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The My3D® Personalized Pelvic Reconstruction system is indicated for use in patients requiring reconstruction of the pelvis and/or hip joint due to disease, deformity, trauma, or revision procedures where other treatments or revisions have failed. The device is a combination of single use guided osteotomy instruments, a pelvic implant, screws, and acetabular/ femoral components. The pelvic implant is intended for cementless application in individuals where bone quality or bony defect size cannot support a standard sized acetabular implant is intended to be fixed to the remaining pelvic anatomy using compatible bone screws to create a prosthetic acetabulum. The reconstructed prosthetic acetabulum is intended to be used with a compatible cemented acetabular cup, dual mobility head (POLARCUP Insert), and femoral components to restore hip function.

The My3D® Personalized Pelvic Reconstruction system is a patient specific combination of single use resection instruments, a pelvic implant, screws, acetabular, and femoral components. The system was developed to address conditions which require reconstruction of the acetabulum and hip joint.

This patient matched device is designed from inputs including imaging, diagnosis, and surgical approach. Together with the surgeon, these inputs are then translated via a design process to create patient specific implants and, if appropriate, instruments to reconstruct the patient's pelvis. If utilized, the patient specific instruments are used to resect the bone and allow for implantation of the patient matched pelvis. The joint is then reconstructed with a cemented acetabular cup, dual mobility head (POLARCUP Insert), and femoral components.

The implants and resection instruments are single use devices. Reusable instrumentation is provided non-sterile in surgical trays which are to be re-processed per validated instructions.

I am sorry, but the provided text content does not contain enough information to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, as per your request. The document is an FDA 510(k) clearance letter and summary for the My3D® Personalized Pelvic Reconstruction device, which primarily addresses substantial equivalence to a predicate device.

Specifically, the document mentions "Performance Data" and lists several types of testing performed (biocompatibility, manufacturing residuals, sterilization validation, mechanical testing of porous structure, fatigue testing, screw performance, cadaveric evaluation of design process). However, it does not provide:

1. A table of acceptance criteria and reported device performance. It only lists the types of tests.
2. Sample size used for the test set and data provenance.
3. Number of experts used to establish ground truth and their qualifications.
4. Adjudication method.
5. Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done or its effect size.
6. Whether a standalone performance study was done.
7. The type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

The document explicitly states: "Clinical data were not deemed necessary for the subject device." This further indicates that no human-centric validation studies (like MRMC or studies requiring expert ground truth and adjudication) were conducted or included in this submission summary. The testing mentioned appears to be primarily engineering and material performance tests.

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The REDAPT Sleeved Monolithic Revision Stems are indicated for:

· Hip components are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or noninflammatory degenerative joint disease (NID) ) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant.

· Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis, atthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; treatments of nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; endoprosthesis, femoral osteotomy, or Girdlestone resection; fracture-dislocation of the hip; and correction of deformity.

The REDAPT™ Revision Hip System (formerly MDF) is intended to be used without cement.

Subject of this Abbreviated premarket notification is the addition of a new stem design to the Smith & Nephew REDAPT Revision Femoral System which are Femoral Components part of Smith & Nephew's Total Hip System. The REDAPT Revision Femoral System currently consists of the Modular Proximally Fluted Hip Stems cleared by K113789, the Modular Sleeved Revision Hip Stems cleared by K121627, and the Monolithic Sleeveless Hip Stems cleared on K151902. The proposed devices are the REDAPT Sleeved Monolithic Revision Stems, new hip stems that will be marketed as part of the REDAPT Revision Femoral System.

The provided text is a 510(k) premarket notification for a medical device (REDAPT Sleeved Monolithic Revision Stems). It describes the device, its intended use, and its technological characteristics. However, it does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of an AI-powered diagnostic device, which your request implies.

The document focuses on the mechanical and material performance of a hip implant device, comparing it to predicate devices to establish substantial equivalence. It explicitly states: "Clinical data was not needed to support the safety and effectiveness of the subject devices." This means there was no multi-reader multi-case (MRMC) study, no standalone algorithm performance, and no ground truth established by expert consensus or pathology data in the way you're asking for an AI/diagnostic device.

Therefore, I cannot fulfill your request as it pertains to acceptance criteria and performance studies for an AI/diagnostic device based solely on the provided text. The information you're asking for (e.g., sample size for test set, number of experts for ground truth, MRMC study, effect size of AI assistance) is characteristic of AI/CAD (Computer-Aided Detection/Diagnosis) device submissions, not mechanical implants like the one described.

If you have a document related to an AI/diagnostic device, please provide that, and I would be happy to analyze it according to your requested criteria.

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