Search Results

The PSI Hip Femoral Component with HA Coating 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 or the failure 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 Kairos™ Orthopaedics Patient Specific Implant (PSI) Hip Femoral Component with HA Coating 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 to 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.

The provided text describes a 510(k) premarket notification for the Kairos™ Orthopaedics Patient Specific Implant (PSI) Hip Femoral Component with HA Coating. This document focuses on demonstrating substantial equivalence to a predicate device rather than detailing acceptance criteria and the results of a formal study proving the device meets those criteria.

Therefore, many of the requested elements for the study that proves device performance against acceptance criteria are not present in this 510(k) summary.

Here's an analysis of the provided text in relation to your request:

Acceptance Criteria and Reported Device Performance

The 510(k) summary does not explicitly state "acceptance criteria" in the typical sense of a target performance metric for the device (e.g., accuracy, sensitivity, specificity for diagnostic devices; specific mechanical endurance thresholds for implants). Instead, the submission focuses on demonstrating substantial equivalence to a predicate device.

The "acceptance criteria" in this context are implicitly that the Kairos™ PSI Hip Femoral Component with HA Coating performs as safely and effectively as, and does not raise new questions of safety or effectiveness compared to, the predicate device.

The reported device "performance" is primarily demonstrated through:

• Feature Comparison: The detailed table comparing characteristics between the subject and predicate devices. The implicit "acceptance" is that these characteristics are sufficiently similar or, where different, do not negatively impact safety or effectiveness.
• Engineering Stress Analysis: "an engineering stress analysis was performed on the envelope of design parameters to ensure fatigue performance of the PSI Hip Femoral Component with HA Coating comparable to a clinically proven standard hip stem."
• Mechanical Testing: "Mechanical testing performed by Kairos™ Orthopaedics on a representative PSI stem verified these stress analysis calculations."

Table of Implicit "Acceptance Criteria" and Reported "Performance":

Study Details (Based on the provided text, many elements are N/A)

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

   • Sample Size: Not explicitly stated as a "test set" in the context of a clinical performance study. The mechanical testing was done on "a representative PSI stem." The engineering stress analysis was performed on "the envelope of design parameters." This is engineering/materials testing, not a clinical trial.
   • Data Provenance: N/A for clinical data. Engineering and mechanical testing would have been conducted in-house by Kairos™ Orthopaedics.

2. 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):

   • N/A. This is not a study assessing diagnostic accuracy or expert-interpreted data. The "ground truth" for the mechanical performance would be established by industry standards, engineering principles, and lab measurements.

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

   • N/A. Not applicable to engineering stress analysis or mechanical testing of an implant.

4. 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:

   • N/A. This is not an AI/diagnostic device.

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

   • N/A. This is not an algorithm or AI device. The mechanical testing and stress analysis could be considered "standalone" performance evaluations of the device itself.

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

   • For the engineering stress analysis and mechanical testing, the "ground truth" would be established by relevant ASTM or ISO standards for implant fatigue and material properties, along with established engineering mechanics principles. The aim was to ensure "fatigue performance... comparable to a clinically proven standard hip stem."

7. The sample size for the training set:

   • N/A. There is no "training set" as this is not a machine learning or AI device. The design parameters are based on the patient's natural bone geometry, facilitated by imaging (CT or X-Ray).

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

   • N/A. Not applicable as there is no training set. The "ground truth" for individual patient designs would be the patient's actual anatomy derived from CT or X-ray data.

Ask a specific question about this device