(61 days)
The Subtalar Implant is indicated for use in treating the hyperpronated foot by stabilizing the subtalar joint. It is intended to block forward, and medial displacement of the talus, thereby limiting the excessive eversion of the hindfoot. Examples include, but are not limited to:
- Symptomatic acquired flat foot treatment in children and adolescents .
- Symptomatic congenital flexible flat foot .
- Tarsal coalitions when associated with the flatfoot deformity .
- Posterior tibial tendon dysfunction with supple feet .
- Paralytic flat foot .
- Subtalar Instability .
- Severely pronated foot .
The Subtalar Implant is a one-piece device comprised of titanium alloy or PEEK-OPTIMA® intended to be implanted into the sinus tarsi of the implant is available in eight sizes to accommodate a wide range of patient sizes. The device is used to stabilize the subtalar joint by restoring the arch of the foot and block anterior movement of the talus.
This 510(k) summary for the Biomet Subtalar Implant (K071498) primarily relies on non-clinical testing for substantial equivalence and does not include any clinical study data or acceptance criteria related to device performance in terms of diagnostic accuracy or clinical outcomes.
Here's an analysis based on the provided document:
Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Stated) | Reported Device Performance |
|---|---|
| Mechanical Needs of Subtalar Joint Function within Intended Use | Mechanical testing confirmed that the Subtalar Implant meets the mechanical needs of the subtalar joint and will function within its intended use. |
Explanation: The document explicitly states "Non-Clinical Testing: Mechanical testing confirmed that the Subtalar Implant meets the mechanical needs of the subtalar joint and will function within its intended use." This is the only "acceptance criteria" and "performance" described. There are no detailed quantitative metrics provided for these mechanical tests (e.g., specific load endurance, fatigue limits, etc.) within this summary, suggesting these details were likely provided in a separate, more comprehensive test report that was part of the 510(k) submission but not included in this publicly available summary.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable/Not mentioned for any human diagnostic or clinical performance study. The "test set" refers to the mechanical tests conducted. The number of physical implants or test specimens used for mechanical testing is not specified in this summary.
- Data Provenance: Not applicable for human data. For mechanical testing, the data would be generated in a laboratory setting. No country of origin is specified for the mechanical testing.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Not applicable. There was no human "test set" requiring expert ground truth establishment for diagnostic or clinical performance. The "ground truth" for mechanical testing would be defined by engineering standards and specifications.
4. Adjudication Method for the Test Set
- Not applicable. No human interpretation or adjudication was involved in the mechanical testing.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No. The document explicitly states: "Clinical Testing: None provided as a basis for substantial equivalence." Therefore, no MRMC study was conducted or provided for human reader improvement with AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This device is a physical implant, not a software algorithm. Therefore, "standalone" algorithm performance is not relevant.
7. The Type of Ground Truth Used
- For the mechanical testing: Engineering specifications and standards. The "ground truth" for mechanical performance is determined by whether the device's physical properties withstand specified forces, fatigue cycles, etc., as per relevant industry or regulatory standards for bone fixation devices.
- For clinical efficacy/safety: Not applicable. No clinical ground truth was established or provided in this submission for substantial equivalence.
8. The Sample Size for the Training Set
- Not applicable. This device is not an AI/ML algorithm that requires a "training set."
9. How the Ground Truth for the Training Set was Established
- Not applicable. As above, no training set was used.
Summary of the K071498 Submission's Approach:
The K071498 submission for the Biomet Subtalar Implant relied on demonstrating substantial equivalence to previously legally marketed predicate devices through:
- Comparison of technological characteristics: Materials (titanium alloy or PEEK-OPTIMA®), design, sizing, and indications were stated to be similar or identical to predicates.
- Non-clinical mechanical testing: To ensure the device's physical integrity and functionality.
- Absence of clinical data: The submission did not provide clinical testing data, meaning substantial equivalence was established without a direct clinical comparison of outcomes. This is common for many Class II devices and 510(k) submissions where predicates exist and the technological changes are considered minor or well-understood in terms of clinical impact.
§ 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.