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The DePuy Synthes 2.7mm VA LCP Clavicle Plate System is indicated for fixation of fractures, and nonunions 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 DePuy Synthes 2.7mm VA LCP Clavicle Hook Plate System is indicated for fixation of lateral clavicle fractures and dislocations of the acromioclavicular joint.

The DePuy Synthes 2.7mm VA LCP Clavicle Plate System consists of lateral, shaft and medial plates designed for temporary fixation, correction or stabilization of clavicle bones. The subject plates are available in various sizes in both sterile and non-sterile configurations and are available in stainless steel and titanium alloy. The system also consists of non-implantable templates that correspond to the implants. Templates are intended for implant size selection and are available in non-sterile.

The DePuy Synthes 2.7mm VA LCP Clavicle Hook Plate System consists of the plate types Long, Short and Button which can be used to treat simple and complex clavicle fractures including malunions, non- unions and isolated ligamentous injuries of the AC joint. The subject plates are available in three hook depths, in left- and right-side versions, in both sterile and non-sterile configurations and are available in stainless steel and titanium. The system also consists of non- implantable templates that correspond to the implants. Templates are intended for implant size selection and are available non-sterile.

The provided text is a 510(k) Pre-market Notification for two medical devices: the DePuy Synthes 2.7mm VA LCP Clavicle Plate System and the DePuy Synthes 2.7mm VA LCP Clavicle Hook Plate System. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through extensive studies in the way a novel device might.

Therefore, the document explicitly states that "Non-clinical performance data was not necessary for the determination of substantial equivalence" and "Clinical testing was not necessary for the determination of substantial equivalence". This means there are no acceptance criteria, device performance data, sample sizes, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance studies described in this document.

The basis for clearance is that the subject devices (DePuy Synthes 2.7mm VA LCP Clavicle Plate System and DePuy Synthes 2.7mm VA LCP Clavicle Hook Plate System) are substantially equivalent to previously cleared predicate devices (K201321 and K201959, respectively). The manufacturer asserts that the design, features, and specifications (technological characteristics) of the subject devices remain unchanged compared to their respective predicate devices. Any differences (e.g., additional contraindications or sterile/non-sterile options for the hook plate system) are argued not to raise new questions of safety and effectiveness.

In summary, this document does not contain the information requested about acceptance criteria and a study proving device performance because such studies were deemed unnecessary for a 510(k) submission based on substantial equivalence.

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The DePuy Synthes 2.7mm VA LCP Clavicle Hook Plate System is indicated for fixation of lateral clavicle fractures and dislocations of the acromioclavicular joint.

The DePuy Synthes 2.7mm VA LCP Clavicle Hook Plate System consists of the plate types Long, Short and Button which can be used to treat simple and complex clavicle fractures including malunions, non-unions and isolated ligamentous injuries of the AC joint. The subject plates are available in three hook depths, in left- and right-side versions, in both sterile and non-sterile configurations and are available in stainless steel and titanium. The system also consists of non-implantable templates that correspond to the implants. Templates are intended for implant size selection and are available non-sterile.

The provided text describes a 510(k) premarket notification for a medical device, the DePuy Synthes 2.7mm VA LCP Clavicle Hook Plate System. This document focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than presenting a study to prove acceptance criteria for a novel AI/software device.

Therefore, many of the requested elements for describing an AI-driven device's acceptance criteria and studies (like sample sizes for test/training sets, experts for ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth types) are not applicable to this document. The document describes a traditional medical device (metallic bone fixation appliance).

Here's a breakdown based on the information that is available in the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't present a table of acceptance criteria in the way it would for an AI device. Instead, it focuses on demonstrating that the performance of the new device is at least equivalent to the predicate device.

2. Sample size used for the test set and the data provenance:

• Not applicable. This document describes mechanical, material, and biological testing, not a clinical study on patient data to evaluate algorithmic performance. The "test set" would refer to physical devices or materials used in the non-clinical performance tests. Specific sample sizes for these tests are not provided in this summary but would be detailed in the full submission. Data provenance is implied to be from laboratory testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. Ground truth in the context of an AI device typically refers to expert labels on a dataset. For this medical device, "ground truth" would be established by validated engineering tests and established biological safety standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not applicable. Adjudication methods are relevant for resolving discrepancies in expert labeling for AI/software ground truth. This is not a study involving expert review of images or data.

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:

• No. An MRMC study is not mentioned as this is not an AI-assisted device. The document explicitly states: "Clinical testing was not necessary for the determination of substantial equivalence."

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• No. This is not an algorithm or AI device.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc.):

• For mechanical performance: Ground truth is established by engineering standards and comparison to a known predicate device's performance.
• For MR Compatibility: Ground truth is established by specific testing protocols and standards (e.g., ASTM F2503).
• For Endotoxin Testing: Ground truth is established by established laboratory methods (LAL test) and regulatory limits (20 EU/device).
• For Biocompatibility: Ground truth is established by international standards (ISO 10993-1) and biological safety evaluations.

8. The sample size for the training set:

• Not applicable. This is not an AI/ML device, so there is no "training set."

9. How the ground truth for the training set was established:

• Not applicable. As there is no training set for an AI/ML model, this question does not apply.

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