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The Diasys Integra II is a non-invasive Ambulatory Blood Pressure (ABP) recorder. It measures the systolic, diastolic, mean blood pressure (BP) and the heart rate (HR). It measures and records the patient position and the arterial rigidity (QKd) at the time of each BP measurement. The BP measurements can be performed using the oscillometric mode, the auscultatory mode or the ECG-gated auscultatory mode. The procedure can be:

• transfert to a computer for further analysis and report printing using the DiasySoft . software
• printed out directly in a report form by a printer connected to the unit .
• transfert to a remote computer through a modem connected to the unit .

The DIASYS INTEGRA II is a non invasive automatic ambulatory blood pressure recorder. It has two I he DITC I o it it it & erating, the auscultatory mode and the oscillometric mode. The required mode is selected with the DiasySoft Software. If neither of these modes has been specially programmed, the Scienced with the Discount of the most appropriate mode for the patient, according to its own criteria : this is the Automatic mode.
The DIASYS INTEGRA II weighs about 195 gr. and contains the electronic system and pneumatic inflation/deflation module. The measurements are saved and can be printed out directly in report form by a printer connected to the unit. If a computer is used, recording conditions and criteria can be set and the a printer of the procedure can be selected, organized, stored and printed out in a fully customised report.
The system is only for measurement, recording and display. It makes no diagnoses.

Here's a breakdown of the requested information about the DIASYS INTEGRA II device's acceptance criteria and the supporting study, based on the provided text:

Important Note: The provided text is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than detailing a rigorous clinical study with acceptance criteria and a full statistical analysis. Therefore, much of the requested information, particularly regarding specific study design elements like sample size calculations, expert qualifications for ground truth, MRMC studies, and detailed training set information, is not explicitly present in this document. The focus here is primarily on device specifications and a general statement of safety and effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't present formal acceptance criteria in a dedicated table format with specific thresholds for accuracy. Instead, it compares the new device's specifications to those of predicate devices and states its claimed precision.

Note on "Acceptance Criteria": In a 510(k) submission, "acceptance criteria" are often implicitly met if the new device's performance is deemed substantially equivalent to a legally marketed predicate device. The explicit "acceptance criteria" for precision are typically derived from industry standards (e.g., AAMI, ISO) for blood pressure monitors, which often specify accuracy within a certain range (e.g., mean difference and standard deviation). The +/- 3 mmHg for BP precision is a common standard, suggesting this was the established benchmark.

2. Sample Size for Test Set and Data Provenance

The provided 510(k) summary does not specify a sample size for a test set or the data provenance (e.g., country of origin, retrospective/prospective). 510(k) summaries often do not include the detailed study protocols or results of the underlying performance studies.

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

The document does not provide any information regarding the number of experts or their qualifications for establishing ground truth. For blood pressure devices, ground truth is typically obtained using a reference standard (e.g., mercury sphygmomanometer readings by trained observers).

4. Adjudication Method for the Test Set

The document does not specify an adjudication method.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not mentioned or implied in this 510(k) summary. Such studies are more common for diagnostic imaging AI devices where human interpretation plays a significant role. This device is an automated measurement system.

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

The device is described as an "automatic ambulatory blood pressure recorder," implying it operates in a standalone mode, providing automated measurements. The stated BP precision of "+/- 3 mmHg" would be the result of a standalone performance evaluation. However, the exact details of this standalone performance study are not provided.

7. The Type of Ground Truth Used

For blood pressure measurement devices, the ground truth is typically established through simultaneous measurements using a recognized reference standard, such as a mercury sphygmomanometer or another validated oscillometric device, often read by trained human observers following a standardized protocol (e.g., AAMI, ISO). The document does not explicitly state the type of ground truth used for its performance evaluation, but this is the widely accepted method for such devices.

8. The Sample Size for the Training Set

The document does not specify a sample size for a training set. This device is a hardware-based measurement system with embedded algorithms, and the concept of a "training set" as understood in machine learning (for an AI algorithm) is not directly applicable in the same way to its core functionality described. While its algorithms would have been developed and tuned, the specific size of a "training set" of patient data is not discussed in this context.

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

As with point 8, the document does not provide information about a training set or how its ground truth might have been established. Device development involves calibration and validation against known standards and potentially clinical data, but the term "training set" in the AI sense is not used here.

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Recorder :

Vista Plus is intended to record one, two or three channels surface ECG data from ambulatory patients (Holter) for period up to 11 days on one channel, 6 days on two channels, 4 days on three channels. Recorded data are intended to be analysed by holterSoft Ultima analysis on the ECG data.

Software :

HolterSoft Ultima is intended to read data acquired by the Vista Plus, analyze, edit, review, report and store these data. The system is intended to be used by trained operators under the direct supervision of a licensed Health Care practitioner in a hospital or a clinic environment.

The VISTA PLUS holter recorder is a miniature ambulatory ECG recorder (ECG holter) which can continuously record one, two or three channels for a period up to several days ( 1 1 days on 1 channel, 6 days on 2 channels, 4 days on 3 channels).

The entire ECG is stored on a removable memory (compact falsh card) and can be read directly by HolterSoft Ultima software installed in a computer.

The VISTA PLUS has a microphone allowing the recording of voice messages from the physician or the patient (patient diary) during monitoring.

This ECG holter recorder does not perform any analysis on the ECG data.

The VISTA PLUS recorder weighs about 100gr. including flash card and batteries and is connected to the patient with a single multilead cable connected to the ECG electrodes.

The VISTA PLUS is supplied in a case containing a 128 MB compact flash memory card, one standard ECG cable 180cm, two neck protective pouches, one protective pouch for belt, one shoulder strap, two 1,5V AAA batterics, and a CD-Rom which contains multilingual user's manual.

The provided text is a 510(k) summary for the NOVACOR VISTA PLUS Holter Recorder and HolterSoft Ultima software. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a dedicated study.

Therefore, many of the requested elements (acceptance criteria table, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for training) are not available in the provided document. The document describes the device's technical specifications and intended use, and then compares these to predicate devices to establish equivalence.

However, I can extract the following information:

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

The document does not explicitly state "acceptance criteria" but instead provides a comparative table of specifications between the Vista Plus and its predicate devices. The implicit acceptance criterion is that the Vista Plus's specifications should be comparable to or better than the predicate devices to demonstrate substantial equivalence.

AFib Module: The document also compares the HolterSoft Ultima AF module to a predicate device for Atrial Fibrillation.

2. Sample sized used for the test set and the data provenance: Not available in the provided text. The submission is a 510(k) summary focusing on substantial equivalence to predicate devices based on technical specifications rather than a new clinical study with a test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available in the provided text. No specific test set or ground truth establishment process is described beyond the device's functional specifications.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not available in the provided text.

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 available in the provided text. The device is an ECG recorder and analysis software without explicit AI assistance described, and no MRMC study is mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not available in the provided text. The software performs analysis, but the submission doesn't detail standalone performance metrics in a study. The "Intended Use" states the system is "intended to be used by trained operators under the direct supervision of a licensed Health Care practitioner."

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not available in the provided text. The submission focuses on comparing technical specifications with predicate devices to establish substantial equivalence, not on validating performance against a "ground truth" derived from patient data.

8. The sample size for the training set: Not available in the provided text. The document does not describe the development of an algorithm that would typically require a training set.

9. How the ground truth for the training set was established: Not available in the provided text.

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The R-Test Evolution 3 is a miniature ambulatory ECG Event Recorder that is connected to the patient. As the R-Test Evolution (previous model), this version is capable of memorizing the most significant pathological events (symptomatic or silent) as well as the patient's continuous heart rate trend, and is capable of up to eight day ambulatory recording. The registered data could be sent by a modem or by an e-mail application software.

The R-Test Evolution 3 is a miniature ambulatory ECG Recorder, which is easy to connect to the patient. The most advanced version (automatic mode) is capable of memorizing the most significant pathological events (symptomatic or silent) as well as the patient's continuous heart rate, and is capable of up to eight days ambulatory recording. The system consists of a unit weighing about 40 grams and includes a lightweight cable which can be worn without any discomfort. The R-Test Evolution 3 is connected to the patient by the electrodes and the cable. Cardiac events are memorized by the R-Test Evolution 3 and then transferred for interpretation: either by a decoder, the Decotest to an electrocardiograph (or an ECG monitor), or to a computer, or by a cable directly to a computer. This transfer is generally done at the physician's surgery at the following visit. It can also be transferred by phone or by e-mail, by modem, either from the patient's home, or from the office of a physician working in connection with an interpretation center. The R-Test Evolution 3 can also transmit real time ECG recordings by telephone; and after reading or not read level and the R-Test Evolution 3 can continue recording any further pathological events which may occur on the same patient. Using a computer enables you to: define the conditions and criteria of the recordings to be made by the R-Test Evolution 3, to select, organize and store the patient data and the results of a procedure, and to print them using specific report parameters.

I am sorry, but the provided text does not contain any information about the acceptance criteria for the R-Test Evolution 3, nor does it describe any specific study conducted to prove the device meets such criteria.

The document primarily focuses on presenting the device for FDA clearance. It includes:

• Safety & Effectiveness Data Summary: This section describes the device, its intended use, and lists conformity to various standards (EN 60601-1, 93/42/EEC, EN 46002, ISO 9001, ISO 13485). It states that testing for conformity to these standards will be completed, reviewed, and approved prior to release, but it does not detail these tests or their results.
• FDA Clearance Letter: This letter confirms the device's substantial equivalence to legally marketed predicate devices.
• Indications for Use: This section reiterates the device's intended use.

Therefore, I cannot provide the requested table or answer the specific questions about sample sizes, ground truth, expert qualifications, or comparative effectiveness studies based on the information given.

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The R-Test Evolution is a miniature ambulatory ECG Event Recorder that is connected to the patient. This version (automatic mode) is capable of memorizing the most significant pathological events (symptomatic or silent) as well as the patient's continuous heart rate trend, and is capable of up to eight day ambulatory recording.

The R-Test Evolution is a miniature ambulatory ECG Recorder, which is easy to connect to the patient. The most advanced version (automatic mode) is capable of memorizing the most significant pathological events (symptomatic or silent) as well as the patient's continuous heart rate, and is capable of up to eight days ambulatory recording. The system consists of a unit weighing about 40 grams and includes a lightweight neck cable which can be worn by the patient unobtrusively and without any discomfort. The R. Test Evolution is connected to the patient by a system of electrodes and the neck cable. Cardiac events are memorized by the R. Test evolution and then transferred by a decoder, the Decotest, to an electrocardiograph or a computer for interpretation: - either directly at the physician's surgery at the following visit, - or by being transmitted telephonically by the patient himself. The R. Test Evolution can also transmit real time ECG recordings by telephone. After making a telephonic or direct transfer, the R. Test Evolution can continue recording any further pathological events which may occur. Using a computer enables you to: - define the conditions and criteria of the recordings to be made by the R. Test Evolution, - to select, organize and store the results of a procedure, and to print them using specific report parameters.

This document does not contain the information required to populate all sections of the requested table and study description. The provided text is a 510(k) summary for the Novacor R.Test Evolution, primarily focusing on general device description, intended use, and substantial equivalence to predicate devices, along with regulatory compliance. It does not detail specific performance studies with acceptance criteria, sample sizes, or ground truth establishment relevant to an AI/algorithm-based device in the way requested.

The device described is an ambulatory ECG recorder, which is a hardware device for recording physiological data, not an AI or software algorithm that interprets data. Therefore, many of the requested fields (like "AI vs without AI assistance," "standalone algorithm performance," "training set sample size," or "adjudication method") are not applicable to the information provided.

However, I can extract the general performance claims and what constitutes "performance standards" based on the provided text.

Here's the information that can be extracted or inferred:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Not applicable / Not provided. The document describes a medical device (hardware), not a software algorithm with a "test set" in the context of AI performance evaluation. The "testing" mentioned refers to compliance with safety and electrical standards, not clinical performance data on a specific dataset.

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

• Not applicable / Not provided. Ground truth, in the context of algorithm performance, is not discussed. The device's function is to record events, not interpret them with an AI. Interpretation requires human experts (physicians) or an electrocardiograph/computer with specific software, which are external to the R-Test Evolution device itself.

4. Adjudication method for the test set

• Not applicable / Not provided.

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 / Not provided. This is not an AI-assisted interpretation device.

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

• Not applicable / Not provided. This device is a recorder, not an analytical algorithm.

7. The type of ground truth used

• Not applicable / Not provided. The device records ECG data. The "ground truth" for whether it records accurately would be comparison to a known accurate ECG source or standard, which is part of its regulatory testing for electrical and safety standards, but not in the context of an algorithm's diagnostic performance.

8. The sample size for the training set

• Not applicable / Not provided. This is not an AI/machine learning device that would require a "training set."

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

• Not applicable / Not provided.

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