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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:

1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
2. inflammatory degenerative joint disease such as rheumatoid arthritis;
3. correction of functional deformity; and,
4. 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:

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.

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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:

1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
2. inflammatory degenerative joint disease such as rheumatoid arthritis;
3. correction of functional deformity; and,
4. revision procedures where other treatments or devices have failed.

The Metal TRANSCEND® Articulation System components are for single use only.

The Metal TRANSCEND® Articulation System consists of components that are identical to the previously submitted components under the Metal TRANSCEND® Articulation System IDE: metal acetabular shells, metal acetabular liners, and metal femoral heads.

Design features of the Metal TRANSCEND® Acetabular Shell are summarized below:

• Manufactured from Ti6Al4V conforming to ASTM F-136 or ASTM F620 .
• Porous coated with commercially pure titanium (ASTM F67 or F 1580) sintered . beads
• Features three screw holes and an apical hole ●
• Designed for use with Apical Hole Plug and bone screws .
• Internal geometry of the shell features an 18.8750° (included) taper to accept . acetabular liners
• Available in 12 sizes ranging from 46mm to 68mm in 2mm increments .

Design features of the Metal TRANSCEND® Acetabular Liner are summarized below:

• Manufactured from cast cobalt-chromium-molybdenum conforming to ASTM . E75
• Designed for use with metal acetabular shell .
• Available in three inside diameters: 28mm, 32mm, and 36mm ●

Design features of the Metal TRANSCEND® Femoral Head are summarized below:

• Manufactured from cast cobalt-chromium-molybdenum conforming to ASTM . E75
• Available in three sizes: 28mm, 32mm, and 36mm .
• Available in four neck lengths: short, medium, long, and extra-long ●

Here's an analysis of the provided text regarding the Metal TRANSCEND® Articulation System.

Please note that the document describes a medical device for total hip arthroplasty, and therefore the "acceptance criteria" and "device performance" are related to clinical outcomes and material properties, not typical AI/software performance metrics like accuracy, sensitivity, or specificity. The study described is a clinical trial, not an AI model validation study.

Acceptance Criteria and Device Performance for Metal TRANSCEND® Articulation System

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size (Clinical Data, which serves as the "test set" for performance evaluation): Not explicitly stated. The document mentions "multi-sites" for data collection but does not give the exact number of patients or procedures. It refers to "a single site with significantly poorer survival" being excluded, implying multiple sites contributed.
• Data Provenance: Prospectively collected from multi-sites. The country of origin is not specified, but the submission is to the US FDA.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• This is not applicable in the context of this device study. "Ground truth" for a total hip arthroplasty device would be derived from structured clinical outcome measures (like Harris Hip Score, SF-12), radiographic assessments, and direct observation of complications. These are typically assessed by orthopedic surgeons, clinical research coordinators, and radiologists involved in the study, but not in the sense of "experts establishing ground truth" for an AI model.

4. Adjudication Method for the Test Set

• Adjudication methods for clinical endpoints are not explicitly detailed. However, the outcomes such as Harris Hip Score, SF-12, radiolucencies, subsidence, and migration are typically based on standardized clinical assessments and radiographic measurements, often reviewed by the study investigators. The document states that a single site was identified as having problems with surgical technique and was excluded, suggesting some level of data quality monitoring or review was performed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

• No, an MRMC comparative effectiveness study with AI assistance was not done. This document describes the clinical validation of a physical medical device (hip implant), not an AI diagnostic or assistive tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Not applicable. This pertains to a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

• Clinical Outcomes Data and Radiographic Assessments: The "ground truth" for the device's safety and effectiveness was established through:
  • Patient-Reported Outcomes: Harris Hip Score, SF-12 physical function component score.
  • Observed Clinical Events: Complications and adverse events.
  • Radiographic Evidence: Presence of radiolucencies (>2mm), subsidence of stem (>2mm), and migration of cup (>2mm).

8. The Sample Size for the Training Set

• Not applicable. This is a clinical trial for a physical medical device, not an AI model. Therefore, there is no "training set" in the machine learning sense. The clinical data collected serves as the evidence for the device's performance.

9. How the Ground Truth for the Training Set Was Established

• Not applicable. See point 8.

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