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The VX1+ assists operators in the real-time manual or automatic annotation of 3D anatomical and electrical maps of human atria for the presence of multipolar intra-cardiac atrial electrograms exhibiting spatiotemporal dispersion during atrial fibrillation or atrial tachycardia.

The clinical significance of utilizing the VX1+ software to help identify areas with intra-cardiac atrial electrograms exhibiting spatiotemporal dispersion for catheter ablation of atrial arrhythmias, such as atrial fibrillation, has not been established by clinical investigations.

The VX1+ is a machine and deep learning based-algorithm designed to assist operators in the real-time manual or automatic annotation of 3D anatomical and electrical maps of the human heart for the presence of electrograms exhibiting spatio-temporal dispersion, i.e., dispersed electrograms (DEs).

The VX1+ device is a non-sterile reusable medical device, composed of a computing platform and a software application. VX1+ works with all existing 510(k)-cleared catheters that meet specific dimension requirements and with one of the three specific data acquisition systems:

• two compatible EP recording systems (identical to VX1 (Volta Medical (K201298)): the LabSystem Pro EP Recording System (Boston Scientific) (K141185) or the MacLab CardioLab EP Recording System (General Electric) (K130626),
• a 3D mapping system (novelty compared to VX1): EnSite X 3D mapping system (Abbott) (K221213).

A connection cable is used to connect the corresponding data acquisition system to the VX1+ system, depending on the type of communication used:

• Unidirectional analog communication with the EP recording systems via a custom-made cable (two different variants: DSUB, Octopus) and an Advantech PCI-1713U analog-todigital converter, which acquires analog data, digitizes it, and transmits the digital signals to the computer that hosts the VX1+ software.
• -Bidirectional digital communication with the EnSite 3D mapping system via an ethernet cable (four different lengths: 20,10, 5 or 2m) which transmits the digital signals directly to the computer.

The computer and its attached display are located outside the sterile operating room area. The VX1+ software analyzes the patient's electrograms to cue operators in real-time to intracardiac electrograms of interest for atrial regions harboring DEs as well as a cycle length estimation from electrograms recorded with the mapping and the coronary sinus catheters. The results of the analysis are graphically presented on the attached computer display and/or on a secondary medical screen or on an operating room widescreen. The identified regions of interest are either manually (all configurations) or automatically (only available in digital bidirectional communication with the EnSite X 3D mapping system) tagged in the corresponding 3D mapping system.

The provided text describes the acceptance criteria and a study for the Volta Medical VX1+ device. However, it does not contain a detailed table of acceptance criteria with specific performance metrics (e.g., sensitivity, specificity, accuracy, F1-score) and corresponding reported device performance, nor does it detail a multi-reader multi-case (MRMC) comparative effectiveness study.

Based on the available information, here's a breakdown of what can be extracted and what is missing:

Acceptance Criteria and Device Performance

The document describes non-clinical and clinical tests performed, implying certain underlying acceptance criteria were met for substantial equivalence to the predicate device (VX1). However, explicit quantitative acceptance criteria (e.g., "sensitivity > 90%") are not provided in the text. The reported device performance is described generally as "acceptably correlate" and "reliably assists."

Table of Acceptance Criteria and Reported Device Performance (as inferred and with missing specifics):

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The VX1 assists operators in the real-time manual annotation of 3D anatomical and electrical maps of human atria for the presence of multipolar intra-cardiac atrial electrograms exhibiting spatiotemporal dispersion during atrial fibrillation or atrial tachycardia.

The clinical significance of utilizing the VX1 software to help identify areas with intra-cardiac atrial electrograms exhibiting spatiotemporal dispersion for catheter ablation of atrial arrhythmias, such as atrial fibrillation, has not been established by clinical investigations.

The VX1 "" is a machine and deep learning based-algorithm designed to assist operators in the real-time manual annotation of 3D anatomical and electrical maps of the human atria for the presence of electrograms exhibiting spatiotemporal dispersion during atrial fibrillation or atrial tachycardia", i.e., dispersed intra-cardiac atrial electrograms (DEs). The device works with all existing 510(k) cleared catheters that meet specific dimension requirements and with two data acquisition systems: the LabSystem Pro Acquisition System (Boston Scientific) (K141185) and the MacLab CardioLab Acquisition System (General Electric) (K130626). A connection cable is used to connect the data acquisition system with an Advantech PCI-1713U analog-to-digital converter, which transmits the acquired information to a nearby computer that hosts the VX1 software. The computer and its attached display are located outside the sterile operating room area. The VX1 software analyzes the patient's electrograms to cue operators in real-time to intra-cardiac electrograms of interest for atrial regions harboring DEs as well as a cycle length estimation from electrograms recorded with the mapping and the coronary sinus catheters. The results of the analysis are graphically presented on the attached computer display.

1. Table of Acceptance Criteria and Reported Device Performance:

   The document does not explicitly present a table of acceptance criteria with corresponding performance values in the way typically seen in a formal statistical analysis plan. However, the outcomes of the "Reader Study" and the "Limited Time Annotation Testing" serve as a form of acceptance criteria, where the device's agreement with expert consensus is evaluated.

   Performance Metric	Acceptance Criteria (Implied)	Reported Device Performance
   Inter-operator agreement	Strong agreement among expert readers	Confirmed. Experts strongly agreed with one another.
   VX1 correlation with expert annotation (Reader Study)	Acceptable correlation with physician annotation	VX1 adjudication acceptably correlates with physician annotation.
   Period estimation performance	Outperform or be comparable to alternative algorithms	VX1 period estimation algorithm outperformed both FFT-based and AC-based algorithms for noisy/non-periodic electrograms.
   VX1 algorithm accuracy (k-fold cross-validation)	High accuracy	Over 89% accuracy.
   VX1 performance vs. unassisted electrophysiologists	Superior agreement to annotating experts than unassisted humans	VX1 algorithm demonstrated superior performance (agreement to annotating experts) to cardiac electrophysiologists.
   Clinical risk and procedure time	No additional risk or procedure time	Not associated with additional risk or procedure time.
   Comparable performance to predicate's CFAE module	Comparable performance	VX1 device demonstrated comparable performance in locating electrical signal transmission pattern disruptions as the predicate's CFAE module.

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

   • Reader Study: 14,370 electrograms.
   • Period Estimation Algorithm Testing: 2,550 electrograms.
   • Limited Time Annotation Testing: 1,020 electrograms.
   • Clinical Study: 300 patients across 8 centers.
   • Data Provenance: The document states "An OUS clinical study was performed..." indicating that at least some clinical data is from outside the US. The "training database of 275,020 1.5 second annotated electrograms" drew on "anonymized information from a very large database". The nature (retrospective/prospective) is not explicitly stated for all datasets, but the clinical study was likely prospective to evaluate usability and efficacy.

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

   • Reader Study and Limited Time Annotation Testing: 3 independent experts were used to adjudicate the 14,370 electrograms for the Reader Study. For the Limited Time Annotation Testing, 2 annotating experts were used (who reached a consensus). Their specific qualifications beyond "independent experts" and "annotating experts" are not detailed (e.g., years of experience or board certification).
   • "Unassisted" Human Readers in Limited Time Annotation Testing: 28 cardiac electrophysiologists who underwent a "full-day seminar on spatiotemporal dispersion."

4. Adjudication method for the test set:

   • Reader Study: "adjudicated by three independent experts". It doesn't specify if this was a 2+1, 3+1, or simple majority.
   • Limited Time Annotation Testing: "two annotating experts who were allowed unlimited time to make a classification determination and reach a consensus". This suggests a consensus-based adjudication between two experts.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size:

   • A comparative study was done during the "Limited Time Annotation Testing" comparing the VX1 algorithm's performance to that of 28 cardiac electrophysiologists. This fits the description of a multi-reader (28 electrophysiologists) multi-case (1,020 electrograms) study.
   • Effect Size: The document states the "VX1 algorithm demonstrated superior performance (agreement to the annotating experts) to the cardiac electrophysiologists in identifying dispersed and non-dispersed intra-cardiac atrial electrograms." However, a specific effect size (e.g., AUC difference, sensitivity/specificity improvement, or statistical significance value) is not provided.

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

   • Yes, the "Reader Study" directly compared the VX1's classification to expert annotation, implying a standalone performance evaluation.
   • The "Period estimation algorithm testing" also evaluated the algorithm's performance independently.
   • The k-fold cross-validation is a standalone algorithm performance test.

7. The type of ground truth used:

   • Expert Consensus: The primary ground truth for the Reader Study and Limited Time Annotation Testing was established by "independent experts" or "annotating experts" reaching a consensus on the presence or absence of dispersed intra-cardiac atrial electrograms.

8. The sample size for the training set:

   • The k-fold cross-validation was performed on a "training database of 275,020 1.5 second annotated electrograms."

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

   • The training database drew on "anonymized information from a very large database... of 1.5 second snippets of multipolar intra-cardiac atrial electrograms located on a dedicated data server". The document does not explicitly state how these 275,020 electrograms were annotated (e.g., by experts, or through a different automated process). However, the context of comparing the algorithm to expert annotations in the validation suggests that expert annotation would be the most robust method for establishing ground truth for training as well. Without explicit mention, it's inferred to be expert-annotated.

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Measuring the refraction of the eye giving both lower and higher order aberrations
Measurement of the shape of the cornea
Retro-illumination imaging of the eye
Measuring the intraocular pressure without contacting the eye for glaucoma evaluation.
Photographing the eye and taking images of the eye to evaluate the thickness of the central cornea.
Full corneal thickness map.
Scheimpflug imaging.
Anterior chamber imaging.
Pupil image.
Image of the cornea relative to the iris.

The VX130 is a multifunctional ophthalmic diagnostic device.
The VX130 combined wavefront aberrometer, corneal topographer, cataract screening device, Scheimpflug pachymeter, and non-contact tonometer is a single platform that contains five different measurement units.
The wavefront aberrometer works on the Shack-Hartmann principle and is used as an advanced autorefractometer that measures both lower and higher order aberrations of the eye. Retro illumination is used to image ocular opacities. The corneal topographer uses a Placido disk to measure keratometry and the detailed shape of the cornea. A linear scanning Scheimpflug pachymeter measures the thickness of the cornea by illuminating it with a slit of light and photographing it using the Scheimpflug technique. Anterior and posterior corneal shape are also measured from the Scheimpflug images. An air puff non-contact tonometer is included for measurement of the intraocular pressure. The device is fully automated and a number of different measurements can be performed by a single command including alignment and focusing.

Here's an analysis of the acceptance criteria and study proving the device meets them, based on the provided text:

Device: VX130 Ophthalmic Diagnostic Device
Primary Function under review (for the comparison study): Pachymetry (corneal thickness measurement)

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state formal "acceptance criteria" in terms of specific thresholds for performance metrics. Instead, the approach is one of demonstrating substantial equivalence to a predicate device (Galilei G4). The implicitly accepted performance is that the VX130's measurements are not significantly different from those of the predicate device, across various anterior segment parameters, and that it demonstrates sufficient repeatability.

Interpretation of Performance: The average differences between the VX130 and Galilei G4 are quite small (e.g., -0.43 µm for CCT), and the 95% confidence intervals (not explicitly provided for CCT, but -15.03 to 14.16 µm for CCT suggests the differences are within a clinically acceptable range for equivalence, especially considering the standard deviations). The repeatability standard deviations for the VX130 are also small, indicating consistent measurements.

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

• Comparison Study (VX130 vs. Galilei G4):

  • Sample Size: Not explicitly stated, however, Table 2 (Repeatability of VX130) mentions "42 eyes were measured 3 times each". It is highly probable that the comparison study (Table 1) also used these 42 eyes, or a similar sample size, as it's part of the same "Tests for pachymetry" section. Assuming 42 subjects, likely n = 42 eyes.
  • Data Provenance: Not specified; retrospective or prospective is not mentioned. Country of origin not mentioned.

• Repeatability Study (Table 2 - Std dev 1):

  • Sample Size: "a single eye was measured ten times".

• Repeatability Study (Table 2 - Std dev 2):

  • Sample Size: "42 eyes were measured 3 times each".

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

The document does not mention the use of experts to establish ground truth for the test set. The study design is a comparison between two devices (VX130 and Galilei G4) and a repeatability assessment of the VX130 itself. The Galilei G4's measurements serve as the reference for comparison, not an expert-derived ground truth.

4. Adjudication Method for the Test Set

No adjudication method is mentioned as there were no human readers/interpreters involved in establishing the ground truth for the measurement comparison. The comparison is between automated device measurements.

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

No MRMC study was done. This study focuses on device performance for automated measurements, not on human reader performance with or without AI assistance.

6. Standalone Performance Study

Yes, a standalone performance study was done for the pachymetry function of the VX130 in two ways:

• Comparison to a predicate device: This evaluates the VX130's agreement with an established device (Galilei G4). The results are presented in Table 1, showing "small differences between the devices."
• Repeatability study: This demonstrates the consistency of the VX130's own measurements. The results are presented in Table 2, showing low standard deviations for repeated measurements.

7. Type of Ground Truth Used

The ground truth for the comparison study was the measurements obtained from a legally marketed predicate device (Galilei G4). This is a common approach for demonstrating substantial equivalence for quantitative diagnostic devices. For the repeatability study, the "ground truth" is inferred from the consistency of the device's own measurements over multiple trials.

8. Sample Size for the Training Set

The document does not mention a training set. This is not an AI/Machine Learning device that requires a training set in the conventional sense. The device's functionality is based on established optical and measurement principles (Shack-Hartmann, Placido disk, Scheimpflug), and its performance is evaluated against a predicate device and through repeatability.

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

Not applicable, as there is no mention of a training set for an AI/ML algorithm.

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The VX120 is a multi-function diagnostic device combining wavefront aberometer, corneal topographer, retro-illuminator, tonometer and pachymeter, indicated for:

Measuring the refraction of the eye giving both lower and higher order aberrations

Measuring the shape of the comea

Retro-illumination imaging of the eye

Measuring the intraocular pressure without contacting the eye for glaucoma evaluation

Photographing the eye and taking images of the eye to evaluate the thickness of the cornea.

The VX120 is a multifunctional ophthalmic diagnostic device.

The VX120 combined wavefront aberrometer, corneal topographer, retro illumination device, Scheimpflug pachymeter, and non-contact tonometer is a single platform that contains five different measurement units.

The wavefront aberrometer works on the Shack-Hartmann principle and is used as an advanced autorefractometer that measures both lower and higher order aberrations of the refraction of the eye.

Retro illumination is used to image ocular opacities.

The corneal topographer uses a Placido disk to measure keratometry and the detailed shape of the cornea.

The Scheimpflug pachymeter measures the thickness of the central cornea by illuminating it with a slit of light and photographing it using the Scheimpflug technique. An air puff non-contact tonometer is included for measurement of the intraocular pressure.

The device is fully automated and a number of different measurements can be performed by a single command including alignment and focusing.

The provided text describes the 510(k) summary for the VX120 Ophthalmic Diagnostic Device, focusing on its tonometry and pachymetry functions for substantial equivalence to predicate devices. It outlines performance data including bench and clinical testing.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based only on the provided text:

Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly derived from the performance claims and the standards the device was tested against. The text explicitly states that the device meets the requirements of the specified standards.

Here's a breakdown of the study details based on the provided text:

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

   • Tonometry: The text mentions "clinical evaluation" and "bench testing." It does not specify the sample size for either.
   • Pachymetry: The text mentions a "comparison study" with Pentacam. It does not specify the sample size for this study.
   • Data Provenance: The text does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective. The manufacturer, Luneau SAS, is based in France. The predicates are from the UK (Keeler) and Germany (Oculus), implying international standards and potentially international data, but this is not confirmed.

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

   • The document describes performance testing against standards (ISO, ANSI) and predicate devices. It does not mention the use of human experts or human readers to establish ground truth for the test sets for tonometry or pachymetry performance. The "ground truth" for tonometry appears to be established by the performance of the predicate device and the specified accuracy and repeatability limits from the standards. For pachymetry, the ground truth is implicitly the measurements from the Pentacam predicate.

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

   • Not applicable, as ground truth was not established by human experts requiring adjudication.

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

   • No MRMC or human-in-the-loop study comparing human readers with and without AI assistance is described. The device is referred to as a "diagnostic device," but the performance studies focus on its intrinsic measurement accuracy and comparison to predicate devices, not its assistance to human interpretation or diagnosis.

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

   • Yes, the performance data presented (bench testing, clinical evaluation against standards, and comparison studies for tonometry and pachymetry) appear to represent the standalone performance of the VX120 device/algorithm. The focus is on the device's output accuracy and consistency.

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

   • Tonometry: The ground truth for the tonometry function appears to be established by:
     • Benchmarking against industry standards: ISO8612:2010 and ANSI Z80.10-2009 for clinical evaluation, and internal specifications for accuracy (±2mmHg) and repeatability (±1.2mmHg) from bench testing.
     • Comparison to predicate device performance: The "Pulsair tonometer" is also stated to have an accuracy of ±2 mmHg.
   • Pachymetry: The ground truth for the pachymetry function is established by comparison to a legally marketed predicate device, the Pentacam, noted as demonstrating "no significant statistical difference."

7. The sample size for the training set:

   • The document is a 510(k) summary, not a detailed technical report on the algorithm development. It does not mention a "training set" or specify its size. The device relies on established physical measurement principles (Shack-Hartmann, Placido disk, Scheimpflug, air puff tonometry) rather than machine learning that typically requires training data.

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

   • Not applicable, as a "training set" is not mentioned or implied for this type of device and its described validation. The device's operation is based on fundamental physics and established optical/measurement techniques rather than trained algorithms in the sense of AI/machine learning.

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