(97 days)
The ArComXL™ Polyethylene Rx90™ Low Profile Acetabular Liners are indicated for single cemented or non-cemented use in cases of:
- Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
- Rheumatoid arthritis
- Correction of functional deformity
- Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques
- Revision of previously failed total hip arthroplasty.
The new device is composed of ArComXL ™ with inner diameters of 28, 32, and 36mm.
The provided text describes a 510(k) premarket notification for a medical device, specifically ArComXL™ Polyethylene Rx90™ Low Profile Acetabular Liners. This document focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing extensive de novo clinical or performance studies with detailed acceptance criteria and performance metrics typically found for novel AI/software devices.
Therefore, for many of the requested categories, the information is not available in the provided text, as the regulatory pathway for this type of device (an acetabular liner) does not typically require the same level of detailed performance studies in the context of AI/software acceptance.
Here's an analysis based on the provided text, indicating where information is present or absent:
Acceptance Criteria and Study Details for ArComXL™ Polyethylene Rx90™ Low Profile Acetabular Liners
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Device: | |
| Designs, Intended Use, Contraindications, and Design Specifications | "The designs, intended use, contraindications, and design specifications of the subject components remain identical to their predicate counterparts." |
| Non-Clinical Testing Standard/Guideline Compliance | "Testing met or exceeded current standards or guidelines." (Specific standards/guidelines not detailed in this summary.) |
| Composition | "The new device is composed of ArComXL™ with inner diameters of 28, 32, and 36mm." The submission allows the predicate system to be composed of ArComXL™ with an inner diameter of 36mm. |
| Intended Use (Identical to Predicate) | Indicated for single cemented or non-cemented use in cases of: 1) Non-inflammatory degenerative joint disease (osteoarthritis, avascular necrosis), 2) Rheumatoid arthritis, 3) Correction of functional deformity, 4) Treatment of specific femoral fractures, and 5) Revision of previously failed total hip arthroplasty. |
2. Sample size used for the test set and the data provenance
- Sample Size (Test Set): Not applicable. This submission relies on "non-clinical testing" of a predicate device and direct comparison of specifications. There is no specific "test set" of patient data in the context of an AI/software performance study.
- Data Provenance: Not applicable in the context of AI/software data. The "non-clinical testing" likely refers to mechanical or material testing as per orthopedic implant standards, not patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. Ground truth, in the sense of expert annotation for AI/software, is not relevant to this device's 510(k) submission.
4. Adjudication method for the test set
- Not applicable. There is no test set of subjective observations requiring adjudication.
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. An MRMC study is not relevant to this device (an acetabular liner). This is a physical orthopedic implant, not an AI-powered diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable in the context of AI/software ground truth. The "ground truth" for this device's regulatory clearance would be compliance with material specifications, mechanical testing standards, and established clinical performance of the predicate device.
8. The sample size for the training set
- Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established
- Not applicable.
§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.
(a)
Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis is a 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 has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II.