(84 days)
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.
| Criteria (Implied by Substantial Equivalence) | Reported Device Performance (Kairos™ PSI Hip Femoral Component) | Predicate Device (Biomet PMI Hip Femoral Component) |
|---|---|---|
| Overall Design | Patient-matched to natural bone geometry | Patient-matched to natural bone geometry |
| Materials | Wrought or Forged Titanium (Ti-6Al-4V) | Wrought Cobalt Chromium (Co-Cr-Mo) or Wrought Titanium (TI-6Al-4V) |
| Intended Use | Uncemented | Cemented/Uncemented |
| Manufacturing Methods | Substantially the same as standard line hip products | (Implied same as subject device) |
| Surface Treatments | • Smooth | |
| • Grit Blasted | • Smooth | |
| • Grit Blasted | ||
| • Plasma Sprayed Coating | ||
| • Ion Nitride (NTS) | ||
| Sterilization Methods | Substantially the same as standard line hip products | (Implied same as subject device) |
| Fatigue Performance | Comparable to a clinically proven standard hip stem (verified by mechanical testing and engineering stress analysis) | Clinically proven standard hip stem (as a benchmark for comparison) |
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."
§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.
(a)
Identification. A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.(b)
Classification. Class II.