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The prostheses from FH Industrie are designed for specific indications such as:

SIMPLE HUMERAL PROSTHESIS

• Humeral head necrosis without injury to the glenoid cavity.
• Extensive humeral head cartilage damage without injury to the glenoid cavity
• Centred osteoarthritis with a glenoid cavity not allowing implantation of a glenoid implant.
• Rheumatoid polyarthritis with thin rotator cuff.
• Off-centred osteoarthritis with irreparable cuff, and with maintained active elevation of at least 120°.

TOTAL ANATOMICAL PROSTHESIS (CEMENTED GLENOID IMPLANT WITH PEGS)

• Centred glenohumeral osteoarthritis with functional rotator cuff
• Rheumatoid polyarthritis with functional rotator cuff
• Post-traumatic sequela, functional rotator cuff with glenoid injury.

TOTAL ANATOMICAL PROSTHESIS (POROUS GLENOID IMPLANT)

• Centred glenohumeral osteoarthritis
• Rheumatoid polyarthritis
• Post-traumatic sequela with glenoid injury
• Revision for glenoid loosening
• Glenoid bone loss, where bone graft is needed

A functional rotator cuff is necessary to use this device

REVERSE PROSTHESIS (METAL-BACK OR POROUS GLENOID IMPLANT)
The ARROW and JARVIS Reverse Shoulder Prosthesis is indicated for patients with severe shoulder arthropathy and a grossly deficient rotator cuff or a previously failed shoulder joint replacement with a grossly deficient rotator cuff. A functional deltoid muscle and adequate glenoid bone stock are necessary to use this device.

For all types of prosthesis, the glenoid baseplate (porous) is intended for cementless use with the addition of bone screws for fixation, the humeral short stem (metaphyseal stem and diaphyseal stem) is intended for cementless use.

At least 2/3 of the metaphyseal component must be implanted in the proximal humeral bone to allow for adequate humeral component fixation.

The JARVIS Diaphyseal Stem Standard is an extension of humeral stem range of the Arrow prosthesis. The JARVIS Diaphyseal Stem Standard is intended to be used with the Metaphyseal component of the modular ARROW Short Stem device (K202024). The JARVIS Diaphyseal Stem Standard is offered in various sizes to accommodate patient anatomy. All implantable components are manufactured from medical grade titanium alloy (Ti6Al4V-ELI) per ASTM F-136/ISO 5832-3.

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The Jarvis Glenoid Reverse Shoulder Prosthesis is indicated for patients with severe shoulder arthropathy and a grossly deficient rotator cuff or a previously failed shoulder joint replacement with a grossly deficient rotator cuff.

The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary. The glenoid baseplate is intended for cementless application with the addition of screws for fixation.

The JARVIS Glenoid Reverse Shoulder Prosthesis is used for reverse shoulder prosthesis, intended for primary, fracture or revision shoulder replacement. The JARVIS Glenoid Reverse Shoulder Prosthesis is made up of three components – glenophere, baseplate, and fixation component (screw or post). All components are offered in varying sizes to accommodate patient anatomy. The baseplate and screw components are manufactured from medical grade titanium alloy (Ti6Al4V-ELI) per ASTM F-136/ISO 5832-3, while the glenophere is manufactured from wrought cobalt chromium molybdenum alloy per ASTM F1537/ISO 5832-12. All components are provided sterile via gamma irradiation.

The subject submission seeks to gain clearance for design modifications to the existing device components.

The provided FDA 510(k) clearance letter for the JARVIS Glenoid Reverse Shoulder Prosthesis does not contain any information regarding clinical studies, acceptance criteria for an AI/CADe device, or performance data related to AI assistance.

The document describes a traditional medical device (a shoulder prosthesis), not an artificial intelligence (AI) or computer-assisted detection/diagnosis (CADe/CADx) device. Therefore, it lacks the specific details requested in your prompt, such as:

• Table of acceptance criteria and reported device performance for an AI/CADe system.
• Sample sizes, data provenance, expert qualifications, or adjudication methods for a test set.
• Information on multi-reader multi-case (MRMC) comparative effectiveness studies.
• Standalone algorithm performance.
• Ground truth types and methods for establishing ground truth.
• Training set sample size and ground truth establishment for AI.

The "Performance Testing" section explicitly states: "Engineering analysis was conducted on the modified locking screws and concluded that the compressive force of the subject screws is equivalent to that of the predicate and therefore locking capabilities are equivalent. Therefore, all previous performance testing and validations are still applicable and no additional testing is necessary." This refers to mechanical testing of the physical implant components, not performance of an AI algorithm.

In summary, the provided text is for a physical medical implant, not an AI-based or software-as-a-medical-device (SaMD) product that would require the kind of data and studies you are asking about.

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The Jarvis Glenoid Reverse Shoulder Prosthesis is indicated for patients with severe shoulder arthropathy and a grossly deficient rotator cuff or a previously failed shoulder joint replacement with a grossly deficient rotator cuff.

The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary. The glenoid baseplate is intended for cementless application with the addition of screws for fixation.

The JARVIS Glenoid Reverse Shoulder Prosthesis is used for reverse shoulder prosthesis, intendedfor primary, fracture or revision shoulder replacement. The JARVIS Glenoid Reverse Shoulder Prosthesis is made up of three components - glenophere, baseplate, and fixation component (screw or post) . All components are offered in varying sizes to accommodate patient anatomy. The baseplate and screw components are manufactured from medical grade titanium alloy (Ti6Al4V-ELI) per ASTM F-136/ISO 5832-3, while the glenophere is manufactured from wrought cobalt chromium molybdenum alloy per ASTM F1537/ISO 5832-12. All components are provided sterile via gamma irradiation.

This document is an FDA 510(k) summary for the JARVIS Glenoid Reverse Shoulder Prosthesis. It does not contain information about an AI/ML medical device. Therefore, I cannot provide the requested information regarding acceptance criteria and study details for an AI-powered device.

The provided text describes a traditional medical device (shoulder prosthesis) and its mechanical and biocompatibility testing, which are standard for such devices to demonstrate substantial equivalence to legally marketed predicates.

To answer your specific questions about an AI/ML device, the input document would need to describe such a device, its intended use, and the performance studies conducted to support its claims.

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The ARROW Off-Centred Humeral Insert is designed for the following indications: REVERSE PROSTHESIS (POROUS GLENOID IMPLANT) The ARROW Reverse Shoulder Prosthesis is indicated for patients with severe shoulder arthropathy and a grossly deficient rotator cuff or a previously failed shoulder joint replacement with a grossly deficient rotator cuff. A functional deltoid muscle and adequate glenoid bone stock are necessary to use this device. The humeral stem is intended for cemented or cementless application while the porous glenoid baseplate is intended for cementless application with the addition of bone screws for fixation.

The ARROW Off-Centered Humeral Insert is used for reverse shoulder prosthesis, with implants of Arrow Reverse Shoulder System (K112193 and K150568), similar to the standard version. This is a modification of the standard ARROW reverse prosthesis (K122193), with the purpose of reducing lateralization of the prosthesis, increase the range of motion, and provide better adaptation for patient anatomy. The ARROW Off-Centered Humeral Insert is made up of four components are manufactured from medical grade titanium alloy (Ti6Al4V-ELI) per ASTM F-136/ISO 5832-3, polyethylene UHMWPE per ASTM F648/ISO 5834-1, and stainless steel 316L per ASTM F138/ISO 5832-1, identical to the previous ARROW Humeral Insert cleared in the 510(k) file ARROW Reverse Shoulder System (K112193). All components are provided sterile via gamma irradiation.

The provided document is a 510(k) summary for the ARROW Off-Centred Humeral Insert, a medical device. It focuses on demonstrating substantial equivalence to predicate devices, primarily through mechanical performance testing and adherence to various ISO standards, rather than clinical performance (e.g., diagnostic accuracy of an AI algorithm).

Therefore, the document does not contain the specific information required to answer the questions about acceptance criteria and study proving device performance as typically applied to a diagnostic AI device or other devices requiring clinical performance metrics.

The document describes pre-market testing relevant to an orthopedic implant, such as:

• Mechanical performance testing: Connections between stem and humeral insert (ASTM F2009), Range of Motion for reverse prosthesis (ASTM F1378).
• Sterilization: ISO 11137
• Packaging: ISO 11607
• Biocompatibility: ISO 10993-1
• Bacterial Endotoxin: LAL validation

These tests are to demonstrate that the new device performs "as well as or better than the predicate devices" and "does not raise new questions about safety and effectiveness," fulfilling the criteria for substantial equivalence.

Therefore, I cannot populate the table or answer the specific questions related to acceptance criteria, ground truth, expert adjudication, or MRMC studies for a diagnostic or AI-driven device, as this information is not present in the provided text.

The provided text describes a physical medical implant, not a software-driven or AI-based diagnostic device. The "study" referenced in the text is mechanical performance testing and compliance with material, sterilization, and packaging standards, not a clinical study involving human readers or AI algorithm performance against ground truth.

If your intention was to ask about a different type of device or a different kind of performance study, please provide the relevant document.

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E-Ortho shoulder is intended to be used as an information tool to assist in the preoperative surgical planning and visualization of a primary total shoulder replacement.

e-Ortho Shoulder software is a web-based surgical planning software application. e-Ortho Shoulder provides a pre-surgical planning tool for surgeons that helps them understand their patient's anatomy prior to surgery. Compared to using two-dimensional (2D) images to plan a shoulder arthroplasty (current method used by FH-Orthopedic surgeons), e-Ortho supplies information to surgeons to help prepare an intraoperative plan. E-Ortho allows surgeons to work in three-dimensional (3D) visualization, implant visualization and positioning within the specific patient's bone model (scapula and humerus), using reliable landmarks. This allows surgeons to preoperatively select the needed implant and determine its desired position.

The subject submission seeks to add humeral planning capabilities to the previously cleared FH E-Ortho Shoulder Software. Additional changes to the software have been made to improve functionality within the previously cleared intended use.

The e-Ortho Shoulder Software v1.1 is intended to be used as an information tool to assist in the preoperative surgical planning and visualization of a primary total shoulder replacement. The performance testing for this device is primarily focused on verification and validation activities, and a comparison against a "gold standard" software.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

   The document doesn't explicitly lay out acceptance criteria in a quantitative table with corresponding device performance metrics like sensitivity, specificity, or AUC as might be seen for diagnostic AI. Instead, the acceptance is demonstrated through the successful completion of verification and validation processes and equivalence to a "gold standard" software.

   Acceptance Criterion Type	Description	Reported Device Performance
   Functional Verification	Verification of functional components of the subject device through test campaigns.	Five test campaigns carried out by five different evaluators in two different environments. Three minor bugs identified, but "not expected to impact the planning itself."
   Usability Validation	Validation of critical features through usability testing.	A usability test campaign conducted with five surgeons. "The result of the validation tests coincides with the expected results for each test case and no test failed."
   Accuracy Testing	Comparison of implant values (version and inclination) obtained from the subject device against a "gold standard" software in simulated dangerous situations and potential harms.	Simulations included right and left-sided scenarios, head-first/feet-first supine positioning, varying reaming depths, and implant visualization from varying angles. Compared to Materialise Innovation Suite (Mimics V22 and 3matic V14) and SolidWork 2016. "All tests passed." "Thus, the accuracy of e-Ortho is adequate to provide safe use of the product."

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

   • Functional Verification Test Set: The sample size is not explicitly stated in terms of patient cases or images. Instead, it refers to "five test campaigns" carried out by "five different evaluators in two different environments" to verify "functional components." This suggests a focus on software functionality testing rather than patient data performance.
   • Usability Validation Test Set: "Usability test campaign, with critical features requiring validation by five surgeons." The number of "test cases" or patient data involved in this usability validation is not specified.
   • Accuracy Testing Test Set: Not specified in terms of patient cases. The testing involved "different virtual cases including right and left sided scenarios in head-first supine positioning of patient as well as feet-first supine patient positioning, varying reaming depths, and implant visualization from varying angles." This implies synthetically generated or modified cases rather than a specific set of retrospective or prospective patient data from a particular country. The data provenance is described as "simulated in different virtual cases."

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

   • For Functional Verification and Usability Validation, the "experts" were the "five different evaluators" and "five surgeons" respectively. Their qualifications are not explicitly detailed beyond being "surgeons" for usability.
   • For Accuracy Testing, the ground truth was established by "gold standard" software: Materialise innovation Suite (Mimics V22 and 3matic V14) and SolidWork 2016. No human experts are described as establishing the ground truth directly for this specific part of the testing.

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

   The document does not describe an adjudication method for establishing ground truth, as the accuracy testing relied on "gold standard" software rather than human consensus. For functional and usability testing, it appears to be direct observation of test results and comparison to expected outcomes.

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 MRMC comparative effectiveness study is mentioned in the document. The study described focuses on the standalone performance and accuracy of the software against "gold standard" software, and its usability. There is no comparison of human reader performance with and without AI assistance described.

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

   Yes, a form of standalone performance assessment was done, particularly in the "Accuracy Testing" section. The device's output for implant values (version and inclination) in various simulated scenarios was compared directly to the output of Materialise Innovation Suite (Mimics V22 and 3matic V14) and SolidWork 2016, which serve as the "gold standard" for these measurements. This is an evaluation of the algorithm's performance in generating specific measurements.

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

   The ground truth for the accuracy testing was established by results from "gold standard" commercial software: Materialise innovation Suite (Mimics V22 and 3matic V14) and SolidWork 2016. For the functional and usability testing, the ground truth was based on expected software behavior and user experience.

8. The sample size for the training set:

   The document does not mention the use of a "training set" or machine learning algorithms in the conventional sense that would require a separate training dataset. The device is described as "web-based surgical planning software" that provides analysis tools and 3D visualization. The performance testing focuses on verification, validation, and accuracy against "gold standard" software, rather than the performance of a machine learning model trained on a specific dataset.

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

   Since no training set is mentioned or described as part of the device's development or evaluation in the document, there is no information on how its ground truth was established.

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The prostheses from FH Industrie are designed for specific indications such as:

SIMPLE HUMERAL PROSTHESIS

• Humeral head necrosis without injury to the glenoid cavity.
• Extensive humeral head cartilage damage without injury to the glenoid cavity
• Centred osteoarthritis with a glenoid cavity not allowing implantation of a glenoid implant.
• Rheumatoid polyarthritis with thin rotator cuff.
• Off-centred osteoarthritis with irreparable cuff, and with maintained active elevation of at least 120°.

TOTAL ANATOMICAL PROSTHESIS (CEMENTED GLENOID IMPLANT WITH 4 PEGS)

• Centred glenohumeral osteoarthritis with functional rotator cuff
• Rheumatoid polyarthritis with functional rotator cuff
• Post-traumatic sequela, functional rotator cuff with glenoid injury.

TOTAL ANATOMICAL PROSTHESIS (POROUS GLENOID IMPLANT)

• Centred glenohumeral osteoarthritis
• Rheumatoid polyarthritis
• Post-traumatic sequela with glenoid injury
• Revision for glenoid loosening
• Glenoid bone loss, where bone graft is needed
• A functional rotator cuff is necessary to use this device

REVERSE PROSTHESIS (METAL-BACK OR POROUS GLENOID IMPLANT)
The ARROW Reverse Shoulder Prosthesis is indicated for patients with severe shoulder arthropathy and a grossly deficient rotator cuff or a previously failed shoulder joint replacement with a grossly deficient rotator cuff. A functional deltoid muscle and adequate glenoid bone stock are necessary to use this device.

For all types of prosthesis, the glenoid baseplate (metal-back or porous) is intended for cementless use with the addition of bone screws for fixation, the humeral short stem (metaphyseal stem) is intended for cementless use. At least 2/3 of the metaphyseal component must be implanted in the proximal humeral bone to allow for adequate humeral component fixation.

The ARROW Humeral Short Stem Humeral System is an extension of humeral stem range of the Arrow prosthesis. The short stem is composed of a metaphyseal part and a cylindrical diaphyseal part. Both components are offered in various sizes to accommodate patient anatomy. This modular stem helps for better adaptation to each patient's anatomy. All implantable components are manufactured from medical grade titanium alloy (Ti6Al4V-ELI) per ASTM F-136/ISO 5832-3. The metaphysis has fins to provide rotational stability; it has a pure titanium plasma spray coating per ASTM 1580.

This document is a 510(k) Pre-Market Notification from the FDA for the ARROW Short Stem Humeral System. It primarily focuses on demonstrating substantial equivalence to predicate devices, rather than providing a detailed study of the device's performance against specific acceptance criteria.

Therefore, many of the requested elements (like acceptance criteria tables, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth methodologies) are not present in this document because they are typically part of a more extensive clinical or validation study report, not a 510(k) summary.

The document states that performance testing was conducted, but it's focused on mechanical testing, sterilization, packaging, and biocompatibility to demonstrate substantial equivalence, not clinical effectiveness against pre-defined acceptance criteria for a new clinical claim.

I will fill in the requested information based on what is available in the provided text. For categories where the information is not provided, I will explicitly state that.

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

This document does not provide a table of acceptance criteria or reported device performance in the manner of clinical efficacy or diagnostic accuracy. Instead, it states that "The results of all mechanical tests have shown them to be substantially equivalent to the predicate device."

Here's an attempt to extract the relevant tests conducted and the general outcome as described:

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

This information is not provided in the document. The testing described is primarily mechanical and material testing, not clinical studies involving patient data. Therefore, the concepts of "test set" or "data provenance" in a clinical sense do not apply to the reported performance 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 information is not provided in the document. The document describes mechanical and material testing for a surgical implant, not a diagnostic device where "ground truth" is typically established by experts.

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

This information is not provided in the document. Adjudication methods are relevant for clinical studies, particularly those involving human interpretation of data, which is not described here.

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 information is not provided in the document. The device is a surgical implant (shoulder prosthesis), not an AI-assisted diagnostic or imaging device. Therefore, MRMC studies and AI assistance metrics are not applicable.

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

This information is not provided in the document. The device is a surgical implant, not an algorithm, so "standalone performance" in this context is not applicable.

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

This information is not provided in the document. For the mechanical and material tests described, the "ground truth" would be the engineering specifications and performance thresholds established by relevant ASTM/ISO standards and internal design requirements, rather than clinical ground truth types like pathology or outcome data.

8. The sample size for the training set

This information is not provided in the document. As this is not an AI/machine learning device, the concept of a "training set" is not applicable.

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

This information is not provided in the document. As this is not an AI/machine learning device, the concept of a "training set" and its associated ground truth is not applicable.

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Fracture of the proximal extremity of the humerus. Fracture of the diaphysis of the humerus.

The FH Industrie TELEGRAPH® EVOLUTION Humeral Nailing System includes short and long intramedullary cannulated humeral nails with right and left orientations, proximal screws and a washer. The nails, screws, and washer are intended for use in treatment of fracture of the proximal extremity of the humerus or fracture of the diaphysis of the humerus. All implantable components are manufactured from medical grade titanium alloy (Ti6Al4V-ELI). The nails that are the subject of this submission are cannulated.

I'm sorry, but I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text.

The document you provided, K200127, is a 510(k) Premarket Notification from the FDA for a medical device called the "TELEGRAPH® EVOLUTION Humeral Nailing System." This document primarily focuses on demonstrating substantial equivalence to previously cleared devices, rather than laying out specific, quantitative performance acceptance criteria or detailed study results for a new, AI-powered diagnostic device.

Here's why the provided text does not contain the information you are looking for:

• Device Type: The device described is a surgical implant (intramedullary fixation rod for humeral fractures), not an AI-powered diagnostic or imaging device. Therefore, the types of performance metrics and study designs you've asked about (e.g., sensitivity, specificity, MRMC studies, ground truth establishment for AI models) are not relevant to this mechanical device.
• Regulatory Pathway: The 510(k) pathway is for demonstrating a new device is "substantially equivalent" to a legally marketed predicate device. This typically involves comparisons of indications for use, technological characteristics (materials, design, dimensions), and often mechanical testing to show similar performance to the predicate. It does not generally require the kind of clinical performance studies with specific statistical acceptance criteria that would be needed for novel diagnostic algorithms (like those typically found in a De Novo or PMA submission for AI/ML devices).
• "Performance Testing" Section: The "Performance Testing" section in the document refers to:
  • Sterilization (ISO 11137), packaging (ISO 11607), and biocompatibility (ISO 10993-1) validations: These are standard tests for medical device safety and sterility, not clinical performance metrics.
  • Mechanical testing per ASTM F1264 and ASTM F543: These are engineering standards for testing the mechanical properties (e.g., strength, fatigue) of orthopedic implants. The conclusion states that "results have shown them to be substantially equivalent to the predicate device," which is a comparative statement rather than a demonstration of meeting predefined absolute performance thresholds.

In summary, the provided document does not discuss:

1. A table of acceptance criteria and reported device performance related to diagnostic accuracy.
2. Sample sizes for test sets in the context of diagnostic performance.
3. Number of experts establishing ground truth or their qualifications.
4. Adjudication methods.
5. MRMC comparative effectiveness studies.
6. Standalone algorithm performance.
7. Types of ground truth like pathology or outcomes data for diagnostic purposes.
8. Training set sample sizes or ground truth establishment for training an AI model.

To answer your prompt, you would typically need a regulatory submission document for an AI/ML device, which would include detailed statistical analysis plans, clinical study results, and defined performance metrics.

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E-Ortho shoulder is intended to be used as an information tool to assist in the preoperative surgical planning and visualization of a primary total shoulder replacement.

e-Ortho Shoulder software is a web-based surgical planning software application. e-Ortho Shoulder provides a pre-surgical planning tool for surgeons that helps them understand their patient's anatomy prior to surgery. Compared to using two-dimensional (2D) images to plan a shoulder arthroplasty (current method used by FH-Orthopedic surgeons), e-Ortho supplies information to surgeons to help prepare an intraoperative plan. E-Ortho allows surgeons to work in three-dimensional (3D) visualization, implant visualization and positioning within the specific patient's bone model (scapula and humerus), using reliable landmarks. This allows surgeons to preoperatively select the needed implant and determine its desired position.

The provided text describes the e-Ortho Shoulder Software, a web-based surgical planning tool for primary total shoulder replacement. It outlines the device's intended use, its substantial equivalence to a predicate device, and a general overview of performance testing but lacks specific details regarding acceptance criteria, study design, and results.

Here's an analysis based on the provided information, with explicit statements about what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

The document mentions that "The result of the validation tests coincides with the expected results for each test case and no test failed." However, it does not provide a specific table of acceptance criteria or quantitative performance metrics for the e-Ortho Shoulder Software. It vaguely states that accuracy testing was carried out to "guarantee the performance," but no specific results are shared.

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

The document states:

• "The validation process was implemented through a usability test campaign, with critical features requiring validation by multiple surgeons."
• "Additional accuracy testing was carried out to guarantee the performance of e-Ortho."

The exact sample size used for the test set is not specified. We only know that "multiple surgeons" were involved in the usability testing.

The data provenance (e.g., country of origin, retrospective or prospective) for the test set is not mentioned.

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

The document mentions "multiple surgeons" for usability testing, but it does not explicitly state how many experts were used to establish the ground truth for any accuracy testing, nor does it detail their qualifications (e.g., years of experience, subspecialty).

4. Adjudication Method for the Test Set:

No adjudication method (e.g., 2+1, 3+1, none) for establishing ground truth from experts is mentioned or described in the provided text.

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

The document does not indicate that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was conducted comparing human readers with and without AI assistance. The focus is on the device as a planning tool for surgeons rather than an assistive AI for diagnostic reading. It mentions that "Compared to using two-dimensional (2D) images to plan a shoulder arthroplasty (current method used by FH-Orthopedic surgeons), e-Ortho supplies information to surgeons to help prepare an intraoperative plan," suggesting a comparison, but no formal MRMC study is detailed.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop) Performance Was Done:

The e-Ortho Shoulder Software is described as an "information tool to assist in the preoperative surgical planning" and states that "the chosen procedure is the responsibility of the Surgeon." It clarifies that an "e-Ortho engineer provides inputs via the e-Ortho software." This suggests that the device operates within a human-in-the-loop workflow, providing tools and visualizations.

While accuracy testing was mentioned, it's not clear if a standalone performance evaluation of the algorithm without human interaction for implant sizing, positioning, etc., was performed and reported. The summary emphasizes its role as an assistive tool for surgeons, with an engineer providing inputs.

7. The Type of Ground Truth Used:

The document does not explicitly state the type of ground truth used for any accuracy testing. Given its use for surgical planning, potential ground truth sources could include:

• Expert Consensus: Likely for the "expected results" in validation tests.
• Pathology/Outcomes Data: Not mentioned, but ideal for long-term clinical validation.
• Physical measurements/ Cadaveric studies: Not mentioned.

The specific source of ground truth for accuracy claims is not detailed.

8. The Sample Size for the Training Set:

The document does not provide any information regarding the sample size for the training set used to develop or train the e-Ortho Shoulder Software. As a pre-market submission, such details about model development are often included.

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

Similar to question 8, since no information regarding a training set is provided, there is no mention of how the ground truth for any potential training set was established.

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