(67 days)
The Synthes 3.5mm LCP Clavicle Plate System is indicated for fixation of fractures, malunions, non-unions, and osteotomies of the clavicle in adults, and in both adolescents (12-18 years) and transitional adolescents (18-21 years), in which the clavicular growth plates have fused or in which the growth plates will not be crossed by the plate system.
The Synthes 3.5mm LCP Clavicle Plate System consists of metallic plates and screws that offer screw to plate locking designed for various fracture modes of the clavicle.
Here's an analysis of the provided text regarding the Synthes 3.5mm LCP Clavicle Plate System, focusing on the acceptance criteria and the study that "proves" the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Stated or Implied) | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate devices (K101536, K073186, K000684) in intended use and design. | "The features of the subject components are substantially equivalent to the predicate devices based on similarities in intended use and design." The intended use and device description are provided, demonstrating alignment with the predicate devices' general function (fixation of clavicle fractures). |
| Substantial equivalence in mechanical strength. | "Mechanical testing demonstrates substantial equivalence of the subject components to the predicate device in terms of mechanical strength." Specifically, "Testing conducted to support the substantial equivalence for the Synthes 3.5mm LCP Clavicle Plate System was performed to assess the bending strength of the subject device compared to the predicate." |
| Identical manufacturing methods, packaging, and sterilization to predicate devices. | "In addition, the intended use, manufacturing methods, packaging, and sterilization of the predicate and subject components are identical." |
| Comparable mechanical and functional properties. | "Functional and mechanical testing demonstrates the comparable mechanical & functional properties of the subject Synthes 3.5mm LCP Clavicle Plate System to the predicate devices." (This is a broader statement encompassing the specific bending strength test). |
| Material composition (stainless steel and titanium alloy). | "The subject and predicate devices are made from stainless steel and titanium alloy." |
Study Details and Analysis:
The provided document describes a 510(k) Premarket Notification, not a clinical study in the traditional sense involving human subjects or extensive clinical efficacy data. The "study" referenced here is focused on demonstrating substantial equivalence to already legally marketed predicate devices, a requirement for 510(k) clearance.
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Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated in terms of the number of unique devices tested. The document mentions "testing conducted" to assess bending strength. For mechanical testing of medical devices, sample sizes are typically determined by statistical power analysis to detect differences, often involving multiple units of each design.
- Data Provenance: The testing was conducted by Synthes (USA), the device manufacturer. The data is internal testing data. There is no mention of country of origin for clinical data because this is not a clinical trial; it's a mechanical testing report.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable in the context of this 510(k) submission. "Ground truth" as it relates to expert consensus for clinical disease states is not relevant here. The "ground truth" for mechanical testing is established by engineering principles, validated testing methodologies, and comparisons to established performance benchmarks (the predicate devices). The experts involved would be qualified engineers and technicians performing the mechanical tests, but their number and specific qualifications are not detailed in this summary.
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Adjudication method for the test set:
- Not applicable. Adjudication methods (like 2+1, 3+1) are used for resolving discrepancies in expert opinions, typically in clinical image interpretation or diagnosis. For mechanical testing, if multiple tests are run, results are compared against a pre-defined acceptance criterion (e.g., maximum load, deflection, fracture point) of the predicate device. Discrepancies would likely be resolved through re-testing or investigation into the testing methodology, not expert adjudication in the clinical sense.
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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:
- No. This is a medical device (bone plate and screws), not an AI imaging or diagnostic algorithm. Therefore, an MRMC study is completely irrelevant and was not performed.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No. This is a physical implantable medical device, not an algorithm. Therefore, "standalone algorithm" performance is not applicable.
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The type of ground truth used:
- The "ground truth" for this submission is the mechanical performance of the predicate devices. The subject device's mechanical properties (specifically bending strength) were compared against those of the predicate devices. This comparison, along with identical materials and other features, forms the basis for demonstrating substantial equivalence.
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The sample size for the training set:
- Not applicable. There is no "training set" in the context of a physical medical device's mechanical testing for 510(k) clearance. Training sets are relevant for machine learning algorithms.
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How the ground truth for the training set was established:
- Not applicable. As there is no training set, this question is not relevant.
Summary of the "Study" (Demonstration of Substantial Equivalence):
The "study" described is a benchtop mechanical testing comparison between the Synthes 3.5mm LCP Clavicle Plate System (subject device) and its predicate devices (Synthes 2.7/3.5mm VA-LCP Anterior Clavicle Plate System, Synthes 3.5mm LCP Clavicle Plate System, and Synthes Small Fragment Dynamic Compression Locking System).
- Objective: To demonstrate substantial equivalence of the subject device to the predicate devices, primarily in terms of mechanical strength (specifically bending strength).
- Methodology: Mechanical testing was performed on the subject device and compared to the predicate devices. The document highlights that "functional and mechanical testing demonstrates the comparable mechanical & functional properties." It also states that manufacturing methods, packaging, and sterilization are identical, and materials are the same (stainless steel and titanium alloy).
- Conclusion: The results of the mechanical testing, coupled with similarities in intended use, design, materials, and manufacturing processes, led the FDA to determine that the device is "substantially equivalent" to the legally marketed predicate devices, thereby clearing it for market.
§ 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.