(171 days)
The Margron™ Hip Replacement System is intended for primary or revision restruction, without bone cement, of the femoral portion of a severely disabled and/or very painful hip joint, where radiographic evidence of sufficient sound bone is present.
The patient should be skeletally mature. The patient's condition should be due to one or more of the following:
- Osteoarthritis
- Rheumatoid arthritis
- Ankylosing spondylitis
- Psoriatic arthritis
- Old osteomyelitis with a long infection free period and a normal WBC, C- Reactive protein and ESR
- Non union of femoral neck fracture or avascular necrosis of the femoral head
- Post-traumatic fracture/dislocation of the hip
- Revision of an unsuccessful arthrodesis with either poor positioning or pain in the hip, or where low back pain or knee pain is becoming disabling
- Revision of an unsuccessful uncemented or cemented hip replacement stem, providing sufficient bone stock is present
- Revision of a previous unsuccessful femoral osteotomy, Girdlestone resection, cup arthroplasty or hemi arthroplasty.
The Margron™ hip replacement stem has been designed to be used in an uncemented mode in bone which is of good quality physiologically and which will heal quickly.
The Margron™ Femoral Stem is a modular prosthesis consisting of:
- A tapering stem cone with two different speed external threads and longitudinal derotation columns.
- A neck component which allows the optimum angle of anteversion to be selected after stem insertion.
- Precision milling and tapping is used to prepare the femur, and stem insertion is by 'screw home' rotation.
- A unique set of instruments have been designed to insert and extract the prosthesis.
The provided document is a 510(k) summary for the Margron™ Hip Replacement System. This type of submission is for medical devices that are substantially equivalent to a legally marketed predicate device, rather than novel devices requiring extensive clinical trials to demonstrate safety and effectiveness.
Therefore, the document does not contain information about a study designed to prove the device meets specific acceptance criteria in the way a clinical trial for a new drug or a novel medical device would. Instead, it focuses on demonstrating substantial equivalence to existing, legally marketed devices.
Because of this, I cannot extract the following information about acceptance criteria and a study proving their fulfillment:
- A table of acceptance criteria and the reported device performance: This document doesn't define quantitative clinical "acceptance criteria" for the Margron system or report clinical performance against such criteria. The "Mechanical Characteristics" section mentions fatigue, torque, and corrosion tests were performed, and the results showed "substantial equivalence to the predicate devices," but no specific numerical criteria or performance data are provided.
- Sample size used for the test set and the data provenance: Not applicable, as there's no clinical "test set" in the context of a comparative effectiveness study mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method for the test set: Not applicable.
- 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 device is a hip replacement system, not an AI-assisted diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable for a clinical performance study. The "ground truth" for substantial equivalence is defined by comparison to predicate devices, which involves design, materials, and intended use, not clinical outcomes from a specific study outlined here.
- The sample size for the training set: Not applicable, as there's no 'training set' in the context of a clinical performance study for this type of device submission.
- How the ground truth for the training set was established: Not applicable.
What the document does provide regarding "acceptance criteria" and "proof":
The "acceptance criteria" for marketing approval of the Margron™ Hip Replacement System under a 510(k) pathway are based on demonstrating substantial equivalence to predicate devices already on the market.
Study/Evidence for Substantial Equivalence:
The document states:
- "The Margron Hip is similar in design, materials and intended use to" a list of predicate devices (Metagen Modular Femoral Hip System, Biomet Impact, Mallory-Head, S-ROM, Infinity, Modular Hip System).
- Mechanical Characteristics: "The Margron Hip System has been evaluated by use of the fatigue, torque and corrosion tests. It has been shown to be substantially equivalent to the predicate devices." (Page 3)
- Materials: The material composition (Chrome Cobalt, Calcium Phosphate Coating) is specified and stated to be "implant grade materials." (Page 3)
- Intended Use/Indications: The stated indications for use are similar to those typically found for hip replacement systems and are implied to be consistent with the predicate devices. (Page 2, Page 5)
In summary, for a 510(k) submission like this, the "study" is a comparison to predicate devices, and the "acceptance criteria" revolve around proving substantial equivalence in terms of design, materials, manufacturing processes, and performance (often assessed through non-clinical testing like mechanical tests). This is distinct from a clinical trial that evaluates specific performance metrics in human subjects against predefined clinical acceptance criteria.
§ 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.