(87 days)
The PLUS-FIT Acetabular Cup is intended for all types of arthrosis, such as advanced destruction of the hip joint due to degenerative, post-traumatic or rheumatoid arthritis, fracture or avascular necrosis of the femoral head, sequelae of previous operations, such as internal fixation, joint reconstruction, arthrodesis, hemiarthroplasty or total hip replacement. The same considerations apply to acetabular revisions. In normal cases, however, the surgeon will use an acetabular implant one size larger and in exceptional cases two sizes larger.
The PLUS-FIT Acetabular Cup is a cementless acetabular cup, which was designed with a triple-radius profile. The advantages are 1) minimal bone resection, 2) press-fit with physiological load transfer through the peripheral zone of the acetabulum, thus ensuring good primary stability without the need for screw fixation and 3) optimal osseous integration due to good primary stability.
The provided document describes a 510(k) submission for the PLUS-FIT Acetabular Cup, a cementless total hip prosthesis. The acceptance criteria and the study proving the device meets them are outlined in the "Performance data" section.
Here's the information extracted and formatted as requested:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Comparability to leading competitive cups | "All tests showed that the PLUS-FIT Acetabular Cup was comparable to, or exceeded, cementless competitive acetabular cups." |
| Specifically, the device was compared to "cups of other leading manufacturers" and showed comparable or superior biomechanical performance. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. The document refers to "biomechanical laboratory tests" comparing "cups of other leading manufacturers" to the PLUS-FIT Acetabular Cup. This implies a comparative study involving multiple cups, but the exact number of units tested for each type is not provided.
- Data Provenance: The tests were "biomechanical laboratory tests." The country of origin of the data is not specified, but the submission is from HHL Consulting for PLUS Orthopedics in San Diego, California, suggesting the tests were likely conducted within a similar regulatory or research environment. The data is prospective in the sense that these tests were conducted specifically for this 510(k) submission to demonstrate equivalence.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not applicable. For biomechanical performance tests of an orthopedic implant, the "ground truth" is typically established through direct measurement and objective physical and mechanical properties, not through expert consensus on interpretation.
- Qualifications of Experts: Not applicable for establishing ground truth in this context.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. The "performance data" refers to biomechanical laboratory tests, not subjective assessments requiring expert adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
- MRMC Study: No, an MRMC comparative effectiveness study was not done. The performance data presented are from biomechanical laboratory tests, not clinical studies involving human readers or interpretation of medical images/cases.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Standalone Performance: Not applicable. This device is a physical medical implant (acetabular cup), not an algorithm or software. Therefore, the concept of "standalone performance" for an algorithm without human-in-the-loop is not relevant.
7. The Type of Ground Truth Used
- Type of Ground Truth: The ground truth for the "Performance data" was based on objective biomechanical measurements and physical properties observed during laboratory testing. This includes characteristics like stability, load transfer, and potentially other mechanical properties that are intrinsic to the device's design and materials.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This is a physical medical device, not an AI/ML algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable. As there is no AI/ML algorithm involved, there is no "training set" or ground truth for one.
§ 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.