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510(k) Data Aggregation
(160 days)
The Disco Subtalar Implant is indicated for use in the treatment of the hyperpronated foot and stabilization of the subtalar joint. It is intended to block the forward, and medial displacement of the talus, thus allowing normal subtalar joint motion but limiting excessive pronation.
The Disco Subtalar Implant consists of a threaded implant, designed to be inserted between the posterior and middle facets of the subtalar joint, and corresponding instrumentation to facilitate insertion. The leading end of the implant is cylindrical in shape and is approximately half of the overall length of the device, with the remaining length being spherical. The full length of the implant incorporates a center cannula designed for use with a guide wire to facilitate proper placement of the implant. Internal threads are machined in the spherical end of the implant and are for use with a removal tool.
The Disco Subtalar Implant's 510(k) summary does not contain information about acceptance criteria or a study proving that the device meets acceptance criteria in the manner typically understood for AI/ML-based medical devices (e.g., performance metrics like sensitivity, specificity, or AUC against a ground truth). This is a traditional medical device, not an AI/ML diagnostic tool.
Instead, the submission focuses on demonstrating substantial equivalence to predicate devices through non-clinical performance and design characteristics, rather than clinical efficacy studies.
Here's an analysis based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Implicit or Explicit from Document) | Reported Device Performance |
|---|---|---|
| Material Composition | Ti-6Al-4V alloy per ASTM F136 | Disco Subtalar Implant uses Ti-6Al-4V alloy per ASTM F136. |
| Functional Equivalence | Block posterior and inferior displacement of the talus, allow normal subtalar joint motion while blocking excessive pronation. | "The Disco Subtalar Implant blocks the posterior and inferior displacement of the talus, thus allowing normal subtalar joint motion while blocking excessive pronation." |
| Mechanical Safety/Performance | Equivalent static compression and pull-out strength compared to predicate devices. | "The results of this testing indicate that the Disco Subtalar system is equivalent to predicate devices. Static compression and pull-out testing was performed." |
| Design Equivalance | Threaded implant, cylindrical leading end (approx. half length), spherical remaining length, center cannula, internal threads for removal tool. | Device description matches these features. Geometric change from predicate noted, but implied to be within acceptable variation for equivalence. |
| Intended Use | Treatment of hyperpronated foot, stabilization of subtalar joint, blocking forward and medial displacement of talus, allowing normal subtalar joint motion but limiting excessive pronation. | Matching statement in "Indications for Use" section. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable. The "tests" mentioned are non-clinical (static compression and pull-out testing on the device itself), not studies on a test set of patient data.
- Data Provenance: Not applicable. The data comes from mechanical testing of the device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Not applicable. Ground truth, in the context of diagnostic AI/ML devices, relates to patient outcomes or expert interpretations. For this mechanical device, "ground truth" relates to engineering specifications and material properties, which are verified through standard engineering tests.
4. Adjudication Method for the Test Set
- Not applicable. There was no 'test set' of patient data requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
- No. The document explicitly states: "No clinical studies were performed." This is a mechanical implant device, not a diagnostic tool typically evaluated with MRMC studies.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. This is a physical medical implant, not an algorithm or software device.
7. The Type of Ground Truth Used
- For mechanical properties: Engineering standards and specifications (e.g., ASTM F136 for material, established benchmarks for static compression and pull-out strength based on predicate devices).
- For intended use/function: Clinical consensus on the biomechanics of subtalar joint stabilization and correction of hyperpronation, as embodied by the predicate devices.
8. The Sample Size for the Training Set
- Not applicable. There is no training set as this is not an AI/ML device.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. There is no training set.
Summary of Device Acceptance:
The acceptance of the Disco Subtalar Implant by the FDA (as indicated by the 510(k) clearance K111834) was based on its successful demonstration of substantial equivalence to already legally marketed predicate devices (Trilliant Twist Subtalar Implant - K103183 and ProStop - K071456).
The study that "proves the device meets the acceptance criteria" in this context is the non-clinical testing summary where:
- Static compression and pull-out testing was performed.
- The results indicated that the Disco Subtalar system is equivalent to predicate devices in these mechanical properties.
- The device's materials (Ti-6Al-4V alloy per ASTM F136), function, intended use, and design (despite a geometry change from the predicate) were also considered substantially equivalent.
The FDA's decision letter confirms this equivalence, allowing the device to be marketed. No clinical studies were required or performed for this 510(k) submission, as per standard regulatory pathways for certain types of mechanical implants claiming substantial equivalence.
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