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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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The Delta Acetabular System is indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:

• · Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis and hip dysplasia;
• · Rheumatoid arthritis;
• · Post-traumatic arthritis,
• · Correction of functional deformity;
• · Fractures, dislocation of the hip and unsuccessful cup arthroplasty;
• · Revisions in cases of good remaining bone stock;
• · Revision of previously failed total hip arthroplasty (Delta Multihole TT Pro only).

The Delta Acetabular System is intended for cementless use.

The Delta Multihole TT Pro Acetabular System consists of a Delta Multihole TT Pro cup, an acetabular liner and a modular femoral head. Bone screws can also be used to provide additional stability of the cup.

The Delta Multihole TT Pro cup is manufactured from titanium alloy; the Delta Multihole TT Pro liners are manufactured from cross-linked UHMWPE with Vitamin E and the femoral heads made of Biolox Delta ceramic or Cobalt Chrome Molybdenum alloy.

The design of shell is similar to the Delta TT Pro Acetabular System (K182099) and the G7 Acetabular System (Biomet, Inc., K140669) devices. The acetabular liners, the Biolox Delta heads, the CoCrMo heads and the bone screws are the same as those cleared in K182099. The Multihole TT Pro cup has a hemispherical design and provides holes in cranial and caudal aspects of the cup to provide additional cup stability by means of fixation screws. The Multihole TT Pro cup is coupled with a Delta TT Pro acetabular liner that is available in neutral, protruded and high wall versions.

This document describes the Delta Multihole TT Pro Acetabular System, a medical device for total hip arthroplasty, and its review by the FDA for substantial equivalence.

Based on the provided text, the device clearance was not based on studies involving AI or complex statistical analysis of human reader performance. Instead, it relied on non-clinical mechanical testing to demonstrate substantial equivalence to predicate devices. Therefore, many of the requested categories related to AI performance, human reader studies, and ground truth establishment for such studies are not applicable to this specific submission.

Here's the breakdown based on the provided text:

Acceptance Criteria and Device Performance

The provided document describes the acceptance criteria for this device as demonstrating substantial equivalence to existing predicate devices through non-clinical testing.

Study Details

1. Sample size used for the test set and the data provenance:

   • Sample Size: Not applicable. The studies were non-clinical mechanical tests, not clinical studies with human subjects. The number of samples/units tested for the mechanical tests is not specified in the provided text, but these would be physical device units, not "data" in the sense of patient information.
   • Data Provenance: Not applicable. The tests were performed on the device itself, not on data from specific countries or patient populations. The tests are non-clinical (laboratory-based).

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

   • Not applicable. Ground truth for mechanical testing is established by engineering standards and measurement equipment, not by human experts interpreting clinical data.

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

   • Not applicable. This concept pertains to clinical image interpretation or diagnosis, not mechanical testing.

4. 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:

   • No. A MRMC study was not conducted. The document explicitly states: "Clinical testing was not necessary to demonstrate substantial equivalence of the Delta Multihole TT Pro Acetabular System to the predicate devices."
   • Effect size of human reader improvement with AI assistance: Not applicable as no such study was performed or required.

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

   • No. This device is a physical hip implant, not an algorithm or AI software. Therefore, standalone algorithm performance studies are not relevant.

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

   • The "ground truth" for the mechanical tests consists of the established engineering standards and requirements set forth in ASTM F1820-13 and ISO 7206-12:2016. Performance against these standards demonstrates "substantial equivalence" for the mechanical properties.

7. The sample size for the training set:

   • Not applicable. This is not an AI/machine learning device; there is no training set in this context.

8. How the ground truth for the training set was established:

   • Not applicable. There is no training set. The "ground truth" for the device's design and mechanical properties is based on established engineering principles and the performance of predicate devices, which the new device aims to match or exceed for relevant parameters.

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The indications for the Corin Trinity™ PLUS Acetabular Shell as a total hip arthroplasty include:
o Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis,
o Rheumatoid arthritis,
o Correction of functional deformity,
o Revision of previously failed total hip arthroplasty
o Developmental dysplasia of the hip (DDH),
The Trinity™ PLUS Acetabular Shell is indicated for cementless use only.

The Trinity™ PLUS Acetabular Shell is a component of a modular cup system consisting of a hemispherical press fit, titanium alloy shell for use with cobalt chrome alloy (Dual Mobility articulations only) or polyethylene liners and a dedicated range of ceramic and cobalt chrome alloy modular 12/14 taper femoral heads providing ceramic on polyethylene and metal on polyethylene articulations for use in total hip replacement procedures using any Corin femoral stem with a 12/14 taper connection. The acetabular shell has an outer porous structure produced by additive manufacturing using titanium alloy powder (ASTM F3001). The shell is available with or without a layer of electrochemically deposited biomimetic calcium phosphate coating. The Trinity™ PLUS acetabular shell is available with or without screw holes which permit the use of dedicated titanium screws to provide additional fixation if required.

The provided text describes a 510(k) premarket notification for a hip implant device, the Corin Trinity™ PLUS Acetabular Shell. The notification focuses on demonstrating substantial equivalence to existing legally marketed predicate devices, rather than proving that the device meets specific acceptance criteria based on a study of its performance in a clinical setting against defined metrics.

Therefore, many of the requested categories (acceptance criteria, reported device performance, sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, ground truth type, training set size, how ground truth for training set was established) are not applicable to this type of submission.

Here's a breakdown based on the information available:

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

This information is not provided in the document as this is a 510(k) submission for substantial equivalence, not a clinical trial report with performance metrics. The "acceptance criteria" here are essentially proving the device is as safe and effective as predicate devices. The document details non-clinical testing to demonstrate this.

Non-Clinical Testing Conducted to Demonstrate Substantial Equivalence:

Conclusion from Non-Clinical Testing: The culmination of the results of the mechanical testing, characterization, and animal data indicate that the devices perform within their intended use and are substantially equivalent to the predicate devices.

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

Not Applicable for this 510(k) submission, as it relies on non-clinical testing and comparison to predicates, not a clinical test set with human subjects. The non-clinical tests would have their own sample sizes for mechanical specimens, but these are not specified in the document.

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

Not Applicable. Ground truth, in the context of clinical studies, is not established for this type of submission. The "ground truth" for a 510(k) is the performance and safety profile of the predicate devices.

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

Not Applicable. There is no clinical test set requiring adjudication in this 510(k) submission.

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 Applicable. This is a medical device for total hip arthroplasty, not an AI-assisted diagnostic or imaging device for human readers. No MRMC study was conducted.

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

Not Applicable. This is a physical implantable device, not a software algorithm.

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

Not Applicable in the traditional sense of a clinical study. The "ground truth" for this 510(k) submission is the established safety and effectiveness of the legally marketed predicate devices, which the new device is being compared against.

8. The sample size for the training set:

Not Applicable. There is no "training set" in the context of a clinical study for this 510(k) submission. Non-clinical tests were performed on device samples.

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

Not Applicable. As there is no training set, there's no ground truth to establish for it in this context.

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