(88 days)
The Prime E-CLASS™ XLPE Liner is an acetabular liner intended for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients. This device is indicated for the following conditions:
- non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankyloses, protrusion 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 Prime E-CLASS™ XLPE Liner is an additional liner option for MicroPort Orthopedics' Prime Acetabular Cup System (K170444; K180798). The subject Liner is intended to be used with Acetabular Shells and optional Cancellous Bone Screws as part of a total acetabular system.
The Prime E-CLASS™ XLPE Liner is manufactured from E-CLASS™, a vitamin E blended XLPE, conforming to ASTM F2695-12. The subject Liner is available in Standard, Lipped, and Lateralized/Face-changing configurations. The subject Liner has a two-part locking detail featuring 12 anti-rotational tabs and a lock flange, which is intended to mate with the 12 antirotational pockets and lock groove of the compatible Prime Acetabular Shells (K170444; K180798).
The provided document is a 510(k) Summary for a medical device (Prime E-CLASS™ XLPE Liner), which focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study proving the device meets specific acceptance criteria with quantifiable performance metrics.
Therefore, the information required for a table of acceptance criteria and proven device performance as typically expected for a diagnostic AI/ML device is not available in this document. The document describes non-clinical testing performed to establish substantial equivalence for a physical implant, not a software algorithm.
Here's a breakdown of why the requested information cannot be fully provided based on the input text:
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Acceptance Criteria & Device Performance: The document does not define specific clinical or diagnostic acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) that the device must meet. Instead, it details non-clinical tests (bacterial endotoxin, mechanical testing, material properties, wear analysis, fatigue, range of motion) to show the device performs similarly to predicate devices. The "reported device performance" are the results of these non-clinical tests, which aim to demonstrate equivalence rather than meeting independent performance criteria.
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Study Type: This is a premarket notification (510(k)) for a physical medical implant, not a study of an AI/ML diagnostic or prognostic device. The "study" here refers to non-clinical bench testing and analysis to show equivalence.
Given the nature of the document, most of the requested fields are not applicable or the information is not present.
However, I can extract what is available regarding the "studies" (non-clinical testing) performed:
1. A table of acceptance criteria and the reported device performance
As mentioned, specific acceptance criteria in terms of clinical performance metrics are not provided. The "acceptance criteria" for this 510(k) submission are implied by successful completion of tests demonstrating substantial equivalence to predicate devices. The "reported device performance" refers to the outcomes of these non-clinical tests.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Bacterial endotoxin limit (USP endotoxin limit of 20 EU/device) | Endotoxins found to be less than the USP endotoxin limit of 20 EU/device. |
| Mechanical performance of lock detail (Push-out, Lever-out, Torque-out, Axial long-term fatigue) per ASTM F1820, ASTM STP1301, FDA Guidance | Testing performed "through Pre- and Post- Fatigue Pushout Lever-out and Torque-out of the subject Liner from a compatible Shell... and testing found in literature." Axial long-term fatigue also evaluated. (Results affirm substantial equivalence, specific numeric results are not provided in this summary.) |
| Material properties of E-CLASS™ per various ASTM/ISO standards | Considered applicable from K171181 (identical material). (Implies material meets these standards.) |
| Smooth wear per ASTM F1714-96 (2003), ISO 14242-2, etc. | Considered applicable from K171181 (identical material and articulating surface). |
| Abrasive wear per ASTM F1714-96 (2003), ISO 14242-3, etc. | Considered applicable from K171181 (identical material and articulating surface). |
| Wear particle analysis per ASTM F1877-05 | Considered applicable from K171181. |
| Long-term fatigue per FDA Draft Guidance Documents | Considered applicable from K171181. |
| Deformation and frictional torque per ISO 7206-12 | Considered applicable from K171181. |
| Range of motion per ISO 21535 | Considered applicable from K170444 (identical articulating surface and configurations). |
| Biocompatibility (extractables, cytotoxicity, irritation, sensitization) | Performed for K171181 (identical E-CLASS™ material). (Implies results were acceptable.) |
| Sterilization residuals per AAMI TIR 28:2009 Annex A | Evaluated. "Sterealization residuals are within the limits determined by the worst case, which was presented in K140043." |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size: Not explicitly stated for each non-clinical test. For mechanical tests, standard testing protocols define sample sizes, but these are not enumerated here.
- Data Provenance: Not applicable. This refers to bench testing of physical components, not patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- Not applicable. Ground truth for clinical data is not relevant to this type of non-clinical device testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. Adjudication is typically for human assessment of images or clinical outcomes, not for mechanical bench testing.
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 is not an AI/ML diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an AI/ML diagnostic device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For non-clinical testing, the "ground truth" is established by adherence to recognized national and international standards (ASTM, ISO, FDA Guidance) and laboratory measurements using calibrated equipment. For example, the ground truth for endotoxin levels is defined by the USP limit. For mechanical properties, it's the measured values compared to established benchmarks or predicate device performance.
8. The sample size for the training set
- Not applicable. This is not an AI/ML diagnostic device, and thus no "training set" of data in that context. The "training" for the device's design comes from engineering principles, material science, and prior designs.
9. How the ground truth for the training set was established
- Not applicable. No "training set" in the context of AI/ML.
§ 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.