(414 days)
The Plasmafit Pro Acetabular Cup System and Vitelene Insert are intended for use with existing Aesculap femoral heads and femoral stems to replace the hip joint.
The devices are intended for:
- Patients suffering from severe hip pain and disability due to rheumatoid arthritis, . osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head and nonunion of previous fractures of the femur
- Patients with congenital hip dysplasia, protrusion acetabuli, or slipped capital . femoral ephiphysis
- Patients suffering from disability due to previous fusion .
- Patients with acute femoral neck fractures ♥
Plasmafit Pro Acetabular Cup System and Vitelene Insert are intended for cementless applications.
Aesculap Plasmafit Pro Acetabular Cup System and Vitelene Insert is a modular hip prostheses system intended to be used in conjunction with a prosthetic femoral head and hip stem in total hip arthroplasty.
Aesculap Plasmafit Pro consists of a cementless titanium acetabular cup, a highly crosslinked (B-75 kGv) ultra-high molecular weight polyethylene (UHMW-PE) vitamin E insert, 40mm Biolox® delta, 40mm ISODUR® heads and optional titanium screws.
The hemispherical titanium cup with a slightly flattened dome is coated with a titanium plasma spray on the outer surface which aims to provide a high level of primary stability with its rough finish. Plasmafit Pro cups are available in three (3) similar designs only varying in the number of holes (0, 3, 5/7) around the apex. The number of holes are adapted for optional anchoring 6.5mm diameter titanium alloy screws that may be used to ensure primary stability. Plasmafit Pro anchoring screws are an option available separately in sizes 16mm to 68mm lengths.
Vitelene is designed with a taper-fit to the interior surface of Plasmfit Pro cups. The vitamin E insert has been shown to be more resistant to oxidation than conventional UHMWPE. Characterization of the oxidation indices of aged (ASTM F2003) and un-aged Vitelene measured according to ISO 5834-4 did not decrease . Further, Vitelene remains resistant to oxidation after 5 million cycles of wear as demonstrated in testing performed in accordance to ISO 14242.
Plasmafit Pro cups are available in sizes ranging from 40mm - 70mm.
Plasmafit Pro Acetabular Cup System and Vitelene insert may be used with Aesculap Biolox® delta and ISODUR® (CoCrMo) 40mm ball heads along with the following cleared compatible components: Aesculap Hip Implant Systems Excia, Metha, Prevision, and Unisyn and cleared Aesculap femoral heads: Biolox® Option, Biolox® Forte, Biolox® Delta, and CoCrMo to offer several interoperative implant options taking into consideration different patient bone conditions.
The provided text is related to a 510(k) Premarket Notification for a medical device (Plasmafit Pro Acetabular Cup and Vitelene Insert), not an AI/ML medical device. Therefore, the concept of "acceptance criteria" and a "study that proves the device meets the acceptance criteria" in the context of diagnostic performance (e.g., sensitivity, specificity) is not applicable here.
Instead, this document describes the device's characteristics, its intended use, and argues for its substantial equivalence to previously cleared predicate devices based on non-clinical performance data.
Here's an analysis based on the provided text, reinterpreting "acceptance criteria" as the basis for substantial equivalence:
1. A table of acceptance criteria and the reported device performance
The document does not present a formal table of quantitative acceptance criteria as would be seen for AI/ML performance. Instead, the "acceptance criteria" for this traditional medical device submission revolve around demonstrating substantial equivalence to existing predicate devices.
| Acceptance Criterion (for Substantial Equivalence) | Reported Device Performance (Summary from text) |
|---|---|
| Indications for Use (IFU) | The Plasmafit Pro Acetabular Cup System and Vitelene Insert have IFUs that are comparable to those of the predicate devices. They are intended for use with existing Aesculap femoral heads and femoral stems to replace the hip joint for conditions like severe hip pain (rheumatoid arthritis, osteoarthritis, etc.), hip dysplasia, previous fusion, and acute femoral neck fractures. Intended for cementless applications. |
| Design | The device is a modular hip prosthesis system consisting of a cementless titanium acetabular cup (with plasma spray coating for primary stability), a highly crosslinked UHMWPE vitamin E insert, and compatible femoral heads (Biolox® delta, ISODUR®). Cup designs vary slightly in the number of holes (0, 3, 5/7). The overall design is presented as substantially equivalent to predicates. |
| Material Composition | Consists of titanium for the cup, highly crosslinked UHMWPE with vitamin E for the insert, and CoCrMo or ceramic for the femoral heads. These materials are consistent with commonly used materials in predicate devices. |
| Function | The device functions as a component in total hip arthroplasty, replacing the hip joint. The Vitelene insert enhances oxidation resistance. The device's primary stability and mechanical properties are designed to be functionally equivalent. |
| Range of Sizes | Plasmafit Pro cups are available in sizes 40mm - 70mm, and anchoring screws from 16mm to 68mm. These ranges are within those typically found in predicate devices. |
| Non-clinical Performance Testing | Testing was performed "where applicable per FDA Guidance documents" to demonstrate substantial equivalence to predicate devices. Specifically mentioned: |
| - Characterization of oxidation indices of aged (ASTM F2003) and un-aged Vitelene (ISO 5834-4) showed no decrease, indicating resistance to oxidation. | |
| - Vitelene remained resistant to oxidation after 5 million cycles of wear (ISO 14242). | |
| - Adherence to FDA Guidance documents for "Testing of Metallic Plasma Sprayed Coating on Orthopedic Implant," "Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement," and "Testing Non-Articulation, 'Mechanically Locked,' Modular Implant Components." | |
| Safety and Effectiveness | The conclusion of the submission, and FDA's determination, is that the device is "substantially equivalent" to predicate devices, implying that it is as safe and effective as legally marketed devices. The non-clinical testing supports this. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The "tests" performed are non-clinical (mechanical, material characterization) on the device components, not diagnostic tests on patient data. Therefore, concepts like "test set," "data provenance," "country of origin," "retrospective/prospective," and "sample size for test set" in the context of an AI/ML device do not apply. The tests mentioned (e.g., ASTM F2003, ISO 5834-4, ISO 14242) are standardized laboratory tests for device materials and wear.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is not an AI/ML device, and there is no "ground truth" derived from expert review of patient data. The "ground truth" for the non-clinical tests would be the established scientific and engineering principles and standards against which the device performance is measured (e.g., the specified oxidation resistance limits in ISO 5834-4).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as there is no "test set" in the diagnostic sense, nor human expert adjudication. The "adjudication" for non-clinical tests typically involves adherence to standardized testing protocols and interpretation of results by qualified engineers/scientists.
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
Not applicable. This is not an AI/ML device, so no MRMC study, human readers, or AI assistance is involved.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical orthopedic implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. For non-clinical performance, the "ground truth" is defined by established engineering and materials science standards and specifications (e.g., ISO and ASTM standards for material properties, wear, and oxidation resistance).
8. The sample size for the training set
Not applicable. This is a physical device, not an AI/ML model that requires a training set. The device itself is manufactured to specifications derived from design and engineering principles.
9. How the ground truth for the training set was established
Not applicable, for the same reasons as above.
§ 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.