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The Prophecy® Preoperative Navigation Alignment System is intended to be used as patient specific surgical instrumentation to assist in the positioning of total ankle replacement components intraoperatively, in guiding the marking of bone before cutting, and in the pre-surgical planning of the ankle and surrounding anatomy to support the total ankle implant. The Prophecy® Preoperative Navigation Alignment Guides and Reports are intended for use with the Inbone®, Infinity® and Invision® Total Ankle Systems and their cleared indications for use, provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans. The Prophecy® Preoperative Navigation Alignment Guides are intended for single use only.

The Prophecy® Preoperative Navigation Alignment System is composed of three components:

• Prophecy® patient-specific guides
• Prophecy® 3D Planner
• Prophecy® Preoperative report

The Prophecy® Preoperative Navigation Alignment guides are patient-specific devices that are designed based on preoperative planning software and assist surgeons in transferring their preoperative plan to surgery by guiding the marking of bone and/or guiding surgical instruments.

The Prophecy® 3D Planner software is a web-based application. The user interface software is intended to be used by orthopedic surgeons, as a preoperative planning and intraoperative viewing software for total ankle replacement surgery.

The Prophecy® Preoperative reports are patient-specific reports created from imaging scans to provide surgeons a template of the patient's distal tibial and proximal talar anatomy and offers relevant information for a successful total ankle replacement surgery.

The Prophecy® Preoperative Navigation Alignment System is compatible with the Inbone™, InfinityTM, and Invision™ Total Ankle Systems.

The Prophecy® Preoperative Navigation Alignment System is intended to be used as patient-specific surgical instrumentation to assist in the positioning of total ankle replacement components intraoperatively, in guiding the marking of bone before cutting, and in the pre-surgical planning of the ankle and surrounding anatomy to support the total ankle implant. The Prophecy® Preoperative Navigation Alignment Guides and Reports are intended for use with the Inbone®, Infinity® and Invision® Total Ankle Systems and their cleared indications for use, provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans. The Prophecy® Preoperative Navigation Alignment Guides are intended for single use only.

1. Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance

The document does not specify the exact sample sizes used for the software verification, validation, or usability tests. It only states that the testing was conducted "in-house." The data provenance is not explicitly mentioned (e.g., country of origin, retrospective/prospective).

3. Number and Qualifications of Experts for Ground Truth

Not applicable. The study is focused on software verification, validation, and usability for a surgical planning system, not on diagnostic accuracy requiring expert panel review for ground truth.

4. Adjudication Method

Not applicable. This type of testing (software V&V, usability) does not typically involve adjudication methods like 2+1 or 3+1.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was mentioned. The submission states that "Clinical testing was not necessary for the determination of substantial equivalence."

6. Standalone Performance (Algorithm Only)

The testing described (software verification, validation, and usability) evaluates the performance of the software components of the device, which would include the algorithm's functionality. However, it's not explicitly stated as a standalone "algorithm only" performance study in the context of comparative effectiveness or diagnostic accuracy. The Prophecy® 3D Planner software allows surgeons to modify implant type, size, and orientation, indicating an interaction with a human user.

7. Type of Ground Truth

For software verification and validation, ground truth would be defined by the design requirements and functional specifications. For usability testing, ground truth would involve evaluating whether the software performs as expected for the intended users and uses, likely based on pre-defined tasks and performance metrics. Pathology or outcomes data are not applicable to the described non-clinical tests.

8. Sample Size for Training Set

Not applicable. This document describes testing for a device that involves software for surgical planning and patient-specific guides generation, not a machine learning model that requires a training set in the traditional sense for diagnostic or predictive tasks.

9. How Ground Truth for Training Set Was Established

Not applicable, as there is no mention of a training set for a machine learning model.

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Wright's PROPHECY™ Preoperative Navigation Alignment System is intended to be used as patient-specific surgical instrumentation to assist in the positioning of total ankle replacement components intraoperatively, in guiding the marking of bone before cutting, and in the pre-surgical planning of the ankle and surrounding anatomy to support the total ankle implant. The PROPHECY™ Preoperative Navigation Alignment Guides and Reports are intended for use with Wright's INBONE™, INFINITY™ and INVISION™ Total Ankle Systems and their cleared indications for use, provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans. The PROPHECY™ Preoperative Navigation Alignment Guides are intended for single use only.

The PROPHECY™ Preoperative Navigation Alignment System is composed of two components:

• . PROPHECY™ Preoperative report
• . PROPHECY™ patient-specific guides

The PROPHECY™ Preoperative reports are patient-specific reports created from imaging scans to provide surgeons a template of the patient's distal tibial and proximal talar anatomy and information relevant to the successful implantation of a total ankle replacement. The PROPHECY™ Preoperative Navigation Alignment guides are patient-specific devices that are based on preoperative planning software and assist surgeons in transferring this preoperative plan to the surgery by guiding the marking of bone and/or guiding surgical instruments. The PROPHECY™ patient-specific guides are accompanied by the preoperative report and serve as a template for traditional alignment instrumentation used with Wright Medical's INBONE™, INFINITY™, and INVISION™ Total Ankle Systems.

The provided text does not contain information about acceptance criteria or a study proving the device meets those criteria for the PROPHECY™ Preoperative Navigation Alignment System.

The document is a 510(k) premarket notification summary, which focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed performance study results against specific acceptance criteria.

Specifically, the document states under "(b)(1). Substantial Equivalence - Non-Clinical Evidence":

• "The following evaluations were conducted to support the safety and effectiveness of the PROPHECY™ Navigation Alignment System changes to the PROPHECY™ Preoperative report: Board Certified Surgeon content, layout and accuracy verification and validation"
• "These evaluations concluded the subject device is substantially equivalent to the predicates and is adequate to perform as intended."

And under "(b)(2). Substantial Equivalence- Clinical Evidence":

• "N/A" (Not Applicable)

This indicates that a formal clinical study with performance metrics against acceptance criteria, as typically seen for novel devices or significant performance claims, was not provided or required for this particular 510(k) submission. The "Board Certified Surgeon content, layout and accuracy verification and validation" seems to be a qualitative assessment for the report's changes, not a quantitative performance study with the details requested in the prompt.

Therefore, I cannot populate the table or answer the specific questions regarding acceptance criteria, sample sizes, expert qualifications, or detailed study methodology because this information is not present in the provided text.

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PreOp is intended for use by a trained/qualified EEG technologist or physician on both adult and pediativ subjects at least 3 years of age for the visualization of human brain function by fusing a variety of EEG information with rendered images of an individualized head model and an individualized MRI image.

PreOp is medical device software that combines EEG data and MR images to visualize recorded EEG activity in 3D in the brain. PreOp can be subdivided in 3 main modules: 3D Electrical Source Imaging (i.e. 3D ESI), Report generation and Viewer generation. The device's input is the MRI and EEG data that are uploaded by the user to the PreOp cloud environment. The output of the device is a report containing the results of the visualization and the ability to evaluate the results in 3D using the 3D viewer. The user can access the output through the PreOp cloud environment.

Here's a breakdown of the acceptance criteria and the study details for the PreOp device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria in a dedicated section. Instead, the acceptance is based on demonstrating "substantial equivalence" to a predicate device, particularly in source localization performance.

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

• Study 1 (Source Localization Equivalence):
  • Sample Size: 18 epilepsy subjects.
  • Data Provenance: Retrospective data analysis. Country of origin is not explicitly stated, but given Epilog is based in Belgium, it's likely European or a mix.
• Study 2 (Spike Source Localization Consistency):
  • Sample Size: Data from 8 patients, evaluating 16 epileptic spikes (13 identical + 3 very close).
  • Data Provenance: Not explicitly stated as retrospective or prospective, but likely retrospective. Country of origin is not specified.

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

• Study 1:
  • Number of Experts: Three experienced epileptologists.
  • Qualifications: "Experienced epileptologists." Specific years of experience are not provided.
• Study 2: Not applicable in the same way, as this study was comparing internal algorithm performance rather than having experts establish a new ground truth based on device output.

4. Adjudication Method for the Test Set

• Study 1: The document states that the three experienced epileptologists "were asked to rate whether each of the algorithm solutions (sLORETA with the finite difference model [FDM] using an idealized or individualized anatomical MRI) were concordant on a sublobular level." The specific method for consolidating these ratings (e.g., 2 out of 3 agreement) is not detailed, but it implies a consensus-based approach for determining "substantial equivalence."

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

No, a traditional MRMC comparative effectiveness study evaluating human reader improvement with AI assistance was not performed. The study focused on comparing the performance of the device's algorithms against a predicate device's algorithms (Study 1) or comparing different internal algorithm configurations (Study 2), with human experts acting as adjudicators for the output in Study 1.

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

Yes, the studies primarily assess the standalone performance of the algorithms.

• Study 1 directly compares "the source localization accuracy of the PreOp software algorithms" to "the predicate algorithm." Human experts then rated the concordance of these algorithm outputs with post-operative reports. This is a standalone comparison.
• Study 2 compares "the performance of spike source localization using HD-EEG recordings... and Low Density LD-EEG recordings" within the PreOp algorithms themselves. This is also a standalone assessment.

7. The Type of Ground Truth Used

• Study 1 (Source Localization Equivalence):
  • Ground Truth: Clinical outcomes data combined with expert consensus. Specifically, the resected zone (operative data) for subjects who were Engel I postoperatively (favorable outcome) was used as the reference. The "summaries of the postoperative reports" were provided to the epileptologists, who then rated the concordance of the algorithm solutions with this clinical ground truth.
• Study 2 (Spike Source Localization Consistency):
  • Ground Truth: The "ground truth" here is internal consistency of the PreOp algorithm itself under different input conditions (HD-EEG vs. LD-EEG). There isn't an external ground truth like pathology for this specific study; instead, it verifies the consistency of the algorithm's output.

8. The Sample Size for the Training Set

The document does not provide information on the sample size for the training set used to develop the PreOp algorithms. The studies described are validation studies (test sets) for the already developed software.

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

Since the document does not mention the training set size, it also does not detail how the ground truth for any training set was established.

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MediClear™ PreOp is indicated for use as a pre-operative (incision/insertion) drape that provides continuous antimicrobial activity to reduce the risk of contamination of the skin site by acting as an external barrier to microbial and other contamination.

MediClear™ PreOp can be left on the preoperative incision site for up to 7 days.

MediClear™ PreOp is intended to be used on intact skin and for external use only.

MediClear™ PreOp consists of a clear polyurethane film coated with an antimicrobial silicone adhesive containing 3% w/w chlorhexidine and 0.5% w/w silver salts and is intended to cover and protect skin from the risk of contamination prior to an invasive procedure (i.e. incision or insertion). The chlorhexidine and silver contained in the adhesive provides continuous antimicrobial activity while the polyurethane barrier film acts as a protective patient covering to isolate a procedural site from microbial and other contamination.

MediClear™ PreOp provides an effective physical barrier against external contamination including fluids, bacteria, and yeast. In vitro testing* demonstrates that the chlorhexidine and silver incorporated within the silicone adhesive provides a rapid bactericidal and fungicidal effect against microorganisms including Staphylococcus aureus (MRSA), Staphylococcus epidermidis, Enterococcus faecalis (VRE), Klebsiella pneumoniae, Pseudomonas aeruginosa, Enterobacter cloacae, Candida albicans, and Candida tropicalis averaging a 99.9% reduction at 10 minutes and a 99.99% reduction at 30 minutes, and prevents their re-growth for up to 7 days during wear. * In vitro effectiveness does not predict clinical performance.

MediClear™ PreOp is a breathable, transparent, self-adhesive silicone film that conforms to the contours of the body.

The document describes the acceptance criteria for the MediClear™ PreOp device and the studies performed to demonstrate that it meets these criteria.

Here's the breakdown:

1. Table of Acceptance Criteria and Reported Device Performance:

*Note: The document explicitly states: "In vitro effectiveness does not predict clinical performance." This is an important disclaimer for the antimicrobial activity results.

2. Sample Size Used for the Test Set and the Data Provenance:
The document does not provide specific sample sizes for any of the non-clinical tests mentioned. All tests listed are in vitro or bench tests conducted in a laboratory setting. There is no indication of human or animal data provenance (e.g., country of origin, retrospective/prospective) for these non-clinical tests.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
This information is not applicable as the studies described are non-clinical bench and in vitro tests. Ground truth in this context would typically refer to the reference standards or control groups used in the laboratory experiments, as well as the expertise of the scientists performing and interpreting the tests according to the cited ISO and ASTM standards. The document does not specify the number or qualifications of these scientific personnel.

4. Adjudication Method for the Test Set:
This information is not applicable as the studies described are non-clinical bench and in vitro tests. Adjudication methods like 2+1 or 3+1 are relevant for clinical studies or studies involving human readers/interpreters where disagreements need to be resolved.

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:
A Multi Reader Multi Case (MRMC) comparative effectiveness study was not performed. The device is a physical surgical drape, not an AI or imaging diagnostic tool that would typically involve human readers or AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
A standalone algorithm-only performance study was not performed. This device is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For the antimicrobial activity, the "ground truth" or reference for evaluating reduction would be the initial microbial counts before exposure to the device, as measured by standard microbiological assays. For biocompatibility tests, the ground truth refers to established biological responses to control materials or the absence of adverse effects as defined by the ISO 10993 series. For barrier performance, it's the ability to prevent penetration under defined conditions specified by ASTM/AAMI standards. These are laboratory-based ground truths derived from scientific standards and experimental controls.

8. The sample size for the training set:
This information is not applicable. The device is a physical medical device and does not involve AI or machine learning algorithms that require a training set.

9. How the ground truth for the training set was established:
This information is not applicable as there is no training set for this device.

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Wright's PROPHECY® Preoperative Navigation Alignment System is intended to be used as patient specific surgical instrumentation to assist in the positioning of total ankle replacement components intraoperatively and in guiding the marking of bone before cutting. The PROPHECY® Preoperative Navigation Alignment Guides are intended for use with Wright's INBONE® and INFINITY® Total Ankle Systems and their cleared indications for use, provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans. The PROPHECY® Preoperative Navigation Alignment Guides are intended for single use only. The PROPHECY® Preoperative Reports are intended for use with Wright's INBONE®, INFINITY® and INVISION® Total Ankle Systems and their cleared indications for use, provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans.

PROPHECY® Preoperative Navigation Alignment System provides the surgeon a template of the patient's distal tibial and proximal talar anatomy. The PROPHECY® alignment report serves as a template for traditional alignmentation used with Wright's INBONE®, INFINITY , and INVISION® Total Ankle Systems.

The provided document does not contain information regarding a specific study with acceptance criteria and a detailed analysis of device performance against those criteria. The document is a 510(k) summary for the PROPHECY® INVISION® Preoperative Navigation Alignment System, which focuses on demonstrating substantial equivalence to predicate devices rather than presenting a performance study with detailed acceptance criteria and reported device performance.

Therefore, I cannot provide the requested information. The sections concerning sample size, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set details are not present in this document.

The "Design repeatability across design engineers" and "Software validation" mentioned in section 7 ("Substantial Equivalence- Non-Clinical Evidence") are very high-level statements and do not provide the detailed performance metrics, acceptance criteria, or study methodologies that would allow for a comprehensive answer to your request.

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The Glenoid Intelligent Reusable Instrument System ("Glenoid IRIS") is a patient specific manual instrument system intended to facilitate preoperative planning and intraoperative placement of the central glenoid guide pin used in the preparation of the glenoid in total shoulder systems that utilize a central guide pin for preparing the glenoid to receive the glenoid implant.

The Arthrex Glenoid IRIS is indicated for use with the Arthrex Univers II and Arthrex Univers Apex, Keeled or Pegged Glenoid components, the Vault Lock Glenoid Component, as well as the Univers Revers Baseplate component.

The indications for use of the Arthrex shoulder systems with which the Arthex Glenoid IRIS is intended to be used are the same as those described in the labeling for these shoulder systems.

The Arthrex OrthoVis Preoperative Plan is a preoperative plan created via the OrthoVis software that facilitates accurate preoperative planning and intraoperative placement of the glenoid component in total shoulder replacement.

The Arthrex Glenoid IRIS is indicated for use with the Arthrex Univers II and Arthrex Univers Apex, Keeled or Pegged Glenoid components, the Vault Lock Glenoid Component, as well as the Univers Revers Baseplate component.

The indications for use of the Arthrex shoulder systems with which the Arthex OrthoVis Preoperative Plan is intended to be used are the same as those described in the labeling for these shoulder systems.

The Arthrex VIP Web Portal is intended for use as a software interface and for the transfer of imaging information from a medical scanner such as a CT scanner. It is also intended as software for displaying/editing implant placement and surgical treatment options that were generated in the OrthoVis Desktop Software by trained COS technicians. The Arthrex VIP Web Portal is intended for use with the Arthrex Glenoid Intelligent Reusable Instrument System (Arthrex Glenoid IRIS) and with the Arthrex OrthoVis Preoperative Plan. It is indicated for use with the following glenoid implant lines: Arthrex Univers II and Arthrex Univers Apex, Keeled or Pegged Glenoid components, the Vault Lock Glenoid Component, as well as the Univers Revers Baseplate component.shoulder systems.

The Glenoid IRIS is an instrument system intended for use in total shoulder replacement to facilitate preoperative planning and intraoperative placement of the glenoid implant component.

This bundled submission contains four traditional 510(k) submissions associated with Arthrex Glenoid IRIS. All of the submissions correspond to components of the system that are intended for use together to place the guide pin, and subsequently the glenoid implant, in a total shoulder replacement surgery. All of the components (subject devices in the bundled submissions) of Arthrex Glenoid IRIS are indicated for use with the Arthrex lines of Glenoid implants. We would now like to add the Arthrex Vault Lock glenoid implant to this list of compatible/indicated implant systems.

The provided text describes a 510(k) submission for the Arthrex Glenoid Intelligent Reusable Instrument System (IRIS) and associated components. However, it does not contain specific acceptance criteria or the details of a study that proves the device meets such criteria. The document primarily focuses on the device's intended use, regulatory classification, and its substantial equivalence to predicate devices, with a brief mention of verification/validation testing.

Therefore, I cannot provide the detailed information requested in the prompt based on the given text. The "SUMMARY OF VERIFICATION/VALIDATION TESTING" section is very high-level and lacks the specifics required to answer your questions.

To answer your questions accurately, I would need a document that describes:

• Specific performance metrics (e.g., accuracy, precision, sensitivity, specificity) for the device.
• Thresholds or targets for these metrics that constitute "acceptance."
• Detailed methodology of studies (e.g., test set demographics, ground truth establishment, reader studies if applicable, statistical analysis).

Without this information, any attempt to populate the requested table or answer the specific questions would be speculative and inaccurate.

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The Arthrex OrthoVis Preoperative Plan is a preoperative plan created via the OrthoVis software accurate preoperative planning and intraoperative placement of the glenoid component in total shoulder replacement.

The Arthrex Preoperative Plan is indicated for use in planning the central glenoid guide pin for the Arthrex Univers™ II and Univers™ Apex Keeled glenoid component, Univers™ II and Univers™ Apex Pegged glenoid component, and the Univers Revers™ Baseplate.

The indications for use of the Arthrex shoulder systems with which the Arthex OrthoVis Preoperative Plan is intended to be used are the same as those described in the labeling for these shoulder systems.

The Arthrex OrthoVis Preoperative Plan is a preoperative plan document that is created in the OrthoVis software. A patient CT scan is loaded into the OrthoVis software and the desired bony anatomy can be separated and segmented with OrthoVis tools, allowing extracted and segmented bones (e.g., scapula, humerus) to be virtually implanted with shoulder replacement implants.

Here's a breakdown of the acceptance criteria and study information for the Arthrex OrthoVis Preoperative Plan, based on the provided text:

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

The document does not explicitly present a table of acceptance criteria with numerical targets. Instead, it describes a "Non-Clinical Testing" section that outlines the studies performed to demonstrate substantial equivalency to a predicate device. The primary performance metric mentioned is related to central guide pin placement accuracy as improved by the preoperative plan.

Given the information, we can infer the acceptance criteria and reported performance qualitatively from the "Inter and Intra User Surgical Planning Comparison Study". The goal of this study would be to show that the Arthrex OrthoVis Preoperative Plan, with the new Arthrex implants, provides comparable or improved accuracy in planning features (like the central glenoid guide pin) compared to the predicate device with its original implants.

Inferred Acceptance Criteria Table:

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

• Sample Size for Test Set: Not specified in the provided document. The "Inter and Intra User Surgical Planning Comparison Study" is mentioned, but details on the number of cases or users included are absent.
• Data Provenance: Not specified. There is no information regarding the country of origin of the CT scans or whether the data was retrospective or prospective.

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)

• The document does not explicitly state how ground truth was established, nor does it specify the number or qualifications of experts for the test set. The study type ("Inter and Intra User Surgical Planning Comparison Study") suggests that potentially human planners (surgeons or trained personnel) were involved in generating plans, which were then compared, but it does not clarify if these plans themselves served as a ground truth or if an independent "true" surgical plan was used for comparison.

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

• The adjudication method is not specified.

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

• The document mentions an "Inter and Intra User Surgical Planning Comparison Study." This study design often involves multiple users (readers/planners) creating plans for multiple cases, which aligns with the "multi-reader multi-case" concept. However, it's not strictly an AI-assistance study in the sense of comparing human performance with and without an AI diagnosis/recommendation. Instead, the device is a planning tool that facilitates planning.
• The study's goal was to demonstrate substantial equivalence to a predicate device. It's likely comparing the planning outcome (e.g., pin placement accuracy) when using the OrthoVis software with the new Arthrex implants versus potentially the predicate device's software with its specific implants, or against a manual planning method.
• Effect Size: The document does not provide any effect size or numerical improvement metrics for human readers using the device. It only states that the testing was performed to demonstrate substantial equivalency.

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

• No, a standalone (algorithm only) performance study is not described. The device is explicitly a "preoperative plan created via the OrthoVis software" that "facilitates accurate preoperative planning and intraoperative placement." This implies a human-in-the-loop process where the software is a tool for a planner/surgeon. The "Inter and Intra User Surgical Planning Comparison Study" further supports this by involving human users.

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

• The type of ground truth is not explicitly stated. For a planning tool, ground truth would ideally be the "optimal" or "correct" surgical plan/placement. This could be established by:
  • Expert Consensus: Multiple highly experienced surgeons or planners agreeing on an optimal plan.
  • Pathology/Intraoperative Images: Post-operative imaging or intraoperative photos confirming the actual placement of components (though this is more for verification than establishment of the preoperative ground truth).
  • Biomechanical Simulation: Computational models determining ideal placement based on patient-specific anatomy and biomechanics.
• Given the nature of the device, it's most probable that an expert consensus or a gold-standard manual planning method was used as a reference for comparison, but the document does not confirm this.

8. The sample size for the training set

• The document does not refer to a training set. This product is described as software that uses patient CT scans to create a preoperative plan. While the software itself would have been developed and "trained" in a broader sense (e.g., development of segmentation algorithms), this 510(k) summary focuses on the validation of the software's output for a specific clinical application (new implants). There is no mention of machine learning or deep learning models that require a distinct "training set" in the context of this regulatory submission. "Software verification and validation" generally refers to traditional software engineering testing.

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

• As no training set is mentioned in the context of this regulatory submission, there is no information on how its ground truth would have been established.

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The OrthoVis Preoperative Plan is a preoperative plan document created via the OrthoVis software that facilitates accurate preoperative planning and intraoperative placement of the glenoid component in total shoulder replacement. The OrthoVis Software and resulting Preoperative Plan is indicated for use with the DePuy Global APTM Shoulder glenoid, Global Shoulder StepTech™ Anchor Peg glenoid, or Delta XtendTM Reverse Shoulder metaglene components.

The indications for use of the DePuy shoulder systems with which the OrthoVis Preoperative Plan is intended to be used are the same as those described in 510(k) KI23122.

The OrthoVis Preoperative Plan is a preoperative plan document that is created in OrthoVis software. A patient CT scan is loaded into OrthoVis software and the desired bony anatomy can be separated and segmented with OrthoVis tools, allowing extracted and segmented bones (e.g., scapula, humerus) to be virtually implanted with shoulder replacement implants. OrthoVis currently is used only with the DePuy Global APG glenoid, DePuy Global StepTech, and DePuy Delta Xtend components for total shoulder arthroplasty. OrthoVis can then produce a preoperative plan document (.pdf file), the OrthoVis Preoperative Plan, that contains text, images, and in electronic format, a rotatable 3D model(s) of the implanted component and bone. This preoperative plan document is labeled, via a watermark, as unapproved until the ordering surgeon approves the plan, at which point such labeling is removed and the final plan provided to the ordering surgeon.

The following information describes the acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state formal acceptance criteria with numerical targets. However, the non-clinical testing performed aims to demonstrate the device's ability to accurately perform its intended use and function, particularly in aiding accurate guide pin placement in total shoulder arthroplasty.

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Wright's PROPHECY® Preoperative Navigation Alignment Guides are intended to be used as patient-specific surgical instrumentation to assist in the positioning of total ankle replacement components intra-operatively and in quiding the marking of bone before cutting. The PROPHECY® Preoperative Navigation Alignment Guides are intended for use with Wright's INBONE® and INFINITY™ Total Ankle Systems and their cleared indications for use, provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans. The PROPHECY® Preoperative Navigation Alignment Guides are intended for single use only.

PROPHECY® Preoperative Navigation Alignment Guides are patient-specific quides created to fit the contours of the patient's distal tibial and proximal talar anatomy. The quides are designed and manufactured from patient imaging data (CT) and are made from biocompatible nylon. The PROPHECY® Guides serve as an alternative to traditional alignment instrumentation used with Wright's INBONE® and INFINITY™ Total Ankle Systems, and thereby reduce the overall number of surgical steps reguired during total ankle arthroplasty. The quides serve to position and align the implants comparable to that attainable with traditional instrumentation.

1. Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state numerical acceptance criteria in a table format. However, the study aims to demonstrate that the PROPHECY® INFINITY™ Preoperative Navigation Alignment Guides achieve comparable placement and alignment to traditional instrumentation. The conclusion across all evaluations was that the subject alignment guides are "substantially equivalent to the predicates."

2. Sample Size and Data Provenance

The document does not specify the exact sample sizes for the "Guide design repeatability," "Guide placement repeatability," and "Software validation" tests.

For the cadaver evaluation, the sample size is not explicitly stated. The data provenance is implied to be experimental, likely conducted in a lab setting, which would be considered prospective. The country of origin is not specified but is presumably the US, where Wright Medical Technology is located.

3. Number of Experts and Qualifications

For the cadaver evaluation, the document states "Cadaver evaluation by end users analyzing placement location and orientation." It does not specify the number of end users or their exact qualifications beyond being "end users," which implies surgical professionals who would typically use such alignment guides.

For the guide design repeatability, it mentions "Guide design repeatability across design engineers." It does not specify the number or qualifications of these design engineers.

4. Adjudication Method

The document does not describe an explicit adjudication method (e.g., 2+1, 3+1) for any of the evaluations. The evaluations conclude with a general statement of "substantial equivalence to the predicates," suggesting a consensus or qualitative assessment rather than a formal adjudication process with multiple independent reviewers and a defined conflict resolution mechanism.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No multi-reader multi-case (MRMC) comparative effectiveness study is mentioned. The evaluations focus on the performance of the alignment guides themselves, not on the improvement of human readers with AI assistance.

6. Standalone Performance (Algorithm Only)

The device described is a physical patient-specific alignment guide manufactured based on imaging data, not solely an algorithm. The "Software validation" was done as part of the overall device evaluation, but it is not presented as a standalone algorithm performance study. The device is intended to be used by a human surgeon in the operating room.

7. Type of Ground Truth Used

• Guide design repeatability: The ground truth would likely be established by comparing multiple designs generated from the same patient imaging data against a predetermined set of design specifications or against each other for consistency.
• Guide placement repeatability: The ground truth would involve comparing repeated placements of the guide on a model or cadaver to a known, ideal placement or to each other.
• Cadaver evaluation: The ground truth for placement location and orientation would be established by direct anatomical measurement or imaging of the implant and guide placement relative to anatomical landmarks on the cadavers, likely verified by surgical experts.
• Software validation: The ground truth would involve comparing software outputs (e.g., guide design, measurements) against known correct values or established benchmarks.

8. Sample Size for the Training Set

The document does not provide information about a "training set" in the context of an algorithm. The alignment guides are designed and manufactured from individual patient imaging data (CT), implying a real-time process for each patient rather than a pre-trained algorithm in the typical sense.

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

As there is no mention of a traditional "training set" for an algorithm, this question is not applicable in the context of the provided document. The patient-specific nature of the guides means each guide's design is based on the individual patient's CT scan, not a pre-trained model on a large dataset.

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The ORTHODOC Preoperative Planner is a software device indicated for the planning of primary total hip arthroplasties on a personal computer. The software is intended to import computed tomography data, provide a constructed image of the data, and use computerized files, representing implant patterns of femoral components, to overlay the constructed image to aid surgeons in their selection and positioning of the femoral components.

This software is designed to run on a PentiumR-based personal computer. The device is a software-only product and is not intended to operate any other medical device or act directly on a patient. The application stores scaled graphic images of femoral stem components and provides a means for surgeons to superimpose these patterns on a CT image of the patient's femur. The implant patterns can be moved over the femur images to select what in the surgeon's judgement is the best stem size, position, neck length, and head diameter to achieve the physician's surgical goal.

The library of implant patterns, called surface model files, is developed from computer-aided-design (CAD) geometric data supplied by the implant's manufacturer. The implant surface model file used by ORTHODOC contains implant identification information as well as geometric data which defines the shape and dimensions of the implant surface.

This premarket notification describes a software device (ORTHODOC Model 500 Preoperative Planning Software) and does not provide an acceptance criterion or a study proving that the device meets an acceptance criterion. The document explicitly states:

"There has been no pre-clinical or clinical performance data Performance data: generated upon which to make a decision of substantial equivalence."

Therefore, I cannot populate the requested table or answer the questions regarding acceptance criteria, study details, sample sizes, expert involvement, or ground truth, as this information is not present in the provided text.

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