(136 days)
The BetaCone is intended for non-cemented use to replace the anatomy of the femur in cases of total hip replacement. It is indicated in the treatment of the following:
- Patient conditions of noninflammatory degenerative joint disease, e.g., avascular necrosis and osteoarthritis; and inflammatory joint disease, e.g., rheumatoid arthritis;
- Those patients with failed previous surgery where pain, deformity, or dysfunction persists; and
- Revision of a previously failed hip arthroplasty.
Both the BetaCone and the predicate Encore, CLS, and Alloclassic Hip Stems use titanium alloy straight, tapered stems to replace the femur in hip replacement procedures. The BetaCone is fabricated from Ti-6Al-4V titanium alloy. BetaCone stems are available in 9 standard and 9 XL sizes. with lengths ranging from 135 to 175 mm. The BetaCone stem has a rectangular cross-section slightly rounded in both planes. BetaCone XL neck lengths are 5 mm longer than standard stem neck lengths. The Beta Cone neck angle is 126°. A 12/14 taper connects with Link's prosthesis heads using the same size taper. The BetaCone is compatible with Link standard acetabular cups. The BetaCone stem is designed for uncemented, press-fit fixation. A proximal trochanter fin supports proximal press-fit fixation.
The acceptance criteria and study proving the device meets them are as follows:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Dynamic fatigue testing per ISO 7206-4:2002 | No prosthesis failed up to 5 million cycles at a maximum load of 2.3kN. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Five samples of the same sized, worst-case stem were tested.
- Data Provenance: The study appears to be a laboratory bench test, rather than a clinical study with patient data. Its provenance isn't explicitly stated as a country but is implied to be internal testing by the manufacturer, Waldemar Link GmbH & Co. KG (Germany).
- Retrospective/Prospective: Not applicable, as this was a bench test.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This was a physical bench test to evaluate mechanical properties, not a study requiring expert clinical judgment or ground truth derived from expert consensus.
4. Adjudication Method for the Test Set
Not applicable. This was a physical bench test; there was no human adjudication of results in the traditional sense of clinical studies. The failure or non-failure of the prosthesis in a dynamic fatigue test is an objective measurement.
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. The document describes a medical device (hip prosthesis) and a bench test for its mechanical integrity, not an AI-based diagnostic tool 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 physical medical device, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this bench test was the objective physical behavior of the prosthesis under specified dynamic fatigue conditions. The standard ISO 7206-4: 2002 defines the parameters and expected outcomes for qualifying a hip prosthesis for fatigue resistance.
8. The Sample Size for the Training Set
Not applicable. This is a physical medical device and a bench test, not a machine learning model requiring a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable. No training set was used.
§ 888.3360 Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis.
(a)
Identification. A hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis is a device intended to be implanted to replace a portion of the hip joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum. This generic type of device includes designs which are intended to be fixed to the bone with bone cement (§ 888.3027) as well as designs which have large window-like holes in the stem of the device and which are intended for use without bone cement. However, in these latter designs, fixation of the device is not achieved by means of bone ingrowth.(b)
Classification. Class II.