(376 days)
The Apex ARC Hip Stem is intended for use as the femoral component of a primary or revision total hip replacement. This femoral hip stem is intended for uncemented fixation and single use implantation. This prosthesis may be used for 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 ARC Hip Stem consists of a curved, rectangular tapered stem, and modular necks that connect to the tapered hole in the stem. The femoral stems are manufactured from titanium alloy and the modular necks are manufactured from cobalt chromium alloy. Three neck sizes are offered, with a neutral, 8 degree, and 12 degree varus-valgus angle, respectively. The necks are compatible with the modular heads that are part of the Apex Modular and Apex K2 hip systems (K000788, K012918, and K073150) and may be used with head diameters and offsets up to a maximum offset of +7 mm. These configurations allow the user to choose a combination of stem, neck, and head components to appropriately fit the anatomy of the patient. The Apex ARC Hip Stem may be used in conjunction with the Apex Modular™ Acetabular Cup (K031110, K062489, and K073150) for total hip arthroplasty.
The provided document describes the 510(k) Summary for the Apex ARC™ Hip Stem (K090845). This is a medical device submission to the FDA, and as such, it focuses on demonstrating "substantial equivalence" to predicate devices rather than proving performance against specific acceptance criteria through a traditional clinical study with defined endpoints as would be expected for a novel AI/software device.
Therefore, the requested information elements (acceptance criteria, study details, sample sizes, expert ground truth, MRMC, standalone performance) are not directly applicable in the context of this device's submission type and the information provided. Traditional clinical trials with acceptance criteria and statistical analysis are typically not required for Class II devices demonstrating substantial equivalence through non-clinical testing.
However, I can extract the relevant information regarding the non-clinical tests conducted which serve a similar purpose to demonstrating the device's functional integrity and safety, and compare them to the general characteristics of the predicate devices.
Here's a breakdown based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
As this is a 510(k) submission for a mechanical implant, "acceptance criteria" are not explicitly defined in terms the performance metrics commonly associated with AI/software (e.g., sensitivity, specificity, AUC). Instead, the device's "performance" is demonstrated through non-clinical mechanical and material testing based on recognized international and ASTM standards. The acceptance criterion for these tests is generally successful completion of the test without failure, meeting the requirements of the specified standard, and demonstrating equivalence to predicate devices.
| Acceptance Criterion (Implicit: Compliance with Standard and Predicate) | Reported Device Performance |
|---|---|
| Mechanical Strength & Durability: | |
| Distal fatigue strength per ISO 7206-4:1989, ISO 7206-8:1992, and ASTM 2068-09. | Tests conducted and results deemed successful. |
| Fretting potential per ISO 17853:2003. | Tests conducted and results deemed successful. |
| Disassembly strength after fatigue testing per ASTM F2009-00. | Tests conducted and results deemed successful. |
| Proximal fatigue strength per ISO 7206-6:1992 and ASTM 2068-09. | Tests conducted and results deemed successful. |
| Torsional strength of the modular neck. | Tests conducted and results deemed successful. |
| Burst test, fatigue test, post-fatigue burst test, pull-off, and rotational stability of the worst case modular neck-ceramic head combination per FDA Guidance for the Preparation of Premarket Notifications for Ceramic Ball Hip Systems, and ISO 7206-10:2003. | Tests conducted and results deemed successful. |
| Functional Compatibility: | |
| Range of motion per ISO 21535:2007. | Tests conducted and results deemed successful. |
| Biocompatibility/Sterilization: | |
| ETO Residuals per ANSI/AAMI/ISO 10993-7. | Tests conducted and results deemed successful. |
| Hydroxyapatite coating clearance. | Previously cleared in K043123. |
| Design and Material Equivalence to Predicates: | |
| Demonstrated through detailed comparison table with Apex K2™ Hip System and Aesculap Metha® Hip System. | Features and materials largely align; differences (e.g., modular neck material and junction) addressed through specific additional testing where needed (e.g., torsional strength, burst/fatigue tests for neck combination). |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified in terms of number of physical devices tested for each non-clinical test. For mechanical tests, representative samples are typically used to meet the requirements of the standards. For material properties, it refers to the composition. The document doesn't detail the number of physical units tested.
- Data Provenance: The tests are non-clinical, meaning they were performed in a laboratory setting, not on human subjects. No country of origin is specified for the testing, but the submitter (OMNI life science, Inc.) is based in E. Taunton, MA, USA. This is a prospective assessment for market clearance, meaning the tests were conducted specifically for this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable to this 510(k) summary. For mechanical devices, "ground truth" typically relates to objective physical measurements or material properties as defined by engineering standards, not expert consensus as in diagnostic imaging. The "experts" involved would be the engineers and technicians conducting and validating the tests, adhering to the specified ISO and ASTM standards. Their qualifications are inherent in the rigorous nature of these testing facilities.
4. Adjudication method for the test set
Not applicable. Adjudication methods like 2+1 or 3+1 are used for expert consensus on clinical findings, not for objective mechanical test results. The results of the non-clinical tests are binary (pass/fail compliance with the standard).
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 total hip replacement device, not an AI/software diagnostic tool, and therefore no MRMC study was performed.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used
The "ground truth" for this device's evaluation is primarily based on engineering standards (ISO, ASTM) for mechanical performance and material properties. This includes objective measurements of fatigue strength, fretting potential, disassembly strength, torsional strength, range of motion, and material composition. Biocompatibility (ETO residuals) is also assessed against established standards.
8. The sample size for the training set
Not applicable. This is a physical device, not a machine learning model, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of device.
In summary: The Apex ARC™ Hip Stem, a Class II medical device, demonstrates its safety and effectiveness for market clearance by showing substantial equivalence to existing predicate devices (Apex K2™ Hip System and Aesculap Metha® Hip System) through a detailed comparison of design, materials, and intended use, and by successfully completing a series of non-clinical mechanical and material tests according to recognized international standards (ISO, ASTM) and FDA guidance documents. No clinical studies or AI-related evaluations were performed for this submission.
§ 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.