(90 days)
The OsteoSpring FootJack™ Subtalar Implant System is indicated for use in the treatment of hyperpronated foot and stabilization of the subtalar joint. It is designed to block the anterior and inferior displacement of the talus, thus allowing normal subtalar joint motion but limited excessive pronation and resulting sequela. The OsteoSpring FootJack Implant System . implants are intended for single patient use only.
The OsteoSpring FootJack™ subtalar implant is intended to be implanted into the sinus tarsi of the foot. It will be available in a range of sizes. The implant is a solid, one-piece, conical, thread shaped and cannulated design.
Acceptance Criteria and Study for the OsteoSpring FootJack™ Subtalar Implant System
Based on the provided 510(k) summary (K112658), the OsteoSpring FootJack™ Subtalar Implant System did not undergo clinical studies to prove its acceptance criteria. Instead, it relied on non-clinical testing and claims of substantial equivalence to predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Mechanical Safety/Integrity | Withstand load testing without functional failure or defect. | "The results of this testing indicate that the OsteoSpring FootJack™ Implant met the acceptance criteria and withstood the load testing without functional failure or defect." |
| Substantial Equivalence | Equivalent in terms of intended use, design, materials used, mechanical safety, and performances to predicate devices (OsteoMed Subtalar Implant System - K031155, Instratek Subtalar Lok™ - K080280, BioArch™ Subtalar Implant - K070441). | "The OsteoSpring FootJack™ subtalar implant is substantially equivalent to the OsteoMed Subtalar Implant System, Instratek Subtalar Lok™ and BioArch™ Subtalar Implant in terms of intended use, design, materials used, mechanical safety and performances." |
| "The OsteoSpring FootJack™ Subtalar Implant System is substantially equivalent to the predicate devices in terms of indications for use, design, material, performance and function." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable. No clinical test set involving patient data was used. The testing was non-clinical.
- Data Provenance: Not applicable. The data comes from in-vitro (Finite Element Analysis and Static Compression Testing) studies, not from human subjects or clinical settings, hence no country of origin or retrospective/prospective classification applies.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. The non-clinical tests (Finite Element Analysis and Static Compression Testing) assess physical and mechanical properties, not interpretations of clinical data that would require expert consensus.
4. Adjudication Method for the Test Set
Not applicable. No clinical test set requiring adjudication was performed.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The device is an implant, not an AI or imaging diagnostic tool that would typically involve human readers.
6. Standalone Performance Study (Algorithm Only)
Not applicable. This device is a physical implant, not an algorithm. Therefore, "standalone performance" in the context of an algorithm does not apply.
7. Type of Ground Truth Used
For the mechanical performance, the "ground truth" was established by the physical and engineering properties of the device as measured by the static compression testing and simulated by the Finite Element Analysis. For the claim of substantial equivalence, the "ground truth" was the characteristics and performance data of the identified predicate devices against which the new device was compared.
8. Sample Size for the Training Set
Not applicable. This device did not involve any machine learning algorithms or AI that would require a training set.
9. How Ground Truth for the Training Set Was Established
Not applicable. As there was no training set for an algorithm, no ground truth needed to be established for it.
§ 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.