(57 days)
The Stryker® External Fixation System is intended to stabilize and provide treatment for fractures of the maxillofacial area, including severe open mandibular fractures, highly comminuted closed fractures, nonunions and delayed unions (especially associated with infection), fractures associated with infections, turnor resections, facial deformity corrections, gunshot wounds, pan facial fractures, burn maintenance, and bone grafting defects.
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This document is a 510(k) summary for a medical device (Stryker® External Fixation System) and does not contain detailed information about specific acceptance criteria or an analytical study proving that the device meets those criteria.
510(k) submissions typically demonstrate substantial equivalence to a predicate device, rather than proving performance against specific quantitative acceptance criteria through a standalone study data as described in the prompt. The focus is on showing that the new device is as safe and effective as a legally marketed predicate device. Therefore, the information requested in the prompt (sample size for test/training sets, expert details, adjudication, MRMC studies, etc.) is generally not found in a 510(k) summary for this type of device.
Based on the provided text, I can extract the following relevant information:
- Device Name: Stryker® External Fixation System
- Intended Use/Indications for Use: To stabilize and provide treatment for fractures of the maxillofacial area, including severe open mandibular fractures, highly comminuted closed fractures, nonunions and delayed unions (especially associated with infection), fractures associated with infections, tumor resections, facial deformity corrections, gunshot wounds, pan facial fractures, burn maintenance, and bone grafting defects.
- Predicate Devices: Hoffman II Compact MRI External Fixation System (K053038), Hoffman II Compact External Fixation System (K961916, K971755 & K973321), Synthes Medium External Fixation System-MR Safe (K040258) and Synthes Sterile Mandible External Fixator (K062299).
- Regulatory Classification: Class II
To answer your specific questions, directly from the provided text:
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A table of acceptance criteria and the reported device performance:
- The document does not provide a table of acceptance criteria with reported device performance metrics in the way one would for an AI/diagnostic device. The basis for clearance is substantial equivalence (SE) to predicate devices, implying similar performance for its intended use without specific quantitative metrics documented here.
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Sample sizes used for the test set and the data provenance: Not applicable. This 510(k) summary does not describe a performance study with a test set that would have a sample size or data provenance in the context of an AI/diagnostic device.
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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 information is not present as the submission is for a mechanical fixation system and not an AI/diagnostic tool requiring ground truth established by experts.
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Adjudication method for the test set: Not applicable for the reasons stated above.
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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 an external fixation system, not an AI or diagnostic tool that would involve human readers or MRMC studies.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This applies to AI algorithms, not a mechanical external fixation system.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to an external fixation system. Its performance evaluation is typically through mechanical testing, biocompatibility, and clinical use experience of its predicates, not "ground truth" derived from expert consensus on diagnostic cases.
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The sample size for the training set: Not applicable. This device is not an AI algorithm requiring a training set.
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How the ground truth for the training set was established: Not applicable. This device is not an AI algorithm.
In summary, the provided 510(k) pertains to a physical medical device (an external fixation system) and therefore does not contain the types of information requested, which are typically relevant for AI/diagnostic software devices. The clearance is based on substantial equivalence to existing devices, implying similar safety and effectiveness without direct performance studies against numerical acceptance criteria presented in this summary.
§ 872.4760 Bone plate.
(a)
Identification. A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.(b)
Classification. Class II.