(60 days)
The MC-Subtalar™ II screw system is for the correction of flexible flat feet in children (6 to 6 years, after conservative treatment did not result in a flat foot correction,
- Age
The MC-Subtalar™ II screws are partly threaded, cannulated and self-tapping screws. They are designed to be implanted into the calcaneus bone of the foot for subtalar extra-articular arthroeresis. A hexagonal shaped shaft end allows easy adjustment while operation. The screws are made of X2CrNiMo 18-15-3 stainless steel and are also available made of Ti6Al4V titanium alloy. The MC-Subtalar™ II is offered in sizes of 25 mm, 30 mm and 35 mm and with different head diameter of 6 mm, 8 mm and 10 mm to meet the specific anatomical requirements for various age groups.
The provided text is a 510(k) premarket notification for a medical device called MC-Subtalar™ II. This document describes the device, its indications for use, and its equivalence to legally marketed predicate devices. However, it explicitly states: "Clinical Data were not needed for these devices to show substantial equivalence."
Therefore, based on the provided text, a "study that proves the device meets the acceptance criteria" in the traditional sense of a clinical or analytical performance study with specific acceptance criteria related to accuracy, sensitivity, or specificity, and human reader performance against an AI, was not performed or required for this 510(k) submission.
The "acceptance criteria" and "device performance" described are mechanical and biomechanical in nature, rather than diagnostic or clinical effectiveness outcomes that would involve complex statistical analyses of sensitivity, specificity, or reader studies.
Here's a breakdown of what is available in the document regarding the device's assessment:
1. A table of acceptance criteria and the reported device performance
The document does not present a formal table of acceptance criteria with corresponding performance metrics in the way one might expect for a diagnostic or AI-driven device. Instead, it describes mechanical and biomechanical testing.
| Acceptance Criteria Category (Implied) | Reported Device Performance |
|---|---|
| Mechanical Properties | Passed tests in accordance with ASTM F543-13. |
| Durability (worst-case scenario) | Successfully passed 10^6 load cycles in biomechanical tests. |
| Overall Performance vs. Predicate | Mechanically as good as 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 explicitly stated in terms of patient data. The "test set" refers to the physical devices subjected to mechanical and biomechanical testing. The number of devices tested is not specified, but such tests typically involve a statistically relevant number of samples to ensure robust results.
- Data Provenance: The tests were conducted by Merete Medical GmbH, a German company (Alt-Lankwitz 102, 12247 Berlin, Germany). The origin of the data (i.e., the conditions under which the mechanical tests were performed) would be laboratory-based and controlled, rather than patient data from a specific country or collected retrospectively/prospectively.
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)
This question is not applicable. The "ground truth" here is based on engineering standards (ASTM F543-13) and mechanical testing results, not expert interpretation of medical images or clinical outcomes. The evaluation relies on standardized physical tests and measurements.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable. Adjudication methods are typically used in clinical studies or expert consensus for ground truth establishment. For mechanical testing, the results are objectively measured against pre-defined engineering specifications.
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, an MRMC comparative effectiveness study was not done. This device is a surgical implant (Subtalar Arthroereisis Implant), not an AI-driven diagnostic or image analysis tool. There is no "human reader" component in its assessment for this 510(k) submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone algorithm performance study was not done. This is not an algorithm or software device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the device's performance is based on:
- Adherence to engineering standards (ASTM F543-13).
- Mechanical and biomechanical test results demonstrating the physical properties (e.g., strength, durability) of the implant.
8. The sample size for the training set
This is not applicable as there is no "training set" for an algorithm. The device is a physical implant.
9. How the ground truth for the training set was established
This is not applicable as there is no "training set" for an algorithm.
§ 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.