(63 days)
Indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:
- non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
- inflammatory degenerative joint disease such as rheumatoid arthritis;
- correction of functional deformity; and,
- revision procedures where other treatments or devices have failed.
The Metal TRANSCEND® Articulation System components are for single use only.
The previously submitted and cleared Metal TRANSCEND® Articulation System (Exhibit 1: 510(k) K004043) is composed of two pieces, a metal shell and a metal liner that mates to the shell by the use of a taper locking mechanism. This two piece design limits the size of the femoral heads. The use of a monoblock superfinished shell allows larger head sizes to be used. The new Metal TRANSCEND® Articulation System (larger sizes) should increase the range of motion and decrease the risk of dislocation as compared to the current TRANSCEND® (510(k) K004043) Metal on Metal bearing couple.
The Metal TRANSCEND® Articulation System (larger sizes) consists of the following components that are substantially equivalent to the previously cleared components submitted under the Metal TRANSCEND® Articulation System (510(k): K004043): metal monoblock acetabular shells, and metal femoral heads.
Design features of the Metal TRANSCEND® Articulation Monoblock Shell (larger sizes) are summarized below:
- Manufactured from cast cobalt-chromium-molybdenum conforming to ASTM . F75
- Porous coated with CoCrMo (ASTM F75) Sintered beads ●
- Available sizes: ranging from 46mm to 64mm (outer diameter) in 2mm ● increments (The inner diameter of each shell is 10mm smaller than the outer diameter)
- . The articulating surface of the implants will be superfinished (1 microinch Ra maximum) to insure form tolerance and a fine surface finish
- . A one-piece acetabular shell allows the surgeon to reconstruct the acetabulum while removing very little bone to accommodate a larger Femoral Head.
Design features of the Metal TRANSCEND® Femoral Head (larger sizes) are summarized below:
- Manufactured from cast cobalt-chromium-molybdenum conforming to ASTM F75
- Available sizes: 38mm, 40mm, 42mm, 46mm, 48mm, 50mm, 50mm, 52mm, . 54mm
- . Available neck lengths: -3.5, 0, +3.5
- The articulating surface of the implants will be superfinished (1 microinch Ra ● maximum) to insure form tolerance and a fine surface finish
- The taper connection for the Metal TRANSCEND® Femoral Heads (larger sizes) will be identical to the Metal TRANSCEND® Femoral Heads (510(k):K004043) and is intended to be used with our existing femoral stems manufactured with WMT12/14 taper.
1. A table of acceptance criteria and the reported device performance:
The submission does not explicitly define "acceptance criteria" in a quantitative sense with specific performance metrics and thresholds. Instead, it relies on demonstrating substantial equivalence to a previously cleared predicate device (Metal TRANSCEND® Articulation System, 510(k): K004043). The key aspect of acceptance is the expectation of similar clinical success based on the equivalence of materials, design features, intended use, and reported wear rates.
However, the clinical data section reports on two key outcomes, which can be interpreted as indicators of "acceptable" performance compared to existing standards:
| Acceptance Criteria (Inferred) | Reported Device Performance (Metal TRANSCEND® Articulation System) |
|---|---|
| 2-year cumulative survival (clinically equivalent to predicate) | Clinically equivalent to (no worse than) the Dobbs metal on metal cohort (a reference standard). |
| "at least good results" by Harris Hip Score (favorable comparison with literature-based cohorts) | Nearly 90% of procedures resulted in "at least good results" at 1 and 2 years, comparing favorably with literature-based cohorts of THR. |
| SF-12 physical function component score increase | More than a 50% increase in the SF-12 physical function component score. |
| Complications and adverse events (rare) | Rare. |
| Radiolucencies >2mm (rare) | Rare. |
| Subsidence of stem or migration of cup >2mm (none) | There were no findings of subsidence of the stem or migration of the cup >2mm. |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not explicitly stated as a single "test set" for this submission. The clinical data cited refers to the data collected for the predicate device (K004043). The study mentions that after excluding one site, the data was analyzed. The exact number of patients included in the analysis for the predicate device is not provided in this document.
- Data Provenance: The data was collected prospectively from multi-sites. The document does not specify the country of origin but implies it was a controlled multi-site clinical trial.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the document. The clinical trial data for the predicate device was collected based on patient outcomes and clinical assessments (e.g., Harris Hip Score), rather than specific "ground truth" established by experts in the context of an AI device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable and therefore not provided, as this is not an AI device validation study requiring expert adjudication of outputs. The clinical data for the predicate device would have involved standard medical assessments by treating physicians.
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. This device is a medical implant (total hip system), not an AI-assisted diagnostic or therapeutic device that would involve human "readers" or an AI component in that context.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a medical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For the clinical study used to support the predicate device, the "ground truth" was based on patient outcomes data, including:
- 2-year cumulative survival
- Harris Hip Score results (indicating "good results")
- SF-12 physical function component score increases
- Occurrence of complications and adverse events
- Radiolucency measurements
- Subsidence or migration of components
8. The sample size for the training set:
Not applicable. This is not an AI device that requires a training set. The clinical data refers to the performance of the predicate device in a clinical trial.
9. How the ground truth for the training set was established:
Not applicable. As noted above, this is an implant, not an AI device with a training set.
§ 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.