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1. Fixation of small bones, including those in the foot, patella, ankle, wrist and elbow.
2. Arthrodesis of the foot, wrist and elbow.
3. Small and long bone osteotomies.
4. Fracture fixation of small bones, small bone fragments and long bones.

The 3.0mm Biomet Cannulated Screw System consists of bone screws of various lengths and are Ti alloy partially threaded screws with the associated 3.0mm washer. They are offered in both a sterile and non-sterile configuration. The 3.0mm Biomet Cannulated Screw System also contains dimensionally optimized corresponding instruments which are used with the 3.0mm Biomet Cannulated Screws and washers to aid in the alignment and stabilization of fractures to the skeletal system.

This document is a 510(k) premarket notification for a medical device called the "3.0mm Biomet Cannulated Screw System." It seeks to demonstrate substantial equivalence to legally marketed predicate devices, not necessarily to prove specific performance criteria against predefined thresholds.

Therefore, the requested information elements related to acceptance criteria and a study proving those criteria are not directly applicable or available in this specific type of regulatory submission document. This document focuses on demonstrating that the new device is as safe and effective as a previously cleared device.

However, I can extract the relevant information from the document as it pertains to the basis for substantial equivalence, which includes some performance data.

Here's a breakdown based on your request, as much as can be derived from the provided text:

1. A table of acceptance criteria and the reported device performance

This document does not specify formal "acceptance criteria" for clinical performance that would typically be seen in a clinical trial. Instead, the performance is compared against predicate devices to demonstrate substantial equivalence. The non-clinical tests indicate that the new device's performance is "equal to or better than the predicate devices."

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 for Test Set: Not specified. The non-clinical tests were conducted per ASTM F543, which specifies testing methodologies, but the sample size used for these specific tests is not provided in this summary.
• Data Provenance: Not specified, but generally, bench testing (non-clinical) occurs in a lab setting, not tied to patient data. Since no clinical studies were performed, there is no patient data provenance to report.

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)

• Not applicable. This device underwent non-clinical (bench) testing, not clinical studies requiring expert ground truth establishment.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable. This was bench testing, not a clinical study involving human judgment or 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

• No. This is a bone fixation screw system, not an AI/imaging device. Therefore, no MRMC study or AI assistance evaluation was performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable. This is a physical medical device (bone screw), not an algorithm or software.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• For the non-clinical tests, the "ground truth" or reference for performance was established by standardized mechanical testing methodologies (ASTM F543) and comparison to the performance of legally marketed predicate devices. There is no clinical ground truth (like pathology or outcomes data) mentioned because no clinical studies were performed.

8. The sample size for the training set

• Not applicable. This is a physical medical device, not a machine learning algorithm that requires a training set.

9. How the ground truth for the training set was established

• Not applicable. As above, this is not a machine learning algorithm.

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The Biomet Headless Compression Screws and Twist-Off Screws are indicated for fixation of a joint (arthrodesis) or bone reconstruction (osteotomy) of the mid-foot bones, metatarsal and phalanges of the foot or the phalanges, metacarpals and carpals of the hand. In the foot, these include procedures to correct Hallux Valgus (bunions), Hallux Varus and Hallux Rigidus, Hammer toe, Claw toe and Mallet toe.

The Biomet Headless Compression and Twist-Off Screws consist of bone screws of various lengths and diameters. The Biomet Headless Compression and Twist-Off Screws are also accompanied by dimensionally optimized corresponding instruments which are used to aid in the alignment and stabilization of fractures to the skeletal system. The Biomet Headless Compression Screws are a cannulated headless screw, which is inserted below the bone surface. The Biomet Headless Compression Screw is designed to minimize soft tissue irritation and provides compression due to a dual thread design. The Biomet Twist-Off Screw is a solid one piece screw that has a direct connection to a drill or large diameter pin driver, this allows the screw to break-off cleanly upon contact. The Biomet Twist-Off Screw also has compression capabilities with a thread-free segment that achieves compression at the osteotomy site.

This document does not describe a study that proves the device meets specific acceptance criteria in the way you've outlined for an AI/algorithm-based device.

The provided text is a 510(k) premarket notification summary for Biomet Headless Compression and Twist-Off Screws, which are physical medical devices (bone screws), not an AI algorithm or software. Therefore, many of the requested categories (like MRMC studies, ground truth for training/test sets, expert adjudication, AI improvement effect size) are not applicable to this type of device submission.

However, I can extract the relevant information from the document regarding the device's performance assessment:

1. A table of acceptance criteria and the reported device performance:

Note: The document states "Results indicate that the subject screws are substantially equivalent to legally marketed devices offering a reasonable assurance of safety and effectiveness." It does not provide specific numerical values for the performance criteria, only that they met the standards of ASTM F543 and were comparable to predicate devices.

The following questions are NOT APPLICABLE to this document as it pertains to a physical medical device (bone screws) and not an AI or algorithm-based device:

• 2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective) - N/A (mechanical testing on screws themselves)
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts - N/A
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set - N/A
• 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 - N/A
• 6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done - N/A
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc) - N/A (Ground truth for mechanical testing is typically the physical measurement itself against established standards).
• 8. The sample size for the training set - N/A
• 9. How the ground truth for the training set was established - N/A

Ask a specific question about this device