(126 days)
The Eminent Foot Plate System is intended for fixation of fractures, osteotomies, non-unions, revisions, replantations, of bones and bone fragments including tarsals, metatarsals, calcaneus, foot, and ankle.
The Eminent Foot Plate System consists of implants and instruments designed for fixation to treat fractures, deformations, revisions and replantations of bones and bone fragments. The system features twenty four (24) types of plates (Evans, Metatarsal, Metatarsal Left, Metatarsal Right, Metatarsal Step Left, Metatarsal Step Right, PMO Right, PMO Right, PMO Wedge Left, PMO Wedge Right, Osteotomy Left, Osteotomy Right, Osteotomy Wedge Left, Osteotomy Wedge Right, Osteotomy L Left, Osteotomy L Right, Peanut Slotted, Utility, Utility Long, Lis' Franc, Calcaneus, Calcaneus Long, and Forefoot H), bone screws for fixation, and a set of instruments to facilitate installation and removal of the implants. The plates have screw holes, which allow for attachment to the bones or bone fragments. The plates are fabricated from medical grade titanium (ASTM F136), and offered in various widths and lengths. Plates and screws are provided non-sterile.
The provided text describes the 510(k) summary for the Eminent Foot Plate System, a medical device for internal bone fixation. It focuses on demonstrating substantial equivalence to predicate devices through technological characteristics and performance testing.
Here's an analysis of the provided information, specifically addressing the requested points:
Acceptance Criteria and Device Performance
The document does not explicitly state "acceptance criteria" in a quantitative manner with reported device performance values. Instead, it describes mechanical tests performed and concludes that the "strength of the Eminent Foot Plate System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices." This implies that the acceptance criteria were met by demonstrating non-inferiority to the predicate devices in these mechanical tests.
The information available for a table is limited to the types of tests performed:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Static Three-point Bending | Sufficient and substantially equivalent to predicate devices. |
| Dynamic Three-point Bending | Sufficient and substantially equivalent to predicate devices. |
| Torsion Testing | Sufficient and substantially equivalent to predicate devices. |
| Static Axial Pullout Test | Sufficient and substantially equivalent to predicate devices. |
Missing Information: The actual quantitative results (e.g., bending strength values, fatigue life cycles, torque values, pullout forces) for both the subject device and the predicate devices are not provided in this document. This makes it impossible to create a more detailed table with specific numerical acceptance criteria and performance data.
Study Details for Demonstrating Acceptance Criteria:
The document does not describe a clinical study or a study involving human subjects or expert review. The "study" here refers to non-clinical mechanical testing.
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Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated for each test. The wording "The Eminent Foot Plate System has been tested in the following test modes" implies that samples of the device were subjected to these tests. Without further detail, specific numbers are unknown.
- Data Provenance: The tests are likely performed in a controlled laboratory environment by the manufacturer or a third-party testing facility (like Empirical Testing Corporation, mentioned in the letter's address). The data is non-clinical/bench testing data. Country of origin is not specified but presumed to be a regulated environment relevant to the US market. The data is prospective in the sense that the device was manufactured and then tested to demonstrate performance.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This section describes mechanical bench testing, not a study involving human experts or ground truth establishment in a diagnostic or clinical context. The "ground truth" for these tests would be the established ASTM standards themselves, and the measurement of physical properties.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods like 2+1 are used in clinical studies or image interpretation where human expert disagreement needs to be resolved. This is mechanical testing against established standards.
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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 device is a bone fixation system, not an AI-powered diagnostic or assistive tool. No MRMC study was conducted.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device does not involve an algorithm or AI.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the mechanical tests would be the physical properties and performance characteristics of the device measured against the requirements of the cited ASTM standards (ASTM F382 and ASTM F543) and compared to the performance of predicate devices. There is no expert consensus, pathology, or outcomes data involved in these specific tests.
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The sample size for the training set:
- Not applicable. This is not a machine learning or AI device that requires a training set.
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How the ground truth for the training set was established:
- Not applicable. As above, no training set is relevant for this type of device and testing.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.