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510(k) Data Aggregation
(132 days)
The PROCOTYL® PRIME Acetabular Cup System is intended 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.
Shells with BIOFOAM® metal foam coating are intended only for uncemented arthroplasty.
The PROCOTYL® PRIME Acetabular Cup System includes acetabular shells, acetabular liners, and optional cancellous bone screws. The design features are summarized below:
- Acetabular Shells
- Manufactured from titanium alloy
- BIOFOAM® coated
- Available in Solid or Quad configurations
- Outer Diameter sizes 42mm to 68mm in 2mm increments
- Acetabular Liners
- Manufactured from A-CLASS® highly crosslinked ultra high molecular weight polyethylene)
- Available in Standard. Lipped Face-changing or Lateralized configurations
- Inner Diameter sizes 22mm to 44mm
- Bone Screws
- Manufactured from titanium alloy
- 6.5mm diameter
- Available in lengths 15mm to 80mm in 5mm increments
This document is a 510(k) summary for the PROCOTYL® PRIME Acetabular Cup System, a medical device for total hip arthroplasty. It describes the device, its intended use, and argues for its substantial equivalence to previously cleared predicate devices.
Here's an analysis of the provided text in relation to your request about acceptance criteria and studies:
Crucially, this document is a 510(k) Pre-Market Notification, which is a regulatory submission to demonstrate that a new device is substantially equivalent to a legally marketed predicate device. It is not a detailed clinical study report or a publication presenting performance metrics against specific acceptance criteria for an AI/ML device.
Therefore, most of the information you are requesting about acceptance criteria, specific performance metrics, sample sizes for test sets, expert ground truth, MRMC studies, or standalone algorithm performance for an AI/ML device is not present in this document. This document concerns a physical orthopedic implant.
However, I can extract the information that is available and clarify what is missing based on your request.
Summary of Device Acceptance Criteria and Performance (Based on available information):
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Mechanical Performance (Nonclinical Testing): | |
| Lock detail strength (Push-out, Lever-out, Torque-out per ASTM 1820) | "The lock detail of the subject PROCOTYL® PRIME Acetabular Cup System was evaluated by testing Push-out, Lever-out and Torque-out of the Liner per ASTM 1820." (Implied: met relevant ASTM standards, but no specific values or thresholds are provided for "meeting" the criteria). |
| Deformation and frictional torque under pinch-loading conditions | "The subject System underwent deformation and frictional torque testing to evaluate the properties under pinch-loading conditions." (Implied: results were acceptable, but no specific values or thresholds are provided.) |
| Fatigue resistance (Long term axial cyclic loading) | "The subject System completed long term axial cyclic loading to evaluate fatigue resistance properties." (Implied: acceptable fatigue resistance, but no specific methodology or pass/fail criteria are defined.) |
| Wear rate and wear particle analysis | "The subject System underwent wear testing to determine the wear rate and a wear particle analysis was performed on the wear debris." (Implied: acceptable wear characteristics, but no specific wear rate thresholds or particle analysis results are given.) |
| Range of motion | "Additionally, a range of motion study was completed for the PROCOTYL® PRIME Acetabular Cup System." (Implied: acceptable range of motion, but no specific values or comparison to predicate is given.) |
| Cancellous bone screw properties (per ASTM F543) | "Finally, per ASTM F543, the properties of the cancellous bone screws were examined." (Implied: met relevant ASTM standards, but no specific values or thresholds are provided.) |
| Biocompatibility: | |
| Pyrogen Limit Specification (per Limulus Amebocyte Lysate (LAL) test) | "The Limulus Amebocyte Lysate (LAL) test was used to determine the subject devices meets the specified pyrogen limit specification of ≤ 20 EU/device." (Explicitly states: "meets the specified pyrogen limit specification of ≤ 20 EU/device.") |
| Substantial Equivalence (Overall Regulatory Goal): | "The design features and materials are substantially equivalent to those of the predicate devices. The fundamental scientific technology of the subject devices has not changed relative to the predicate devices. The safety and effectiveness of the subject devices are adequately supported by the substantial equivalence information, materials information, and analysis data provide within this Premarket Notification." (This is the overarching "acceptance criterion" for a 510(k), demonstrated by comparing to predicate devices and performing nonclinical testing to support this claim). |
Missing Information (as per your request, because this is not an AI/ML device nor a typical clinical study report):
- Sample size used for the test set and the data provenance: Not applicable. The "test set" here refers to physical components tested in a lab, not a diagnostic dataset. The document does not specify sample sizes (e.g., number of cups, liners, or screws) for any of the nonclinical tests. Data provenance, in the sense of country of origin or retrospective/prospective for patient data, is also not applicable here.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an orthopedic implant's mechanical properties is typically established through recognized engineering standards (e.g., ASTM) and validated testing methodologies, not expert medical consensus on diagnostic images.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This applies to human review of diagnostic outputs, not mechanical testing.
- 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 is not an AI/ML diagnostic device with human-in-the-loop.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): For mechanical testing, the "ground truth" is defined by the specifications and performance standards (e.g., ASTM standards) that the device must meet. For biocompatibility, it's defined by the pyrogen limit specification (≤ 20 EU/device). It's not based on expert consensus, pathology, or outcomes data in the conventional sense used for diagnostic devices.
- The sample size for the training set: Not applicable. This is not an AI/ML device that requires a training set.
- How the ground truth for the training set was established: Not applicable.
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