(126 days)
PROCOTYL® PRIME hip system is intended for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients.
Indications for Use
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non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankyloses, protrusion acetabuli. and painful hip dysplasia:
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inflammatory degenerative joint disease such as rheumatoid arthritis;
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correction of functional deformity; and,
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revision procedures where other treatments or devices have failed.
Shells with BIOFOAM® metal foam coating are intended only for uncemented arthroplasty.
The PROCOTYL® PRIME E-CLASS™ XLPE Liner is an additional liner option for MicroPort Orthopedics' PROCOTYL® PRIME Acetabular Cup System (K170444). The design features are summarized below:
- Manufactured from E-CLASS™ vitamin E blended highly crosslinked ultra high . molecular weight polyethylene (VEXLPE) conforming to ASTM F2695-12
- Available in Standard, Lipped, or Face-Changing Lateralized Configurations .
- Inner Diameter sizes 22mm to 44mm o
The provided text describes a 510(k) premarket notification for a medical device, the PROCOTYL® PRIME E-CLASS™ XLPE Liner. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and efficacy through extensive clinical trials with specific acceptance criteria as might be seen for a novel device. Therefore, the response will focus on the non-clinical testing performed to establish this substantial equivalence.
1. Table of acceptance criteria and the reported device performance
Since this is a 510(k) submission, the "acceptance criteria" are generally implied to be meeting the performance of existing, legally marketed predicate devices and established standards (ASTM, ISO). The "reported device performance" refers to the results of the non-clinical tests that demonstrate this equivalence.
| Performance Test (simulated surrogate for acceptance criteria) | Reference Standard / Basis for Acceptance | Reported Device Performance |
|---|---|---|
| Material Properties Testing | Comparison to currently marketed UHMWPE | Subject Acetabular Liner underwent material properties testing to compare its properties to those of currently marketed UHMWPE. (Implied: results were comparable, supporting substantial equivalence) |
| Bacterial Endotoxins | USP endotoxin limit of 20 EU/device | Found to be less than the USP endotoxin limit of 20 EU/device. |
| Pre- and Post-fatigue Push-out, Lever-out, and Torque-out Testing | Evaluation of lock detail | Subject Acetabular Liner underwent pre- and post-fatigue push-out, lever-out, and torque-out testing to evaluate its lock detail. (Implied: results indicated satisfactory lock detail, supporting substantial equivalence) |
| Frictional Torque Testing | Evaluation of properties under pinch-loading conditions | Subject Acetabular Liner underwent frictional torque testing to evaluate properties under pinch-loading conditions. (Implied: results demonstrated satisfactory frictional torque properties, supporting substantial equivalence) |
| Long Term Axial Cyclic Loading | Evaluation of mechanical integrity and fatigue resistance | Subject Acetabular Liner underwent complete long term axial cyclic loading to evaluate the subject Acetabular Liner's mechanical integrity and fatigue resistance properties. (Implied: results demonstrated adequate mechanical integrity and fatigue resistance for its intended use, supporting substantial equivalence) |
| Impingement Testing | Evaluation of mechanical integrity during lip impingement in a fatigue loading profile | Subject Acetabular Liner underwent impingement testing to evaluate its mechanical integrity during lip impingement in a fatigue loading profile. (Implied: results demonstrated adequate mechanical integrity under impingement, supporting substantial equivalence) |
| Wear Testing | Determination of wear rate | Subject Acetabular Liner underwent wear testing to determine the wear rate. A wear particle analysis was performed on the wear debris. (Implied: wear rate and particle analysis were comparable to predicate devices or acceptable for the intended use, supporting substantial equivalence) |
| Range of Motion Study | Performed for the PROCOTYL® PRIME Acetabular Cup System (K170444) | A range of motion study was performed for the PROCOTYL® PRIME Acetabular Cup System, originally submitted as part of K170444. (Since the liner is an additional option for this system, presumably the range of motion is maintained or comparable.) |
| Extractables Study (E-CLASS™ material) | Determine irritant potential and compare to currently marketed Vitamin E UHMWPE | The E-CLASS™ material underwent an extractables study to determine its irritant potential and to compare this potential to currently marketed Vitamin E UHMWPE. (Implied: irritant potential was comparable or acceptable, supporting biocompatibility and substantial equivalence) |
| Cytotoxicity Testing (E-CLASS™ material) | Determine irritant potential using cell monolayers | The E-CLASS™ material underwent cytotoxicity testing, performed using cell monolayers, to determine the irritant potential of the material. (Implied: irritant potential was acceptable, supporting biocompatibility) |
| Irritation and Sensitization Studies (E-CLASS™ material) | Determine irritant and allergenic potential on animal specimens | The E-CLASS™ material underwent irritation and sensitization studies, performed on animal specimens, to determine the irritant and allergenic potential of the material. (Implied: irritation and allergenic potential were acceptable, supporting biocompatibility) |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes (e.g., number of test specimens) for each non-clinical test. It generally states that "testing was performed" or "underwent testing." The data provenance is internal to MicroPort Orthopedics, Inc. and is generated through their non-clinical testing. This is typically prospective in nature for these types of bench and animal studies. No country of origin of the data is explicitly mentioned beyond the company's location in Arlington, Tennessee.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable to a non-clinical 510(k) submission focused on demonstrating substantial equivalence through bench and animal testing. "Ground truth" established by experts is typically relevant for clinical studies, particularly those involving diagnostic accuracy or human interpretation.
4. Adjudication method for the test set
This information is not applicable to the non-clinical testing described. Adjudication methods (like 2+1, 3+1) are used in clinical studies to resolve discrepancies in expert interpretations or assessments.
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
No MRMC comparative effectiveness study was done. The document explicitly states: "Clinical data was not provided for the subject devices." This implies that no human reader studies (with or without AI assistance) were conducted as part of this submission. The device is a physical implant, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No standalone algorithm performance study was done. The device is a physical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Given that "Clinical data was not provided," there is no "ground truth" in the sense of clinical outcomes or expert diagnoses from human patients. The "ground truth" for the non-clinical tests would be the established scientific principles, engineering standards (e.g., ASTM F2695-12 for the material), and performance characteristics of predicate devices against which the new liner's properties are compared.
8. The sample size for the training set
This information is not applicable. There is no "training set" as this is a physical medical device, not an AI algorithm requiring a training dataset.
9. How the ground truth for the training set was established
This information is not applicable, as there is no "training set."
§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.
(a)
Identification. A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.(b)
Classification. Class II.