(29 days)
The hip prosthesis MiniMAX is designed for cementless use in total or partial hip arthroplasty in primary or revision surgery. Hip Replacement is indicated in the following cases:
• Severely painful and/or disabled joint as a result of arthritis, traumatoid polyarthritis, or congenital hip dysplasia.
· Avascular necrosis of the femoral head.
· Acute traumatic fracture of the femoral head or neck.
· Failure of previous hip surgery: joint reconstruction, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
MiniMax anatomical stems are coated cementless stems intended to be used in total or partial hip arthroplasty in primary or revision surgery.
The anatomical design of the MiniMax stems results in a 9° anteversion of the neck which is mirror polished with 12/14 Eurocone taper and a 127° neck-shaft angle. The macrostructures are negative medially and positive laterally which increases the contact area. The lateral flare is rounded and non-invasive. The MiniMAX stems' distal tip has a 5° curvature to follow the contours of the femoral canal to aid in the insertion and avoiding distal interference.
MiniMAX stems can be combined with the CoCr ball heads (K072857, K080885 and K103721), Endo Head (K111145) or with the MectaCer BIOLOX® Forte (K073337), MectaCer BIOLOX® Delta Femoral Heads (K112115) or MectaCer BIOLOX® Option Heads (K131518).
MiniMAX stems are made of Titanium Aluminum Niobium Alloy (Ti-6Al-7Nb). The surface treatment consists of titanium plasma spray coating, Ra 300um, in the proximal 2/3 of the shaft to improve proximal fixation and HA (Hydroxyapatite) coating, Ra 80um, along the entire length of the shaft.
This submission seeks add Size 9 left and right anatomical stems to the currently marketed MiniMAX product line.
The provided text describes a 510(k) premarket notification for a medical device (MiniMAX hip prosthesis) and does not contain information about the acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML powered device. The document is a traditional medical device submission focused on substantial equivalence to a predicate device, primarily through mechanical testing and material characterization.
Therefore, most of the requested information regarding acceptance criteria, device performance tables, sample sizes, ground truth establishment, expert qualifications, adjudication methods, and MRMC/standalone studies for an AI/ML device is not present in the provided text.
However, I can extract the information that is present regarding the device's performance data and how it was evaluated.
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of acceptance criteria with numerical targets and reported performance for an AI/ML device. Instead, it lists the types of performance tests conducted for a mechanical hip prosthesis and states that the "subject devices do not represent a new worst case when compared to the previously cleared devices."
| Test Type | Standard/Reference | Reported Outcome |
|---|---|---|
| Range of Motion (ROM) | EN ISO 21535:2009 (Joint Replacement Implants - Specific Requirements for Hip-Joint Replacement Implants) | "subject devices do not represent a new worst case when compared to the previously cleared devices (K170845)." |
| Fatigue Testing (Stem) | ISO 7206-4 Third Edition 2010-06-15 (Implants for Surgery Partial and Total Hip Joint Prostheses - Part 4: Determination of Endurance Properties and Performance of Stemmed Femoral Components) | "subject devices do not represent a new worst case when compared to the previously cleared devices (K170845)." |
| Fatigue Testing (Head and Neck Region) | ISO 7206-6 Second Edition 2013-11-15 (Implants for Surgery Partial and Total Hip Joint Prostheses - Part 6: Determination of Endurance Properties of Head and Neck Region of Stemmed Femoral Components) | "subject devices do not represent a new worst case when compared to the previously cleared devices (K170845)." |
| Static Fatigue Testing (Modular Femoral Heads) | ISO 7206-10:2003 (Implants for Surgery -- Partial and Total Hip-Joint Prostheses -- Part 10: Determination of Resistance To Static Load of Modular Femoral Heads) | "subject devices do not represent a new worst case when compared to the previously cleared devices (K170845)." |
| Pull Off Force Testing (Taper Connections) | ASTM F2009-00 (Reapproved 2011) (Standard Test Method O for Determining the Axial Disassembly Force of Taper Connections of Modular Prostheses) | "subject devices do not represent a new worst case when compared to the previously cleared devices (K170845)." |
| Coating Characterization Testing | Not explicitly stated, implied to be standard material characterization. | "subject devices do not represent a new worst case when compared to the previously cleared devices (K170845)." |
| Pyrogenicity | USP and USP | "subject devices do not represent a new worst case when compared to the previously cleared devices (K170845)." |
| Additional Evaluation (Stem and Neck Fatigue) | ISO 21535 (via Finite Element Analysis) | The analysis concluded that the "additional size (longer stem length and larger neck offset) does not introduce a new worst case with respect to biomechanical or clinical performance." |
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 mentions "worst-case device" testing for the predicate device, K170845. This typically implies a very small sample size, potentially N=1 or N=3, for each test as per engineering standards for mechanical devices. It's not a 'test set' in the sense of an AI/ML validation. There's no information on data provenance (country of origin, retrospective/prospective).
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. This is a mechanical device submission, not an AI/ML study requiring expert ground truth for interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.
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 mechanical device, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For mechanical testing, the "ground truth" is defined by the passing criteria of the specified international standards (e.g., ISO, ASTM). For example, fatigue tests would have an endurance limit or cycles to failure requirement specified in the standard.
8. The sample size for the training set
Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established
Not applicable.
§ 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.