(72 days)
Synthes Ti Tube to Tube Clamp is intended for use in the construction of an external fixation frame for the treatment of long bone fractures that require external fixation. The clamps attach the two carbon fiber rods or stainless steel tubes.
Synthes Ti Tube to Tube Clamp is intended for use in the construction of an external fixation frame for the treatment of long bone fractures that require external fixation. The clamps attach the two carbon fiber rods or stainless steel tubes. The device is manufactured from a Titanium Alloy.
This document appears to be a 510(k) summary for a medical device submitted to the FDA in 1996. It details a comparison between the "Synthes Ti Tube to Tube Clamp" and the "Ace Medical's Articulation Coupler."
Based on the provided text, the document describes a medical device clearance submission, not a study involving AI or complex performance metrics as typically seen in modern diagnostic device studies. Therefore, many of your requested fields are not applicable to this type of document. I will fill in the relevant information and indicate where information is not present or not applicable.
Here's the breakdown of the information based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial equivalence to Ace Medical's Articulation Coupler based on mechanical test results. | "Based on mechanical test results, the Ti Tube to Tube Clamp has been found to be substantially equivalent to the Articulation Coupler." |
2. Sample sized 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 in the document. The general nature of mechanical testing for such devices in 1996 would typically involve a small number of samples for each test (e.g., a few clamps per test type like bending, torsional, tensile strength).
- Data Provenance: Not explicitly stated. Given that Synthes (USA) is the submitter, it's highly probable the testing was conducted in the USA. The data would be prospective for the purpose of the 510(k) submission, meaning the tests were performed specifically for this comparison.
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)
- Number of Experts: Not applicable. This is a mechanical device comparison, not a diagnostic device requiring expert interpretation of results for ground truth. "Ground truth" here would be the objective results of the mechanical tests.
- Qualifications of Experts: Not applicable.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable. Mechanical test results are objective measurements and do not typically involve adjudication in the expert consensus sense.
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: No. This is not an imaging or diagnostic device involving human readers or AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. This device does not involve an algorithm or AI.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Type of Ground Truth: Objective mechanical test results (e.g., strength, stiffness, fatigue properties) comparing the Synthes clamp to the predicate device.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. There is no "training set" as this is not a machine learning or AI-based device.
9. How the ground truth for the training set was established
- How Ground Truth for Training Set was Established: Not applicable. There is no training set for this type of 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.