(120 days)
The Plus Orthopedics' Ceramic Ball Heads are intended for mechanical fixation to a mating hip stem and indicated for treatment of patients who are candidates for primary and revision total hip arthroplasty where the hip joint needs restructuring due to disease or trauma. These devices are intended to aid the surgeon in relieving the patient of hip pain and restoring hip motion. Please note that the patient should be skeletally mature and the patient's condition should be due to the following:
- Osteoarthritis
- Rheumatoid arthritis
- Tumor conditions involving the upper third of the femur of the Acetabular
- Ankylosing spondylitis
- Psoriatic arthritis
- Old osteomyelitis -- with a long infection-free period and a normal WBC. ESR and C-reactive protein
- Non-union of femoral neck fracture or avascular necrosis of the femoral head
- Post-traumatic fracture/dislocation of the hip
- Revision of an unsuccessful arthrodesis with either poor positioning or pain in the hip, or where low back pain or knee pain is becoming disabling
- Revision of an unsuccessful cemented or un-cemented hip replacement, providing sufficient bone stock is present
- Revision of a previous unsuccessful osteotomy, Girdlestone resection, cup arthroplasty or hemi-arthroplasty.
These ceramic ball heads are to be used only with hip stems manufactured by Plus Orthopedics AG, specifically SL-PLUS®/SLR-PLUS®, SL-PLUS® Lateral, Modular-PLUS® and IPM stem.
The Plus Orthopedics' Ceramic Ball Heads are intended for mechanical fixation to a mating hip stem and indicated for treatment of patients who are candidates for primary and revision total hip arthroplasty where the hip joint needs restructuring due to disease or trauma. These devices are intended to aid the surgeon in relieving the patient of hip pain and restoring hip motion. These ceramic ball heads are to be used only with hip stems manufactured by Plus Orthopedics AG, specifically SL-PLUS®/SLR-PLUS®, SL-PLUS® Lateral, Modular-PLUS® and IPM stem. Manufactured by CeramTec AG, the Ceramic Ball Heads are made of BIOLOX® forte, a high purity aluminum oxide per ISO 6474, with a small amount of magnesium to prevent grain growth. The Ceramic Ball Heads are available in various sizes from 28, 32 up to 36 mm, in small medium and large for each.
This is a 510(k) premarket notification for a medical device (Ceramic Ball Heads), not an AI/ML device. Therefore, the concepts of "acceptance criteria," "study that proves the device meets the acceptance criteria," "sample size for test set," "data provenance," "number of experts for ground truth," "adjudication method," "MRMC study," "standalone performance," and "ground truth for training set" are not applicable in the context of AI/ML device evaluation.
The provided document describes a traditional medical device submission seeking substantial equivalence to a predicate device. Here's how the relevant information from the document addresses your request, interpreted for a non-AI/ML device:
1. A table of acceptance criteria and the reported device performance
For non-AI/ML devices submitted via 510(k), "acceptance criteria" are typically demonstrating substantial equivalence to a legally marketed predicate device. This is achieved through comparisons of indications for use, technological characteristics, and performance testing, often against recognized standards.
| Acceptance Criteria (Demonstrating Substantial Equivalence) | Reported Device Performance (Summary) |
|---|---|
| Indications for Use / Intended Use: Must be substantially equivalent to the predicate device. | The Ceramic Ball Heads are intended for mechanical fixation to a mating hip stem for primary and revision total hip arthroplasty due to disease or trauma, aiding in relieving hip pain and restoring motion. The specific conditions listed (Osteoarthritis, Rheumatoid arthritis, etc.) are comparable to the predicate. They are to be used only with Plus Orthopedics AG hip stems. This was deemed substantially equivalent to the predicate. |
| Technological Characteristics: Must be substantially equivalent or modifications do not raise new questions of safety or effectiveness. | The Ceramic Ball Heads are made of BIOLOX® forte, a high purity aluminum oxide per ISO 6474. Available in various sizes (28, 32, 36 mm). The comparison was based on design control documentation and predicate device information. This was deemed substantially equivalent to the predicate. |
| Performance Standards & Testing: Compliance with recognized standards and design verification/validation (bench testing) to demonstrate safety and effectiveness. | The device complies with ISO 6474:1994 (Implants for surgery -- Ceramic materials based on high purity alumina), ISO 7206-10, 2003 (Implants for surgery -- Partial and total hip-joint prostheses --Part 10), and AAMI / ANSI / ISO 11137:1994 (Sterilization). Bench testing was performed according to FDA's Design Control Requirements (21 CFR Part 820.30). |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable. This is a submission for a non-AI/ML medical device, and the "test set" concept in the context of data used to evaluate AI performance does not apply here. The evaluation relies on design control documentation, compliance with established standards, and bench testing, not on human-read data sets.
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)
This information is not applicable. "Ground truth" in the context of human expert adjudication for AI model evaluation is not relevant for this traditional medical device submission. The "truth" is established by adherence to engineering specifications, material science, and performance testing against recognized standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable. Adjudication methods are specific to AI/ML device evaluation where human experts resolve discrepancies in ground truth labeling. This concept does not apply to the safety and performance evaluation of a ceramic hip ball 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. MRMC studies are used to evaluate the impact of AI on human reader performance, which is entirely outside the scope of evaluating a physical hip implant component.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. There is no algorithm or AI component in this device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For this type of device, what could be considered "ground truth" relates to:
- Material specifications: Conforming to the requirements of ISO 6474:1994 for high purity alumina.
- Mechanical performance: Meeting the test criteria established in ISO 7206-10, 2003 for hip-joint prostheses (bench testing).
- Sterilization efficacy: Adherence to AAMI / ANSI / ISO 11137:1994 for radiation sterilization.
- Design intent: Verification and validation carried out according to FDA's Design Control Requirements (21 CFR Part 820.30) to ensure the device performs as intended and is safe.
8. The sample size for the training set
This information is not applicable. There is no AI/ML model, and therefore no "training set."
9. How the ground truth for the training set was established
This information is not applicable as there is no training set for an AI/ML model.
§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.
(a)
Identification. A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.(b)
Classification. Class II.