(24 days)
HyProCure II (HYP II and HYP IIs) is an implant stabilization device used in the treatment of hyperpronating instability of the hindfoot. The implant is designed to stabilize the talus to prevent excessive anterior, and/or plantarflexion of the talus, while allowing normal talotarsal joint motion.
The HyProCure II is an implant which stabilizes the talus on the tarsal mechanism. The system consists of an implant designed to be inserted into the sinus tarsi and corresponding instrumentation to facilitate insertion.
This document is a 510(k) summary for the HyProCure II device. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and detailed device performance metrics. Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, expert qualifications, and ground truth establishment is not present in the provided text.
Here is an attempt to address the points based only on the provided text, with clear indications where the information is missing:
1. A table of acceptance criteria and the reported device performance
Based on the document, direct acceptance criteria and reported device performance in the context of a formal study with quantitative metrics are not provided. The document states:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Stabilize the talus to prevent excessive anterior, and/or medial, and/or plantarflexion of the talus, while allowing normal talotarsal joint motion. (from Intended Use) | The document focuses on demonstrating substantial equivalence to a predicate device (K042030 HyProCure Subtalar Implant System) based on:Similar sizesMaterial choicesConfigurationsIntended UseTechnological Characteristics |
| No specific performance data (e.g., in terms of degrees of motion, force resistance, or patient outcome scores) is provided in this summary. The conclusion states it is "safe and effective for its intended use" based on this comparison. |
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 applicable/Not provided. The document explicitly states: "Non-clinical data was not necessary to show substantial equivalence." This implies a performance study (with a test set) comparing the device to performance criteria was not conducted for this 510(k) submission.
- Data Provenance: Not applicable/Not provided.
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/Not provided, as no traditional test set requiring expert ground truth was mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not provided, as no traditional test set requiring expert adjudication was mentioned.
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 MRMC study was mentioned. The device, HyProCure II, is a physical implant (sinus tarsi implant), not an AI-powered diagnostic tool, so such a study would not be relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. The device is a physical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable/Not provided, as no traditional test set requiring ground truth was mentioned. The basis for safety and effectiveness is substantial equivalence to a legally marketed predicate device.
8. The sample size for the training set
- Not applicable/Not provided. The device is a physical implant and does not involve machine learning algorithms that require a training set.
9. How the ground truth for the training set was established
- Not applicable/Not provided, as 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.