(209 days)
The ULTIMA* TPS Cemented Stem is indicated for use in total or partial hip replacement procedures for patients suffering severe pain and disability due to:
- structural damage in the hip joint from rheumatoid arthritis,
- osteoarthritis,
- post-traumatic arthritis,
- collagen disorders,
- avascular necrosis,
- nonunion of femoral fractures,
- congenital hip dysplasia,
- protrusio acetabuli,
- slipped capital femoral epiphysis, and
- disability due to previous fusion where bone stock is inadequate for other reconstruction techniques.
The ULTIMA* TPS Cemented Stem is indicated for use only with PMMA bone cement.
The ULTIMA* TPS Cemented Stem is forged from a Cobalt-Chromium alloy which conforms to ASTM F799 (EXHIBIT IV); this material has high strength and good hardness properties and is also highly immune to fatigue. The ULTIMA* TPS Cemented Stem is polished to a bright finish on all surfaces below the spigot and can be used interchangeably in either the left or the right hip. The stem is straight, tapering towards the distal tip in both the mediolateral and anteriorposterior sections. It does not have a proximal collar.
The ULTIMA* TPS Cemented Stem has a 10/12 Morse taper; it will be available in six sizes (0, 1 - 5), each of the 1 - 5 sizes have a choice of either a 37.5 mm (standard) offset, or a 44.0 mm (medialized "M") offset. In addition to this central range, there shall be two long stern options. The stem can be used with various neck heads (22.225, 26, 28 and 32 mm) as well as neck options (-5 (32), -3 (28), 0, +5 and +10). All of the stems in the range have a neck angle of 125°.
The distal centralizer that is used with the ULTIMA* TPS stem comes in a range of sizes and is manufactured from PMMA. There are three wings on the centralizer which ensure the orientation of the stem distally. These increase in size through the centralizer range to deal with the variation in anatomy of the medullary canal. In revision surgery, a "wingless" centralizer is required, thus a 7mm diameter version is available which simply acts to provide the void, and does not centralize the stem.
The provided text describes the ULTIMA* TPS Cemented Stem, a hip joint prosthesis, and focuses on its substantial equivalence to predicate devices, rather than a study proving new performance criteria through clinical trials. Therefore, much of the requested information regarding acceptance criteria specific to a performance study, sample sizes, expert adjudication, MRMC studies, or multi-reader multi-case comparative effectiveness studies cannot be extracted directly from this document.
The document primarily establishes "substantial equivalence" based on design, materials, intended use, and mechanical testing results.
Here's the information that can be extracted or inferred based on the document's content:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance (ULTIMA* TPS Cemented Stem) |
|---|---|---|
| Substantial Equivalence (Functional) | Functionally equivalent to Howmedica Exeter hip stem (#K891454) and Zimmer CPT hip stem. | Stated to be substantially equivalent. |
| Mechanical Performance | Withstand a maximum load of 2,300N force. | Meets this criterion. |
| Mechanical Performance | Withstand 5,000,000 cycles. | Meets this criterion. |
| Material Conformance | Material conforms to ASTM F799 (Cobalt-Chromium alloy). | Forged from a Cobalt-Chromium alloy which conforms to ASTM F799. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not detail specific sample sizes for mechanical testing. It mentions "testing results" indicating the device meets the criteria, which implies that mechanical tests were conducted on an unspecified number of device samples.
- Sample Size for Test Set: Not specified for mechanical testing.
- Data Provenance: Not explicitly stated, but assumed to be from laboratory testing conducted by Johnson & Johnson Professional, Inc. (the manufacturer). This is a pre-market notification (510(k)) and not a clinical trial; therefore, there is no patient data provenance in this context.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. This document describes mechanical testing for substantial equivalence, not a study requiring expert clinical assessment for ground truth. The "ground truth" for mechanical properties is established by engineering standards (e.g., ASTM F799) and the specified thresholds (e.g., 2,300N force, 5,000,000 cycles).
4. Adjudication Method for the Test Set
Not applicable. This is not a study requiring adjudication of expert opinions.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No. This document does not describe an MRMC comparative effectiveness study. It focuses on demonstrating substantial equivalence based on design, materials, and mechanical properties against predicate devices.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, in the context of mechanical testing. The "performance" being assessed here is the device's physical response to specified forces and cycles, which is a standalone evaluation of the device itself (analogous to "algorithm only" in an AI context, but for a physical product).
7. The Type of Ground Truth Used
The ground truth used for this type of device's "performance" is based on:
- Engineering standards (e.g., ASTM F799 for material properties).
- Predefined mechanical thresholds (e.g., 2,300N force, 5,000,000 cycles) typically derived from industry acceptance or predicate device performance.
- Comparison of design features and materials to predicate devices to establish substantial equivalence.
8. The Sample Size for the Training Set
Not applicable. This is not a machine learning or AI study, so there is no concept of a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set, there is no ground truth establishment for it.
§ 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.