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This device is intended for use in total and hemi-hip arthroplasty. The device is intended for uncemented, press-fit use only in cases of:

1. Notably impaired hip joint due to osteoarthritis, rheumatoid arthritis, and/or post traumatic arthritis.
2. Previously failed hip surgery.
3. Proximal femoral neck fractures or dislocation.
4. Idiopathic avascular necrosis of the femoral head.
5. Non-union of proximal femoral neck fractures.
6. Treatment of fractures that are unmanageable using other forms of therapy.
7. Benign or malignant bone tumors, congenital dysplasia or other structural abnormalities where sufficient bone stock exists to properly seat the prosthesis.

Trivictal is a single-piece, tapered, collared and non-collared, hydroxyapatite (HA) and sintered bead commercially pure (Cp) Titanium coated femoral hip stem designed for single use. The stem has a neck with a 12/14 trunnion taper for modular attachment to femoral heads. Trivicta is manufactured from titanium alloy and device fixation is achieved through uncemented press-fit in the medullary canal and through the use of biocompatible HA coating and porous sintered bead coating. The stem has a variety of sizes to accommodate most patients encountered: lengths (101-119mm), horizontal offsets (38-53mm), vertical offsets (29-36mm), resection angle of 41°, and neck angle of 132°. The stem is offered with both standard (STD) and extended (EXT) offsets and with and without a collar. Trivicta™ is compatible with the following Ortho Development devices: CoCr Femoral Heads, Biolox Delta Ceramic Femoral Heads, Solitude™ Unipolar Head, Escalade Acetabular Cup System, Legend® Acetabular Liner, Escalade Legend® Acetabular Shell, and Tri-plus™ DCM Liner.

This looks like a 510(k) summary for a medical device (Trivicta Hip Stem), not an AI/ML powered device. Therefore, the questions related to AI/ML performance criteria, such as "effect size of how much human readers improve with AI vs without AI assistance," "standalone performance," training set information, and adjudication methods for ground truth, are not applicable.

The document focuses on demonstrating substantial equivalence to predicate devices through design, materials, indications for use, and performance testing related to the physical characteristics and safety of the hip stem, not software performance.

Here's an analysis of the provided information, focusing on the available details:

1. A table of acceptance criteria and the reported device performance

The document does not present acceptance criteria in a structured, quantitative table with specific target values for performance attributes, as would be typical for an AI/ML device. Instead, it outlines the types of non-clinical mechanical tests performed and states that the device was found to be "safe for its intended use" and "performs as well as the legally marketed predicates" based on these tests.

However, based on the categories of testing performed, we can infer some general "acceptance criteria" and "reported performance":

• Range of Motion Test (ISO 21535:2023)
• Shear Fatigue Test (ASTM F1160-14)
• Neck Fatigue Test (ISO 7206-6:2013)
• Distal Stem Fatigue Test (ISO 7206-4:2010)
• Engineering analysis of impingement performance (ASTM F2582-20)"

The overall conclusion states: "The results of verification and validation activities demonstrate that Trivicta performs as well as the legally marketed predicates." This implies that the device met the performance requirements of these tests relative to the predicate devices and applicable standards. |

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This document details tests on the physical medical device (hip stem), not a data-driven AI/ML model. Therefore, "sample size for the test set" typically refers to the number of physical device units or test specimens used in mechanical testing. The document does not specify the exact number of samples for each mechanical test, nor does it refer to "data provenance" in the context of patient data. The tests are in vitro (laboratory) tests on the device itself.

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 question is not applicable. "Ground truth" in the context of AI/ML refers to expert labels on data. For a physical medical device like a hip stem, ground truth is established by objective engineering and scientific measurements and adherence to established material and mechanical standards. There are no human "experts" establishing ground truth in the AI/ML sense for these in vitro physical tests.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This question is not applicable as it relates to expert review for AI/ML ground truth, which is not relevant to the physical testing of a hip stem.

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 question is not applicable. MRMC studies are used to evaluate the diagnostic performance of AI-assisted systems compared to human readers. This document describes a physical medical device, not an AI system.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This question is not applicable as it pertains to AI/ML algorithm performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the physical device, the "ground truth" for its performance is based on:

• Adherence to recognized international and national standards (e.g., ISO 11137 for sterilization, ISO 11607 for shelf life/packaging, ISO 10993-1 for biocompatibility, ISO 21535, ASTM F1160, ISO 7206-6, ISO 7206-4, ASTM F2582 for mechanical testing).
• Objective physical and chemical measurements obtained during laboratory testing.
• Comparison to predicate devices that have established safety and effectiveness.

8. The sample size for the training set

This question is not applicable as this is not an AI/ML device.

9. How the ground truth for the training set was established

This question is not applicable as this is not an AI/ML 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.

Ask a specific question about this device