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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 POLARSTEMTM femoral stems with Ti/HA are indicated for:

• · Advanced degeneration of the hip joint as a result of degenerative, post-traumatic or rheumatoid arthritis.
• · Fracture or avascular necrosis of the femoral head.
• · Failure of previous hip surgery: joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.

The POLARSTEMIM with Ti/HA is intended for single use only and is to be implanted without bone cement.

The Subject Device is a reusable tool intended to be used with the hip implant POLARSTEM™ Collared (Standard and Lateral) and POLARSTEM™ Valgus Femoral Stem with Ti/HA. The Subject Device is used to prepare the bony bed of the proximal femur to allow implantation of the implant POLARSTEM™ in the femoral bone. The Subject Device is designed to be clipped onto the trial rasp to guide the calcar reamer/planer when preparing the proximal femur for a collared POLARSTEM™ and to define the physical stop of the calcar reamer or planer.

The provided text describes a 510(k) premarket notification for a medical device called the POLARSTEM™ Calcar Reamer Guide. This document asserts substantial equivalence to a predicate device and includes a section on performance testing. However, it does not provide a specific table of acceptance criteria or detailed results of a study as typically outlined for AI/ML device performance.

Instead, the performance testing section broadly states:

"To further support a determination of substantial equivalence, functional testing was conducted on the Subject Device to evaluate its usability, safety, and effectiveness with regard to the associated implants, reference materials and combinable medical devices. Testing demonstrated that the Subject Device met or exceed the performance testing of the Predicate Device."

This statement indicates that the device's performance was evaluated against the predicate, but it doesn't quantify specific metrics or provide a direct comparison table.

Given the information provided, I cannot fully answer your request for acceptance criteria and a study that proves the device meets those criteria in the typical format for AI/ML device evaluations. The details you requested (sample size, provenance, expert qualifications, etc.) are not present in this regulatory document.

However, I can extract the available information regarding performance testing and present it in a modified format based on what is available:

1. A table of acceptance criteria and the reported device performance

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 specified. The document mentions "cadaver/Sawbone surgery" but does not quantify the number of cadavers or Sawbones used.
• Data Provenance: Not specified, beyond the mention of "cadaver/Sawbone surgery." It's typically considered prospective simulation.

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)

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified. The document implies surgical assessment during the cadaver/Sawbone testing.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

• Adjudication Method: Not specified.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not done. This device is a mechanical surgical guide, not an AI/ML diagnostic or assistive technology for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Standalone Performance: Not applicable. This is a mechanical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Type of Ground Truth: The ground truth appears to be based on successful surgical preparation and implantation, as assessed during cadaver/Sawbone surgery. This likely involves qualitative and quantitative assessments by the surgical team of the fit and proper preparation achieved using the guide.

8. The sample size for the training set

• Training Set Sample Size: Not applicable. This is a mechanical device, not an AI/ML system that undergoes training.

9. How the ground truth for the training set was established

• Training Set Ground Truth: Not applicable. This is a mechanical device, not an AI/ML system that undergoes training.

Summary of Device and Performance Testing Context:

The POLARSTEM™ Calcar Reamer Guide is a mechanical accessory tool used in hip replacement surgery. Its purpose is to guide a calcar reamer/planer and define its physical stop during the preparation of the femoral bone. This 510(k) submission seeks to demonstrate substantial equivalence to a previously cleared predicate device. The "performance testing" described is functional testing comparing the subject device's usability, safety, and effectiveness to that of the predicate device, primarily through simulated surgical use (cadaver/Sawbone surgery). The document explicitly states that the subject device "met or exceed the performance testing of the Predicate Device," but it does not provide specific metrics or acceptance thresholds in a detailed, quantifiable manner as one would expect for an AI/ML device.

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