(60 days)
The Apex ARC™ Hip Stem is intended for use as the femoral component of a primary, or revision total hip replacement when used with the Apex Interface™ Acetabular System. The Apex Interface™ Acetabular System articulates with the Apex Modular Femoral Head (Cobalt Chromium or Ceramic). The femoral hip stem is intended for uncemented fixation and single use implantation. These prostheses may be used for 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.
The Apex Hip System ARC™ Hip Stem is also intended for use in hemiarthroplasty when used with the Apex Bipolar Head.
The Apex Hip System Bipolar Head is intended for use in combination with an Apex Hip System femoral stem for uncemented primary or revision hemiarthroplasty of the hip. This prosthesis may be used for the following conditions, as appropriate:
- · Femoral neck and trochanteric fractures of the proximal femur;
- · Osteonecrosis of the femoral head;
- Revision procedures where other treatments or devices for these indications have failed.
The Apex ARC Hip Stem consists of a curved, rectangular tapered stem, and modular necks that connect to the tapered hole in the stem. The height of the anterior and posterior lateral protrusions (Lateral T-Flange) was reduced on Size 1 and 2 ARC Hip Stems. Three new neck sizes are offered, Long Neutral, Long 8 ° Varus/Valgus and Anteverted. The necks are compatible with the Cobalt Chromium and Ceramic modular heads, and may be used with head diameters and offsets up to a maximum offset of +7 mm. The Apex ARC Hip Stem may be used in conjunction with the Apex Interface™ Acetabular System (Shells and Inserts) for total hip arthroplasty.
The Apex Hip System ARC™ Hip Stem is a medical device and the provided text describes its acceptance criteria and the study conducted to prove it meets them.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Apex Hip System ARC™ Hip Stem are based on demonstrating substantial equivalence to a predicate device (Apex ARC Hip Stem - K090845). This equivalence is primarily shown through non-clinical performance testing.
| Acceptance Criteria Category | Specific Acceptance Criteria (Demonstrated Equivalence to Predicate) | Reported Device Performance |
|---|---|---|
| Intended Use | Primary and revision total hip replacement (same as predicate) | Met |
| Design | - T-Flange reduction (by half on Size 1 and 2 ARC Hip Stem) | Met (Design change described and tested for performance) |
| - Curved, rectangular tapered stem (same as predicate) | Met | |
| - New neck designs: Long neutral, long 8° varus/valgus, anteverted | Met (Compatibility and performance tested) | |
| Materials | - Apex ARC Hip Stem (Ti6Al4V per ASTM F136) (identical to predicate) | Met |
| - Plasma spray Titanium coating (Unalloyed titanium plasma spray per ASTM F1580) (identical to predicate) | Met | |
| - Hydroxyapatite Coating (Hydroxyapatite plasma spray coating per ASTM F1185) (identical to predicate) | Met | |
| - Apex ARC Modular Neck (CoCr alloy per ASTM F1537) (identical to predicate) | Met | |
| Packaging & Sterilization | - Sterilization (Ethylene oxide) (identical to predicate) | Met |
| - SAL (10^-6^) (identical to predicate) | Met | |
| - Packaging (Paper Board Box, Double Tyvek inner pouch) (identical to predicate) | Met | |
| Non-Clinical Performance | - Fatigue Strength Testing per ISO 7206-6, ISO-7206-4, ISO 7206-8 and ASTM 2068-09 (demonstrate equivalence/safety after design changes) | Met (Tests conducted) |
| - ROM evaluation per ISO 21535 (demonstrate equivalence/safety after design changes) | Met (Tests conducted) |
2. Sample size used for the test set and the data provenance
The document states, "Non-Clinical Test: The following tests were conducted." It then lists fatigue strength testing and ROM evaluation. However, the exact sample size (number of devices or components tested) for these non-clinical tests is not specified in the provided text.
The data provenance is from non-clinical laboratory testing performed on the device itself (or its components) according to specified ISO and ASTM standards. No human or animal data is involved; thus, there is no country of origin or retrospective/prospective distinction in the typical sense.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device is a mechanical implant, and the acceptance criteria for performance are based on engineering standards and physical testing, not subjective expert assessment of medical images or patient outcomes as would be the case for an AI device.
4. Adjudication method for the test set
Not applicable. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in AI studies where human experts disagree on interpretations. For mechanical performance testing of an implant, the results are objective measurements against defined standards, not subject to expert 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
Not applicable. This is a hardware medical device (hip stem), not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies and assessments of human reader improvement with AI assistance are irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical implant, not an algorithm, so "standalone performance" in the context of AI does not apply.
7. The type of ground truth used
The "ground truth" for this device's performance is established by objective measurements against recognized industry standards (ISO and ASTM) for mechanical properties (fatigue strength) and range of motion. The predicate device's performance under these same standards effectively sets the benchmark for "ground truth" for demonstrating substantial equivalence.
8. The sample size for the training set
Not applicable. This section usually refers to the data used to train an AI model. Since this is a physical medical device, there is no "training set" in this context. The manufacturing and design process follows established engineering principles and quality systems; it's not "trained" on data.
9. How the ground truth for the training set was established
Not applicable. As there is no training set for a physical device, this question is not relevant.
§ 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.