The Exactech All Polyethylene Acetabular Cup is indicated for use in skeletally mature individuals undergoing primary surgery for total hip replacement due to osteoarthritis, osteonecrosis, congenital hip dysplasia, rheumatoid arthritis, ankylosing spondylitis and/or posttraumatic degenerative problems. It is also potentially indicated for revision of failed previous reconstructions where sufficient bone stock is present.

Device Description

The Exactech All Poly Acetabular Cup consists of various sizes and is made from Medical Grade Ultra High Molecular Weight polyethylene (UHMWPE) with a Cobalt Chrome F 90-87 radiographic marker wire. The component is produced in various inside and outside diameters and accommodates numerous femoral head sizes. The device is designed for use with all Exactech femoral components and femoral heads. A complete trial set and instrumentation is available to assist in accurate implantation of the prosthetic components. Design drawings are typical for such components that have been used in the industry since their introduction by Charnley in the late '60's.

AI/ML Overview

This 510(k) summary (K9633313) for the Exactech All Poly Acetabular Cup is a premarket notification for a medical device and therefore describes substantial equivalence to existing devices rather than presenting a study demonstrating the device meets a set of acceptance criteria in the manner of a novel medical device. The document focuses on establishing equivalence based on design, materials, and historical use, rather than presenting new performance data from a dedicated study with acceptance criteria.

The information requested in the prompt is generally associated with performance studies for novel devices or significant modifications, which are not typically found in a 510(k) for a device claiming substantial equivalence to older, well-established technologies.

Below is an attempt to structure the available information relevant to your request, but it's important to note the limitations inherent in this type of submission.

Analysis of the Provided Text (K9633313 - Exactech All Poly Acetabular Cup):

The document primarily establishes substantial equivalence to predicate devices marketed before May 28, 1976, and other legally marketed devices. It does not present a new study with explicit acceptance criteria and corresponding device performance metrics in the typical sense of a clinical trial or performance study for a novel device. Instead, the "performance" is implicitly deemed acceptable due to its similarity to historically successful, legally marketed devices.

However, we can infer some "acceptance criteria" through the design considerations and material specifications, and the "study" is the cumulative historical clinical evidence of the predicate devices and the material itself.

1. Table of Implicit Acceptance Criteria and Reported Device "Performance"

Acceptance Criteria (Inferred from Equivalence)	Reported Device "Performance" (Based on Equivalence & Material Science)
Biocompatibility: Safe for use in the human body.	"Excellent biocompatibility" demonstrated by a "long history of use in orthopaedic applications" for Ultra High Molecular Weight Polyethylene (UHMWPE), characterized by extensive clinical studies (Charnley et al., Halley & Charnley, Mirra et al.) and laboratory studies (Turner et al., Compatibility of Biocompatibility of Materials for Total Joint Replacement).
Mechanical Design & Function: Similar geometry and interlock surface for cemented use, equivalent poly surface finish for head/cup articulation, adequate component thickness.	"Has a geometry typical of currently used prostheses that incorporate an outer interlock surface intended for cemented use." "The poly surface finish at the head/cup articulation is equivalent to all approved components currently sold by Exactech." "Assures adequate component thickness as put forth by Bartel." Overall design "similar to those used by Charnley and others since the early introduction of Total Hip Arthroplasty."
Material Composition: Use of Medical Grade Ultra High Molecular Weight Polyethylene (UHMWPE) and Cobalt Chrome for radiographic marker.	Manufactured from "Medical Grade Ultra High Molecular Weight polyethylene (UHMWPE) with a Cobalt Chrome F 90-87 radiographic marker wire." Adheres to specific ASTM standards (F648-84 for UHMWPE, F90-87 for Cobalt Chrome).
Sterilization: Achieves a specified Sterility Assurance Level (SAL).	Sterilized by gamma irradiation with a SAL of 10-6. Utilizes "Method 3, Protocol B from the 'AAMI Guideline for gamma radiation sterilization' for the sterility dose setting and validation procedure."
Indications & Contraindications: Appropriate for target patient population.	Aligns with indications for total hip replacement (osteoarthritis, osteonecrosis, etc.) and similar contraindications for existing hip prostheses.
Compatibility: Functional with other components.	"Designed for use with all Exactech femoral components and femoral heads."

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not applicable in the context of this submission. There is no new "test set" of patients or devices specifically studied for this 510(k). The "evidence" is based on the performance of predicate devices and the established properties of the materials.
Data Provenance: The data provenance for the biocompatibility comes from published clinical and laboratory studies cited for UHMWPE and from the historical performance of predicate devices which would have been used globally (Charnley in the UK, etc.). This is primarily retrospective evidence from existing literature and market history.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Number of Experts: Not applicable. No "ground truth" for a new test set was established by a panel of experts for this 510(k) in the way one would for a diagnostic AI device. The "ground truth" is the historical clinical acceptance and performance of the predicate devices and the established biocompatibility of the materials.
Qualifications of Experts: The experts involved are the authors of the cited scientific literature and the developers/manufacturers of the predicate devices whose designs and materials inform the Exactech All Poly Acetabular Cup.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. No specific test set requiring adjudication was used.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

MRMC Study: No, an MRMC comparative effectiveness study was not done. This device is a passive implantable medical device, not a diagnostic tool where human readers assess cases.

6. Standalone Performance Study

Standalone Study: Yes, in an indirect sense, the properties of the materials (UHMWPE, Cobalt Chrome) and the design principles of the acetabular cup have undergone extensive standalone evaluation through decades of research, clinical use, and regulatory scrutiny by various bodies and researchers. The biocompatibility studies cited (Charnley, Halley, Mirra, Turner, etc.) represent a form of "standalone performance" evaluation of the material itself. However, there isn't a single prospective standalone study for this specific device mentioned in the 510(k).

7. Type of Ground Truth Used

Type of Ground Truth: The ground truth used is primarily historical clinical outcomes data and expert consensus from the long-term use of UHMWPE in hip arthroplasty, as documented in published clinical literature and the established safety and effectiveness of predicate devices. Pathology data from these historical studies also contributes to the understanding of material biocompatibility and performance.

8. Sample Size for the Training Set

Sample Size for Training Set: Not applicable. This is not an AI/ML device that requires a "training set" in the computational sense. The "training" for the design of this device comes from decades of cumulative engineering knowledge, clinical experience, and material science research in total hip arthroplasty.

9. How the Ground Truth for the Training Set Was Established

How Ground Truth for Training Set Was Established: Not applicable. The "ground truth" for the cumulative knowledge base that informed this device's design was established through a combination of:
- Clinical observation and follow-up of millions of patients who received total hip replacements using similar designs and materials over several decades (e.g., Charnley's extensive work).
- Mechanical testing and material science research on UHMWPE and other orthopedic biomaterials.
- Pathological examination of explanted prostheses and surrounding tissues.
- Regulatory review and approval processes for predicate devices, which established their safety and effectiveness.

Summary

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EXACTECH®

4613 N.W. 6th STREET GAINESVILLE, FLORIDA 32609 HONE (352) 377-1140 800) 392-2832 ( (352) 378-2617

K9633313

NOV I 4 1996

510(k) Summary

Sponsor:

Exactech, Inc. 4613 N.W. 6th Street Gainesville, FL 32609

(352) 377-1140 Phone (352) 378-2617 Fax

Contact:

Martha C. Miller V.P. Regulatory Affairs

August 20, 1996

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510(K) Summarv

SUMMARY OF THE SAFETY AND EFFECTIVENESS INFORMATION IN THE PREMARKET NOTIFICATION FOR THE EXACTECH ALL POLY ACETABULAR CUP

Exactech, Inc.

Fstablishment Registration Number 1038671

The Exactech All Poly Acetabular Cup is made of similar materials and is of a similar design to prostheses that were on the market before May 28, 1976. Additionally, the All Poly Acetabular Cup is of similar design to other components on the market that have been determined to be equivalent to devices on the market prior to May 28, 1976. These predicates include, but are not limited to:

T.A.R.A. by DePuy .
Dual Lock by DePuy .
New England Baptist System by DePuy .
Triad System by Johnson and Johnson .
Modular Hip System by Richard .
Spectron Total Hip System by Richards .
Exactech® All Poly Cup .

In addition, Exactech provided to the FDA, design drawings, and material specifications characterizing the All Poly Acetabular Cup.

The Food and Drug Administration, in rules listed in the Federal Register, Friday, September 4, 1987, as Hip Joint Metal/Polymer Semi-Constrained Prosthesis, Section 888.3350 and Docket No. 78N3075, as a class II Device.

Design Considerations

The All Poly Cup has a geometry typical of currently used prostheses that incorporate an outer interlock surface intended for cemented use. The poly surface finish at the head/cup articulation is equivalent to all approved components currently sold by Exactech. It is manufactured to the same standards as detailed in Exactech's components drawings and specifications for all polyethylene acetabular components. In addition, its overall design is similar to those used by Charnley and others since the early introduction of Total Hip Arthroplasty and assures adequate component thickness as put forth by Bartel for such components.

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Design Parameters

Under this premarket notification, the device is available in outside diameters ranging from 42mm through 70mm with internal diameters accommodating femoral head sizes in 22mm, 26mm, 28mm and 32mm.

Material Specifications

The Exactech All Poly Acetabular Cup is manufactured from Medical Grade Ultra High Molecular Weight Polyethylene corresponding with ASTM F648-84. It also has a Radiographic marker wire made from Cobalt Chrome corresponding to ASTM F90-87.

Biocompatibility

Ultra High Molecular Weight Polyethylene has a long history of use in orthopaedic applications. Its biological response has been well characterized by a history of clinical studies (Charnley, J., Cupiz, A., "The Nine and Ten Year Results of the Low Friction Arthroplasty of the Hip", Clinical Orthopaedics, Vol 95, No. 9, 1973 .; Halley, D., Charnley, J. "Results of Low Friction Arthroplasty in Patients 30 Years of Age and Younger", Clinical Orthopaedics, No. 112, October, 1975 and Mirra, J., Amstutz, H., Matos, M., and Gold, R., "The Pathology of Joint Tissues and Its Clinical Relevance in Prosthesis Failure". Clinical Orthopaedics, No. 117, June, 1976) and by laboratory studies (Turner, J., Lawrence, W., and Autian, J., "Subacute Toxicity Testing of Biomaterials Using Histopathologic Evaluation of Rabbit Muscle Tissue," Journal of Biomedical Materials Research. Vol 7, 1973. Compatibility of Biocompatibility of Materials for Total Joint Replacement". Journal of Biomed. Mater. Research, Vol 10, No.2, 1976.). These tests include data on human and animal performance and show that the tissue exhibits excellent biocompatibility.

Sterilization

The Exactech All Polyethylene Cups will be sterilized by gamma irradiation. The Sterility Assurance Level (SAL) is 10th Exactech utilizes Method 3, Protocol B from the "AAMI Guideline for gamma radiation sterilization" for the sterility dose setting and validation procedure.

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Utilization and Implantation

Selection of the Exactech All Polyethylene Acetabular Cup depends on the judgement of the surgeon in relationship to the requirements of the patient. The surgeon should become thoroughly familiar with the technique of implantation by appropriate reading of the literature, and training in the operative skills and techniques required for total hip arthroplasty surgery.

Indications

Contraindications

Use of the Exactech® All Poly Acetabular Cup is contraindicated in patients with active infection, patients without sufficient bone stock to allow appropriate insertion and fixation of the prosthesis, in neuromuscular disorders that do not allow control of the hip joint, and in patients whose weight, age, or activity level would cause the surgeon to expect early failure to the system.

Regulation Number and Section

§ 888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis.

(a)
Identification. A hip joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.