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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.

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.

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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:

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.

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