(88 days)
The Modular Head Bone Screw is indicated for the following conditions:
- Fixation of fractures in long bones such as the fibula, tibia, humerus, radius and ulna, as well as fractures in the patella
- Fixation of small bones such as those in the foot, ankle, wrist and elbow
- Ligament reconstruction
- Arthrodesis of the foot, ankle, wrist and elbow
- Small bone osteotomies
- Osteochondritis dissecans
This device is a metal screw shaft with a corresponding resorbable screw head. It also has an optional corresponding metal screw head for back-up purposes should the resorbable screw head become contaminated in the surgical environment.
The provided document is a 510(k) premarket notification for a medical device called the "Modular Head Bone Screw." This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through clinical trials with specific acceptance criteria, performance metrics, and detailed study designs for a new device.
Therefore, many of the requested details about acceptance criteria, clinical study methodology, ground truth establishment, expert involvement, and sample sizes for training/test sets are not applicable to this type of regulatory submission.
Here's an explanation based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not Applicable (N/A): For 510(k) submissions, the primary "acceptance criterion" is "substantial equivalence" to a predicate device. This is typically met by demonstrating that the new device has the same intended use and technological characteristics as the predicate, or if there are differences, that those differences do not raise new questions of safety or effectiveness. | The device's "Summary of Technologies" states: "The Modular Head Bone Screw's technological characteristics are similar to or identical to the predicate devices." |
The "Non-Clinical Testing" section states: "Mechanical testing was performed to establish substantial equivalence to the predicate devices." Specific performance metrics from this mechanical testing are not provided in this summary. |
2. Sample Size Used for the Test Set and Data Provenance
This information is Not Applicable. The document explicitly states: "Clinical Testing: Clinical testing was not used to establish substantial equivalence to predicate devices." Therefore, there was no test set of patient data, no data provenance information, and no clinical performance evaluated in this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
This information is Not Applicable as no clinical testing was performed and therefore no ground truth needed to be established for a clinical test set.
4. Adjudication Method for the Test Set
This information is Not Applicable as no clinical testing was performed and therefore no test set data requiring 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
This information is Not Applicable. This device is a bone screw, not an AI-powered diagnostic or assistive technology. No MRMC study was performed, nor would it be relevant for this type of medical device submission.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
This information is Not Applicable. This device is a bone screw; it is not an algorithm or AI system.
7. The Type of Ground Truth Used
This information is Not Applicable. Since no clinical testing was performed, no "ground truth" (such as expert consensus, pathology, or outcomes data) was established for clinical performance. The substantial equivalence was based on mechanical testing and comparison of technological characteristics to predicate devices.
8. The Sample Size for the Training Set
This information is Not Applicable. There was no AI algorithm involved, so no training set was used.
9. How the Ground Truth for the Training Set was Established
This information is Not Applicable. There was no AI algorithm involved, so no ground truth for a training set was established.
Summary of the Study (as described in the document):
The study to "prove the device meets the acceptance criteria" (in this context, substantial equivalence to predicate devices) was non-clinical mechanical testing. The document states:
- "Non-Clinical Testing: Mechanical testing was performed to establish substantial equivalence to the predicate devices."
- "Clinical Testing: Clinical testing was not used to establish substantial equivalence to predicate devices."
The specifics of the mechanical testing (e.g., number of samples, specific tests like bending strength, torsional strength, pull-out strength, etc., and the results compared to predicate devices) are not detailed in this summary document but would have been part of the full 510(k) submission. The "acceptance criteria" for this mechanical testing would involve demonstrating that the Modular Head Bone Screw's mechanical properties were comparable to or better than those of the identified predicate devices (Self-Countersinking Bone Screw K013534 and Synthes Sterile 3.0mm cannulated Screw K962823) for its intended uses.
§ 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.