Search Results

The A.L.P.S. Clavicle Plating System is indicated for fixation of fractures, osteotomies and nonunions of the clavice including osteopenic bone.

The A.L.P.S. Clavicle Plating System is designed to address fractures of the clavicle. The system is comprised of plates, screws, and instruments to facilitate the installation of the implants.

The provided text is a 510(k) summary for the A.L.P.S. Clavicle Plating System. This document is related to a medical device (bone fixation appliance), not an AI/Software as a Medical Device (SaMD) or a diagnostic device.

Therefore, the concepts of "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of AI/SaMD performance metrics (like sensitivity, specificity, AUC), "test sets," "ground truth by experts," "MRMC studies," etc., as requested in your prompt, are not applicable to this submission.

This 510(k) focuses on demonstrating substantial equivalence to a predicate device (K173767, also an A.L.P.S. Clavicle Plating System by Biomet Inc.) based on:

• Identical intended use and indications for use.
• Similar technological characteristics (materials, design features, sterilization).
• Non-clinical tests (Guide Comparison, Drilling Test) to validate a design change to a soft tissue guide, aimed at improving safety and effectiveness without altering the fundamental mode of action or indications.

The document explicitly states "Clinical Tests: NA" (Not Applicable). This further confirms that there were no human subject studies or performance evaluations in the way one would typically assess an AI/SaMD.

In summary, your prompt's questions are designed for AI/SaMD products, and this 510(k) submission is for a physical orthopedic implant. As such, I cannot extract the information you are requesting from this document.

Ask a specific question about this device

The A.L.P.S. Clavicle Plating System is indicated for fixation of fractures, osteotomies and non-unions of the clavice including osteopenic bone.

The purpose of this submission is to request clearance for the new A.L.P.S Clavicle Plating System. The A.L.P.S Clavicle Plating System implants are designed to address fractures of the clavicle. The system is comprised of plates and instruments to facilitate the installation of the implants. The plates are manufactured from Titanium Alloy per ASTM F136. Implants and instruments will be provided in non-sterile configuration and will require steam sterilization prior to use.

This document is an FDA 510(k) summary for the A.L.P.S. Clavicle Plating System. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving a device meets specific acceptance criteria in the manner requested for AI/ML devices. Therefore, a direct answer to the prompt's structured questions is not possible from the provided text.

However, I can extract information related to the device's performance justification from a regulatory perspective:

1. A table of acceptance criteria and the reported device performance

The document does not provide a table of acceptance criteria and reported device performance in the context of an AI/ML algorithm. Instead, it relies on demonstrating substantial equivalence to a predicate device based on common characteristics and non-clinical testing.

• Construct Static Testing
• Galvanic Corrosion Evaluation |

Regarding the other requested information:

• 2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

  • Not applicable/Not provided. The document relies on engineering non-clinical tests and comparison to a predicate device, not a test set of data like an AI/ML study.

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

  • Not applicable/Not provided, as this is not an AI/ML study involving expert ground truth.

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

  • Not applicable/Not provided.

• 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/No MRMC study was done, as this is a physical medical device (plating system), not an AI/ML diagnostic or assistive tool.

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

  • Not applicable/No algorithm is involved.

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

  • For the non-clinical tests, the "ground truth" is defined by established engineering standards and specifications, for example, the performance criteria for Construct Static Testing and Galvanic Corrosion Evaluation.

• 8. The sample size for the training set

  • Not applicable/No training set for an AI/ML algorithm.

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

  • Not applicable/No training set for an AI/ML algorithm.

Ask a specific question about this device

a: Distal Radius Plates are indicated for the fixation of Intra- and extra-articular fractures and ostectomies of the distal radius.
b. Clavice plates are indicated for the fixation of fractures, mal-unions, non-unions and ostectomies of the clavicie.
c. Proximal Humerus plates are indicated for the fixation of fractures, fracture dislocations, non-unions and osteotomies of the proximal humerus, particularly in the osteopenic bone.

Not Found

I am sorry, but based on the provided document, I cannot answer your request. The document is a 510(k) premarket notification letter from the FDA regarding orthopedic plating systems. It does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, or other details related to proving a device meets acceptance criteria. The document only confirms the substantial equivalence of the OIC Distal Radius Plating System, OIC Proximal Humerus Plating System, and OIC Clavicle Plating System to legally marketed predicate devices.

Ask a specific question about this device

The OrthoHelix Clavicle Plating System Plates are indicated for fixation of fractures, fusions and osteotomies of the clavicle and small bones in the hand, wrist, foot and ankle.

The OrthoHelix Clavicle Plating System is a set of metallic, implantable, bone fixation plates. The CPS includes universal plates and indication specific plates of different sizes. All plates are made from implant grade titanium alloy.

The provided text is for a 510(k) premarket notification for a Clavicle Plating System. This type of document focuses on establishing substantial equivalence to a predicate device rather than detailing specific acceptance criteria and the rigorous study results one would expect for a new AI/software device.

Therefore, many of the requested elements (like sample sizes, ground truth establishment, expert qualifications, MRMC studies, and standalone performance) are not applicable to this document. The submission aims to demonstrate that the new device is as safe and effective as a legally marketed predicate device through mechanical testing and Finite Element Analysis, not through clinical performance metrics against a defined ground truth.

Here's an interpretation based on the provided text, highlighting what is (and isn't) present:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Not Applicable. This submission relies on mechanical testing and Finite Element Analysis (FEA), not a "test set" of clinical data or images. The "samples" would be the physical implants and associated materials used for mechanical testing and the computational models for FEA. The document does not specify the number of implants tested or the specifics of the FEA models.
• Data Provenance: Not applicable in the context of clinical data. The "provenance" of the engineering data would stem from internal testing and simulations conducted by OrthoHelix Surgical Designs, Inc.

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

• Not Applicable. No "ground truth" in the clinical AI sense is established. The "ground truth" here is adherence to mechanical and material standards, and equivalence to predicate devices, verified through engineering analyses.

4. Adjudication method for the test set:

• Not Applicable. No human-based adjudication of clinical performance against a "test set" occurred. The assessment is based on engineering principles and regulatory review.

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. This is a hardware medical device (bone plating system), not an AI/Software as a Medical Device (SaMD). Therefore, no MRMC study involving human readers or AI assistance was performed or is relevant.

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

• Not Applicable. This is a hardware device; there is no an algorithm or software to evaluate in a standalone manner.

7. The type of ground truth used:

• Engineering Standards and Predicate Device Performance: The "ground truth" for this submission refers to the established mechanical properties, material specifications, and performance characteristics of legally marketed predicate devices, as well as relevant engineering standards for bone fixation implants. The new device is considered "substantially equivalent" if it meets or exceeds these characteristics.

8. The sample size for the training set:

• Not Applicable. There is no "training set" as this is not an AI/machine learning device.

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

• Not Applicable. There is no "training set" or corresponding ground truth establishment process in the context of this traditional medical device submission.

Ask a specific question about this device