Search Results

The Acumed Polarus® Connect System includes plates, nails, screws and accessories designed to address fractures, fusions, and osteotomies of the humerus.

The Acumed Polarus® Connect System of bone plates, intramedullary nails, screws and accessories are designed to provide fixation for fractures of the humerus while they heal. The Polarus® Connect System also includes instruments to facilitate placement of implants.

This document seems to be a 510(k) summary for a medical device called the "Acumed Polarus® Connect System," which is a humerus intramedullary nail and plate fixation system. This type of submission relies on demonstrating substantial equivalence to predicate devices, rather than conducting new clinical performance studies in the way you might for novel AI/software devices.

Therefore, the provided text does not contain the detailed information required to describe acceptance criteria and a study proving a device meets those criteria for software or AI-driven medical devices.

Specifically, it lacks information about:

• Performance metrics like sensitivity, specificity, AUC, etc., which are typical for software/AI.
• Test sets in terms of patient data (images, clinical records).
• Ground truth establishment by experts.
• Human reader studies (MRMC).
• Standalone algorithm performance.
• Training set details.

The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to mechanical and material testing standards for orthopedic implants, and the "proof" is that the device met these engineering standards and demonstrated substantial equivalence in design, materials, and intended use to existing cleared devices.

Here's how I can describe what is available in the document, framed against your request, and explicitly stating what is not present:

Analysis of the Provided 510(k) Summary:

The Acumed Polarus® Connect System is a hardware medical device (bone plates, intramedullary nails, screws, and accessories) designed for humerus fracture fixation. The regulatory submission (510(k)) for such a device primarily focuses on demonstrating "substantial equivalence" to predicate devices already on the market, rather than novel clinical performance studies or AI/software evaluations.

Therefore, the "acceptance criteria" and "study" described in this document are related to mechanical performance and material compatibility, not diagnostic accuracy or AI performance.

Acceptance Criteria and Reported Device Performance (Based on Mechanical Testing for Hardware):

Information Not Applicable or Not Found in This Document (as it pertains to software/AI studies):

This submission is for an orthopedic implant, not an AI/software device. Therefore, the following points in your request are not applicable or details are not provided within this hardware 510(k) summary:

• 2. Sample size used for the test set and the data provenance: Not applicable. The "test set" here would refer to
  • Mechanical test specimens (e.g., number of nails, plates, screws tested). This is not detailed in the summary.
  • No patient data/images as it's not a diagnostic AI device.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for mechanical testing is based on engineering specifications and measurements, not expert consensus on clinical data.
• 4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
• 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 not an AI-assisted diagnostic device.
• 6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical implant.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For mechanical testing, the "ground truth" is adherence to established engineering standards (ASTM F382, F543, F1264) and the physical properties observed during testing. Not clinical expert consensus or pathology.
• 8. The sample size for the training set: Not applicable. There is no "training set" as it's not an AI/ML model.
• 9. How the ground truth for the training set was established: Not applicable.

Conclusion:

The provided 510(k) summary successfully demonstrates substantial equivalence of the Acumed Polarus® Connect System to predicate devices based on design, materials, intended use, and adherence to relevant mechanical testing standards (ASTM F382, F543, F1264). It is important to note that this device is a physical orthopedic implant, and as such, the regulatory evidence focuses on engineering performance and safety, not on the type of clinical performance or AI evaluation metrics you've inquired about.

Ask a specific question about this device