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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 VSP PEEK Cranial Implant is indicated for use to fill a bony void or defect area in the cranial skeleton of patients 21 years of age and older.

The VSP PEEK Cranial Implants are non-load bearing, single use devices showing the following characteristics:
• The implants are designed individually for each patient to correct defects in cranial bone.

• The implants are 3D printed using material extrusion technology.
• The implants are manufactured using Polyetheretherketone (PEEK) implantable grade filament (i.e., Evonik VESTAKEEP® i4-3DF).
• The VSP PEEK Cranial Implants are designed using CT imaging data and surgeon input.
• · The implant size is ranging from 35 mm x 35 mm to 150 mm x 150 mm, and its thickness is constant, ranging from 3 mm to 6 mm with a nominal thickness of 3 mm.
• If minor intra-operative adjustments are required, the implants can be modified by the surgeon with standard surgical burrs.
• The implants are fixed to the native bone using commercially available cranial fixation screws and/or systems
• The implants are provided non-sterile for sterilization prior to implantation.

The provided text describes the 510(k) premarket notification for the "VSP PEEK Cranial Implant," which is a Class II device intended to fill bony voids or defects in the cranial skeleton. The information pertains to a medical device's regulatory clearance rather than an AI/ML-driven device, so many of the requested criteria related to AI acceptance, ground truth, and human reader studies are not applicable.

However, I can extract the relevant information regarding the device's acceptance criteria and the studies performed to demonstrate its performance.

Here's a breakdown based on the provided document:

1. Acceptance Criteria and Reported Device Performance (Table)

There are two main categories of acceptance criteria and performance reporting mentioned: Biocompatibility and Performance Bench Testing.

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

• Sample Size: The document does not specify exact sample sizes (e.g., number of implants or test specimens) for each test. It uses phrases like "All samples" and "Several implantations."
• Data Provenance: The data is generated through laboratory bench testing and pre-clinical animal studies (rat model for implantation effects). The data origin is not specified by country, but it relates to the manufacturing and testing done by "3D Systems, Inc." located in Littleton, CO, USA. The studies are prospective in the sense that they were conducted for the purpose of this 510(k) submission.

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

• Experts: For the Anatomical Fit Testing, "surgeons" were involved in performing simulated surgical procedures and reviewing the results.
• Qualifications: The general qualification is "surgeons." No specific number or detailed qualifications (e.g., years of experience, subspecialty) are provided in this summary.
• Ground Truth: For the "anatomical fit," the ground truth was established by the subjective assessment of "surgeons" performing simulated implantations on anatomical models and completing a questionnaire.

4. Adjudication Method for the Test Set

• For the anatomical fit, the document states "reviewed by each surgeon." This suggests individual assessments, but it doesn't specify a formal adjudication method (e.g., consensus, majority vote) if multiple surgeons were involved. It can be inferred that simple agreement among the involved surgeons was sufficient for the "acceptable" conclusion.
• For other analytical and mechanical tests, adjudication would be based on predefined quantitative thresholds or qualitative observations against standards.

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

• No, an MRMC comparative effectiveness study was not done. This type of study is primarily relevant for diagnostic devices that involve interpretation by human readers (e.g., radiologists interpreting images). The VSP PEEK Cranial Implant is a structural implant, and its performance evaluation does not involve differential human interpretation of medical images.

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

• Not applicable directly. This question primarily applies to AI/ML software devices. The "VSP PEEK Cranial Implant" is a physical device. While its design involves "CT imaging data and surgeon input," implying a design process that might be aided by software, the performance evaluation described here is for the physical implant itself, not a separate AI algorithm for image analysis or diagnosis. The "standalone" performance here refers to the device's intrinsic mechanical and biological properties.

7. The Type of Ground Truth Used

• Bench Testing Standards & Expert Consensus/Subjective Assessment:
  • For biocompatibility, the ground truth is established by international standards (ISO 10993 series) and the measured physical/chemical properties or biological responses compared against the acceptance criteria defined by these standards.
  • For mechanical performance, the ground truth is established by literature research (as "there is no industry accepted standard governing mechanical testing for non-load bearing implantable prosthetic plates") and internal technical specifications, and the device's ability to withstand forces.
  • For anatomical fit, the "ground truth" is based on the subjective assessment and "acceptance" by the surgeons performing the simulated implantations.

8. The Sample Size for the Training Set

• Not applicable. This device is a physical implant, not an AI/ML algorithm that requires a training set. The design of each implant is "individually for each patient" using their specific CT imaging data and surgeon input, which is a custom manufacturing process rather than a machine learning training process.

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

• Not applicable. As there is no AI/ML training set, there is no ground truth to establish for such a set.

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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 3D Systems VSP® Bolus product is a device that will be placed on the skin of a patient as a radiotherapy accessory intended to help control the radiation dose received by the patient. VSP Bolus is generated using input from radiation therapy professionals and medical imaging data to produce a bolus that is specific to the patient being treated. The VSP Bolus product is verified and approved by the radiation therapy professional prior to use on the patient, and is intended for patients of all ages receiving radiotherapy treatment.

VSP Bolus was evaluated using 6 MV photons but has not been assessed for use with protons. electrons, or at orthovoltage X-rays.

Boluses are used in external beam radiation therapy (EBRT) to change the depth of the radiation dose delivery to overcome the skin-sparing effect. The bolus is generated in accordance with a clinical treatment plan. The patient-specific bolus conforms to the patient anatomy to reduces airgaps for complex patient contours. The bolus is produced with additive manufacturing in a soft elastomeric material to conform to the patient's skin. The bolus is placed on the patient and verified for fit and accordance to the treatment plan prior to a radiation dose delivery to the patient.

The provided document is a 510(k) summary for the VSP® Bolus, a device used in radiation therapy. It does not describe an AI/ML device or a study comparing AI assistance with human readers. Therefore, I cannot extract information related to AI/ML specific acceptance criteria or an MRMC study from this document.

However, I can provide the acceptance criteria and performance data for the VSP® Bolus as described in the document.

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

The document does not explicitly list "acceptance criteria" in a quantitative format for the VSP® Bolus. Instead, it describes performance characteristics and validation activities demonstrating the device's fitness for clinical use and substantial equivalence to a predicate device. The performance is primarily assessed through simulated use testing and biocompatibility.

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

The document states, "Clinically relevant validation study was performed." However, it does not specify the sample size for this simulated use test set, nor does it provide details on the data provenance (e.g., country of origin, retrospective or prospective nature of the simulated cases).

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 states that "VSP Bolus was deemed fit for clinical use by radiation therapy professionals." However, it does not specify the number of experts used or their specific qualifications (e.g., number of years of experience, specific certifications) for establishing this ground truth in the simulated use testing.

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

The document does not explicitly describe an adjudication method for the simulated use testing. It only states that the device was "deemed fit for clinical use by radiation therapy professionals," implying a consensus or approval process, but no specific adjudication method (e.g., 2+1, 3+1) is mentioned.

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

There is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study in the document. This device (VSP® Bolus) is a physical, patient-specific bolus used in radiation therapy and does not involve AI assistance for human readers in its described function or evaluation.

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

The VSP® Bolus is a physical device, not an algorithm. Therefore, a standalone (algorithm-only) performance study is not applicable and was not performed. The device requires human input (radiation therapy professional input, DICOM data) for its design and human verification/approval (radiation therapy professional) prior to use.

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

For the simulated use testing, the ground truth was established by the judgment and approval of "radiation therapy professionals" who "deemed [the device] fit for clinical use." This can be considered a form of expert consensus or professional judgment.

8. The sample size for the training set

The document describes performance testing for a physical device and states, "Clinical testing was not performed as part of the development of this product." It refers to "clinically relevant validation study" and "simulated use testing." There is no mention of a training set in the context of machine learning or algorithm development, as this is not an AI/ML device.

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

As there is no mention of a training set or AI/ML components, this question is not applicable to the provided document.

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The VSP® Orthopedics System is intended to be used as a surgical instrument to assist in preoperative planning and/or in guiding the marking of bone and/or in guiding surgical instruments in non-acute, non-joint replacing osteotomies for adult patients in the distal femur, tibia, and non-sacrum pelvis.

The VSP® Orthopedics System is intended to assist a surgeon with pre-operative planning and transfer of the pre-operative plan to the surgery in orthopedic procedures. The system contains several physical and digital outputs including patient-specific anatomical models, templates, and guides (physical outputs); and patient-specific surgical plans and digital files (digital or documentation outputs).

Outputs of the VSP® Orthopedics System are designed with physician input and reviewed by the physician prior to finalization and distribution.

The VSP® Orthopedics System also contains Stainless Steel Drill Inserts (VSP® Orthopedics System Accessories) which are intended to be used by the physician to guide drilling activities during the surgical procedure. The inserts fit into a standard hole in the cutting / drill guides and can be used across all VSP® Orthopedics System guides and templates.

The provided text describes a 510(k) summary for the VSP® Orthopedics System, which is a device for surgical planning and guiding. However, the document does not contain specific information regarding acceptance criteria for device performance studies, nor does it detail a study that proves the device meets specific performance acceptance criteria.

Instead, the document focuses on:

• Regulatory classification and intended use.
• Comparison to a predicate device, highlighting that the new device is "substantially equivalent" with only differences in a new material (SLA printing resin Accura ClearVue for anatomical models).
• Verification and validation testing related to manufacturing processes, cleaning, sterilization, biocompatibility, and shelf life of the components of the system, rather than a clinical performance study measuring an output metric against an acceptance criterion.

The document explicitly states: "Clinical testing was not necessary for the determination of substantial equivalence." This means a clinical performance study, often involving human readers or direct measurement of an output against a functional criterion, was not performed or deemed necessary for this 510(k) submission.

Therefore, I cannot provide the requested table or answer the specific questions about performance studies, sample sizes, ground truth establishment, or MRMC studies, as this information is not present in the provided text.

The closest information found pertains to general testing conducted:

Summary of Testing Mentioned (not device performance acceptance criteria):

Regarding the specific questions:

1. A table of acceptance criteria and the reported device performance: See table above, but note these are for manufacturing/material V&V, not device performance in terms of accuracy or clinical utility.
2. Sample sizes used for the test set and the data provenance: Not specified for device performance. Sample sizes for validation tests (e.g., biocompatibility batch sizes, number of sterilization cycles) are not detailed. Data provenance is implied to be internal testing by 3D Systems.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no such performance study is described. The device involves "physician input" and review, but this is part of its design and workflow, not a ground truth establishment for a performance study.
4. Adjudication method for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No. The document explicitly states "Clinical testing was not necessary."
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. The device is a system involving physical and digital outputs, and intended for use "to assist in preoperative planning and/or in guiding..." indicating a human-in-the-loop product. No standalone algorithmic performance is described.
7. The type of ground truth used: Not applicable, as no performance study requiring ground truth is described.
8. The sample size for the training set: Not applicable, as this is not an AI/ML device requiring a training set in the conventional sense. It's a surgical planning and guiding system.
9. How the ground truth for the training set was established: Not applicable.

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The VSP® System is intended for use as a software system and image segmentation system for the transfer of imaging information from a medical scanner such as a CT based system. The input data file is processed by the VSP® System and the result is an output data file that may then be provided as digital models or used as input to a rapid prototyping portion of the system that produces physical outputs including anatomical models, and surgical guides for use in maxillofacial surgery. The VSP® System is also intended as a pre-operative software tool for simulating / evaluating surgical treatment options.

The VSP® System utilizes a combination of Commercial Off-The-Shelf (COTS) and custom software to manipulate 3D medical images (CT based systems) to create virtual and physical anatomical models, templates, surgical guides, and surgical plans for reconstructive surgical procedures.

The provided text is a 510(k) Summary for the VSP® System and primarily focuses on demonstrating substantial equivalence to a predicate device, rather than proving that the device meets specific acceptance criteria through a study with a test set, expert ground truth, and statistical analysis as would be done for an AI/ML-driven device.

The VSP® System is described as a software system and image segmentation system for maxillofacial surgery, which processes imaging information (CT-based) to create digital models, physical outputs (anatomical models, surgical guides), and aids in pre-operative simulation. The primary change in the current submission is the addition of a new material (Accura® ClearVue™) for anatomical models, not a change or new feature related to an AI/ML algorithm's diagnostic or predictive performance.

Therefore, the document does not contain the information required to answer the questions regarding acceptance criteria for an AI/ML device, such as performance metrics (e.g., sensitivity, specificity), sample sizes for test sets, expert ground truth establishment, or MRMC studies. The "performance testing" described (Operational Qualification, Performance Qualification, Cleaning Validation, Sterilization Validation, Biocompatibility Validation) are related to manufacturing processes and material safety, not the diagnostic or prognostic performance of a software algorithm on a test dataset.

The only "performance testing" mentioned is:

• Operational Qualification: Assessed manufacturing process over allowable parameters. All test method acceptance criteria were met.
• Performance Qualification: Assessed manufacturing process repeatability at nominal parameters. All test method acceptance criteria were met.
• Cleaning Validation: Performed in accordance with AAMI TIR 30. All test method acceptance criteria were met.
• Sterilization Validation: Performed in accordance with ISO 17665-1:2006 to a SAL of 10^-6. All test method acceptance criteria were met.
• Biocompatibility Validation: Evaluated in accordance with ISO 10993-1. Sensitization, irritation, and acute systemic toxicity testing conducted on the subject device manufactured from Accura ClearVue are within the pre-defined acceptance criteria.

The document explicitly states: "Clinical Performance Data - Clinical testing was not necessary for the determination of substantial equivalence." This further confirms that no study of the software's performance on a diagnostic/predictive task, using clinical data and ground truth, was performed or presented in this 510(k) summary.

In summary, based on the provided text, it is not possible to fill out the requested information as it pertains to an AI/ML driven device's performance study because such a study was not conducted or reported for this submission.

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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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