(89 days)
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.
| Test Type | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Torsional properties testing (ASTM F543-17) | Conformance to ASTM F543-17 standards for screw performance. | The subject device successfully underwent torsional properties testing per ASTM F543-17. (Implies satisfactory performance relative to the standard) |
| Axial pullout testing (ASTM F543-17) | Conformance to ASTM F543-17 standards for screw performance. | The subject device successfully underwent axial pullout testing per ASTM F543-17. (Implies satisfactory performance relative to the standard) |
| Driving and removal torque (ASTM F543-17) | Conformance to ASTM F543-17 standards for screw performance. | The subject device successfully underwent driving and removal torque testing per ASTM F543-17. (Implies satisfactory performance relative to the standard) |
| Stress Analysis | Stress levels in the pelvic implant with locking screws do not create a new worst-case for failure compared to the predicate device. | A stress analysis was performed to support the development of an engineering rationale demonstrating that the subject locking screws do not create a new worst-case for failure of the pelvic implant due to stress. |
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.
§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.
(a)
Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across the joint. This generic type of device has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II.