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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 POLARSTEM Cemented Femoral Stem is indicated for advanced degeneration of the hip joint as a result of degenerative, post-traumatic or theumatoid arthritis; fracture or avascular necrosis of the femoral head; failure of previous hip surgery, such as joint reconstruction, arthrodesis, hemiarthoplasty, surface replacement arthoplasty, or total hip replacement.

The POLARSTEM Cemented Femoral Stem is intended for single use only and is to be implanted with bone cement.

The subject of this traditional 510(k) is the POLARSTEM Cemented Femoral Stems. The POLARSTEM Cemented are manufactured from stainless steel according to ISO 5832-9. These subject POLARSTEM hip stems include same design features as the POLARSTEM Standard and Lateral Femoral Stem cleared under K130728.

The POLARSTEM cemented is suitable for partial or total replacement of the hip joint to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in skeletally mature individuals.

The POLARSTEM is available for cemented use in 9 sizes of standard stems (125.5mm to 159.5mm), and 8 sizes of lateral stems (131.5mm to 159.5mm).

This document does not contain information about the acceptance criteria and study that proves a device meets given acceptance criteria. It is a 510(k) premarket notification for a medical device (POLARSTEM Cemented Femoral Stem) and primarily discusses its substantial equivalence to a legally marketed predicate device.

The content focuses on:

• Device Description and Indications for Use: What the device is, its material, sizes, and what it's used for (hip joint replacement).
• Substantial Equivalence: Comparing the subject device to a predicate device (POLARSTEM Standard and Lateral Femoral Stems - K130728) in terms of intended use, indications for use, design, material, and performance.
• Performance Testing (Non-Clinical): Listing various ISO and ASTM standards applied for mechanical, biocompatibility, and other physical tests (e.g., Finite Element Analysis, Neck Fatigue, Corrosion Analysis).
• Clinical Performance: A brief mention of "Clinical evidence of the subject POLARSTEM SS Cemented Femoral Stem from their outside United States (OUS) use has been provided to support the safety and effectiveness of the subject device."

It explicitly states: "To further support a determination of substantial equivalence, mechanical testing was conducted on the POLARSTEM Cemented femoral stem." and "A review of the mechanical data and the technical memo, indicates that the subject POLARSTEM SS Cemented femoral stem is substantially equivalent to predicate device listed in the table above."

Therefore, the document does not provide the specific details requested in your prompt regarding acceptance criteria, target performance, sample sizes for test sets, data provenance, number or qualifications of experts, adjudication methods, MRMC studies, standalone performance, or detailed ground truth establishment for either training or test sets. These types of detailed studies are more commonly found in PMA (Premarket Approval) applications or more extensive clinical trial reports, rather than a 510(k) summary focused on demonstrating substantial equivalence to a predicate.

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