(14 days)
Synthes Resorbable Tack System is intended for fractures of the craniofacial skeleton including, but not limited to, comminuted fractures of the naso-ethmoidal and infraorbital areas, comminuted fractures of the frontal sinus wall, and midfacial fractures; and reconstructive procedures of the midface or craniofacial skeleton.
Synthes Resorbable Tack System is not intended for use in the mandible or other full load-bearing situations, for areas with active infection or for patient conditions including blood supply limitations, insufficient quantity or quality of bone, or latent infections.
Synthes Automated Tack Driver is designed for use with Synthes Resorbable Tacks. Resorbable Tacks provide fixation and aid in the alignment and stabilization of craniofacial bones when used in conjunction with Resorbable Fixation System plates and meshes. To facilitate tack insertion into a predrilled hole in bone, the Self-Retaining Tack Driver previously cleared has been modified for more controlled and repeatable insertion force. A compression spring has been added to the design, which upon release allows automatic tack insertion into a pre-drilled hole in bone.
This document is a 510(k) summary for the Synthes Automated Tack Driver, an accessory to the Synthes Resorbable Tack System. It describes the device, its intended use, and indicates its substantial equivalence to a predicate device.
Here's an analysis of the provided text in relation to your request about acceptance criteria and a study proving their fulfillment:
Analysis:
The provided text is a 510(k) summary and the accompanying FDA clearance letter. It is not a study report or a document that details performance testing with specific acceptance criteria and results.
A 510(k) submission primarily focuses on demonstrating substantial equivalence to a predicate device, meaning it is as safe and effective as a legally marketed device. While a 510(k) typically includes performance data to support this claim, the summary provided here only gives a high-level description of the device and its intended use. It does not contain the detailed information required to answer most of your questions about specific acceptance criteria and a study demonstrating compliance.
The critical sentence "A compression spring has been added to the design, which upon release allows automatic tack insertion into a pre-drilled hole in bone" suggests a modification from a manual to an automated process. This modification would likely necessitate performance testing (e.g., insertion force, repeatability, consistency) to ensure the automated driver performs as intended and is equivalent to the predicate. However, those test details are not present in this document.
Therefore, many of your requested items cannot be extracted from the provided text.
Here's what can be stated based on the provided text, and what cannot:
1. A table of acceptance criteria and the reported device performance
- Cannot be provided from the text. The document does not specify any quantitative acceptance criteria or reported performance metrics for the Synthes Automated Tack Driver (e.g., specific insertion force ranges, success rates, or repeatability measures).
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Cannot be provided from the text. The document does not mention any sample sizes for testing or details about data provenance.
3. 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/Cannot be provided from the text. This type of information is relevant for studies involving diagnostic image interpretation or complex clinical assessments. The Synthes Automated Tack Driver is a mechanical surgical instrument; its performance would likely be assessed through engineering and mechanical testing, not by expert interpretation of clinical "ground truth" in the same way.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Cannot be provided from the text. Adjudication methods are typically used in clinical studies, particularly for subjective assessments or when reconciling differing expert opinions. This is unlikely to be relevant for the mechanical testing of a tack driver.
5. 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/Cannot be provided from the text. This is relevant for AI-powered diagnostic devices. The Synthes Automated Tack Driver is a mechanical surgical instrument and does not involve AI or human readers for diagnostic interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable/Cannot be provided from the text. This question also pertains to AI/algorithm performance. The Synthes Automated Tack Driver is a physical device, and its "standalone" performance would typically refer to its mechanical function, not an algorithm's.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable/Cannot be provided from the text. As explained, the concept of "ground truth" as it applies to diagnostic or prognostic studies is not directly applicable to a mechanical surgical instrument. Performance would be measured against engineering specifications (e.g., force, precision, durability).
8. The sample size for the training set
- Not applicable/Cannot be provided from the text. This question relates to machine learning models. The Synthes Automated Tack Driver is a mechanical device, not an AI/ML system, and therefore does not have a "training set."
9. How the ground truth for the training set was established
- Not applicable/Cannot be provided from the text. As above, this pertains to AI/ML systems and is not relevant for this device.
Summary:
The provided 510(k) summary and FDA letter confirm the clearance of the Synthes Automated Tack Driver based on substantial equivalence to a predicate device. However, this document does not contain the detailed acceptance criteria or the specifics of the study (including sample sizes, ground truth establishment, or expert involvement) that would have been conducted as part of the full 510(k) submission to demonstrate the device meets those criteria. Such details would typically be found in the comprehensive testing reports submitted to the FDA, not in the public 510(k) 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.