(88 days)
The Zeta MultiZone Locking Nail System is intended to provide temporary stabilization of various types of fractures, malunions and nonunions of the femur and tibia. The nails are inserted using an opened or closed technique and can be statically or dynamically locked.
The Zeta MultiZone Locking Nail System consists of a family of round nails used for intramedullary nailing of femoral and tibial fractures. The system includes two styles of femoral nails, tibial nails, reconstruction nails, screws and end caps. The nails are available in varying diameters and lengths and have proximal and distal holes for cross-locking. The nails and additional components are fabricated from either titanium alloy or stainless steel.
This 510(k) submission (K982958) concerns the Zeta MultiZone Locking Nail System, an intramedullary fixation rod system for femoral and tibial fractures.
Based on the provided documents, it is important to note that this is a traditional 510(k) submission for a medical device (intramedullary nail system), not an AI/ML-powered diagnostic device. Therefore, many of the requested criteria related to AI/ML performance, such as acceptance criteria based on metrics like sensitivity/specificity, sample sizes for test/training sets, ground truth establishment by experts, adjudication methods, MRMC studies, and standalone AI performance, are not applicable to this type of submission.
The "acceptance criteria" for this device are established by its substantial equivalence to legally marketed predicate devices, as determined by the FDA. This means the device is deemed safe and effective because its intended use, materials, designs, and operational principles are similar to existing devices.
Here's an analysis based on the provided information, addressing the relevant points and indicating where information is not applicable:
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Table of acceptance criteria and the reported device performance
Acceptance Criteria (for 510(k) Substantial Equivalence) Reported Device Performance (based on equivalence) Intended Use Equivalence: The device's intended use must be similar to legally marketed predicate devices. The Zeta MultiZone Locking Nail System is intended for temporary stabilization of various types of fractures, malunions, and nonunions of the femur and tibia. This is equivalent to the intended uses of the predicate devices. Materials Equivalence: The materials used must be the same or offer equivalent biocompatibility and mechanical properties as predicate devices. Fabricated from either titanium alloy or stainless steel, materials commonly used in predicate intramedullary nailing systems. Design Equivalence: The design and operational principles must be similar to predicate devices. This typically involves demonstrating similar mechanical properties and features (e.g., nail styles, diameters, lengths, locking mechanisms). The system consists of round nails with proximal and distal holes for cross-locking, available in varying diameters and lengths. This design is considered equivalent to Howmedica's Alta IM Rod System, Grosse & Kempf Locking Nail System, and Gamma Locking Nail System. The ability to be inserted using opened/closed techniques and statically/dynamically locked is also considered equivalent. Performance Equivalence: Device performance (e.g., mechanical strength, fatigue life) must be demonstrated to be equivalent or superior to predicate devices through engineering analyses and/or testing. (While not explicitly detailed in this summary, such testing would have been part of the full submission). The submission claims "substantial equivalence... based on an equivalence in intended use, materials, designs and operational principles." This implies that the performance aspects relevant to the device's function (e.g., structural integrity, fixation capabilities) were demonstrated to be comparable to or meet accepted standards for the predicate devices. Specific performance metrics are not provided in this summary. -
Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable. This submission relies on substantial equivalence to predicate devices, not a clinical study with a "test set" in the context of diagnostic performance or AI model validation. The "testing" would have been primarily engineering bench testing to demonstrate mechanical properties, which doesn't typically involve a "test set" or data provenance in the same way.
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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)
- Not applicable. Ground truth establishment by experts is not a component of a 510(k) for this type of implantable device. The evaluation is based on engineering principles and comparison to existing devices.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No adjudication method for a "test set" is relevant for this type of device submission.
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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 not an AI-powered diagnostic device, so MRMC studies and AI assistance are irrelevant to this submission.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a mechanical implantable device, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. The "ground truth" for this device's acceptance is its demonstrated equivalence in design, materials, and performance (via bench testing and engineering analysis) to existing, legally marketed predicate devices, which have a history of safe and effective use.
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The sample size for the training set
- Not applicable. There is no "training set" as this is not an AI/ML device.
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How the ground truth for the training set was established
- Not applicable. There is no "training set" or associated ground truth establishment for this type of device.
Summary for K982958: Zeta MultiZone Locking Nail System
The FDA's review and determination of substantial equivalence for the Zeta MultiZone Locking Nail System were based on a comparison of its intended use, materials, designs, and operational principles to several predicate devices already on the market (Howmedica's Alta IM Rod System, Grosse & Kempf Locking Nail System, and Gamma Locking Nail System). This is the standard pathway for typical Class II medical devices in a 510(k) submission. The provided documents do not contain information related to AI/ML performance evaluation, clinical study data beyond what would support substantial equivalence, or the specific details of bench testing that would have been included in the complete submission to justify the equivalence claims.
§ 888.3020 Intramedullary fixation rod.
(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.