(150 days)
The Heritage Hip prosthesis is a single-use device intended for use in cemented total and hemi-hip arthroplasty procedures.
The indications for total hip arthroplasty are:
- Patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, and nonunion of previous fractures of the femur.
- Patients with congenital hip dysplasia, protrusio acetabuli, or slipped capital femoral epiphysis.
- Patients suffering from disability due to previous fusion.
- Patients with previously failed endoprostheses and/or total hip components in the affected extremity.
- Patients with acute femoral neck fractures.
The indications for hemi-hip arthroplasty are:
- Fracture dislocation of the hip.
- Elderly, debilitated patients when a total hip replacement is contraindicated.
- Irreducible fractures in which adequate fixation cannot be obtained.
- Certain high subcapital fractures and comminuted femoral fractures in the aged.
- Nonunion of femoral neck fractures.
- Secondary avascular necrosis of the femoral head.
- Pathological fractures of the femoral neck.
- Osteoarthritis in which the femoral head is primarily affected.
The Heritage Hip Prosthesis is a modular cemented femoral hip prosthesis manufactured from forged high-strength Zimaloy Alloy. The design of the stem includes a small proximal collar with flats included on the anterior and posterior sides of the stem The medial surface of the stem is designed with a semispherical radius. The stems also have a distal hole for use with an optional distal centralizer. The angle of the stem neck is 132 degrees for greater offset and increased range of motion. The stem is designed with a Morse taper for use with modular femoral heads. The outer surface of the stems are smoothly polished for cemented use. Five primary stem sizes are available and described as sizes one through five. Two stems, CDH and valgus, are available with slightly less offset neck lengths as needed. Three revision stems are available.
The provided text describes a "Summary of Safety and Effectiveness for the Heritage™ Hip Prosthesis System" (K963109). This document is typically submitted to regulatory bodies like the FDA for medical device approval. The "Performance Data" section specifically addresses acceptance criteria and the study that proves the device meets them.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Predetermined design criteria for fatigue | All stems survived at the specified load for 10,000,000 cycles. |
| Ability to perform similarly to other stems tested to the same criteria | Testing demonstrated that the stems can be expected to perform similarly. |
2. Sample size used for the test set and the data provenance
- Sample size: Two stem sizes were tested for the proximal section, and one stem size for the distal section. (The exact number of individual stems per size is not specified but it implies at least one per size).
- Data provenance: Not explicitly stated whether it's retrospective or prospective. Given it's a pre-market submission describing laboratory fatigue testing, it is prospective in the sense that the tests were conducted specifically for this submission. The country of origin is not specified, but the applicant (Zimmer, Inc.) is based in Warsaw, IN, USA.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This type of information (experts establishing ground truth) is typically associated with clinical studies or imaging-based diagnostic devices. For a mechanical device undergoing fatigue testing, the "ground truth" is established by engineering design principles, ASTM/ISO standards, and the physical setup of the testing equipment, not by human experts adjudicating results. The predetermined design criteria serve as the benchmark.
4. Adjudication method for the test set
- Not applicable in the context of mechanical fatigue testing. The results are typically quantitative (e.g., did it survive X cycles at Y load) and don't require human adjudication beyond verifying the test setup and reading the machine output.
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 prosthesis, a mechanical implant, not an AI-assisted diagnostic device that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a mechanical device, not an algorithm. The fatigue testing is inherently "standalone" in the sense that the device's mechanical performance is evaluated independently of human interaction beyond the initial setup.
7. The type of ground truth used
- Ground truth: The "ground truth" for this performance data is based on predetermined design criteria and mechanical engineering standards for fatigue life of orthopedic implants. The success criterion is surviving a specified number of cycles (10,000,000) at a specified load.
8. The sample size for the training set
- Not applicable. This is fatigue testing for a mechanical device, not a machine learning model, so there is no concept of a "training set."
9. How the ground truth for the training set was established
- Not applicable for the same reason as in point 8.
§ 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.