(134 days)
The hip prosthesis is designed for cementless use in total hip arthroplasty in primary or revision surgery. The patient should be skeletally mature. The patient's condition should be due to one or more of: Severely painful and/or disabled joint: as a result of osteoarthritis, posttraumatic arthritis, rheumatoid arthritis or psoriatic arthritis, congenital hip dysplasia, ankylosing spondylitis. Avascular necrosis of the femoral head. Acute traumatic fracture of the femoral head or neck. Failure of previous hip surgery: joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement where sufficient bone stock is present.
The Mpact DM Converter is a highly polished CoCrMo (ASTM F1537) liner with a tapered locking mechanism which assures the connection with the acetabular shell. The Mpact DM Converter can only be coupled with Medacta Double Mobility UHMWPE (ISO 5834-2 Type 1) liners (K083116) or HighCross® highly crosslinked UHMWPE liners (K092265) and can only be used with Mpact Primary (K103721) or Mpact Extension (K122641) acetabular shells. The Mpact DM Converter has a 5° shoulder which increases the jump distance and it also has a small tooth which can be used in case of revision to extract the liner. The six available sizes have a nomenclature that identifies the cup liner size (first letter) and the double mobility liner size (final three letters): D/DMB, E/DMC, F/DME, G/DMF, J/DMH and K/DML. This submission also includes one new size (22.2/DMB) of the Medacta Double Mobility liner in both UHMWPE (ISO 5834-2 Type 1) and HighCross® highly crosslinked UHMWPE. These liners are identical to the liners in the K083116 and K092265 submissions but have a smaller external diameter than the predicates. These new liners can only be coupled with a 22.2mm ball head and have a minimum thickness of 5 mm.
The provided text is a 510(k) summary for the Medacta Mpact DM Converter, a medical device. This type of document focuses on establishing substantial equivalence to previously cleared devices rather than presenting a detailed clinical study with acceptance criteria in the manner one might find for a novel diagnostic algorithm.
Therefore, the requested information, particularly regarding acceptance criteria, sample sizes for test/training sets, expert ground truth, adjudication methods, MRMC studies, standalone performance, and effect sizes, is not present in the provided text as this device is a physical hip prosthesis component, not an AI/software device that would undergo such testing.
The "Performance Testing" section describes mechanical testing conducted on the device. While this involves "pre-defined acceptance criteria," these are engineering specifications for the physical properties of the implant, not diagnostic performance metrics (like sensitivity, specificity, AUC) for an AI system.
Here's a breakdown of what can be extracted from the document relevant to performance and equivalence, organized to align with your request where possible, and noting where information is absent:
1. A table of acceptance criteria and the reported device performance
| Performance Test | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Range of Motion | To be substantially equivalent to predicate devices / meet established mechanical standards. | Tested on worst-case component size and option/design. Results considered adequate to demonstrate substantial equivalence. |
| Pull-off | To be substantially equivalent to predicate devices / meet established mechanical standards. | Tested on worst-case component size and option/design. Results considered adequate to demonstrate substantial equivalence. |
| Push-out | To be substantially equivalent to predicate devices / meet established mechanical standards. | Tested on worst-case component size and option/design. Results considered adequate to demonstrate substantial equivalence. |
| Torsion | To be substantially equivalent to predicate devices / meet established mechanical standards. | Tested on worst-case component size and option/design. Results considered adequate to demonstrate substantial equivalence. |
| Wear | To be substantially equivalent to predicate devices / meet established mechanical standards. | Tested on worst-case component size and option/design. Results considered adequate to demonstrate substantial equivalence. |
| Fretting Corrosion | To be substantially equivalent to predicate devices / meet established mechanical standards. | Tested on worst-case component size and option/design. Results considered adequate to demonstrate substantial equivalence. |
| Jump Distance | To be substantially equivalent to predicate devices / meet established mechanical standards. (Specifically, the 5° shoulder of the Mpact DM Converter increases jump distance, implying this is a design feature, not a performance metric to meet a specific lower bound in testing). | Tested on worst-case component size and option/design. Results considered adequate to demonstrate substantial equivalence. |
| Overall | Device is substantially equivalent to predicate devices in design features and materials. | The mechanical testing performed demonstrates that the Mpact DM Converter is substantially equivalent. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not applicable in the context of clinical/AI data. The testing involved "worst case component size and option/design" for mechanical tests, implying a limited number of physical samples representing critical configurations.
- Data Provenance: Not applicable. These are mechanical engineering tests, not data from human subjects.
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. Ground truth for mechanical tests refers to established engineering standards and measurements, not expert human 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 physical implant, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This is a physical implant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this device's performance testing is based on established engineering principles, material science standards (e.g., ASTM F1537, ISO 5834-2), and the performance characteristics of the predicate devices. The aim is to show that the new device performs within acceptable mechanical parameters and is comparable to existing, cleared devices.
8. The sample size for the training set
- Not applicable. This device is not an AI algorithm.
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.