(231 days)
The H-Max S stems are indicated for use in total and partial hip arthroplasty and are intended for press-fit (uncemented) use. The H-Max S Stem are intended for use with CoCrMo femoral heads or Biolox Delta femoral heads and Limacorporate cemented acetabular cups or cementless Delta TT acetabular cups. In partial Hip arthroplasty H-Max S stem is intended for use with Limacorporate Lock Bipolar heads.
Hip arthroplasty is intended for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:
· non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis and hip dysplasia;
· rheumatoid arthritis;
· treatment of femoral head and neck fractures;
· revisions in cases of good remaining femoral bone stock.
The H-MAX S femoral system consists of the H-MAX S femoral stem, a femoral head and an acetabular cup. In total hip arthroplasty, the H-MAX S stems are intended for use with modular CoCrMo femoral heads or Bioloz Delta ceramic femoral heads and a compatibile Limacorporate Cemented Cup or uncemented Delta TT acetabular cup. When used in partial hip arthroplasty, H-MAX S stems are intended for use with Limacorporate Lock Bipolar Heads.
The H-MAX S femoral stem is a monolithic cementless stem made from Ti6Al4V (ISO 5832-3, ASTM F1472). The external surface has a macro-roughened surface. A layer of hydroxyapatite is applied along the length of the stem. The H-MAX S stem is manufactured in 11 sizes for each of two configurations (conventional and lateralizing) that vary in the CCD angle.
This document is a 510(k) premarket notification for the H-MAX S Stem, a hip joint prosthesis. It addresses a modification to an already cleared device, primarily regarding a new supplier for the hydroxyapatite (HA) coating and an expanded indication for use in partial hip arthroplasty.
Here's the information requested, based on the provided text:
1. A table of acceptance criteria and the reported device performance:
The document mentions validation of the HA coating and analysis of the range of motion for partial hip arthroplasty. However, specific numerical acceptance criteria (e.g., "HA coating thickness > X microns" or "Range of motion > Y degrees") and their corresponding reported device performance values are not explicitly provided in the text. The document broadly states that "The testing results demonstrated the system's ability to perform substantially equivalent to the predicate devices considered."
We can infer the categories of acceptance criteria from the "Non-Clinical Testing" section:
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| HA Coating Validation (in accordance with FDA Guidance "510(k) Information needed for hydroxyapatite coated orthopedic implants") | Demonstrated the system's ability to perform substantially equivalent to predicate devices. |
| Range of Motion Analysis for H-MAX S Stem coupled with Lock Bipolar Heads (for partial hip arthroplasty) | Demonstrated the system's ability to perform substantially equivalent to predicate devices. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
The document states: "Non-Clinical Testing: The materials, design, femoral head sizes and acetabular components remain the same as described in previously cleared submissions. All non-clinical testing performed for the previous submissions of H-MAX S Stems remain applicable. The changes of this submission were evaluated through: Validation of the HA coating...; Analysis of the Range of Motion..."
This indicates the testing was non-clinical (laboratory-based), not on patient data. Therefore, questions of sample size for a "test set" in the context of patient data, country of origin, retrospective/prospective, number of experts, and adjudication methods are not applicable to this submission, as it focuses on device characteristics and performance in a non-clinical setting.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
Not applicable, as the testing was non-clinical and did not involve establishing ground truth from patient data with expert review.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable, as the testing was non-clinical.
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 submission for a hip implant, not an AI-powered diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a submission for a hip implant, not an AI-powered algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
For the non-clinical testing mentioned (HA coating validation and range of motion), the "ground truth" would be established by engineering and material science standards and specifications. For example:
- HA Coating Validation: Conformance to specified chemical composition, crystallinity, adhesion strength, thickness, and dissolution rates (as per FDA Guidance).
- Range of Motion Analysis: Conformance to biomechanical requirements for hip joint functionality, potentially drawing from established anatomical and clinical ranges.
8. The sample size for the training set:
Not applicable, as this is non-clinical device testing, not an AI development with a "training set" in the conventional machine learning sense for patient data. If interpreted as the number of devices or components tested, this specific detail is not provided in the document.
9. How the ground truth for the training set was established:
Not applicable, as this is non-clinical device testing.
§ 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.