(105 days)
The Cannulated Screw for the Proximal Humerus Plating System is indicated for internal fixation of fractures of the proximal humerus.
The Miami Device Solutions (MDS) Cannulated Screw is a cannulated bone screw intended for use with the MDS Proximal Humerus Plating System cleared in K141493. The MDS cannulated bone screw is 3.5 mm in diameter, 30 to 60 mm in length in 3 mm increments, fully cannulated and threaded, and can interface with MDS Proximal Humerus Plates and Locking Caps cleared in K141493. The MDS device is supplied not sterile and is single-use only.
Materials: Ti-6Al-4V ELI alloy conforming to ASTM F136.
The provided document describes a 510(k) premarket notification for a medical device called the "Cannulated Screw." This document focuses on demonstrating the substantial equivalence of the new device to legally marketed predicate devices, primarily through performance testing. However, it does not describe a study that involves an AI algorithm, human readers, or image analysis for diagnosis.
Therefore, I cannot fill in any details for the following requested information, as the document does not contain them:
- Acceptance Criteria and Reported Device Performance (as typically defined for AI/diagnostic devices)
- Sample size used for the test set and data provenance
- Number of experts used to establish ground truth and qualifications
- Adjudication method for the test set
- Multi-reader multi-case (MRMC) comparative effectiveness study
- Standalone (algorithm-only) performance
- Type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Sample size for the training set
- How the ground truth for the training set was established
However, I can extract information related to the device's performance testing for its substantial equivalence claim:
Device: Cannulated Screw (intended for internal fixation of fractures of the proximal humerus)
Type of Study Conducted: Performance testing against consensus standard ASTM F543 to demonstrate substantial equivalence to predicate devices (Zimmer cannulated screw and Arthrex screw). This testing is for the physical and mechanical properties of the screw, not for diagnostic performance.
1. A table of acceptance criteria and the reported device performance
The document states that the acceptance criterion was that the MDS device possess "similar strength and performance characteristics" as the predicate devices. The reported performance was that "the results of these tests showed the MDS device to possess similar performance properties as the Zimmer predicate device, and the Arthrex predicate device (K041965), and therefore do not raise new questions of safety when used per the products labeling."
| Metric / Test | Acceptance Criteria (Implicit) | Reported Device Performance (MDS Cannulated Screw) |
|---|---|---|
| Torsional Strength | Similar to predicate devices (Zimmer, Arthrex) | Showed similar performance properties |
| Torque-out | Similar to predicate devices (Zimmer, Arthrex) | Showed similar performance properties |
| Axial Pull Out Strength | Similar to predicate devices (Zimmer, Arthrex) | Showed similar performance properties |
Note: The document only provides a qualitative statement of "similar performance properties" and does not list specific numerical thresholds or results for these tests.
2. Sample sized used for the test set and the data provenance
- Sample Size: Not explicitly stated for the performance tests. The testing was done on the physical devices themselves (MDS Cannulated Screw and predicate Zimmer Cannulated Screw).
- Data Provenance: Not applicable in the traditional sense of human patient data. This refers to in-vitro mechanical testing of manufactured medical devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. Ground truth for mechanical performance testing is established by the specifications defined in the ASTM F543 consensus standard, not by human experts interpreting clinical data.
4. Adjudication method for the test set
- Not applicable.
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 medical device (screw) clearance, not an AI diagnostic software.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is a medical device (screw) clearance.
7. The type of ground truth used
- The "ground truth" for the performance testing was the established performance characteristics and specifications outlined in the ASTM F543 consensus standard for bone screws, and the performance observed from the legally marketed predicate devices (Zimmer and Arthrex cannulated screws). This is a technical performance ground truth, not a clinical ground truth like pathology or outcomes data.
8. The sample size for the training set
- Not applicable. This is a device clearance for a physical medical implant, not an AI algorithm.
9. How the ground truth for the training set was established
- Not applicable.
§ 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.