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The A-PULSE CASPal+ and MC3100+ Monitors are intended for use on patients who are eighteen (18) years and older, and for the CASPal+, have a palpable radial pulse.

Brachial Blood pressure, CASP and pulse rate readings obtained using the A-PULSE CASPal+ and MC3100+ Monitors are intended for use by qualified healthcare personnel as an aid to diagnosis and treatment.

The HealthSTATS A-PULSE CASPal® and MC3100™ are standalone noninvasive blood pressure monitors which are designed to measure (1) conventional oscillometric blood pressure with a brachial cuff and (2) Central Aortic Systolic Pressure (CASP) and other indices based on arterial tonometry at the radial artery of the wrist.

The CASPal®+ Monitor is comprised of four main elements:

• System embedded processing unit.
• Integrated oscillometric blood pressure module for calibration (identical to the BPCalibrator [listed device K041546], also cleared iin CASPal device K101002).
• Wrist sensor module for acquistion of central aortic systolic pressure (CASP) via radial arterial tonometry at the wrist [cleared accessory and method K101002].
• Bluetooth® wireless communications module.

The MC3100™* is a reduced feature set of the CASPal®* which only offers the oscillometric blood pressure measurement and not the CASP measurement, but is otherwise identical. my-BP™ PC software may be used with either device to store and display blood pressure and pulse rate measurements on a suitably equipped computer.

The provided 510(k) summary does not contain the information necessary to fully describe the acceptance criteria and the study that proves the device meets those criteria, particularly as it relates to AI/machine learning performance studies.

This document describes a blood pressure monitor (HealthSTATS A-PULSE CASPal®+ and MC3100™+ Monitors) and associated software. The "Clinical Tests Submitted" section explicitly states that no new clinical data was submitted for this specific 510(k) submission (K131788). Instead, it relies on clinical testing performed on a cleared predicate device (A-PULSE CASPal) because the current devices are considered "functionally and physically identical" except for the addition of Bluetooth wireless data transmission.

Therefore, many of the requested details about acceptance criteria, test set characteristics, expert involvement, and ground truth establishment are not present in this document, as they would have been part of the predicate device's clearance.

However, I can extract what is stated:

Summary of Acceptance Criteria and Device Performance (based on provided text):

The document frames "acceptance criteria" through the lens of substantial equivalence to predicate devices, focusing on safety and effectiveness.

Study Details (based on provided text):

Since this submission relies on a predicate device's clearance for clinical data, the details of the original clinical study are not provided in this document. The following points represent what can be inferred or are explicitly absent:

1. A table of acceptance criteria and the reported device performance: See table above. Specific numerical clinical performance metrics (e.g., mean difference and standard deviation of BP readings compared to a reference) are not provided in this summary, as clinical data was not submitted anew for this device.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not provided in this document. This information would have been part of the predicate device's 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/provided. For a blood pressure monitor, the "ground truth" is typically established by concomitant measurements using a validated reference method (e.g., auscultation by trained observers using a mercury sphygmomanometer, intra-arterial catheterization for CASP, or another FDA-cleared device with established accuracy), not by human experts adjudicating images or reports. The document does not describe the specifics of the clinical study method for the predicate.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable/provided. As per point 3, this is not a study type where human adjudication of results would typically occur.
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. This is not an AI/machine learning device that assists human readers. It's a medical device for measuring blood pressure.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device measures blood pressure automatically, so its performance is inherently "standalone" in that sense. It does not involve a human in a decision-making loop that an AI would typically augment. The performance of the measurement algorithms themselves would have been evaluated in the predicate device’s clinical study against reference methods.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For blood pressure measurement, the ground truth is typically a reference measurement from a validated standard method (e.g., intra-arterial catheter, or manual auscultatory measurement by trained personnel according to a standard protocol). The specific method used for the predicate device's clinical study is not detailed in this 510(k) summary.
8. The sample size for the training set: Not applicable. This device is not described as utilizing a machine learning algorithm that has a "training set." Its function is based on established physiological principles and signal processing, not a trained AI model.
9. How the ground truth for the training set was established: Not applicable. (See point 8).

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The Fundus Photo Digital Imaging System Model CFD-440 Model is intended to capture, archive, and display digital images of the retina and surrounding areas of the eye.

The Fundus Photo Digital Imaging System Model CFD-440 is an automated imaging device used in conjunction with an ophthalmic fundus camera that requires minimal intervention during the capture of an image. The system is simple to use and requires nominal training for a user to become proficient. Like the predicate device, the Fundus Photo Digital Imaging System Model CFD-440 is an accessory attachment comprised of a digital imaging camera or cameras, computer hardware and software platform intended to capture, store, archive, and display images acquired by the fundus camera.

The provided text describes the Fundus Photo Digital Imaging System Model CFD-440, a device intended to capture, archive, and display digital images of the retina and surrounding areas of the eye. It is an accessory attachment that works with existing ophthalmic fundus cameras. The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device (Zeta Diagnostic Retinal Imaging System, K02216), rather than detailing specific acceptance criteria in terms of clinical performance metrics for the CFD-440 itself.

The document states: "Fundus Photo has performed software verification, validation and performance tests. The results indicate that the Fundus Photo Digital Imaging System Model CFD-440 is substantially equivalent to the software standards exhibited by the predicate device." However, no specific performance metrics, acceptance criteria, or the details of these performance tests are provided beyond this general statement.

Therefore, many of the requested details about acceptance criteria and the study proving the device meets them cannot be extracted from this document, as the submission focuses on demonstrating equivalence in intended use, principles of operation, and technological characteristics rather than quantitative performance against defined acceptance criteria.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

• Acceptance Criteria: Not explicitly stated in the document in terms of quantitative performance metrics (e.g., resolution, accuracy, sensitivity, specificity). The primary "acceptance criteria" for the 510(k) submission appears to be demonstrating substantial equivalence to the predicate device.
• Reported Device Performance: No specific quantitative performance data is provided. The document states that "software verification, validation and performance tests" were done and "the results indicate that the Fundus Photo Digital Imaging System Model CFD-440 is substantially equivalent to the software standards exhibited by the predicate device."

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 in the provided text.

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/Not specified as no such test set or ground truth establishment is detailed in the submission.

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

• Not applicable/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, as this device is a digital imaging system, not an AI or diagnostic aid that assists human readers.

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

• Not applicable. The device is an imaging system, not a standalone diagnostic algorithm. Its performance is tied to the images it captures, stores, and displays, which are then interpreted by a human user.

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

• Not applicable/Not specified. The submission focuses on substantial equivalence in function and technical characteristics, not diagnostic accuracy against a ground truth.

8. The sample size for the training set

• Not applicable/Not specified. The device is not an AI/ML algorithm that requires a "training set" in the conventional sense. Its development involved software verification and validation, but not machine learning training.

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

• Not applicable/Not specified.

In summary, the provided 510(k) submission for the Fundus Photo Digital Imaging System Model CFD-440 is focused on demonstrating substantial equivalence to a predicate device based on intended use, principles of operation, and technological characteristics (hardware and software functions). It does not present detailed performance studies against specific clinical acceptance criteria, nor does it involve aspects like AI algorithms, human-reader studies, or ground truth establishment in the context of diagnostic accuracy.

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The A-PULSE CASPro/CASPal Monitors are intended to measure systolic and diastolic blood pressure and pulse rate, and to utilize the radial pulse waveform to derive central aortic systolic pressure (CASP) and other waveform indices.

Cardiovascular disease remains among the leading causes of death worldwide. Hypertension assessment is one of the primary factors in the evaluation of cardiovascular disease. Assessment of CASP may improve the stratification and management of patients with elevated cardiovascular risk.

The A-PULSE CASPro/CASPal Monitors are compact standalone monitors that combine two methods of blood pressure measurement:

• Conventional oscillometric blood pressure via a brachial cuff on the upper arm, and
• Radial arterial pulse acquisition via a wrist-mounted tonometer sensor.

The A-PULSE CASPro/CASPal Monitors first measure systolic and diastolic blood pressure and pulse rate via the oscillometric method, and then acquire the radial arterial pulse waveform to derive the Central Aortic Systolic Pressure (CASP) non-invasively.

The A-PULSE CASPro monitor has a graphical display that displays the arterial pulse waveform as well as a range of other pulse indices. The A-PULSE CASPal monitor has a numeric display. Both models have a nonvolatile memory to store and recall measurements.

Brachial Blood pressure, CASP and pulse rate readings obtained using the A-PULSE CASPro/CASPal Monitors are intended for use by qualified healthcare personnel as an aid to diagnosis and treatment.

The A-PULSE CASPro/CASPal Monitors are intended for use on patients who are eighteen (18) years and older and who have a palpable radial pulse.

Caution: Federal law (U.S.A.) restricts this device to sale by or on the order of a physician or other licensed practitioner.

HealthSTATS A-PULSE CASPro/CASPal Monitors are standalone noninvasive blood pressure monitors which are designed to measure (1) conventional oscillometric blood pressure with a brachial cuff and (2) Central Aortic Systolic Pressure (CASP) and other indices based on arterial tonometry at the radial artery of the wrist.

The CASPro/CASPal Monitors are comprised of four main elements:

• Integrated oscillometric blood pressure module for calibration . (identical to the BPCalibrator [listed device K041546]).
• . Wrist sensor module based on the technology of the BPro® monitor device [listed device K060315].
• Software algorithm for radial arterial blood pressure measurement . and calculation of CASP based on the A-PULSE PC Software [listed device K072593].
• A-PULSE CASPro®, A-PULSE CASPal® main processing unit. .

Two functionally equivalent monitors are offered in this 510(k), the A-PULSE CASPro Monitor and the A-PULSE CASPal Monitor:

• . The CASPro Monitor device is equipped with a full featured color TFT LCD panel to display blood pressure readings and radial arterial pulse waveforms. The device also has a real time calendar clock for time-stamped stored readings.
• The A-PULSE CASPal Monitor device is equipped with a simplified . monochrome LCD panel to provide numeric blood pressure readings and a pulse bar to display radial arterial pulsations.

The operation sequence of both A-PULSE CASPro and CASPal Monitors is the same and both devices use identical hardware and software alqorithms to measure and report conventional systolic and diastolic blood pressure readings (BP), Central Aortic Systolic Pressure (CASP), and pulse rate (PR).

The provided text describes the HealthSTATS A-PULSE CASPro/CASPal Monitors, which are non-invasive blood pressure monitors designed to measure conventional oscillometric blood pressure, Central Aortic Systolic Pressure (CASP), and other indices based on arterial tonometry.

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

1. Table of Acceptance Criteria and Reported Device Performance:

The document states that the A-PULSE CASPro/CASPal Monitors were "clinically tested in comparison with listed devices for the measurement of central aortic systolic pressure (CASP). Test results demonstrate CASP measurements that are consistent with the predicate devices within the stated accuracy claims." However, the specific numerical acceptance criteria for CASP accuracy or other measurements (e.g., conventional blood pressure, pulse rate) are not detailed in the provided text. Therefore, a complete table cannot be constructed with specific numerical acceptance criteria.

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

The document states that the A-PULSE CASPro/CASPal Monitors were "clinically tested," but does not specify the sample size used for the test set.

The data provenance (country of origin, retrospective or prospective) is not mentioned in the provided text.

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

The document does not specify the number of experts used to establish ground truth or their qualifications. The clinical testing was performed "in comparison with listed devices" for CASP measurement, suggesting that the predicate devices' measurements were used as a reference, rather than independent expert ground truth establishment.

4. Adjudication Method for the Test Set:

The document does not describe any adjudication method. The testing was a comparison against predicate devices.

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

A multi-reader multi-case (MRCM) comparative effectiveness study was not explicitly mentioned or described. The testing focused on the device's measurements relative to predicate devices, not on human reader performance with or without AI assistance.

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

Yes, a standalone study was performed. The device, an "A-PULSE CASPro/CASPal Monitor," is described as a "standalone noninvasive blood pressure monitor" that uses "software algorithm for radial arterial blood pressure measurement and calculation of CASP." The clinical tests evaluate the accuracy of these measurements directly against predicate devices, indicating a standalone performance assessment.

7. Type of Ground Truth Used:

The ground truth for the clinical tests was established by comparison with measurements obtained from predicate devices. The text states, "The A-PULSE CASPro/CASPal Monitors were clinically tested in comparison with listed devices for the measurement of central aortic systolic pressure (CASP)." This implies that the measurements from the predicate devices served as the reference standard.

8. Sample Size for the Training Set:

The document does not provide any information regarding a training set or its sample size. The focus is on the clinical testing against predicate devices. It is possible that the software algorithms used in the device were developed using internal data that is not disclosed in this summary, or that the algorithms are based on established methods from the predicate devices without requiring a separate "training set" in the context of this submission.

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

Since no training set information is provided, the method for establishing its ground truth is not mentioned.

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