(28 days)
The Apex Hip System is intended for primary and revision total hip replacement. The femoral hip stem and acetabular cup are intended for uncemented fixation and single use implantation. The Apex Acetabular Cup Liners, standard and ApeX-LNK Poly, are intended for use with the Apex Modular Acetabular Cup, in combination with the Apex Modular, Apex K1 Hip in total hip replacement procedures. The acetabular cup liners are intended to articulate with a metal (cobalt chromium) or ceramic (alumina) femoral head. These prostheses may be used for total hip arthroplasty to treat the following conditions, as appropriate:
- Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis;
- Rheumatoid arthritis;
- Correction of functional deformity;
- Congenital dislocation;
- Revision procedures where other treatments or devices have failed;
- Femoral neck and trochanteric fractures of the proximal femur.
ApeX-LNK Poly™ Acetabular Cup Liners are manufactured of compression molded, cross-linked and stabilized ultrahigh molecular weight polyethylene oxide. The articular geometry of the liners are compatible with existing Apex Modular femoral heads, manufactured from cobalt chrome or alumina ceramic, 40 mm diameter, with various offsets.
Apex Modular Heads have a standard tapered bore that corresponds to the mating taper on the modular neck (ASTM F1636). Various industry standard head diameters are included to allow use of a wide range of acetabular cups, at the discretion of the orthopaedic surgeon.
Here's an analysis of the provided text, focusing on acceptance criteria and study details.
Analysis based on the provided document:
The provided document is a 510(k) premarket notification for ApeX-LNK Poly™ Acetabular Cup Liners and Apex Modular Heads. It is a regulatory submission for medical devices, primarily focused on demonstrating substantial equivalence to predicate devices, rather than establishing numerical performance acceptance criteria through clinical studies in the way an AI/software device would.
Therefore, the requested information categories (e.g., sample size for test set, number of experts for ground truth, adjudication method, MRMC study, standalone performance) are not applicable in the context of this medical device submission. These categories are typically relevant for AI/ML-based diagnostic or screening devices where performance is measured against a ground truth from human expert interpretation or pathology.
This document demonstrates equivalence through design, materials, manufacturing processes, and in some cases, performance testing (often mechanical bench testing) to ensure safety and effectiveness are comparable to legally marketed devices. It does not involve "performance metrics" in the sense of diagnostic accuracy (sensitivity, specificity) or human reader improvement with AI.
Here's a breakdown of the relevant information from the document, acknowledging the difference in context:
1. Table of Acceptance Criteria (for Substantial Equivalence) and Reported Device Performance
For this type of device, "acceptance criteria" are primarily established by the requirements for demonstrating substantial equivalence to a legally marketed predicate device. The "performance" is judged by meeting these equivalence criteria and by ensuring the device functions as intended and is safe.
| Acceptance Criterion (for Substantial Equivalence to Predicate) | Reported Device Performance (as presented in the submission) |
|---|---|
| Intended Use (Apex Hip System for primary & revision THA, uncemented fixation, single use implantation, specific articulating components and conditions) | Meets Predicate: "Same indicated use: (see indications statement)" |
- ApeX-LNK Poly™ Acetabular Cup Liners: Used with Apex Modular Acetabular Cup, with Apex Modular, Apex K2 Hip, articulating with metal (cobalt chromium) or ceramic (alumina) femoral head for conditions like degenerative joint disease, rheumatoid arthritis, functional deformity, congenital dislocation, revision procedures, and fractures.
- Apex Modular Heads: Used in total hip replacement, compatible with various acetabular cups. |
| Operating Principle ("ball-in-socket" cobalt chromium-UHMWPE articular bearing components) | Meets Predicate: "Same operating principle: 'ball-in-socket' cobalt chromium-UHMWPE articular bearing components" |
| Materials (UHMWPE for liners, wrought cobalt chromium for heads as per specific ASTM standards) | Meets Predicate: "Same materials as predicates: the ApeX-LNK Acetabular Cup Liners are manufactured from ultra high molecular weight polyethylene (UHMWPE, ASTM F648) with identical specifications and processing parameters as the predicate ApeX-LNK Acetabular liners; the Apex Modular Heads are manufactured from the same material as the predicate Apex Modular Heads (wrought cobalt chromium per ASTM F1537)" |
| Basic Design (UHMWPE liners, cobalt chromium heads, identical modular interface dimensions, surface finish, taper dimensions, locking features) | Meets Predicate: "Same basic design: UHMWPE liners, cobalt chromium heads; identical modular interface dimensions and specifications as the predicates, including surface finish, taper dimensions, and locking features" - Liner Engagement: 19° taper and PE locking ring (same as ApeX-LNK predicate K073150).
- Liner Options: Neutral and 10° hooded (same as ApeX-LNK predicate K073150).
- Taper Design (Heads): Identical (size "N" bore in ASTM F1636-95) (same as Apex Modular Femoral Heads predicate K000788).
- Offsets (Heads): -3.5, +0, +3.5, +7 (same as Apex Modular Femoral Heads predicate K000788). |
| Shelf Life (5 years from date of manufacture) | Meets Predicate: "Same shelf life: 5 years from date of manufacture." |
| Packaging & Sterilization (ETO, SAL 10^-6^) | Meets Predicate: "Packaged and sterilized using the same materials and processes: ETO, SAL 10^-6^*." - Packaging: Paper board box, Foil outer pouch, Double Tyvek inner pouch (same as ApeX-LNK predicate K073150 and Apex Modular Femoral Heads predicate K000788). |
| Functional Equivalence (demonstrated via performance testing, design comparisons, functional analysis) | Meets Predicate: "Performance testing, design comparisons, and functional analysis conducted on these devices demonstrate that they are equivalent to the predicate devices." (Specific details of any new performance testing are not provided in this summary, but would typically involve mechanical tests for wear, fatigue, static strength, etc., to support the safety and effectiveness of the new sizes, not a clinical study comparing outcomes to a "ground truth" established by experts). The modifications are limited to the addition of a 40mm size head and a 40mm ID liner. |
Regarding the other requested points:
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2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- N/A. This is a medical device 510(k) submission, not a study evaluating an AI/ML diagnostic algorithm. "Test sets" in the context of this document refer to mechanical testing of physical device components, not data for an AI model.
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3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- N/A. Ground truth from experts is not applicable here. Mechanical tests typically compare physical measurements or observed failures against engineering specifications, often established by material science experts or engineers.
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4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- N/A. Not applicable for a device 510(k) submission.
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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:
- N/A. This is not an AI/ML device.
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6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- N/A. This is a physical medical device (hip implants), not an algorithm.
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7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- N/A in the context of AI. For this device, the "ground truth" for demonstrating safety and effectiveness relies on established engineering principles, material science data from ASTM standards, and performance characteristics (e.g., strength, wear resistance) that are comparable to previously approved, equivalent predicate devices.
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8. The sample size for the training set:
- N/A. This is not an AI/ML device.
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9. How the ground truth for the training set was established:
- N/A. This is not an AI/ML device.
In summary: The provided document is a regulatory submission for a physical medical device. It demonstrates substantial equivalence to predicate devices based on design, materials, intended use, manufacturing processes, and fundamental operating principles. The concepts of "acceptance criteria" and "studies" as typically applied to AI/ML software performance (e.g., diagnostic accuracy, reader studies) are not relevant to this document. The "study" here is the entire 510(k) submission process, which involves demonstrating that the new device is as safe and effective as a legally marketed one, often supported by detailed engineering and mechanical testing data (which is not fully detailed in this summary document).
§ 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.