(38 days)
The Synthes 1.0/1.2 mm craniofacial screws are intended for use as follows:
Specific Indications:
- Nasoethmoidal fractures .
- Infraorbital area fractures .
- Frontal sinus wall fractures .
- Infant craniofacial surgery .
General Indications:
- Maxillofacial surgery .
The 1.0/1.2 mm Craniofacial Screws are either self-drilling or self-tapping, have a flat head profile with rounded edges with a cruciform recess, and are available in various lengths.
Here's a breakdown of the acceptance criteria and study information based on the provided text, recognizing that this is a 510(k) summary for a medical device and not a clinical trial report of an AI algorithm. Therefore, many of the requested fields related to AI performance, ground truth, and expert evaluation will be absent or not directly applicable.
This document describes a 510(k) premarket notification for the Synthes 1.0/1.2 mm Craniofacial Screws, a physical medical device. The information provided heavily focuses on regulatory submission for substantial equivalence rather than performance data from a clinical study on an AI device. As such, many of the requested fields regarding acceptance criteria, AI performance, ground truth, and expert evaluation do not apply in the context of this document.
The primary "acceptance criteria" for a 510(k) submission is demonstrating substantial equivalence to a legally marketed predicate device. The study described here is focused on establishing this equivalence, not on measuring specific performance metrics against pre-defined thresholds for a novel AI algorithm.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Acceptance Criteria | Reported Device Performance / Method of Proof |
|---|---|---|
| Regulatory Acceptance (510(k)) | Substantial equivalence to legally marketed predicate devices. This means the device is as safe and effective as the predicate device(s) and does not raise new questions of safety or effectiveness. This is the overarching "acceptance criteria" for this type of submission. | Concluded that the Synthes 1.0/1.2mm Craniofacial Screws are substantially equivalent to other legally marketed devices, specifically citing the KLS Martin 1.0mm System Center-Drive Screw System and the Synthes Maxillofacial Titanium Micro Set as predicates. The FDA concurred with this determination. |
| Material/Design Characteristics | Not explicitly stated as acceptance criteria, but implied conformance to predicate device characteristics. | The device description outlines key characteristics: self-drilling or self-tapping, flat head profile with rounded edges, cruciform recess, and various lengths, which are presumably consistent with or improved upon predicate devices. |
| Intended Use & Indications for Use | The device's intended use and specific indications must align with established medical practice and be comparable to predicate devices. | The intended uses are specified for nasoethmoidal, infraorbital area, and frontal sinus wall fractures, as well as infant craniofacial and general maxillofacial surgery. These indications were reviewed and accepted by the FDA. |
| Performance (Biocompatibility, Strength, etc.) | Not explicitly detailed in this summary, but would typically involve mechanical testing (e.g., tensile strength, torsion, fatigue) and biocompatibility testing according to relevant standards (e.g., ISO 10993) to demonstrate equivalence to the predicate device. These tests would have acceptance criteria based on established standards or predicate device performance. | The 510(k) summary states, "Documentation is provided which demonstrates that the Synthes 1.0/1.2mm Craniofacial Screws are substantially equivalent to other legally marketed devices." This documentation, though not detailed here, would implicitly include performance testing results that meet relevant safety and functional standards, comparing them to the predicate devices. |
Study Details (Applicable to a 510(k) Submission, Not an AI Study)
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Sample size used for the test set and the data provenance:
- N/A: This document does not describe a clinical study with a "test set" in the context of an AI algorithm trying to classify data. Instead, it's a regulatory submission for a physical medical device. The "study" here refers to the process of demonstrating substantial equivalence, which would involve comparing the new device's specifications and performance to predicate devices. This typically involves benchmark testing on physical prototypes or models, rather than data samples.
- Data Provenance: Not applicable in the sense of patient data. The provenance of the evidence would be internal company testing and comparisons to predicate device specifications.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- N/A: Ground truth, as understood in AI/ML, is not established for this type of submission. The "ground truth" for a physical device's safety and efficacy is typically established through adherence to recognized consensus standards (e.g., ISO, ASTM) and comparison to predicate devices, which have a history of safe and effective use. The FDA's review involves their own experts.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- N/A: Not applicable for this type of regulatory submission. Adjudication methods are typically used in clinical studies for diagnostic accuracy, which is not what is being reported here.
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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:
- N/A: This document is for a physical medical device (screws), not an AI-assisted diagnostic tool. Therefore, an MRMC study is completely irrelevant.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- N/A: This is not an AI algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- N/A: As mentioned previously, for a physical device 510(k), "ground truth" relates to compliance with engineering specifications, mechanical performance, biocompatibility, and clinical history of predicate devices. There isn't a "ground truth" in the AI sense.
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The sample size for the training set:
- N/A: This document does not pertain to an AI algorithm. There is no concept of a "training set."
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How the ground truth for the training set was established:
- N/A: No training set or associated ground truth for an AI algorithm.
§ 872.4880 Intraosseous fixation screw or wire.
(a)
Identification. An intraosseous fixation screw or wire is a metal device intended to be inserted into fractured jaw bone segments to prevent their movement.(b)
Classification. Class II.