(29 days)
The Taperloc Complete hip stems are intended for uncemented biological fixation. This is the same intended use as the predicate Taperloc® stems cleared in K101086.
Indications For Use:
- Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
- Rheumatoid arthritis
- Correction of functional deformity
- Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques.
- Revision procedures where other treatment or devices have failed.
Porous coated components are intended for uncemented biological fixation.
The Taperloc® Complete hip stems are a line extension of the legally marketed Taperloc® Complete stems cleared in K101086.
Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the Taperloc® Complete, Sizes 5mm and 6mm:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion (Test) | Device Performance |
|---|---|
| Distal Pot Fatigue Testing (ASTM F-1612-95) | All components passed. |
| Proximal Pot Fatigue Testing (ASTM F-2068-03) | All components passed. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample size (i.e., number of stems) used for the non-clinical fatigue tests. It only mentions "All components passed."
The data provenance is from non-clinical testing conducted in accordance with ASTM standards. This implies laboratory testing rather than human subject data. Therefore, questions of country of origin and retrospective/prospective do not apply in the typical sense for clinical studies.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
This information is not applicable as the studies were non-clinical fatigue tests based on established ASTM standards, not clinical studies requiring expert interpretation or ground truth establishment in a medical context.
4. Adjudication Method for the Test Set
This information is not applicable as the studies were non-clinical fatigue tests. Adjudication methods are typically relevant for clinical trials where multiple evaluators assess outcomes and discrepancies need to be resolved.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
This information is not applicable. The submission describes a medical device (hip stems) and its non-clinical performance, not an AI-assisted diagnostic or interpretative tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable. The device is a physical implant, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the non-clinical tests was adherence to the performance requirements specified in the respective ASTM standards:
- ASTM F-1612-95, Cyclic Fatigue Testing of Metallic Stemmed Hip Arthroplasty Femoral Components with Torsion: The standard itself defines the pass/fail criteria for the fatigue test.
- ASTM F-2068-03 Standard Specification for Femoral Prostheses - Metallic Implants: This standard specifies the requirements for femoral prostheses, including fatigue testing, and defines what constitutes a "pass."
8. The Sample Size for the Training Set
This information is not applicable. The device is a physical implant, and the testing described is non-clinical performance evaluation, not machine learning model training.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reasons as above.
§ 888.3330 Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis.
(a)
Identification. A hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis is a two-part 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 consist of a femoral and an acetabular component, both made of alloys, such as cobalt-chromium-molybdenum. The femoral component is intended to be fixed with bone cement. The acetabular component is intended for use without bone cement (§ 888.3027).(b)
Classification. Class III.(c)
Date PMA or notice of completion of PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before May 18, 2016, for any hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component that was in commercial distribution before May 28, 1976, or that has, on or before May 18, 2016, been found to be substantially equivalent to a hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component that was in commercial distribution before May 28, 1976. Any other hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.