(106 days)
Biomet's Segmental Femoral Replacement components are intended for use in total knee, total hip, or total femoral replacement procedures. Specific indications are:
- Painful and disabled joint resulting from avascular necrosis, osteoarthritis, rheumatoid arthritis, or traumatic arthritis.
- Correction of varus, valgus or post-traumatic deformity.
- Correction or revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement.
- Ligament deficiencies.
- Tumor resections.
- Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques. *
- Revision of previously failed total joint arthroplasty.
- Trauma.
These devices are to be used with bone cement unless a proximal femur is indicated for use (USA).
*Not applicable to Regenerex Ultra Porous Construct titanium knee augment usage (not licensed in Canada), or any other knee component.
When components of the Orthopedic Salvage System are used with Biomet's Compress Segmental Femoral Replacement System, they are intended for uncemented application and indicated for:
- Correction or revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement.
- Tumor resections.
- Revision of previously failed total joint arthroplasty.
- Trauma.
The Orthopedic Salvage System is a system of modular components that are intended to be used for difficult revision surgeries or limb salvage procedures. The components can replace any portion of, or the total femur and/or the knee and proximal tibia.
Here's an analysis of the provided text regarding acceptance criteria and the study that proves the device meets those criteria:
Device: Orthopedic Salvage System (OSS) with modified male tapers (roller hardened and machined taper).
The manufacturer conducted non-clinical testing to demonstrate that the modified tapers perform equivalently or better than the predicate device's tapers. Clinical testing was not required.
1. Table of Acceptance Criteria and Reported Device Performance
| Test Type | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Cantilever Fatigue Test | Met acceptance criteria (explicitly stated) | Roller hardened tapers were stronger in cantilever fatigue than the predicate tapers. |
| Compressive Fatigue Test | Met acceptance criteria (explicitly stated) | Compressive fatigue strength of rollercoaster hardened tapers was equivalent to or greater than the predicate tapers. |
| Static Axial Separation Test | Met acceptance criteria (explicitly stated) | Pull-off strength of rollercoaster hardened tapers was equivalent to or greater than the predicate tapers. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample sizes (number of test articles) used for each non-clinical test (Cantilever Fatigue, Compressive Fatigue, Static Axial Separation).
The data provenance is from non-clinical laboratory testing conducted by Biomet Manufacturing Corp. (the applicant/sponsor). No country of origin is explicitly stated for the testing, but the company is based in Warsaw, Indiana, USA. The testing is inherently prospective as it evaluates new modifications.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The ground truth for this device (mechanical performance) is established through objective engineering measurements in non-clinical laboratory tests, not through expert consensus on medical images or patient outcomes.
4. Adjudication Method for the Test Set
Not applicable. As noted above, the "ground truth" for mechanical testing is based on engineered measurements and comparisons to predefined acceptance criteria, not human interpretation or adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This is a medical device (orthopedic implant) where performance is evaluated through mechanical testing, not through human interpretation of medical images. The document explicitly states: "Clinical testing was not required to demonstrate substantial equivalence of the design modifications proposed to the cleared predicate devices."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. The device is a physical orthopedic implant, not a software algorithm.
7. The Type of Ground Truth Used
The ground truth used is based on established engineering standards and mechanical test results. The performance of the modified device (roller hardened tapers) was compared against the performance of predicate device tapers. The acceptance criteria for these tests serve as the ground truth benchmarks.
8. The Sample Size for the Training Set
Not applicable. This is a physical medical device, not an AI/ML algorithm that requires a "training set" of data.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
§ 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.