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The Salto Talaris Ankle PSI System is intended to be used as patient specific surgical planning and instrumentation to assist in the positioning of total ankle replacement components intraoperatively, and in guiding bone cutting. The Salto Talaris Ankle PSI System is intended for use with Smith + Nephew's Salto Talaris Total Ankle System and its cleared indications for use, provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging CT scans.

3D Systems' Salto Talaris Ankle PSI System consists of patient specific outputs including surgical guides, anatomical models, and case reports. The Salto Talaris Ankle PSI System guides are made from biocompatible nylon and surgical grade stainless steel and are designed to fit the contours of the patient's distal tibial and proximal talar anatomy. The surgical guides in combination with the Smith+Nephew Salto Talaris Total Ankle System instruments, facilitate the positioning of Salto Talaris Total Ankle Prostheses.

The provided document describes the FDA clearance (K243173) for the Salto Talaris Ankle PSI System. However, it does not contain a detailed study with acceptance criteria and reported device performance in the format requested.

The document states:

• "Non-clinical performance testing on the Salto Talaris Ankle PSI System included cadaveric comparison testing in order to compare Implant Alignment Accuracy and Guide Usability between the subject device and reference device."
• "Accuracy and functionality were shown to be similar to that of the standard instrumentation used for the Salto Talaris Total Ankle System."

This indicates that a comparison study was performed, but the specific acceptance criteria, reported performance values, sample size, ground truth establishment, or expert details are not provided in this 510(k) summary. The summary concludes that the device is substantially equivalent and "performs as well as the predicate device" based on this testing, but the numerical data from the study is not included.

Therefore, I cannot populate the table or answer the specific questions about the study design with the information available in the provided text. The document focuses on regulatory clearance based on substantial equivalence, rather than a detailed presentation of performance study results against predefined acceptance criteria.

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The Cadence Ankle PSI System is intended to be used as patient specific surgical planning and instrumentation to assist in the positioning of total ankle replacement components intraoperatively, and in guiding bone cutting. The Cadence Ankle PSI System is intended for use with Smith + Nephew's Cadence Total Ankle System and its cleared indications for use, provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging CT scans.

3D Systems' Cadence Ankle PSI System consists of patient specific outputs including surgical guides, anatomical models, and case reports. The Cadence Ankle PSI System guides are made from biocompatible nylon and surgical grade stainless steel and are designed to fit the contours of the patient's distal tibial and proximal talar anatomy. The surgical guides in combination with the Smith+Nephew Cadence Total Ankle System instruments, facilitate the positioning of Cadence Total Ankle Prostheses.

The provided text does not contain detailed information about the acceptance criteria or a specific study that proves the device meets those criteria in a format that would allow for a precise population of the requested table and points. The document is a 510(k) summary for a medical device (Cadence Ankle PSI System), which focuses on demonstrating substantial equivalence to a predicate device rather than presenting extensive performance study results like those typically found for AI/ML-based diagnostic devices.

However, I can extract the available information regarding non-clinical performance testing:

Non-clinical Performance Testing:

The relevant section states: "Non-clinical performance testing on the Cadence Ankle PSI System included cadaveric comparison testing in order to compare Implant Alignment Accuracy and Guide Usability between the subject device and reference device. Accuracy and functionality were shown to be similar to that of the standard instrumentation used for the Cadence Total Ankle System."

This indicates that the study focused on Implant Alignment Accuracy and Guide Usability. The acceptance criteria are implied to be "similar to that of the standard instrumentation used for the Cadence Total Ankle System," which served as the reference device.

Based on the provided text, the following information is not available:

• A formal table of acceptance criteria with reported device performance metrics (e.g., specific thresholds for accuracy or usability scores).
• Detailed sample size for the test set (only "cadaveric comparison testing" is mentioned).
• Data provenance (e.g., country of origin, retrospective/prospective).
• Number of experts, their qualifications, or adjudication methods for ground truth.
• Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done.
• If a standalone (algorithm only) performance was measured (this device is a surgical guide system, not an AI diagnostic algorithm in the typical sense).
• The specific type of ground truth used beyond "comparison to the standard instrumentation."
• Sample size for the training set.
• How the ground truth for the training set was established.

In summary, the document states performance testing focused on implant alignment accuracy and guide usability through cadaveric comparison, indicating similarity to standard instrumentation as the performance benchmark. However, granular details about specific acceptance criteria metrics, study design, and ground truth establishment are not provided.

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The Salto Talaris PSI System is intended to be used as patient specific surgical planning and instrumentation to assist in the positioning of total ankle replacement components intraoperatively, and in guiding bone cutting. The Salto Talaris PSI System is intended for use with Smith + Nephew's Salto Talaris Total Ankle System and its cleared indications for use.

3D Systems' Salto Talaris Ankle PSI System consists of patient specific outputs including surgical guides, anatomical models, and case reports. The Salto Talaris Ankle PSI System guides are made from biocompatible nylon and surgical grade stainless steel and are designed to fit the contours of the patient's distal tibial and proximal talar anatomy. The surgical guides in combination with the Smith+Nephew Salto Talaris Total Ankle System instruments, facilitate the positioning of Salto Talaris Total Ankle Prostheses.

The provided text is a 510(k) summary for the Salto Talaris Ankle PSI System. It describes the device, its intended use, and a summary of non-clinical testing. However, it does not contain the detailed information necessary to fully answer all aspects of your request, particularly regarding specific acceptance criteria, expert qualifications, adjudication methods, details of ground truth establishment, or specific sample sizes for training and testing sets in the context of an AI-based system.

The Salto Talaris Ankle PSI System is described as patient-specific surgical planning and instrumentation to assist in positioning total ankle replacement components and guiding bone cutting. This device primarily involves physical surgical guides and anatomical models derived from CT data, rather than a standalone AI algorithm for diagnosis or image analysis. Therefore, some of the requested information, such as an MRMC comparative effectiveness study with AI assistance or standalone algorithm performance, is not directly applicable to this type of device as typically described for AI/ML-based diagnostic software.

Here's a breakdown of the available information based on your request:

1. Table of acceptance criteria and the reported device performance

The document states that the Salto Talaris Ankle PSI System met all acceptance criteria for mechanical integrity, debris generation, and inter-designer variability analysis. For implant alignment accuracy and guide usability, cadaveric comparison testing showed similarity to standard instrumentation. The specific quantitative acceptance criteria values (e.g., specific thresholds for mechanical integrity or debris generation, or a numerical range for alignment accuracy) are not provided in this summary.

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

The document mentions "Non-clinical cadaveric comparison testing." However, it does not specify the sample size (number of cadavers or cases) used for this test set, nor does it provide information about the data provenance (e.g., country of origin, retrospective or prospective).

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

The document does not provide this information. Since the device involves surgical guides and bone cutting, "ground truth" in this context would likely relate to anatomical measurements or surgical outcomes, potentially assessed by orthopedic surgeons. However, no details on experts or their qualifications are given.

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

The document does not specify any adjudication method.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance

An MRMC comparative effectiveness study of the type typically performed for AI/ML diagnostic software (where human readers evaluate cases with and without AI assistance) was not mentioned and is unlikely to be applicable based on the device description. This device provides physical guides for surgery, not AI-based image analysis for diagnosis. The non-clinical cadaveric testing compared the device to standard instrumentation, not to human readers using or not using AI.

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

The device is described as "patient specific surgical planning and instrumentation to assist in the positioning... and in guiding bone cutting." This inherently implies a "human-in-the-loop" scenario (a surgeon using the guides). The "non-clinical cadaveric comparison testing" assessed the performance of the device in use, which is a form of standalone performance for the instrumentation itself but not in the context of an AI algorithm without human interaction for diagnosis or interpretation. The document does not describe a standalone algorithm performance test in the way it would be applied to AI/ML diagnostic software.

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

For the cadaveric comparison testing, the "ground truth" implicitly relates to implant alignment accuracy and guide usability, compared against the results achieved using standard (non-PSI) instrumentation. The summary doesn't explicitly state how this ground truth was definitively established (e.g., by highly accurate post-operative CT measurements validated by multiple experts), but it refers to comparison rather than an absolute ground truth method.

8. The sample size for the training set

The document describes the device as being "designed with CT-based methods to produce patient-specific instrumentation." This suggests a design process based on anatomical data, but there is no mention of a "training set" in the context of an AI/ML algorithm. The device is a custom-manufactured surgical guide, not a learned AI model.

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

Since there's no mention of a "training set" for an AI/ML algorithm, this question is not applicable in the context of the provided document. The "design" information would likely come from anatomical studies, engineering specifications, and clinical experience with total ankle arthroplasty, rather than a formal "ground truth" establishment for an AI training set.

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The Cadence Ankle PSI System is intended to be used as patient specific surgical planning and instrumentation to assist in the positioning of total ankle replacement components intraoperatively, and in guiding bone cutting. The Cadence Ankle PSI System is intended for use with Smith + Nephew's Cadence Total Ankle System and its cleared indications for use.

3D Systems' Cadence Ankle PSI System consists of patient specific outputs including surgical guides, anatomical models, and case reports. The Cadence Ankle PSI System guides are made from biocompatible nylon and surgical grade stainless steel and are designed to fit the contours of the patient's distal tibial and proximal talar anatomy. The surgical guides in combination with the Smith+Nephew Cadence Total Ankle System instruments, facilitate the positioning of Cadence Total Ankle Prostheses.

The manufacturer, 3D Systems, Inc., has introduced the Cadence Ankle PSI System, a device intended for patient-specific surgical planning and instrumentation to assist in total ankle replacement component positioning and bone cutting. This device is designed for use with Smith + Nephew's Cadence Total Ankle System.

The information provided by the FDA 510(k) summary for K241326 primarily focuses on non-clinical performance testing to demonstrate substantial equivalence to the predicate device, not on clinical performance with human readers or standalone AI performance. Therefore, many of the requested details regarding clinical study design (e.g., MRMC studies, human reader improvement, expert consensus for ground truth) are not applicable based on the provided document.

Here's an analysis of the acceptance criteria and the study conducted, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary mentions "all acceptance criteria for all performance tests" were met, but it does not explicitly list the quantitative acceptance criteria. It broadly states the types of tests conducted and their qualitative outcomes.

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

The document indicates "Non-clinical cadaveric comparison testing", which implies a test set was used. However, the exact sample size (number of cadavers or anatomic specimens) is not specified.
The data provenance is cadaveric testing, which is a form of pre-clinical, laboratory-based testing, not human patient data (retrospective or prospective). The country of origin for the data is not specified, though 3D Systems, Inc. is based in the USA.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable as the studies described are non-clinical, cadaveric, and mechanical/design verification tests. There is no mention of experts establishing a "ground truth" in the context of diagnostic or clinical interpretation. Performance was assessed mechanically or by comparison to standard instrumentation.

4. Adjudication Method for the Test Set

This is not applicable as the studies are non-clinical and do not involve human diagnostic interpretation requiring adjudication.

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

No, an MRMC comparative effectiveness study was not done. The document describes non-clinical and cadaveric testing, not studies involving human readers or clinical cases.

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

The device is a "patient specific surgical planning and instrumentation" system. While it likely involves algorithms for design and manufacturing, the studies described are for the physical outputs (surgical guides, anatomical models) and their performance (mechanical integrity, debris, accuracy in cadavers), rather than a standalone AI algorithm's diagnostic performance. Therefore, a standalone AI performance study in the typical sense of evaluating an algorithm’s output without human-in-the-loop was not explicitly described for this submission. The focus is on the device's accuracy in physical guidance.

7. The Type of Ground Truth Used

For the non-clinical tests (mechanical integrity, debris generation, intra-/inter-designer variability), the "ground truth" would be established by engineering specifications, quality control standards, and measurement protocols.
For the cadaveric comparison testing, the "ground truth" for "Implant Alignment Accuracy" and "Guide Usability" would be based on direct measurements against design specifications and comparison to the performance of established standard instrumentation (the reference device, K151459 Cadence Total Ankle Replacement System). This is a technical, rather than a clinical, ground truth.

8. The Sample Size for the Training Set

The document does not describe the use of a "training set" in the context of machine learning or AI algorithm development. The device is a patient-specific instrument system, and its design is CADD-based. If there's an underlying AI component that uses a training set, this information is not provided in the summary.

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

As no training set is described for an AI algorithm, this information is not applicable based on the provided document. If there are proprietary algorithms involved in the patient-specific design, the "training" data (if any) and its ground truth would be part of the manufacturer's internal development process, not typically disclosed in this level of detail in a 510(k) summary focused on the final product's performance.

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The Vantage PSI System is intended to be used as patient specific surgical planning and instrumentation to assist in the positioning of total ankle replacement components intra-operatively, and in guiding bone cutting. The Vantage PSI System is intended for use with Exactech's Vantage Total Ankle System and its cleared indications for use.

3D System's Vantage PSI System is patient-specific guides created to fit the contours of the patient's distal tibial and proximal talar anatomy. The guides and models are designed and manufactured from patient imaging data (CT) and are made from biocompatible nylon. The surgical guides in combination with Exacted Vantage Total Ankle reusable instruments, facilitate the positioning of Vantage Total Ankle Implants. 3D System s Vantage PSI System produces a variety of patient specific outputs including surgical quides, anatomic models, and case reports.

Here's an analysis of the acceptance criteria and supporting study for the Vantage PSI System, based on the provided FDA 510(k) summary:

• This device is a patient-specific surgical guide system, not an AI device. Therefore, many of the typical AI/ML-specific questions regarding ground truth, expert consensus, and multi-reader studies are not applicable in the way they would be for an AI diagnostic or prognostic tool. The "performance" here relates to its accuracy in guiding surgical procedures compared to existing instrumentation.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated as a number of "patients" or "cases." The testing was described as "Cadaveric comparison testing." This implies a limited number of cadavers were used.
• Data Provenance: Cadaveric. Specific country of origin is not mentioned. It is a prospective study in the sense that the test was conducted specifically for this submission.

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

• This is not applicable in the traditional sense for this device. The "ground truth" for a surgical guide system is its ability to accurately direct cuts and component placement. The comparison was to an existing instrumentation system (Exactech instrumentation), which serves as the benchmark. The "experts" would be the surgeons or engineers performing the cadaveric tests and assessing the outcomes. Their qualifications are not specified in this summary.

4. Adjudication Method for the Test Set

• Not explicitly stated. Given it's a comparison of mechanical accuracy and functionality on cadavers, it's likely measurements were taken and compared directly, rather than requiring a complex expert adjudication process for image interpretation.

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 is not applicable as the Vantage PSI System is a physical surgical guide system, not an AI/ML diagnostic or prognostic tool for human readers.

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

• This is not applicable as the Vantage PSI System is a physical surgical guide intended for human use in surgery. Its "performance" is inherently human-in-the-loop.

7. The Type of Ground Truth Used

• The "ground truth" was established by comparing the subject device's guidance and resulting anatomical modifications (e.g., bone cuts, component placement) to those produced by Exactech's established instrumentation system. This comparison was done on cadavers, implying direct measurement or visual assessment of the outcome of the guided procedure.

8. The Sample Size for the Training Set

• This is not applicable. The Vantage PSI System is a custom-manufactured guide based on a patient's individual CT scan. There isn't a "training set" in the machine learning sense for the device itself. The design principles and manufacturing process might be informed by historical data or engineering principles, but not a "training set" for an algorithm.

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

• This is not applicable for the same reasons as #8.

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The Axiom PSR System is intended to be used as patient specific surgical planning and instrumentation to assist in the positioning of total ankle replacement components intraoperatively, and in guiding bone cutting. The Axiom PSR System is intended for use with the Kinos Axiom Total Ankle System and its cleared indications for use.

restor3d's Axiom PSR System is an ankle surgical guide system, designed for an individual patient from the patient's CT imaging scans. The subject Axiom PSR System is intended to aid in the placement of Kinos Axiom Total Ankle System (K192778) implant components when used in conjunction with the Kinos Axiom standard, reusable instruments. The Axiom PSR System includes preoperative plans developed with and approved by the operative surgeon, tibia and talus resection guides, manufactured from implant grade titanium, bone models manufactured from biocompatible polymer for use with the Kinos Axiom Total Ankle System.

The restor3d Axiom PSR System is a patient-specific surgical planning and instrumentation system designed to assist in the positioning of total ankle replacement components intraoperatively and in guiding bone cutting. The information provided does not include specific acceptance criteria with numerical thresholds. However, the study conducted aims to demonstrate that the Axiom PSR System is at least as accurate as, or more accurate than, the previously cleared Kinos Axiom Total Ankle System standard instruments alone, with respect to implant placement relative to the pre-operative plan in six degrees of freedom.

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

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not provide a table with specific numerical acceptance criteria. Instead, it states a comparative performance objective.

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

• Sample Size for Test Set: The document mentions "cadaver testing" but does not specify the number of cadavers or individual surgical procedures performed.
• Data Provenance: Retrospective or Prospective is not explicitly stated, but "cadaver testing" implies a controlled, experimental setting, likely
  prospective for the purpose of the study. The origin (country/region) of the cadavers is not mentioned.

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

This information is not provided in the document. The ground truth ("pre-operative plans") is established as a digital design workflow, which is later compared to post-operative CT scans. The experts involved in creating these pre-operative plans and evaluating the post-operative scans are not specified.

4. Adjudication Method for the Test Set:

The document mentions that post-operative CT scans were obtained, and the final implant positions were evaluated in 3D space about six degrees of freedom and then compared to the pre-operative plans. It does not describe any specific multi-reviewer adjudication method (e.g., 2+1, 3+1). The evaluation method appears to be a direct comparison of physical outcomes (post-operative CT) to digital plans.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly stated or described. The study compared the device's performance to the standard method rather than comparing human readers with and without AI assistance. The "AI" aspect is in the patient-specific surgical planning and guiding, not in assisting human readers in diagnosis or interpretation.

6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance):

This aspect is not directly applicable in the typical sense of standalone AI performance for diagnostic algorithms. The Axiom PSR System is a surgical guidance system, and its "performance" is inherently tied to its use in a surgical setting. The digital design workflow is an algorithmic process that creates the patient-specific guides and plans, but the "standalone" performance isn't measured in isolation from the surgical act. The evaluation "compared to the pre-operative plans" could be considered an evaluation of the system's output (the guides) against its intended design.

7. Type of Ground Truth Used:

The ground truth for comparison was the "pre-operative plans." These plans are a digital design output, established through a digital design workflow. The "final implant positions" from post-operative CT scans were then compared against these pre-operative plans.

8. Sample Size for the Training Set:

The document does not provide any information regarding a training set sample size. The Axiom PSR System is a patient-specific device based on individual patient CT scans, not a machine learning model that requires a separate training set for algorithm development in the traditional sense. The "digital design workflow" is likely based on established biomechanical and engineering principles rather than supervised machine learning requiring a training dataset.

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

Since there is no mention of a training set or a machine learning model requiring such a set, this information is not applicable based on the provided document. The device's functionality is based on individual patient imaging and a digital design workflow to create custom surgical guides and plans, not on learning from a large labeled training dataset.

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The Vantage PSI System is intended to be used as patient specific surgical planning and instrumentation to assist in the positioning of total ankle replacement components intraoperatively, and in guiding bone cutting. The Vantage PSI System is intended for use with Exactech's Vantage Total Ankle System and its cleared indications for use.

3D System's Vantage PSI System is patient-specific guides created to fit the contours of the patient's distal tibial and proximal talar anatomy. The guides and models are designed and manufactured from patient imaging data (CT) and are made from biocompatible nylon. The surgical guides in combination with Exactech Vantage Total Ankle reusable instruments, facilitate the positioning of Vantage Total Ankle Implants. 3D System's Vantage PSI System produces a variety of patient specific outputs including surgical guides, anatomic models, and case reports for use with Exactech's Vantage Total Ankle System (K152217 and K183343).

Here's an analysis of the provided text regarding the acceptance criteria and study for the Vantage PSI System:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a specific table of acceptance criteria with numerical targets and the corresponding device performance tied to those targets. Instead, it describes general compliance with standards and successful meeting of "all test method acceptance criteria" or "pre-defined acceptance criteria."

However, we can infer some performance aspects from the Cadaver Study / Design Validation.

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

• Sample Size for Cadaver Study: The document states that the cadaver and design validation studies utilized three surgeon users and compared the subject device to standard instrumentation. The number of cadavers or individual surgical procedures performed is not explicitly stated.
• Data Provenance: Not specified, but given the nature of cadaver studies for device validation, it would be prospective data collection. The country of origin is not mentioned.

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

• The cadaver study involved three surgeon users.
• Their specific qualifications (e.g., years of experience, subspecialty) are not provided. They are simply referred to as "surgeon users."
• It's implied these surgeons contributed to evaluating the outcome, but the document doesn't explicitly state they established the "ground truth." The ground truth appears to be derived from objective measurements (2D and 3D analysis) comparing actual placement to pre-operative plans.

4. Adjudication Method for the Test Set

• The document does not specify an adjudication method for the cadaver study's results. It describes 2D and 3D analysis conducted but doesn't detail how discrepancies or interpretations between the three surgeon users, or between the measurements and the pre-operative plan, were resolved or adjudicated.

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, an MRMC comparative effectiveness study was not done. The Vantage PSI System is a patient-specific surgical guide intended for use with total ankle replacement components and guiding bone cutting, not an AI-based diagnostic or interpretative system where human readers would interpret results with or without AI assistance.
• The cadaver study was a comparative performance study between the device and standard instrumentation, not an AI assistance study.

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

• The device itself (Vantage PSI System) is a physical surgical guide designed from imaging data via software, not a standalone algorithm that provides a diagnosis or output without human intervention. The "design and development process" involves software creating the guides based on patient imaging. The "performance testing" described primarily pertains to the physical aspects of the device and its manufacturing process, along with its accuracy in facilitating surgical procedures as a tool.
• The closest to "algorithm only" performance would be the accuracy of the software-generated patient-specific guides and models against the patient data, which is implicitly covered by the "Process Qualification" and the "Cadaver Study / Design Validation" where the physical output is compared to the pre-operative plan. However, it's not a standalone diagnostic algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

• For the cadaver study, the ground truth appears to be based on objective measurements derived from post-operative imaging (CT scans for 3D analysis, fluoroscopic images for 2D analysis) compared against the pre-operative plan. This combines objective measurement with a pre-defined target.

8. The Sample Size for the Training Set

• The document does not provide information on a separate "training set" sample size. The Vantage PSI System involves designing patient-specific guides based on individual patient imaging (CT data), rather than a machine learning model that requires a discrete training dataset for algorithm development. The "design and development process" converts the CT data into a guide.

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

• As there is no explicit mention of a "training set" in the context of a machine learning algorithm, the process of establishing ground truth for such a set is not applicable based on the provided text. The "ground truth" for the device's function is the patient's anatomy derived from imaging and the surgeon's pre-operative plan based on that anatomy.

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