro (bench testing) rather than in vivo data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This question is not applicable to this type of device clearance. "Ground truth" in the context of expert consensus is typically relevant for diagnostic or AI-driven devices where human interpretation provides a reference standard. For a mechanical implant device, the "ground truth" is defined by established engineering and biological safety standards (e.g., ASTM standards for mechanical properties, USP standards for endotoxins) and the expert interpretation is embedded within the test methodologies and regulatory review process.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods (like 2+1 or 3+1) are used to resolve disagreements among multiple experts when establishing ground truth for diagnostic decisions. For mechanical testing, results are quantitative and either meet or do not meet pre-defined criteria; expert adjudication of test results is not typically part of the process, though expert interpretation of the implications of the results is part of the regulatory review.
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
Not applicable. This is a clearance for a physical orthopedic implant (Titanium Interference Screws), not an AI or imaging device that would involve human readers or diagnostic interpretation.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is an orthopedic implant, not an algorithm.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical tests described, the "ground truth" is derived from:
- Established engineering standards: For cyclic loading, failure torque, insertion torque, and pull-out strength, these likely refer to industry-accepted mechanical testing standards (e.g., ISO, ASTM standards for orthopedic implants). The "ground truth" is the established performance benchmarks or thresholds for these mechanical properties that ensure safety and effectiveness for the intended use.
- Biological safety standards: For Bacterial Endotoxins, the "ground truth" is the regulatory limit of ≤20 Endotoxin units (EU)/Device per USP41-NF36 Chapter .
8. The Sample Size for the Training Set
Not applicable. This device is not an AI algorithm, so there is no training set in the machine learning sense.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
§ 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.