(106 days)
Z1 Hip System is intended for total or hemi hip arthroplasty and is indicated for the following conditions:
- · Advanced wear of the joint due to degenerative, post-traumatic or rheumatic diseases.
- · Failed previous hip surgery including joint reconstruction (osteotomy), arthrodesis, hemiarthroplasty or total hip replacement (THR).
- · Acute traumatic fracture of the femoral head or neck.
- · Avascular necrosis of the femoral head.
Z1 Hip System is for cementless use only.
Z1 Hip System consists of femoral hip stems intended for use in total or hemi hip arthroplasty. The stem is designed for cementless implantation into the proximal femur and mates with compatible femoral heads and adapters for use in total or hemi hip arthroplasty through a 12/14 male taper connection. The stems are manufactured from a forged titanium alloy Ti-6Al-4V and have a wedge-shaped design, with a proximal-to-distal taper. Apart from the highly polished femoral neck region, the entire surface of the stem is grit-blasted and sprayed with a Ti-6Al-4V titanium alloy plasma coating followed by a hydroxyapatite (HA) overcoat. Offered in multiple sizes and neck lengths, the stems are available in Standard, High Offset, and Coxa Vara offsets and as collared or collarless stems in each offset to accommodate various patient anatomies. The hip stems are provided sterile and are for single use only. System-specific instrumentation is available to prepare the femur for implantation of the Z1 Hip System femoral stems. The Z1 Hip System is for use only with the Zimmer Biomet femoral heads and adapters, bipolar heads, and acetabular shells and liners identified in the package insert as compatible components.
This document describes the Z1 Hip System, a medical device for hip arthroplasty. However, the provided text does not contain any information regarding clinical studies with human subjects, acceptance criteria for such studies, or information about AI/algorithm performance. The document is a 510(k) premarket notification to the FDA, focusing on demonstrating substantial equivalence to a predicate device through non-clinical performance testing.
Therefore, I cannot provide details for most of your requested points, as they pertain to clinical trials and AI/algorithm performance, which are not present in this document.
Here's what can be extracted based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document provides a summary of non-clinical performance testing performed according to various ISO and ASTM standards. The "acceptance criteria" discussed are related to the successful completion of these engineering tests, demonstrating that the device meets the requirements of the standards and is substantially equivalent to the predicate device. The document does not specify quantitative acceptance criteria with reported numerical values for each test in a comparative table format. Instead, it states that "All necessary testing has been performed... to assure substantial equivalence... All testing was performed on worst case implants or test coupons as dictated by the relevant performance standards." and "Based on the similarities of... the results of the non-clinical performance testing, the subject device is substantially equivalent to the legally marketed predicate device."
Here's an interpretation based on the non-clinical tests mentioned:
| Acceptance Criteria (Implied) | Reported Device Performance (Summary) |
|---|---|
| Mechanical Performance: | |
| Conformity to ISO 7206-4 (Distal Fatigue) | Testing performed, demonstrating performance as intended. |
| Conformity to ISO 7206-6 (Proximal Fatigue) | Testing performed, demonstrating performance as intended. |
| Conformity to ISO 21535 (Range of Motion Evaluation) | Testing performed, demonstrating performance as intended. |
| Material/Coating Characterization: | |
| Conformity to ISO 13779, ISO 2360, ASTM F1926, ASTM F1147, | Testing performed for HA and Ti-6Al-4V Coating, demonstrating performance as intended. |
| ASTM F1044, ASTM F1854, ASTM F1160, ASTM F1978, ISO 13179-1 | |
| Modular Connection & Corrosion Performance: | Rationale provided, demonstrating performance as intended. |
| Conformity to relevant standards (implied) | |
| MR Compatibility: | |
| Conformity to ASTM F2213, ASTM F2182, ASTM F2119, and RF Heating Modeling | Testing performed, demonstrating MR compatibility. |
| Sterilization: | |
| Conformity to ISO 11137-2, ISO 17665-1 (SAL 10-6) | Testing performed, demonstrating appropriate sterilization. |
| Endotoxin: | |
| Conformity to AAMI ST72 | Testing performed, demonstrating acceptable endotoxin levels. |
| Biocompatibility: | |
| Conformity to ISO 10993-1, ISO 10993-5 | Testing performed, demonstrating biocompatibility. |
| Overall Substantial Equivalence: | Demonstrated through the entirety of non-clinical performance testing and comparison to predicate device. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This document discusses non-clinical performance testing (mechanical, material, sterilization, etc.) on implants or test coupons, not clinical data from human subjects. Therefore, the concepts of "test set," "data provenance," "country of origin," "retrospective or prospective," and "sample size" in the context of human data are not applicable here. The document refers to "worst case implants or test coupons" for testing.
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 is not applicable as the document describes non-clinical engineering and material testing, not human-read clinical data requiring expert ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable, as there is no clinical test set or adjudication process described.
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
There is no mention of an MRMC study or AI assistance in this document. The device is a physical hip implant (Z1 Hip System).
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable, as the document refers to a physical hip implant and not an algorithm or AI product.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical testing, the "ground truth" is defined by the specifications and requirements of the referenced ISO and ASTM standards (e.g., a specific fatigue load cycle, a particular coating thickness range, sterility assurance level). The device's performance is compared against these engineering and material standards.
8. The sample size for the training set
This is not applicable, as there is no training set mentioned for an algorithm or AI.
9. How the ground truth for the training set was established
This is not applicable, as there is no training set mentioned for an algorithm or AI.
§ 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.