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Maxxi Rip Sensor is a device intended to capture respiratory effort from a patient and output the signal to a PSG device for sleep studies. This signal is captured using an elastic belt fastened around the thorax or abdomen that will exhibit a change in tension as the thorax or abdomen expands or contracts. This change in tension is measured and converted to a signal output by the interface and processed by a PSG device.

The product is composed of 3 major parts, the interface box, the cable and the belt.

Cables are used to connect between the respiratory effort sensor (RIP belts) and the applicable sleep recorder/polysomnography (PSG) system.

The device is offered in different sizes to be used on adult patients.

The Maxxi Rip was validated with Neurovirtual BWMini PSG device recorder only, therefore we don't quarantee compatibility with other devices.

AI/ML Overview

The provided document describes the Neurovirtual Maxxi RIP Sensor, an accessory for sleep/polysomnography (PSG) systems intended for measuring respiratory effort signals. The document outlines performance testing conducted to demonstrate its safety and effectiveness.

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

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

Performance Test Protocol	Description	Acceptance Criteria	Reported Device Performance
Belt Signal Verification	Verify the signal output stretching and releasing the inductive belt in order to get a sine wave form in the output.	The signal must have a clean sine wave form following the belts stimulation. Devices showing the signal output with interferences will be rejected.	The document states: "Based on the performance test applied to this Maxxi Rip Sensor... we conclude that the quality and performance for the specified Indications for use for this product was reached..." This implies the device met the signal quality criteria.
Belt Dimensions	Verify if the dimensions of the belts in rest are within the acceptable range in accordance with the product specifications.	Smaller adjustment: 900mm, Larger adjustment: 1200mm, Allowance: +-10%	The document states: "Based on the performance test applied to this Maxxi Rip Sensor... we conclude that the quality and performance for the specified Indications for use for this product was reached..." This implies the device met the dimensional criteria.
Belt Connectivity	Using a multimeter in continuity scale, check if the internal belt wiring has connectivity.	Not allowed false contact, or no connectivity.	The document states: "Based on the performance test applied to this Maxxi Rip Sensor... we conclude that the quality and performance for the specified Indications for use for this product was reached..." This implies the device met the connectivity criteria.
Belt Visual Conditions	Verify the visual aspects of the product. Any scratches, ruptures, wrong labels, oxidation, packing flaws, and connector conditions will be rejected.	All damage types are not allowed, products with scratches, wire ruptures, wrong labeling, oxidation, packing flaws or connector issues will be rejected and not put to sales.	The document states: "Based on the performance test applied to this Maxxi Rip Sensor... we conclude that the quality and performance for the specified Indications for use for this product was reached..." This implies the device met the visual condition criteria.
Cable Dimensions	Verify if the cable length is within the acceptable range.	Cable A: 250mm, Cable B: 2000mm, Allowance: +-5%	The document states: "Based on the performance test applied to this Maxxi Rip Sensor... we conclude that the quality and performance for the specified Indications for use for this product was reached..." This implies the device met the dimensional criteria.
Cable Connectivity	Using a multimeter in continuity scale, check if the cable has connectivity.	Not allowed false contact, or no connectivity.	The document states: "Based on the performance test applied to this Maxxi Rip Sensor... we conclude that the quality and performance for the specified Indications for use for this product was reached..." This implies the device met the connectivity criteria.
Cable Visual Conditions	Verify the visual aspects of the product. Any scratches, ruptures, wrong labels, oxidation, packing flaws, and connector conditions will be rejected.	All damage types are not allowed, products with scratches, wire ruptures, wrong labeling, oxidation, packing flaws or connector issues will be rejected and not put to sales.	The document states: "Based on the performance test applied to this Maxxi Rip Sensor... we conclude that the quality and performance for the specified Indications for use for this product was reached..." This implies the device met the visual condition criteria.
Interface Functional Test	Verify if the signal output from the pre-approved belt is working properly.	The signal must have a clean sine wave form following the belts stimulation. Devices showing the signal output with interferences will be rejected.	The document states: "Based on the performance test applied to this Maxxi Rip Sensor... we conclude that the quality and performance for the specified Indications for use for this product was reached..." This implies the device met the signal quality criteria.
Interface Visual Conditions	Verify the visual aspects of the product. Any scratches, ruptures, wrong labels, oxidation, packing flaws, and connector conditions will be rejected.	All damage types are not allowed, products with scratches, wire ruptures, wrong labeling, oxidation, packing flaws or connector issues will be rejected and not put to sales.	The document states: "Based on the performance test applied to this Maxxi Rip Sensor... we conclude that the quality and performance for the specified Indications for use for this product was reached..." This implies the device met the visual condition criteria.
Safety and Effectiveness	Submitted to standard IEC 60601-1 test.	Full compliance with IEC 60601-1.	Resulted in full compliance as reported in the test reports.
EMC Testing	Submitted to electromagnetic compatibility test, standard IEC 60601-1-2.	Full compliance with IEC 60601-1-2.	Resulted in full compliance as reported in the test reports.
Risk Analysis	Developed according to the ISO14971.	Appropriate actions related to risks found during the development to reach appropriate performance, safety and substantially equivalence with the predicate.	The Maxxi Rip was developed according to ISO14971 for appropriate actions related to risks found during the development.
Signal Quality and Comparison	Signal integrity tests were conducted for the Maxxi Rip Sensor with focus on signal to noise ratio, signal range, bandwidth and linearity.	Test results compared to the signal integrity test conducted for the predicate NOX-RIP. (Implied acceptance is comparable performance to predicate)	Signal integrity tests were conducted for the Maxxi Rip Sensor with focus on signal to noise ratio, signal range, bandwidth and linearity and the test results compared to the signal integrity test conducted for the predicate NOX-RIP. No specific performance metrics or direct comparison results are provided.

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

The document states: "The performance test is executed for certain % amount of the products manufactured." It does not specify the exact sample size for the individual performance tests (Belt Signal Verification, Belt Dimensions, etc.). No information is provided regarding the country of origin of the data, or whether the tests were 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)

This section is not applicable as the performance tests described are for a physical device (Maxxi RIP Sensor) and its components, and do not involve human interpretation or a "ground truth" derived from expert consensus in the clinical sense. The "ground truth" here is the expected physical or electrical characteristic according to specifications.

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

Not applicable, as this is a physical device testing, not a clinical study involving human assessment of data. The pass/fail criteria are objective measurements.

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 Maxxi RIP Sensor is a hardware device for measuring respiratory effort. It is not an AI algorithm or a diagnostic tool that involves human readers or assessment of AI assistance.

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

Not applicable. This is a hardware device, not an algorithm.

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

The "ground truth" for the performance tests (e.g., Belt Dimensions, Cable Connectivity) is based on the pre-defined product specifications and engineering standards (e.g., 900mm-1200mm for belt length, continuity for cables, clean sine wave form for signal). For safety and EMC testing, it is compliance with international standards (IEC 60601-1, IEC 60601-1-2) and risk analysis (ISO14971). For signal quality, it is a comparison to the predicate device, although no specific metrics were reported.

8. The sample size for the training set

Not applicable. This is a hardware device and does not involve machine learning or training sets.

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

Not applicable. As there is no training set for this device.

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