PATIENT SPECIFIC IMPLANT (PSI) HIP FEMORAL COMPONENT by HAYES MEDICAL, INC.

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.

Device Description

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.

AI/ML Overview

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."

Summary

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JAN 27 1997

K964395

Premarket Notification 510(k) Summary

In accordance with the Food and Drug Administration Interim Rule to implement provisions of the Safe Medical Devices Act (SMDA) of 1990 and in conformance with 21 CFR 807, this is to serve as a 510(k) Summary for the Kairos™ Orthopaedics Patient Specific Implant (PSI) Hip Femoral Component.

Submitter:	Kairos™ Orthopaedics819 Striker Avenue, Suite 10Sacramento, California 95834Telephone: (916) 646-5403Fax: (916) 646-5432
Date:	November 1, 1996
Contact Person:	Brian ClearyDirector, Regulatory Affairs
Classification Name:	Hip joint metal/ceramic/polymer semi-constrainedcemented or nonporous uncemented prosthesis (21 CFR888.3353)
Common Name:	Patient Matched Hip Stem
Trade/Proprietary Name:	Patient Specific Implant (PSI) Hip Femoral Component
Product Code:	87 LZO

Device Description:

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Substantial Equivalence:

Several commercially available standard line hip products are substantially equivalent to the Kairos™ Orthopaedics' PSI hip femoral component with respect to overall design, materials, intended use, and sterilization methods. Additionally, the manufacturing methods and applied surface treatments are substantially the same as those used in the production of a wide range of currently marketed standard line hip products.

It is our understanding that other anatomically based hip stems have received 510(k) clearance in the past, including the following:

1. Patient Matched Implant (PMI) Hip Femoral Component Biomet, Inc. (Warsaw, Indiana)
1. Techmedica CAD/CAM Custom Hip Techmedica, Inc. (Camarillo, California)
1. Biopro DRG Custom Hip Replacement System Biopro, Inc. (Port Huron, Michigan)

Of these. Biomet's Patient Matched Implant (PMI) is the most similar and is still presently marketed. Biomet's PMI hip stem is also a patient matched hip stem which uses patient data to design and manufacture a hip stem to match a particular patient's naturally occurring bone geometry. Due to the similarities in the general device design concept, Kairos™ Orthopaedics believes that the Biomet PMI stem is ideal for comparison to demonstrate the substantial equivalence of Kairos™ Orthopaedics' PSI stem. The table on the following page summarizes these feature comparisons.

Additionally, an engineering stress analysis was performed on the envelope of design parameters to ensure fatigue performance of the PSI femoral component comparable to a clinically proven standard hip stem. Mechanical testing performed by Kairos ™Orthopaedics on a representative PSI stem verified these stress analysis calculations.

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Feature comparisons between the Kairos™ Orthopaedics PSI hip femoral component and Biomet, Inc. PMI hip femoral component. Differences are indicated in bold print.

	Subject Device	Predicate Device
Characteristics	Kairos ™ Orthopaedics	Biomet, Inc.
	Patient Specific Implant (PSI)	Patient Matched Implant (PMI)
Manufacturer	Kairos™ Orthopaedics	Biomet, Inc.
510(k) Approved	-	Yes
Materials	Wrought or Forged Titanium(Ti-6Al-4V)	Wrought Cobalt Chromium(Co-Cr-Mo) or WroughtTitanium (TI-6Al-4V)
Intended Use	Uncemented	Cemented/Uncemented
Patient Matched	Yes	Yes
Collar	Yes	Yes
Distal Flutes	Yes	Yes
Surface Treatments	• Smooth• Grit Blasted	• Smooth• Grit Blasted• Plasma Sprayed Coating• Ion Nitride (NTS)
Stem Length fromResection Level	90mm - 300mm	unknown
Distal Diameter	8mm - 20mm	unknown
Patient Information	CT or X-Ray	CT or X-Ray
Sterilization Status	Sterile & Non-sterile	Sterile

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Regulation Number and Section

§ 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.