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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 TaperSet™ Hip System is designed for total or partial hip arthroplasty and is intended to be used with compatible components of the Consensus Hip System.
The indications for use are:

• A. Significantly impaired joints resulting from rheumatoid, osteo, and post-traumatic arthritis.
• B. Revision of failed femoral head replacement, cup arthroplasty or other hip procedures.
• C. Proximal femoral fractures.
• D. Avascular necrosis of the femoral head.
• E. Non-union of proximal femoral neck fractures.
• F. Other indications such as congenital dysplasia, arthrodesis conversion, coxa magna, coxa plana, coxa vara, coxa valga, developmental conditions, metabolic and tumorous conditions, osteomalacia, osteoporosis, pseudarthrosis conversion, and structural abnormalities.
  The TaperSet™ hip stem is indicated for cementless use.

The TaperSet Hip System (THS) is a monolithic, titanium alloy tapered hip stem design with a proximal, plasma sprayed, porous CP Ti coating. The stem has a dual wedge geometry and is available in both standard and 7mm lateral offsets in sizes currently designated as 7.5mm to 24mm. The stems feature a neck shaft angle of 135° and a 12/14 Morse taper trunnion. The TaperSet Hip System is designed for total or partial hip arthroplasty and is intended to be used with compatible components of the Consensus Hip System. The stem is compatible with previously cleared CoCr heads, zirconia or Biolox delta ceramic heads, unipolar heads, bipolar heads. UHMWPE inserts and acetabular cups. The modification addressed here is the addition of two stems in sizes 5mm and 6mm.
The new stems are manufactured from forged titanium alloy (Ti-6AI-4V ELI, ASTM F620) and the proximal portion of the femoral stem component is plasma sprayed with commercially pure titanium (C. P. Ti. ASTM F1580). The new femoral stems are available in both standard and 7mm lateralized options and have the identical neck and taper design, and porous coating as the predicate TaperSet stems cleared under K102399 in design and indications.

The provided FDA 510(k) summary (K121935) describes the TaperSet Hip System Small Stems, which are orthopedic implants, not an AI/ML powered device. Therefore, many of the requested categories related to AI/ML device performance and study design are not applicable to this submission.

However, I can extract the relevant information regarding the acceptance criteria and the non-clinical study that demonstrates the device's performance based on mechanical testing.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Test Set Sample Size: The document refers to testing of a "worst-case example," specifically "the 5mm lateral femoral stem." This implies that at least one of these stems was tested. The document also states "The stems were to achieve...", suggesting that multiple stems may have been tested to confirm consistency, but the exact number isn't specified beyond "the 5mm lateral femoral stem was determined to be the worst-case example per analysis report (R11-007)." The study is a non-clinical, laboratory-based mechanical test.
• Data Provenance: This is not applicable in the context of clinical data for a mechanical test. The testing was performed on newly manufactured devices to evaluate their mechanical properties.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts

This is not applicable as the study involves mechanical testing of an orthopedic implant, not the evaluation of a device by human experts or the establishment of a ground truth for diagnostic purposes. The "ground truth" here is the physical performance of the device under specific loading conditions, measured by engineering standards.

4. Adjudication Method for the Test Set

This is not applicable for a non-clinical mechanical test. The test results are determined by instrumentation and adherence to engineering standards, not through human adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No. This is not an AI/ML device or a device that requires human interpretation of outputs.

6. If a Standalone Performance (i.e. algorithm only without human-in-the-loop performance) was Done

No. This is not an AI/ML device.

7. The Type of Ground Truth Used

The "ground truth" for this study is defined by established biomechanical and engineering standards for hip prostheses:

• ASTM F2068-2009 (Standard Specification for Femoral Prostheses – Mechanical Performance)
• ISO 7206-4:2010(E) (Implants for surgery — Partial and total hip joint prostheses — Part 4: Determination of endurance properties of stemmed femoral components)

The acceptance criteria (5 million cycles at 517 lbs/2300 N without failure) are directly derived from these standards.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device that requires a training set.

9. How the Ground Truth for the Training Set was Established

Not applicable. This is not an AI/ML device.

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1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
2. Rheumatoid arthritis
3. Correction of functional deformity
4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques.
5. Revision procedures where other treatment or devices have failed.
   Porous coated components are intended for uncemented biological fixation.

The TaperIoc® Complete Microplasty Stems are an update to the existing TaperIoc® Microplasty Stems and are designed to replace the patient's natural hip, femoral neck, and head, due to disease or accident. The Taperloc® Complete Microplasty Stems will combine the design features of the Taperioc® Complete full-length stems to the shortened design of the existing Taperloc® Microplasty Stems. These design features include: a reduced neck angle, shorter/longer neck lengths, reduced Type 1 taper geometry with neck flats, polished neck, standard and high offset versions, two distal profiles, and an updated insertion hole. Stem sizes ranges are within the ranges of legally marketed predicates. The substrate material is Ti-6AI-AV, ASTM F-136. The proximal intramedullary region is sprayed with porous plasma spray.

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

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Mechanical Testing: 6 worst-case stems were used for both distal and proximal stem fatigue testing. The sample size for the Range of Motion analysis is not explicitly stated but implies at least one simulation.
• Data Provenance: The data is from non-clinical testing performed by Biomet Manufacturing Corp. The country of origin is not explicitly stated, but the company is based in Warsaw, IN, USA. The data is prospective in the sense that it was generated for the purpose of this 510(k) submission, not gathered retrospectively from existing patient data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This section is not applicable as the studies described are non-clinical mechanical engineering tests, not studies requiring human expert assessment of medical images or patient outcomes. The "ground truth" for these tests is defined by the international standards (e.g., ISO, ASTM) and the specified load/cycle requirements.

4. Adjudication Method for the Test Set

This section is not applicable for the same reasons as above. There were no human expert assessments requiring adjudication. The tests were objective mechanical measurements against predefined pass/fail criteria.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document explicitly states: "Clinical Testing: None provided as a basis for substantial equivalence." This device is a hip implant, and the testing described is mechanical, not related to AI-assisted human reading.

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

No, a standalone algorithm performance study was not done. This device is a physical medical implant, not an algorithm or AI system.

7. The Type of Ground Truth Used

The ground truth used for these non-clinical tests was based on internationally recognized engineering standards and specifications. Specifically:

• Distal Stem Fatigue: ISO 7206-4:2002, ASTM F2068-03
• Proximal Stem Fatigue: ISO 7206-6:1992
• Range of Motion Analysis: ISO 21535:2009
• PPS Plasma Sprayed Coating: "Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement" and 21 CFR 888.3358.

The "ground truth" is therefore adherence to these established mechanical performance and material characterization standards.

8. The Sample Size for the Training Set

This section is not applicable. There is no "training set" as this is not an AI/machine learning device. The number of samples for mechanical testing (6 worst-case stems) served as the test set.

9. How the Ground Truth for the Training Set Was Established

This section is not applicable for the same reason as above. There is no training set mentioned or implied.

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