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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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Total 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, inflammatory joint disease such as rheumatoid arthritis, or noninflammatory degenerative ioint disease (NIDJD) or any of its composite diagnoses such as osteoarthritis; avascular necrosis; traumatic arthritis; slipped capital epiphysis; fused hip; fracture of the pelvis; diastrophic variant; nonunion; femoral neck fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; femoral osteotomy, or Girdlestone resection; fracture dislocation of the hip; and correction of deformity. The subject devices are intended for single use only.

Subject of this Traditional 510(k) Premarket Notification are the Smith & Nephew, Inc. 10/12 Taper Oxinium Femoral Heads. The subject devices are geometrically similar to the femoral head component in the Echelon Titanium Hip System cleared via submission K072817 and will include the addition of 32 mm and 36 mm diameter head sizes. This premarket notification seeks to add the 10/12 taper femoral head in oxidized zirconium material. Oxidized zirconium is the material of manufacture for 12/14 taper Femoral Heads cleared via submission K021673. The subject device will be offered in a size of 22 mm with offsets of -3, +0, and +3 mm; and is sizes ranging from 26 mm - 36mm, all with offsets of -5, +0, and +5 mm.

The provided document describes a 510(k) premarket notification for the "10/12 Taper Oxinium Femoral Heads" and its substantial equivalence to previously cleared predicate devices. It focuses on the physical and mechanical performance of the device rather than AI/software performance. Therefore, many of the requested fields related to AI model evaluation are not applicable or cannot be extracted from this document.

Here's the information that can be extracted from the provided text, along with an explanation for the inapplicable fields:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

This document describes physical and mechanical testing of a medical device (femoral head), not a software/AI device evaluated with a test set of data. Therefore, this information is not applicable. The "test set" here refers to physical components subjected to mechanical tests, not a data set.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable. Ground truth, in the context of expert review, typically relates to software predictions or image interpretations. For a physical device, performance is evaluated through engineering tests against established standards or predicate device performance, not expert consensus on data.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods (like 2+1, 3+1) are used for resolving disagreements among human experts in evaluating data, which is not relevant to the mechanical testing of a femoral head.

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

This information is not applicable. This study concerns the physical performance of a hip implant component, not an AI software or assistance system for human readers.

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

This information is not applicable. No algorithm or AI is described or evaluated in this document.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For the performance data, the "ground truth" or reference for comparison is the performance of previously cleared predicate devices (Total Hip Femoral head - 12/14 Taper, K021673; and Echelon Titanium Hip System, K072817) in the specified mechanical and environmental tests. The underlying criteria for these tests would be derived from engineering standards and regulatory requirements for such devices.

8. The Sample Size for the Training Set

This information is not applicable. This document describes the testing of a physical medical device, not the training of an AI model.

9. How the Ground Truth for the Training Set was Established

This information is not applicable. There is no training set mentioned or implied as this is not an AI/software device.

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The ESOP® Co-Cr Femoral Heads are intended for use in degenerative and inflammatory arthritis of the hip joint, trauma, non-acute femoral neck fracture, revision of previously failed hip arthroplasties, and idiopathic avascular (osteo) necrosis where radiographic evidence shows there is sufficient sound bone to seat the prosthesis. This device is intended for cementless application.

The Metallic Femoral Heads are intended to be adapted to special cones machined for this purpose. Femoral head are available in several diameters for use in full hip or intermediary replacement. The length of the neck on the femoral stem can be adjusted by using the heads available in different insertion depths (short, medium, long and extra-long collars), and of different diameters.

The provided text describes a 510(k) submission for the ESOP® Co-Cr Femoral Head, a medical device. This type of submission relies on demonstrating substantial equivalence to a predicate device, rather than conducting a de novo study to establish new acceptance criteria and prove performance against them.

Therefore, the input does not contain the kind of information requested in the prompt, such as pre-defined acceptance criteria, details of a study (sample sizes, ground truth, experts, adjudication, MRMC, standalone performance, training set details), or the reported device performance against such criteria.

The submission focuses on comparing the new device (ESOP® Co-Cr Femoral Head) to existing legally marketed predicate devices (ESOP® Co-Cr Femoral Heads (K021109) and Total Hip Femoral Head - 12/14 Taper (K021673)) in terms of intended use, material, size, and dimensions, to demonstrate that the new device is substantially equivalent. It states that "Verification/validation and design control activities demonstrate the safety and effectiveness," but does not detail the specifics of these activities in the way requested for acceptance criteria and study results.

Therefore, I cannot provide the requested information from the given text. The document describes a regulatory submission for a medical device built on the principle of substantial equivalence, not a study designed to establish and meet specific performance acceptance criteria for a novel device.

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