(97 days)
The Metasurg subtalar implant is indicated for use in the treatment of the hyperpronated foot and stabilization of the subtalar joint. It is designed to block forward, downward and medial displacement of the talus, thus allowing normal subtalar joint motion but blocking excessive pronation and the resulting sequela.
Indications include:
- Severe pronation .
- Calcaneal valgus deformity .
- Plantarflexed talus .
- Failed correction with long term orthotic treatment .
- Congenital and painful flatfoot deformity .
- . Repair of tarsal coalitions
- Subtalar instability .
- Posterior tibial tendon dysfunction .
- Paralytic flat foot deformity .
The Metasurg subtalar implants are intended for single use only.
The Metasurg Subtalar Implant is a one-piece device made of titanium intended to be implanted into the sinus tarsi of the foot. The implant is offered in 5 sizes ranging from 8mm to 12mm in diameter. The implant is used in the treatment of the talus relative to the calcaneus.
The provided K111265 document is a 510(k) summary for the Metasurg Subtalar Implant. It describes the device, its intended use, and states that substantial equivalence has been demonstrated to other legally marketed devices.
However, the document does not contain any information regarding acceptance criteria or the results of a specific study proving the device meets acceptance criteria. 510(k) summaries typically focus on proving substantial equivalence to a predicate device based on similarities in intended use, technology, and performance, often relying on non-clinical testing (e.g., mechanical testing, biocompatibility) or comparison with existing clinical data of the predicate. They generally do not include detailed clinical study reports with specific acceptance criteria and performance metrics for the new device as would be seen in a PMA or a detailed clinical trial publication.
Therefore, I cannot provide the requested table or detailed information about a study proving the device meets acceptance criteria because that information is not present in the provided text.
Based on the available document, I can infer the following about the regulatory intent, although direct "acceptance criteria" as you've defined them for a clinical study are not present:
Implied "Acceptance Criteria" for 510(k) Equivalence (not performance criteria):
| Acceptance Criteria (Implied for 510(k) Equivalence) | Reported Device Performance (Implied from K111265) |
|---|---|
| Substantial Equivalence to Predicate Device: |
- Similar intended use
- Similar technological characteristics
- Similar material composition (titanium alloy) | Documentation is provided which demonstrates the Metasurg Subtalar Implant to be substantially equivalent to other legally marketed devices. The device is a one-piece titanium implant for the sinus tarsi, intended to treat hyperpronated foot and stabilize the subtalar joint by blocking excessive pronation. Made of Titanium Alloy (Ti 6Al-4V ELI). |
| Biocompatibility: - Material commonly used in implants | Titanium Alloy (Ti 6Al-4V ELI) is a well-established and accepted biocompatible material for implantable devices, implying it meets biocompatibility requirements. (No specific test results provided in this summary). |
| Mechanical Performance: - Meets strength/durability for intended use | While not detailed, for orthopedic implants, there's an implicit requirement for sufficient strength and durability. The K111265 typically relies on non-clinical performance data (e.g., mechanical testing) to show it performs as safely and effectively as a predicate. (No specific test results reported in this summary). |
Regarding the specific questions you asked, based solely on the provided K111265 document:
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A table of acceptance criteria and the reported device performance:
- As explained above, the document does not present specific clinical acceptance criteria or performance metrics from a dedicated study. The "performance" described is in the context of demonstrating substantial equivalence to a predicate device.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- No clinical "test set" or associated data provenance is mentioned in this 510(k) summary. 510(k)s often rely on non-clinical (e.g., bench) testing and comparison to existing predicate devices rather than new clinical trials.
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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 information is not applicable and not present, as no clinical test set or ground truth establishment process is described.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable; no clinical test set or adjudication process is mentioned.
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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:
- Not applicable. This is a medical device (implant), not an AI diagnostic/imaging device that would typically undergo MRMC studies involving human readers.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a medical implant, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable. No clinical ground truth is described in this 510(k) summary. The "ground truth" for a 510(k) is effectively the safety and efficacy track record of the predicate device, which the new device aims to be equivalent to.
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The sample size for the training set:
- Not applicable; implants do not typically have "training sets" in the context of AI or machine learning.
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How the ground truth for the training set was established:
- Not applicable.
In summary, the provided 510(k) summary (K111265) for the Metasurg Subtalar Implant focuses on demonstrating substantial equivalence to a predicate device based on material, design, and intended use, rather than presenting results from a clinical study with specific acceptance criteria for performance.
§ 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.