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ONE Planner™ Hip is intended for use as preoperative surgical planning software to aid orthopedic surgeons in component selection, sizing and placement for primary total hip arthroplasty.

ONE Planner™ Hip (OPH) is an interactive software application intended to be used as a preoperative tool for Total Hip Arthroplasty. It enables 2D sizing and positioning of implants in the patient's anatomy, calculates biomechanical measurements and performs functional analysis based on the patient's pelvic kinematics. The biomechanical measurements include measurements related to leg length and femoral offset. The functional analysis includes determination of pelvic parameters (e.g. pelvic tilt), and cup orientation calculations.

The software application consists of an automated templating system and a web-based templating user interface.

The provided document is an FDA 510(k) clearance letter for the ONE Planner™ Hip, a software device for preoperative surgical planning in total hip arthroplasty. It details the device's intended use, technological characteristics, and the non-clinical testing performed to establish substantial equivalence to a predicate device.

However, the document does not provide information on:

• Specific acceptance criteria and reported device performance in a table format.
• Details of the test set: sample size, data provenance, number/qualifications of experts, or adjudication methods.
• MRMC comparative effectiveness study.
• Standalone algorithm performance.
• Type of ground truth used for performance evaluation.
• Details about the training set: sample size, or how its ground truth was established.

The document explicitly states:

• "Software verification and validation testing was conducted to satisfy the requirements of the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices and IEC 62304 (Medical Device Software- Life Cycle Process)."
• "The software is considered a 'moderate' level of concern, a malfunction in the device could lead to a minor injury."
• "Non-clinical testing was performed to assess the usability and performance of the ONE Planner™ Hip to demonstrate that the device functions as intended."
• "Clinical testing was not necessary for the determination of substantial equivalence."

This indicates that the clearance was based on non-clinical software verification and validation, and usability/performance testing, demonstrating that the device functions as intended and does not introduce new questions of safety and effectiveness compared to the predicate device. It does not describe a study involving an AI component with specific performance metrics against a ground truth, expert readers, or a test/training set in the context of an AI-driven medical device. The "Acceptance Criteria" and "Study that proves the device meets the acceptance criteria" in the context of AI performance metrics (like sensitivity, specificity, or reader improvement) are not present in this document.

Therefore, many of the requested details cannot be extracted from the provided text.

Based on the available information, here's what can be addressed:

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

• Not provided in the document. The document mentions "Software verification and validation testing" and "Non-clinical testing to assess the usability and performance...to demonstrate that the device functions as intended." It does not specify quantitative performance metrics or acceptance criteria for those metrics.

2. Sample sized used for the test set and the data provenance

• Not provided in the document. The document refers to "non-clinical testing" but does not detail the size or provenance of any "test set" in the context of evaluating an AI model's performance; instead, it refers to software V&V and usability.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not provided in the document. Since "clinical testing was not necessary" and no AI performance study with a test set evaluated by experts is described, this information is absent.

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

• Not provided in the document.

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

• Not provided in the document. The document does not describe any MRMC study or AI assistance to human readers.

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

• Not provided in the document. The device is described as "interact[ing]" with the user, suggesting a human-in-the-loop, but no standalone performance data is presented.

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

• Not provided in the document.

8. The sample size for the training set

• Not provided in the document. There is no mention of a training set as would be relevant for an AI model.

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

• Not provided in the document.

Summary of what's described in the document regarding testing:

• Type of Testing: Software Verification & Validation Testing and Non-Clinical Testing (Usability and Performance).
• Purpose of Testing: To satisfy FDA guidance (IEC 62304) and demonstrate that the device functions as intended and does not introduce new safety and effectiveness questions compared to the predicate device.
• Level of Concern: Moderate (malfunction could lead to minor injury).
• Clinical Testing: Not deemed necessary for substantial equivalence determination.

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Avenir® Müller Stem is intended for:
Advanced wear of the joint due to degenerative, post-traumatic or rheumatic diseases.Failed previous hip surgery (not THA) where pain, deformity or dysfunction persists.Optional use in revision: in some medical conditions (e.g., early revision when healthy and good bone stock exists), the surgeon may opt to use primary implants in a revision procedure.Acute traumatic fracture of the femoral head or neck.Avascular necrosis of the femoral head.
Avenir® Müller Stems are for cementless use only.

The Avenir® Cemented Hip Stem is intended for total or hemi hip arthroplasty with cemented applications for rehabilitating hips damaged as a result of:
Advanced wear of the joint due to degenerative, post-traumatic, or rheumatic diseasesFailed previous hip surgery including joint reconstruction (osteotomy), arthrodesis, hemiarthroplasty or total hip replacement (THR)Acute traumatic fracture of the femoral head or neckAvascular necrosis of the femoral head.

The Avenir® Müller Stem is a titanium alloy femoral stem designed to replace the proximal femur in total or hemi-hip arthroplasty. It is a wedge-shaped, collarless design and features a three dimensional proximal-to-distal taper. The stem and neck are a single unit and the stem features proximal ribs on the anterior and posterior surfaces which are designed to increase stability. Except for the polished neck area, the surface of the stem is coated with Ti-6Al-4V titanium alloy plasma spray and oversprayed by a hydroxyapatite coating. The stem is available as both a lateralized and standard version.

The Avenir® Cemented Hip Stem is a stainless steel alloy femoral stem designed to replace the proximal femur in total or hemi-hip arthroplasty. It is a wedge-shaped, collarless design and features a three dimensional proximal-to-distal taper. The stem and neck are a single unit. The stem is highly polished and available as both a lateralized and standard version.

This document, K193030, is a 510(k) premarket notification for Zimmer GmbH's Avenir Müller Stem and Avenir Cemented Hip Stem. It's a submission for hip prostheses, and the "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the non-clinical performance testing conducted to demonstrate substantial equivalence to predicate devices, rather than a clinical study evaluating AI performance as would be expected for a software-based device.

Based on the provided text, the device in question is a medical implant (hip stem), not an AI/software device. Therefore, the questions about "effect size of how much human readers improve with AI vs without AI assistance," "standalone (algorithm only without human-in-the-loop performance)," "training set," and "ground truth for the training set" are not applicable to this submission. The "acceptance criteria" here relate to the physical and mechanical properties of the implant and its packaging.

Here's an analysis of the provided information regarding the acceptance criteria and the study that proves the device meets them:

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

• any differences (modifications) do not raise new questions of safety and effectiveness as established with performance testing; and
• the subject devices are at least as safe and effective as the legally marketed predicate device. The devices have the same intended use and similar indications for use, use the same operating principle, incorporate the same basic design and labeling, and are manufactured and sterilized using the same materials and processes as the predicate device. |

2. Sample sized used for the test set and the data provenance

• Sample Size:
  • For Packaging Configuration testing: "Packaging Configuration testing was conducted by representative worst-case products." A specific number is not provided, but the approach indicates a focus on challenging scenarios to ensure robustness.
  • For Instrument Classification (mechanical integrity and resistance): Not explicitly stated, but implies testing of the instruments.
• Data Provenance: The document does not specify the country of origin of the data or whether the tests were retrospective or prospective, as these are non-clinical (laboratory/engineering) tests rather than human subject studies. Such tests are typically conducted in a controlled lab environment.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This question is not applicable as this submission is for a physical medical device (hip stem) and its associated instruments and packaging, not an AI/software device that requires expert-established ground truth from medical images. The "ground truth" here is compliance with engineering standards and performance specifications.

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

This question is not applicable for the same reason as point 3. Adjudication methods like 2+1 or 3+1 are used in clinical studies involving interpretation (e.g., of medical images) where there might be disagreements among human readers. This submission describes non-clinical engineering and packaging tests.

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. This describes a physical medical device, not an AI-assisted diagnostic or treatment planning tool.

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

This question is not applicable. This describes a physical medical device, not a software algorithm.

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

The "ground truth" for this device's acceptance criteria is based on established engineering standards and regulatory requirements for the performance of medical device packaging (e.g., ISO 11607-1:2006 and ISO 11607-2:2006) and the mechanical integrity of instruments. These are objective, measurable criteria, not subjective expert consensus or clinical outcomes data.

8. The sample size for the training set

This question is not applicable. There is no "training set" in the context of a 510(k) submission for a physical medical device. This term is relevant to AI/machine learning models.

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

This question is not applicable for the same reason as point 8.

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