(64 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 (Cobait 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 hemiathroplasty 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 with a distal slot, and modular necks that connect to the tapered hole in the stem. The larger size stems have a lateral feature referred to as a lateral t-flange. The T-flange is reduced in size on the smaller stem sizes (size 1 and 2), and further reduced to no t-flange on the smallest (subject) size 0 stem. The femoral stems are manufactured from titanium alloy and the modular necks are manufactured from cobalt chromium alloy. The Apex ARC Hip Stem is available with and without HA coating.
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.
Here's an analysis of the provided text regarding the Apex ARC™ Hip Stem, focusing on acceptance criteria and the study proving conformance.
Important Note: The provided document is a 510(k) Pre-market Notification for a medical device. This type of submission primarily focuses on demonstrating substantial equivalence to a previously legally marketed device (predicate device), rather than proving efficacy or meeting specific acceptance criteria through extensive clinical studies as one might find for a novel drug or a high-risk device requiring a PMA.
Description of Acceptance Criteria and the Study Proving the Device Meets Acceptance Criteria
The document states that the Apex ARC™ Hip Stem (specifically the new Size 0) is substantially equivalent to its predicate devices (Apex ARC Hip Stem K090845 and K111193). The primary method used to demonstrate this substantial equivalence, and thus "meet acceptance criteria," is through non-clinical testing and comparison of design features, materials, and intended use.
1. Table of Acceptance Criteria and Reported Device Performance
Given that this is a 510(k) for substantial equivalence based on a new size of an existing device, the "acceptance criteria" are not explicitly defined as pass/fail thresholds for clinical outcomes, but rather demonstrate that the new size performs comparably to the predicate device in relevant biomechanical tests.
| Acceptance Criteria (Implied by Substantial Equivalence to Predicate) | Reported Device Performance |
|---|---|
| Fatigue Strength: Must meet or exceed established standards for hip femoral components. | Testing performed per ISO 7206-6, ISO-7206-4, ISO 7206-8, and ASTM 2068-09. (Specific numerical results not provided in this summary, but the conclusion is that the device is substantially equivalent, implying it met these standards.) |
| Range of Motion (ROM): Must exhibit acceptable ROM. | Evaluation performed per ISO 21535. (Specific numerical results not provided, but the conclusion implies acceptable performance.) |
| Biocompatibility: (Implicit for titanium alloy and HA coating) | Manufactured using equivalent materials to predicate(s). (Implies biocompatibility is assumed to be met based on predicate). |
| Material Properties: (Implicit) | Manufactured using equivalent materials to predicate(s). |
| Design Features, Intended Use, Indications for Use: (Implicit) | Compared to predicate device(s) and found to be substantially equivalent. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated as this is a non-clinical mechanical and material testing summary. For such tests, the sample size typically refers to the number of individual test articles (e.g., hip stems) subjected to each specific test. This information is usually detailed in the full test reports, which are not provided here.
- Data Provenance: The testing was "conducted," implying laboratory testing. The country of origin for the data is implied to be within the scope of the submitter, OMNIlife science, Inc., based in East Taunton, MA, USA, and adherence to international standards (ISO, ASTM). The data is prospective in the sense that the new size 0 was manufactured and then tested.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not Applicable. For non-clinical, biomechanical testing of a medical device, "ground truth" is established by relevant engineering standards (ISO, ASTM) and the objective measurements obtained from properly calibrated testing equipment. There is no expert consensus involved in establishing the "ground truth" for the mechanical properties of a hip stem.
4. Adjudication Method for the Test Set
- Not Applicable. Adjudication methods (like 2+1 or 3+1) are typically used in clinical studies or image-based diagnostic studies where human interpretation of data is involved. Here, the "study" is a series of non-clinical tests with objective, quantitative outcomes.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No. The document explicitly states: "No clinical studies were performed." Therefore, no MRMC comparative effectiveness study was conducted.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done
- Not Applicable. This device is a physical hip stem, not a software algorithm or AI-driven diagnostic tool. Therefore, the concept of "standalone algorithm performance" does not apply.
7. The Type of Ground Truth Used
- For the non-clinical tests (Fatigue Strength, ROM Evaluation), the "ground truth" is defined by established engineering standards and specifications (ISO 7206 series, ASTM 2068-09, ISO 21535) for hip implant performance. The device's measured performance against these standards constitutes the "ground truth" for its mechanical properties. There is no pathology, outcomes data, or expert consensus used for the "ground truth" in this context.
8. The Sample Size for the Training Set
- Not Applicable. This report does not involve machine learning or AI, 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, there is no ground truth establishment for it.
Summary of the Study Proving Device Acceptance Criteria:
The "study" proving the Apex ARC™ Hip Stem (Size 0) meets its "acceptance criteria" (which in this 510(k) context means demonstrating substantial equivalence) is a non-clinical testing program.
This program involved:
- Fatigue Strength Testing: Performed according to international standards ISO 7206-6, ISO-7206-4, ISO 7206-8, and ASTM 2068-09. This testing assesses the material's ability to withstand repeated stress without failure, simulating the forces experienced during daily activity.
- Range of Motion (ROM) Evaluation: Performed according to ISO 21535. This evaluates the articulation capabilities of the hip stem in conjunction with other components to ensure proper biomechanical function and prevent impingement.
The conclusion drawn from these studies is that the "addition of one new stem size for the Apex ARC Hip Stem, in our opinion, is substantially equivalent to the predicate device." This implicitly means that the new size 0 performed comparably to the predicate devices and met the relevant performance standards for hip stems. No clinical studies were performed to support this submission.
§ 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.