Search Results

The PSI device is indicated for uncemented use as the femoral component in total hip arthroplasty (THA) for replacing the hip joint of patients whose hip joint has been damaged by degenerative joint disease, fracture of previous arthroplasty. Each PSI stem is specifically designed for clinical cases where the patient would see added benefit from a femoral component designed to match the natural bone geometry of the femur.

The Kalros™ Orthopaedics Patient Specific Implant (PSI) hip femoral component is designed using the patient's natural bone geometry to construct an implant to better fit and fill the patient's femoral canal relative to other commercially available standard hip stems. Since each stem is matched to a particular patient, a precise device description cannot be provided, as the device design will vary from patient depending upon their unique, naturally occurring bone geometry. Kairos™ Orthopaedics specifies eight design parameters that define an "envelope" of dimensional limits within which all PSI stems are defined.

This document describes a 510(k) summary for the Kairos™ Orthopaedics Patient Specific Implant (PSI) Hip Femoral Component, which is a medical device, not an AI/ML device. Therefore, the questions related to AI/ML device performance and studies are not applicable.

Here's the relevant information based on the provided text:

1. Table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" for performance. Instead, it focuses on demonstrating substantial equivalence to existing, legally marketed predicate devices. The primary "performance" reported is that the PSI Hip Femoral Component has comparable fatigue performance to a clinically proven standard hip stem.

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

The document mentions "mechanical testing performed by Kairos™ Orthopaedics on a representative PSI stem." This suggests a single or very small sample size for mechanical testing, not a large test set. The provenance of this mechanical testing data (e.g., country of origin) is not provided. It is a prospective test specifically for this device.

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. This is a medical device, not an AI/ML diagnostic tool requiring expert ground truth for a test set.

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

Not applicable, as there's no diagnostic test set or adjudication process for this type of device.

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 hip femoral component, not an AI-assisted diagnostic or imaging system.

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

Not applicable. This is a physical implant, not a standalone algorithm.

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

For the mechanical testing, the "ground truth" would be the established engineering standards for fatigue performance of hip stems, and the results of a "clinically proven standard hip stem" used for comparison. The document confirms that "mechanical testing performed by Kairos ™Orthopaedics on a representative PSI stem verified these stress analysis calculations."

8. The sample size for the training set

Not applicable. This is a physical device, not an AI/ML model that requires a training set. The "design parameters" are based on anatomical geometry, not a learned model.

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

Not applicable. See point 8. The device design is based on "the patient's natural bone geometry" and "eight design parameters that define an 'envelope' of dimensional limits."

Ask a specific question about this device