(28 days)
The indications for the use of the Osteonics® Primary Secur-Fit™ Plus Hip Stems , in keeping with those of other legally marketed Osteonics femoral components, are as follows:
For Use as a Bipolar Hip Replacement:
- Femoral head/neck fractures or non-unions.
- Aseptic necrosis of the femoral head.
- Osteo-, rheumatoid, and post-traumatic arthritis of the hip with minimal acetabular involvement or distortion.
Other Considerations:
- Pathological conditions or age considerations which indicate a more conservative acetabular procedure and an avoidance of the use of bone cement in the acetabulum.
- Salvage of failed total hip arthroplasty.
For Use as a Total Hip Replacement:
- Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis.
- Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure.
- Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.
The Osteonics® Primary Secur-Fit™ Plus Hip Stems are currently marketed devices that are being modified. The modification involves the addition of two smaller sizes, 5 and 6, and elimination of the distal tri-slot on stems with a 9mm or 10mm distal diameter. All other aspects of the Osteonics® Primary Secur-Fit™ Plus Hip Stems will remain unchanged.
The provided document is a 510(k) summary for a medical device modification, specifically for the Osteonics® Primary Secur-Fit™ Plus Hip Stems. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than establishing new safety and effectiveness claims. As such, the concept of "acceptance criteria" and a "study proving the device meets acceptance criteria" as it would apply to a novel AI/software medical device is not directly applicable here.
However, I can interpret the request in the context of this 510(k) submission, focusing on how the manufacturer demonstrated equivalence and what evidence was presented.
Here's an analysis based on the provided text, addressing the points you raised, with explanations for why some are not applicable to this type of submission:
Acceptance Criteria and Study for Osteonics® Primary Secur-Fit™ Plus Hip Stems (Modified)
The core "acceptance criteria" for this 510(k) submission are that the modified device remains substantially equivalent in terms of safety and effectiveness to the predicate device, despite the modifications. The study performed aims to demonstrate this equivalence, particularly regarding mechanical performance.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (for Substantial Equivalence to Predicate) | Reported Device Performance against Criteria |
|---|---|
| Mechanical Equivalence: The modified device (with smaller sizes and without distal tri-slot on certain diameters) must maintain equivalent fatigue strength compared to the predicate device. | "Mechanical testing has been performed to demonstrate the substantial equivalence of this Osteonics stem design to predicate stem designs in terms of its fatigue strength." |
| Material Equivalence: Must be manufactured from the same material type as the predicate. | "The Osteonics® Primary Secur-Fit™ Plus Hip Stems are manufactured from titanium alloy (ASTM F-620-96)," which implicitly matches the predicate (as the modification is not about material change). |
| Intended Use Equivalence: The modified device must share the same intended use as the predicate device. | The stated "Intended Use" for the modified device is identical to the predicate device. |
| Technological Characteristics Equivalence (beyond modification): All other aspects of the device not subject to this specific modification must remain unchanged. | "All other aspects of the Osteonics® Primary Secur-Fit™ Plus Hip Stems will remain unchanged." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated in the document. For mechanical testing of implantable devices like hip stems, "sample size" typically refers to the number of individual stems tested for each configuration (e.g., each size, with/without tri-slot). This exact number is not provided.
- Data Provenance: The document does not specify the country of origin for the mechanical testing data. It's implicitly (and standardly) generated by the manufacturer (Osteonics Corporation, based in Allendale, NJ, USA). The testing would be prospective in nature, as it involves newly manufactured devices being subjected to controlled mechanical loads.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This concept is not applicable to this 510(k) submission. "Ground truth" and "expert evaluation" are typically relevant for diagnostic or AI-driven devices where human experts establish the true condition (e.g., presence of disease in an image). For mechanical testing of a hip stem, the "ground truth" is established by the physical testing itself, measuring properties like fatigue strength against established engineering standards (e.g., ASTM standards).
4. Adjudication Method for the Test Set
This is not applicable for the same reasons as #3. Adjudication methods (like 2+1 or 3+1) are used to resolve disagreements among human experts when establishing ground truth. Mechanical testing involves repeatable measurements against objective standards, not subjective expert interpretation.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done
- No, an MRMC study was NOT done. This type of study assesses how human performance (e.g., diagnostic accuracy) changes with or without AI assistance. This submission is for a mechanical orthopedic implant, not a diagnostic or AI-powered device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was Done
- Not applicable in the context of typical AI/algorithm standalone studies. This device is a passive mechanical implant. The "standalone" performance here refers to the device's inherent mechanical properties (fatigue strength) as measured in a lab setting, without human interaction beyond the setup and execution of the tests. This is what the "Mechanical testing has been performed" statement refers to.
7. The Type of Ground Truth Used
- Engineering/Mechanical Standards and Benchmarking against Predicate: The "ground truth" for this submission would be adherence to relevant ASTM (American Society for Testing and Materials) standards for orthopedic implants (e.g., for fatigue testing of metallic hip prostheses) and, crucially, demonstrating that the modified design performs equivalently to the previously cleared predicate device in those mechanical tests. It's based on quantitative physical measurements against established criteria.
8. The Sample Size for the Training Set
- Not applicable. This submission is for a physical medical device (hip stem), not for an AI model that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As there is no AI model or training set, this question is not relevant.
Summary in the Context of a 510(k):
The manufacturer demonstrated substantial equivalence by:
- Clearly defining the modifications (smaller sizes, removal of distal tri-slot).
- Stating that all other aspects remained unchanged (material, overall design principles).
- Asserting that mechanical testing was performed to prove equivalent fatigue strength between the modified design(s) and the predicate device.
- Confirming the intended use remains the same.
The FDA reviewed this information and concurred that the device is substantially equivalent, but placed specific labeling limitations related to "biological attachment" or "enhanced fixation" claims, indicating that equivalence was shown only for a "conventional press-fit hip prosthesis (i.e., mechanical interlock, only)."
§ 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.