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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 subject submission adds locking screw component options and associated instrumentation to the subject My3D® Personalized Pelvic Reconstruction system.

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.

This FDA 510(k) summary for the My3D® Personalized Pelvic Reconstruction device (K223348) primarily focuses on establishing substantial equivalence to a predicate device (K212815) for an addition of locking screw components and associated instrumentation. It does not describe a clinical study in the typical sense of evaluating diagnostic accuracy or clinical outcomes in human subjects with acceptance criteria.

Instead, the "acceptance criteria" and "study" are related to mechanical performance testing of the newly added locking screw components to demonstrate that they are comparable to existing, legally marketed devices and do not negatively impact the overall device's safety and effectiveness.

Here's a breakdown of the requested information based on the provided document:

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

The document does not explicitly state numerical acceptance criteria for each test or detailed performance reports with specific values. Instead, it refers to industry standards (ASTM F543-17) and implies that the device met these standards. The "reported device performance" is a general statement that the device underwent testing and a stress analysis, which supported its safety.

2. Sample size used for the test set and the data provenance

• Sample Size: The document does not specify exact sample sizes (e.g., number of screws tested) for the mechanical tests. Mechanical testing often involves a smaller number of samples compared to clinical trials, determined by statistical considerations for materials testing.
• Data Provenance: The data provenance is from mechanical laboratory testing performed on the device components (locking screws). It is not clinical data from human subjects. The country of origin of the data is not explicitly mentioned but is likely associated with the manufacturer (Onkos Surgical, Inc., based in Parsippany, New Jersey, USA) or a third-party testing facility. This is not retrospective or prospective clinical data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable in this context. The "ground truth" for mechanical testing is established by engineering principles and adherence to recognized industry standards (e.g., ASTM F543-17). There are no "experts" establishing a clinical ground truth for a test set in this 510(k) submission, as it focuses on mechanical equivalence.

4. Adjudication method for the test set

This information is not applicable. Adjudication methods (e.g., 2+1) are typically used in clinical or image-based studies where multiple reviewers assess data and reconcile discrepancies. Mechanical testing results are objective measurements against defined physical standards.

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

No, a MRMC comparative effectiveness study was not done. This device is a physical medical device (pelvic reconstruction system) and not an AI/imaging device that would involve human readers or AI assistance in interpretation.

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

No, a standalone algorithm performance study was not done. This device is a physical medical device and does not involve a standalone algorithm in the way this question implies (e.g., a diagnostic AI algorithm).

7. The type of ground truth used

The "ground truth" for the mechanical testing is based on:

• Industry Standards: Adherence to established mechanical testing standards like ASTM F543-17.
• Engineering Rationale: Demonstrating through stress analysis that the new components do not compromise the structural integrity or safety of the overall pelvic implant.

8. The sample size for the training set

This information is not applicable. There is no "training set" in the context of mechanical laboratory testing for a physical device like this. This question is typically relevant for machine learning or AI models.

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

This information is not applicable, as there is no training set for this type of submission.

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The ELEOSTM Bipolar Acetabular System is indicated for the following conditions:

1. pathological fractures of the femoral neck
2. non-union of femoral neck fractures
3. aseptic necrosis of the femoral head and neck
4. primary pathology involving the femoral head or femur but with a non-deformed acetabulum.

ELEOS™ Bipolar Acetabular System is a bipolar hip implant design that features a cross-linked polyethylene bearing surface with a lock detail enhanced for strength. Historical concerns with traditional bipolar designs have included loosening of the insert, disassociation of the head from the shell, and osteolysis resulting from polyethylene wear. This system is designed to address these concerns to give surgeons greater confidence when using a bipolar implant.
There is an UHMWPE support ring inside the shell that is permanently fixed. There is also an UHMWPE locking ring that assembles above the support ring and locks into place once the head is inserted into the shell. Bipolar heads are available in a variety of diameters with corresponding internal diameters for 22, 28, 32 and 36mm femoral heads with skirts are not compatible with the bipolar shells.

The provided text is a 510(k) summary for the ELEOS™ Bipolar Acetabular System. It states that no performance data for the subject device (ELEOS™ Bipolar Acetabular System) is provided. Instead, the submission relies on the substantial equivalence principle, asserting that the subject device has the same materials, technology, and sterilization methods as the predicate device (GLADIATOR® Bipolar System, K062693).

Therefore, I cannot extract information about acceptance criteria and a study proving the device meets those criteria from this document. The document explicitly states:

"No performance data is provided. A copy of the full 510(k) for the predicate device (K062693) is provided because there are no technological differences between the subject and predicate devices."

As such, I cannot populate the table or answer the specific questions about sample size, provenance, experts, adjudication, MRMC studies, standalone performance, ground truth types, or training set details, as this information is related to performance data that is explicitly stated to be not provided for the subject device in this document.

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ELEOSTM Limb Salvage System Hip Components:

Indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:

1. Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusion acetabuli. and painful hip dysplasia;

2. Inflammatory degenerative joint disease such as rheumatoid arthritis;

3. Correction of functional deformity

4. Revision procedures where other treatments or devices have failed; and,

5. Treatment of fractures that are unmanageable using other techniques.

Limb salvage system is also indicated for procedures where radical resection and replacement of the proximal, distal and/ or total femur is required with the following conditions:

1. Patients suffering from severe arthropathy of the hip that does not respond to any conservative therapy or better alternative surgical treatment;

2. Surgical intervention for severe trauma, revision hip arthroplasties, and/or Oncology indications.

3. Metastatic diseases

ELEOSTM Limb Salvage System Knee Components:

Indicated for cemented use in knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with the following conditions:

1. Non-inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis;

• 2. Inflammatory degenerative joint disease including rheumatoid arthritis;
• 3. Correction of functional deformity;
• 4. Revision procedures where other treatments or devices have failed; and
• 5. Treatment of fractures that are unmanageable using other techniques.

Limb salvage system is also indicated for procedures where radical resection and replacement of the proximal tibia is required with the following conditions:

1. Patients suffering from severe arthropathy of the knee that does not respond to any conservative therapy or better alternative surgical treatment;

2. Surgical intervention for severe trauma. revision knee arthroplasties, and/or Oncology indications.

• 3. Metastatic diseases

The Onkos Surgical ELEOS™ Limb Salvage System consists of components that are used in the reconstruction of the lower limb. The reconstruction applications are proximal femur, distal femur, total femur, proximal tibia, and hinged knee. The ELEOS Limb Salvage components are femoral head, mid-section, stem, distal hinge femur, tibial hinge assembly, axial pin, tibial poly spacer, tibial sleeve, male mid-section, resurfacing hinge femur, and proximal tibia, patella. stem extension, tibial wedges and augments. Instrumentation is provided non-sterile in surgical trays which are to be re-processed per the validated instructions stated below.

The provided text is a 510(k) summary for a medical device (ELEOS Limb Salvage System) seeking FDA clearance based on substantial equivalence to a predicate device. It does not describe a study involving acceptance criteria for a device's performance in the context of an AI/algorithm-driven system. Therefore, I cannot extract the information required to answer your questions as they pertain to AI/algorithm performance studies.

The document states:

• "No performance data is provided." (Page 7, Section VII. Performance Data)
• "A copy of the full 510(k) for the predicate device (K013035) is provided because there are no technological differences between the subject and predicate devices." (Page 7, Section VII. Performance Data)
• The conclusion is based on the subject device being "identical with respect to fit, form, function and manufacturing processes as the predicate device" (Page 7, Section VIII. Conclusions).

This indicates that the clearance for the ELEOS Limb Salvage System was based on demonstrating substantial equivalence to a previously cleared device, not on independent performance testing against specific acceptance criteria for a new, AI-driven functionality.

Therefore, questions about acceptance criteria, reported device performance, sample sizes, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set information are not applicable to this document.

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