(116 days)
Z1 Cemented Hip System is intended for total or partial (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, hemi-arthroplasty or total hip replacement (THR).
· Acute traumatic fracture of the femoral head or neck.
· Avascular necrosis of the femoral head.
Z1 Cemented Hip System consists of implants that are for cemented use only.
The Z1 Cemented Hip System consists of femoral hip stems intended for use in total or partial (hemi-) hip arthroplasty. The stem is designed for cemented implantation into the proximal femur and mates with compatible femoral heads and adapters for use in total or partial (hemi-) hip arthroplasty through a 12/14 male taper connection. The stems are manufactured from forged stainless steel and have a wedge-shaped design, with a proximal-to-distal taper. Offered in multiple sizes and neck lengths, the stems are available in standard and high 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 Cemented Hip System femoral stems. The Z1 Cemented Hip System is for use only with the Zimmer Biomet femoral heads and adapters, bipolar heads, acetabular shells, acetabular liners, and distal centralizers / positioners identified in the package insert as compatible components.
This document is an FDA 510(k) clearance letter for a medical device called the "Z1 Cemented Hip System." It primarily focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and study results for device performance as typically understood in the context of an AI/software device.
The information provided describes the hip system itself, not an AI or software component. Therefore, the questions about sample size for test/training sets, expert ground truth adjudication, MRMC studies, or standalone algorithm performance are not applicable to this document. The document discusses mechanical performance testing of a physical implant.
However, I can extract information related to the physical device's "acceptance criteria" and the studies used to prove it meets those criteria based on the provided text.
Here's the breakdown of what's provided, framed as closely as possible to your request, but with the understanding that this is about a physical orthopedic implant, not an AI device:
1. Table of Acceptance Criteria and Reported Device Performance
The document lists performance tests conducted, but does not provide specific quantitative acceptance criteria or reported values for the Z1 Cemented Hip System. Instead, it states that "All necessary testing has been performed... to assure substantial equivalence to the predicate device and to demonstrate the subject device performs as intended." This implies that the acceptance criteria are met if the device performs comparably to the predicate or within established safety and efficacy standards for such devices.
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Mechanical Performance: | |
| Distal Stem Fatigue (ISO 7206-4) | Engineering Analysis performed to assure substantial equivalence. |
| Proximal Stem Fatigue (ISO 7206-6) | Engineering Analysis performed to assure substantial equivalence. |
| Range of Motion (ISO 21535) | Evaluation performed to assure substantial equivalence. |
| Material/Design Compatibility: | |
| Modular Connection & Corrosion | Engineering Analysis performed to assure substantial equivalence. |
| MR Compatibility | Justification provided via adoption. |
| Sterilization & Biocompatibility: | |
| Steam & Gamma Sterilization | Adoption justification provided (SAL 10-6 implied for gamma). |
| Endotoxin (USP , AAMI ST72) | Testing performed. |
| Biocompatibility (ISO 10993-1, -5) | Testing performed. |
Note: The document states "engineering analysis" or "evaluation" was performed. Specific numerical results or pass/fail thresholds are not detailed in this summary, as is typical for 510(k) summaries which focus on demonstrating equivalence rather than raw data.
2. Sample Size Used for the Test Set and Data Provenance
This document describes pre-market testing of a physical medical device, not a software or AI algorithm. Therefore, the concept of a "test set" in the context of data points is not directly applicable.
- Sample Size: The document mentions that "All testing was performed on worst case implants as dictated by the relevant performance standards." This implies a representative sample of the manufactured device variants (e.g., different sizes, offsets) were tested, focusing on the configurations most likely to fail. Specific numbers of units tested are not provided in this summary.
- Data Provenance: Not applicable in the context of data origin; this refers to the origin of the physical products tested, which would be the manufacturer, Orchard Medical Development, LLC. The testing is described as pre-market, implying prospective testing of newly manufactured devices.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. This is a physical device where "ground truth" is established through standardized engineering and material testing methods, not expert consensus on image interpretation or clinical outcomes data.
4. Adjudication Method for the Test Set
Not applicable. This concept applies to expert review processes, which are not relevant for the mechanical and material testing described here.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
Not applicable. MRMC studies are used for evaluating the effectiveness of diagnostic tools (often imaging-based AI) on human reader performance. This document is about a hip implant.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a physical hip implant, not an algorithm.
7. The Type of Ground Truth Used
For this physical device, "ground truth" is established by:
- Adherence to recognized industry standards (e.g., ISO 7206-4, ISO 7206-6, ISO 21535, ISO 10993) for mechanical, material, and biocompatibility testing.
- Engineering analyses and calculations demonstrating design robustness.
- Comparison to the performance characteristics of an existing, legally marketed predicate device (K193030 Zimmer, Inc. Avenir Cemented Hip Stem).
8. The Sample Size for the Training Set
Not applicable. There is no AI training set for this physical device.
9. How the Ground Truth for the Training Set was Established
Not applicable. There is no AI training set for this physical device.
§ 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.