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The Vericor Support Catheter is intended for use in small vessel or superselective anatomy for diagnostic and interventional procedures, including peripheral use.

The Vericor Support Catheter with hydrophilic coating is a braided, kink-resistant catheter designed to facilitate wire guide exchange, wire guide support and to provide a conduit for the delivery of saline solutions or diagnostic contrast agents. The Vericor Support Catheter will be available in three catheter lengths which are 90 cm, 135 cm and 150 cm. The proposed device is a single-lumen catheter. The hub of the catheter incorporates standard luer adapter to facilitate the attachment of accessories. The outer surface of the distal catheter has a hydrophilic coating. The catheter has three radiopaque markers at the distal end to facilitate fluoroscopic visualization. The device is provided in single use and sterile.

This document, a 510(k) Summary, describes the Vericor Support Catheter and its substantial equivalence to a predicate device. This is a medical device, not an AI/ML product, so the questions regarding AI/ML clinical studies are not applicable.

Here's the breakdown of the acceptance criteria and the study (non-clinical) that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA 510(k) Summary details numerous non-clinical tests. The column "Test Method Summary" indirectly describes the acceptance criteria by outlining what the test aims to demonstrate (e.g., "To demonstrate that the device meets the corrosion resistance"). The "Results and Conclusion" column reports that the device met these criteria.

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

The document does not explicitly state the sample sizes for each non-clinical test. It generally states that "Non clinical tests were conducted to verify that the proposed device met all design specifications." The data provenance is not applicable in terms of country of origin or retrospective/prospective for these non-clinical, laboratory-based tests. The tests were performed on the Vericor Support Catheter itself.

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

This is not applicable as the studies are non-clinical, laboratory-based performance tests, not studies involving human interpretation or clinical data. Ground truth in this context is established by adherence to specified standards and measurement techniques.

4. Adjudication Method for the Test Set

Not applicable. The tests are based on objective measurements and adherence to established standards, not expert adjudication of subjective interpretations.

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

Not applicable. This is a conventional medical device (support catheter), not an AI/ML diagnostic or assistive device.

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

Not applicable. This device does not involve an algorithm.

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

For these non-clinical tests, the "ground truth" is defined by the objective criteria within the referenced international and national standards (e.g., ISO 10993, ISO 10555-1, ASTM standards, USP). Performance is measured against these established technical specifications and benchmarks.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI/ML system that requires a training set.

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

Not applicable. This device does not involve a training set.

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Vericore ® Gradient Temporary discs is a device made from Polymethylmethacrlate. It is used to mill/fabricate temporary crown or bridge for use in the oral cavity for up to six (6) months while awaiting a permanent restoration. Restorations are designed virtually by a dental professional/technician then manufactured (milled) using CAD technology.

Vericore ® Gradient Temporary Discs is a device made from high quality PMMA (polymethylmethacrylate) that is >98%. It is intended for use in the oral cavity as a temporary restoration up to six (6) months while awaiting a permanent restoration. Two (2) pontics are allowed between two (2) abutment teeth. Restorations are designed by the dental technician using CAD technology and uses scans or models from the basis of the restoration to be milled. Vericore ® Gradient Temporary Discs are circular in form and available in a variety of thicknesses for different milling systems and are also available in Vita shades of A1, A2, A3, B1, B2, and Bleach. The device is fabricated in the standard dental laboratory environment.

Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets them:

Device: Vericore® Gradient Temporary Disc (K152443)
Predicate Device (Primary for performance): Copra-Temp discs manufactured by White Peaks Dental Systems (K131664)

1. Table of Acceptance Criteria and Reported Device Performance

The document provides performance data primarily in comparison to a predicate device, and against ISO standards. The acceptance criteria are implicitly derived from the ISO standard requirements.

Summary of Device Performance against Acceptance Criteria:

• Flexural Strength: The device's reported flexural strength (82 MPa) meets the minimum requirement of 50 MPa per ISO 10477.
• Chemical Solubility & Water Sorption: The document states that "all tests passed the requirements" for these two characteristics according to ISO 10477. The specific numerical acceptance criteria from the ISO standard are not explicitly listed, but the reported values (-0.2 µg/mm³ for solubility and 22 µg/mm³ for water sorption) are provided in comparison to the predicate. The statement "all tests passed the requirements" implies these values were within acceptable limits.
• Biocompatibility: The device demonstrated no irritation effects on test subjects for the oral mucosa, indicating it met the biocompatibility requirements related to its specific shading ingredients.

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

• Sample Size for Test Set: Not specified in the provided document. The tests conducted (Flexural Strength, Water Sorption, Chemical Solubility, Biocompatibility focusing on irritation effects) would have involved specific numbers of samples, but these are not detailed.
• Data Provenance: Not specified in terms of country of origin or retrospective/prospective nature. The testing was conducted by Whip Mix Corporation ("Whip Mix performed biocompatibility test...") for the specific shading ingredients, or referenced predicate data based on similar testing ("same tests as performed on the predicate K131664" and "White Peaks performed biocompatibility tests").

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

• This information is not applicable to this type of device and study. The testing described (mechanical properties and biocompatibility) relies on objective measurement and laboratory analysis, not expert consensus or interpretation of subjective data like images. There is no "ground truth" established by experts in the context of diagnostic accuracy for this device.

4. Adjudication Method for the Test Set

• This information is not applicable as there is no "adjudication" in the context of mechanical properties or biocompatibility testing for this device. The results are based on objective measurements against defined standards.

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

• No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human readers interpreting cases (e.g., radiology AI). The Vericore® Gradient Temporary Disc is a dental material, not a diagnostic imaging device.

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

• No, a standalone algorithm-only performance study was not done. This device is a physical material, not an algorithm or AI system.

7. The Type of Ground Truth Used

• For Flexural Strength, Chemical Solubility, and Water Sorption: The "ground truth" (or reference standard) is established by physical measurements according to the protocols defined in ISO 10477.
• For Biocompatibility: The "ground truth" is established by biological response assessments (e.g., observing for irritation effects) conducted according to relevant parts of the ISO 10993 series (specifically mentioned: ISO:10993-3, ISO:10993-5, and ISO:10993-10 for the predicate, and performed for oral mucosa irritation for the new device).

8. The Sample Size for the Training Set

• This concept is not applicable. This device is a physical dental material, not a machine learning model that requires a "training set."

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

• This concept is not applicable as there is no training set for this type of device.

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Vericore zirconia blanks are made from pre-sintered zirconium dioxide intended to be used with many CAD/CAM or manual milling machines. Vericore zirconia blanks are biocompatible and designed to fabricate;

• Zirconia Substructures .
• -Restorations (Including inlays, onlays, and veneers)
• . Crown Framework in the Anterior and Posterior regions
• . Bridge Framework in the Anterior and Posterior regions

Vericore Zirconia Blanks is a device made from pre-sintered zirconia powder. It is available in various shades, shapes, and sizes to accommodate the customers CAD/CAM or manual milling equipment/strategies and is not machine specific. Vericore Zirconia Blanks are made from a biocompatible zirconia powder. It is intended to be used by professionals for the fabrication of dental restorations.

The provided text is a FDA 510(k) premarket notification for a dental device, "Vericore Zirconia Blanks". This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study of a device's performance against specific acceptance criteria in a clinical setting. Therefore, most of the requested information regarding acceptance criteria, sample sizes, expert involvement, and ground truth establishment for a clinical study is not available in the provided text.

However, I can extract information related to the bench testing conducted.

Here's a breakdown of the available information:

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

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

• Sample Size: Not specified for the bench tests.
• Data Provenance: Not specified, but generally, bench testing data for medical devices would originate from the manufacturer's testing facilities (likely in the USA, given the applicant's address). The tests are prospective in nature as they are conducted for this specific submission.

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)

• Not applicable. Bench testing does not typically involve human experts for establishing ground truth as it measures material properties based on established standards.

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

• Not applicable. Bench testing does not involve adjudication.

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. This document is for a physical dental material, not an AI-powered diagnostic device.

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

• No, a standalone performance study was not done. This document is for a physical dental material, not an algorithm.

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

• For the bench tests (Flexural Strength, Chemical Solubility, Density), the "ground truth" is based on established international standards (ISO 6872) for material properties.

8. The sample size for the training set

• Not applicable. This is a physical dental material, not a machine learning algorithm, so there is no "training set."

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

• Not applicable. There is no training set for a physical dental material.

In summary, the provided document details the regulatory submission for a dental material (Vericore Zirconia Blanks). The "study" described refers to bench testing to ensure the material meets specified physical and chemical properties according to international standards (ISO 6872). It does not involve a clinical study with human subjects, expert readers, or AI performance metrics.

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Vericore zirconia blanks are made from pre-sintered zirconium dioxide intended to be used with CAD/CAM or manual milling machines. Vericore zirconia blanks are biocompatible and designed to fabricate;

• -Zirconia Substructures
• Restorations (Including inlays, onlays, and veneers) -
• -Crown Framework in the Anterior and Posterior regions
• -Bridge Framework in the Anterior and Posterior regions

Vericore Zirconia Blanks is a device made from pre-pressed and pre-sintered zirconia powder. It is available in various shades, shapes, and sizes to accommodate the customers CAD/CAM or manual milling equipment/strategies and is not machine specific. Vericore Zirconia Blanks are made from a biocompatible zirconia powder. It is intended to be used by professionals for the fabrication of dental restorations.

The provided document is a 510(k) summary for a medical device (Vericore Zirconia Blanks), which primarily focuses on establishing "substantial equivalence" to a predicate device rather than presenting a detailed clinical study for novel device performance. Therefore, many of the requested fields related to clinical study design (e.g., sample size for test set, number of experts, adjudication methods, MRMC studies, standalone performance with AI) are not applicable or findable in this type of submission.

However, I can extract information related to acceptance criteria, device performance, and limited testing details.

Here's the information based on the provided document:

Acceptance Criteria and Device Performance

Study Details

• Sample size used for the test set and the data provenance: Not explicitly stated for the "test set" in the context of a clinical performance study. The "test set" here refers to the samples of Vericore Zirconia Blanks that underwent bench testing. The provenance of these physical samples would be the manufacturer (Whip Mix Corporation).
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This device is a material, and its performance is evaluated through physical and chemical property testing (bench testing) against international standards, not against expert human interpretations.
• Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. Performance is determined by objective measurements compared to standard thresholds, not by human adjudication of clinical outcomes.
• 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: Not applicable. This is not an AI-enabled diagnostic device.
• If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an AI-enabled device.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc): The ground truth for the bench tests are the established performance requirements outlined in the ISO 6872 standard for dental ceramic materials and ISO 10993 for biocompatibility.
• The sample size for the training set: Not applicable. This device is a material, not a machine learning model.
• How the ground truth for the training set was established: Not applicable. No training set is involved for this device.

Additional Information from the document:

• Study Type: Bench testing (physical and chemical property evaluation) and comparison to a legally marketed predicate device to establish substantial equivalence.
• Predicate Device: White Peaks Copran ZR/Origin ZR (K092496).
• Basis for Biocompatibility: The document states, "No further biocompatibility tests are necessary because Whip Mix Vericore Blanks are made from the same powder as the predicate," which indicates a reliance on the biocompatibility testing performed for the predicate device (in accordance with ISO 10993-10, 10993-3, and 10993-5).

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The Vericore Abutment is intended for use as an accessory to an endosseous implant to support a prosthetic device in a partially or completely endentulous patient. It is intended for use to support single and multiple tooth prosthesis, in the mandible or maxilla. The prosthesis can be cement retained to the abutment. The abutment screw is intended to secure the abutment to the endosseous implant.

The abutment is placed over the implant and is mounted on to the implant with an abutment screw.

This device is compatible with the following manufacturers' implant systems: Nobel Biocare, Southern Hexed, 3i, 3i Certain, Zimmer, Endopore, Nobel Replace, Southern Trilobe, Astra and Straumann.

This device may be used in an early load situation, but is dependent on the specific implant system and protocol used by the dental professional.

Angled abutments and narrow diameter implants are intended for the anterior region of the mouth and are not intended for the posterior region due to limited strength of the implant.

The Devices covered in this submission are abutments which are placed on the dental implant to provide support for a prosthetic restoration.

Vericore Abutments are made from Titanium grade Ti-6Al-4V. The abutment screws and are made from Titanium grade Ti-6A1-4V. The abutment is made to be placed over the implant and is mounted on to the implant with an abutment screw. The abutments are compatible with the following implant systems: Zimmer - Narrow, Regular, Wide Nobel Biocare - Narrow, Regular, Wide 3i - Regular Hexed 3i Certain - Narrow, Regular, Wide Southern Hexed - Narrow, Regular, Wide Endopore -- Narrow, Regular and 5mm Nobel Replace- Narrow, Regular, Wide and 6mm Southern Trilock - Narrow, Regular and Wide Astra - Narrow and Regular Straumann - Narrow, Regular and Wide

Here's a breakdown of the acceptance criteria and study information for the Vericore Custom Abutment in Titanium, based on the provided text:

Acceptance Criteria and Device Performance

Study Information

The provided document describes a premarket notification (510(k)) for a medical device, which primarily relies on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting a de novo clinical study with specific acceptance criteria in the way a new drug or novel medical device might. Therefore, some of the requested categories are not directly applicable in the traditional sense of a clinical trial or AI performance study.

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

• Sample Size: Not specified for the fatigue testing. It refers to "the worst case scenario for each connection platform style." This implies a selection of representative abutment designs for testing, but not a large statistical sample of patient data.
• Data Provenance: Not specified. The testing was described as "conducted according to ISO 14801," an international standard, suggesting it was laboratory-based testing rather than data from human patients.

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)

• Not applicable. The "ground truth" here is based on engineering and materials science principles and international standards (ISO 14801) for mechanical performance, not expert human interpretation of medical data.

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

• Not applicable. This type of adjudication is relevant for human-interpreted medical image or diagnostic studies, not for the mechanical testing described.

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

• Not applicable. This is a medical device (dental implant abutment) and the submission details mechanical performance testing, not an AI-assisted diagnostic or interpretation tool.

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

• Not applicable. This device is a physical medical implant component, not an algorithm.

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

• The "ground truth" for the performance evaluation derives from established engineering principles, materials science specifications (Titanium grade Ti-6Al-4V), and an international standard for mechanical testing (ISO 14801). Compliance with these standards and comparison to a predicate device's measured performance serves as the basis for evaluation.

8. The sample size for the training set

• Not applicable. There is no concept of a "training set" in the context of this type of medical device submission.

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

• Not applicable. As there's no training set, this question is not relevant.

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The Vericore Abutment is intended for use as an accessory to an endosseous implant to support a prosthetic device in a partially or completely endentulous patient. It is intended for use to support single and multiple tooth prosthesis, in the mandible or maxilla. The prosthesis can be cement retained to the abutment. The abutment screw is intended to secure the abutment to the endosseous implant.

The abutment is placed over the implant and is mounted on to the implant with an abutment screw.

This device is compatible with the following manufacturers' implant systems: Branemark, Southern Hexed, 3i, 3i Certain, Zimmer and Endopore.

This device may be used in an early load situation, but is dependent on the specific implant system and protocol used by the dental professional. Also highly angled abutments (i.e. 15 degrees) on implants with diameters less than 4 mm are intended for the anterior region of the mouth and are not intended for the posterior region due to limited strength of the implant.

Zimmer - Narrow, Regular, Wide Nobel Biocare - Narrow, Regular, Wide 3i -Micro Mini, Regular Hexed, 5mm 3i Certain - Narrow, Regular, Wide Southern Hexed - Narrow, Regular, Wide Endopore - Narrow, Regular and 5mm Astra - Narrow and Regular Straumann - Narrow, Regular, Wide

The Devices covered in this submission are abutments which are placed on the dental implant to provide support for a prosthetic restoration.

Vericore Abutments are made from biocompatible yttria-stablized zirconia blocks. The abutment screws are made from Titanium grade Ti-6A1-4V The abutment is placed over the implant and is mounted on to the implant with an abutment screw The abutments are compatible with the following implant systems:

Zimmer - Narrow, Regular, Wide Nobel Biocare - Narrow, Regular, Wide 3i -Micro Mini, Regular Hexed, 5mm 3i Certain - Narrow, Regular, Wide Southern Hexed - Narrow, Regular, Wide Endopore - Narrow, Regular and 5mm Astra - Narrow and Regular Straumann - Narrow, Regular, Wide

This is a medical device 510(k) premarket notification for a dental abutment, not an AI/ML device. Therefore, the requested information (acceptance criteria for AI/ML performance, study details for AI/ML validation, sample sizes for training/test sets, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, and standalone performance) is not applicable and cannot be extracted from the provided text.

The document discusses the substantial equivalence of the "Vericore™ Abutment" to previously marketed dental abutments, based on its materials, intended use, and compatibility with various implant systems. It's a traditional medical device submission, not involving AI or machine learning.

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The Vericore Abutment is intended for use as an accessory to an endosseous implant to support a prosthetic device in a partially or completely edentulous patient. In is intended for use to support single and multiple tooth prosthesis, in the mandible or maxilla. The prosthesis can be cement retained to the abutment. The abutment screw is intended to secure the abutment to the endosseous implant.

The abutment is placed over the implant and is mounted on to the implant with an abutment screw; an abutment adaptor will be added between the implant and the abutment. The abutment adaptor is intended to interface between the abutment and the implant allowing the abutment to meet with and be sealed to the parts of the implan that can not be milled into the abutment.

This device is compatible with the following manufacturers' implant systems: Nobel Biocare, Southern Trilock.

This device may be used in an early load situation, but is dependent on the specific implant system and protocol used by the dental professional.

Also highly angled abutments (i.e. 28 degrees) on implants with diameters less than 4 mm are intended for the anterior region of the mouth and are not intended foor the posterior region due to limited strength of the implant.

Replace- Narrow (3.5mm), Regular (4.3mm), Wide (5.0mm) and 6mm Southern Trilock - Narrow (3.5mm), Regular (4.3mm) and Wide (5.0mm)

The Devices covered in this submission are abutments which are placed on the dental implant to provide support for a prosthetic restoration.

Vericore Abutments are made from biocompatible yttria-stablized zirconia blocks. The abutment screws and adaptors are made from Titanium grade Ti-6A1-4V for the screws and Grade 4 for the adaptors. The abutment is placed over the implant and is mounted on to the implant with an abutment screw; an abutment adaptor will be added between the implant and the abutment. The abutment adaptor is intended to interface between the abutment and the implant allowing the abutment to meet with and be sealed to the parts of the implant that can not be milled into the abutment. The abutments are compatible with the following implant systems:

Replace- Narrow (3.5mm), Regular (4.3mm), Wide (5.0mm) and 6mm Southern Trilock - Natrow (3.5mm), Regular (4.3mm) and Wide (5.0mm)

The provided text is a 510(k) summary for the Vericore™ Abutment, a dental implant abutment. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain any information regarding acceptance criteria, study methodologies, sample sizes, ground truth establishment, or expert qualifications that would typically be found in a study demonstrating device performance.

Therefore, I cannot provide the requested table and study details.

The document primarily focuses on:

• Device Description: What the Vericore Abutment is made of and how it functions.
• Intended Use: The clinical purpose of the abutment.
• Predicate Device: The legally marketed device (Atlantis Zirconia Abutments) to which equivalence is claimed.
• Regulatory Information: FDA’s determination of substantial equivalence and general controls applicable to the device.

There is no mention of any performance studies, clinical trials, or bench tests with specific acceptance criteria or results. The FDA's 510(k) clearance process for devices like this often relies on demonstrating substantial equivalence to a predicate device, sometimes through physical and mechanical testing, but the details of such testing (if performed and submitted) are not present in this summary.

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The VeriCor is indicated for use in estimating non-invasively, left ventricular end-diastolic (LVEDP) pressure. This estimate, when used along with clinical signs and other patient test results. including weights on a daily basis, can aid the clinician in the selection of further diagnostic tests in the process of reaching a diagnosis and formulating a therapeutic plan when abnormalities of intravascular volume are suspected.

The device has been clinically validated in males only. Use of the device in females has not been investigated. Certain patient conditions should be considered as a basis for excluding individual patients for testing based on a possible risk to them of the Valsalva maneuver, such as the following:.

• Weight <88 pounds (40 kilograms)* 1.
• Atrial flutter or atrial fibrillation with irregular ventricular response
• Significant atrial or ventricular ectopy 3
• Hypertrophic obstructive cardiomyopathy 4.
• History of paradoxical emboli 5.
• Known intracardiac shunt 6.
• Significant aortic valvular disease 7.
• 8. Unstable angina
• History of embolic CVA
• 10. Myocardial infarction within one week of intended VeriCor testing
• 11. Uncontrolled hypertension (systolic BP > 160mmHg or diastolic BP > 100mmHg)
• 12. Hypotension (systolic BP<90mmHg)
• 13. Symptomatic bradycardia
• 14. Known cholesterol emboli
• 15. Poor LV function with LV thrombus

*Colin tonometer recommendation

The VeriCor device is intended to be used as one of several tools that will assist the cardiologist in assessment of the volume status of a patient, i.e., when the questions of either volume overload or volume depletion arises. A principal measure of intravascular volume status is the filling pressure in the left ventricle as best reflected by the left ventricular enddiastolic pressure (LVEDP). Measurement of the left ventricular enddiastolic pressure requires the placement of a catheter in the left ventricle of the heart to measure the pressures directly. This procedure involves a moderate risk to the patient but could result in arterial hemorrhage, stroke and death. Accordingly, it cannot be used as a routine procedure for patient assessment or for monitoring over time.

An estimate of LVEDP may be obtained with somewhat less risk to the patient by catheterization of the pulmonary artery as described above. The resulting measurement, called the Pulmonary Capillary Wedge Pressure (PCWP), correlates well with LVEDP. PCWP is widely used as an alternative to direct measurement of LVEDP, even though it has potential for complications and limitations in accuracy that are recognized.

The proposed device, the VeriCor, is intended to provide another point on the risk/benefit curve for assessment tools. The VeriCor is non-invasive, so it involves much less risk than catheterization of either the left ventricle or the pulmonary artery. The VeriCor device provides measurements that are well correlated with PCWP measurements.

The Colin CBM7000 Pulse Tonometer and the W. E. Collins Airway Pressure Monitor each have an interface connection for a computer to read data from the devices. In the VeriCor, a computer reads data from these devices during a sequence of procedures with the patient, including the Valsalva maneuver, and, using a proprietary algorithm, converts the data to estimates of the left ventricular pressure.

The digital manometer is used to measure the airway strain of the patient blowing into the mouthpiece. The pulse tonometer provides an instantaneous and continuous measure of non-invasive blood pressure before, during and after the Valsalva manuever. Data are recorded from both devices so as to provide a baseline followed by a minimum of eight and a maximum of 15 seconds of modest expiratory strain which is followed by 15 to 20 seconds of post-strain recording. The computer controller acquires the data from the devices and provides a dialog with the health-professional user. The user coaches the patient to perform the necessary actions, and one or more practice sessions are used to ensure that the patient can perform those actions correctly.

The provided text describes the VeriCor device, its intended use, and its substantial equivalence to predicate devices, but it does not contain detailed acceptance criteria or a specific study proving the device meets those criteria, nor does it provide a performance table with reported device performance against acceptance criteria.

The document states: "The performance testing carried out on the device assures substantial equivalence" and "The results from clinical studies of the device are presented in the 510(k)." However, the content of these studies or the specific performance metrics and acceptance thresholds are not included in the provided snippets.

Therefore, I cannot populate the table or answer most of the questions directly. However, based on the available information, I can infer some details.

Here's an attempt to answer the questions based on the limited information:

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

No explicit acceptance criteria or a performance table are provided in the given text. The document only mentions that the device provides measurements "well correlated with PCWP measurements" and that "performance testing carried out on the device assures substantial equivalence." Specific numerical thresholds for this correlation or other performance metrics are absent.

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

Not specified. The document mentions "clinical studies" but does not provide details on sample size, data provenance, or whether the study was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not specified. The document does not describe how ground truth was established for the clinical studies.

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

Not specified.

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

Not applicable. The VeriCor is described as a device that aids clinicians in assessing intravascular volume status by non-invasively estimating LVEDP. It's not an AI-based interpretation tool for human readers in the sense of image analysis. It provides an estimate, which is then used "along with clinical signs and other patient test results." Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this device's function as described.

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

The device itself is a "standalone" system in the sense that it generates the LVEDP estimate. The description states: "the VeriCor, a computer reads data from these devices during a sequence of procedures with the patient, including the Valsalva maneuver, and, using a proprietary algorithm, converts the data to estimates of the left ventricular pressure." This suggests an algorithm-only component for the estimation. However, the output is intended to be used by a clinician, implying a human-in-the-loop is essential for diagnosis and therapeutic planning. The clinical validation would have assessed the performance of this algorithm.

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

Given the device aims to estimate Left Ventricular End-Diastolic Pressure (LVEDP), and it's stated that "PCWP [Pulmonary Capillary Wedge Pressure] is widely used as an alternative to direct measurement of LVEDP," it is highly probable that Pulmonary Capillary Wedge Pressure (PCWP) measurements, obtained via catheterization, were used as the ground truth or a strong reference standard for validating the VeriCor's estimates. The document states: "The VeriCor device provides measurements that are well correlated with PCWP measurements."

8. The sample size for the training set

Not specified. The document mentions clinical studies for validation but does not separate training and test sets or provide their sizes.

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

Not specified. (See point 7 for the likely nature of the ground truth if it were described).

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