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The Nox RIP Belts are intended for measuring of respiratory effort signals. They function as accessories for sleep/polysomnography (PSG) systems.
The Nox RIP Belts are indicated for use on patients greater than 2 years of age.
The intended environments are hospitals, institutions, sleep centers, sleep clinics, or other test environments, including the patient 's home.

The RIP Belt Cables are intended to interconnect Nox RIP belts (respiratory effort sensors) and Nox sleep devices, to allow measuring of respiratory effort signals.
The RIP Belt Cables are indicated for use on patients greater than 2 years of age.
The intended environments are hospitals, institutions, sleep centers, sleep clinics, or other test environments, including the patient´s home.

The Third Party RIP Belt Cables are intended to allow measuring of respiratory effort signals by interconnecting Nox RIP belts (respiratory effort sensors) and sleep devices with oscillation circuitry capable of measuring inductance between 1 and 5 µH.
The Third Party RIP Belt Cables are indicated for use on patients greater than 2 years of age.
The intended environments are hospitals, institutions, sleep centers, sleep clinics, or other test environments, including the patient's home.

The Nox RIP Belts are respiratory effort sensors that are intended to function as an accessory with sleep/polysomnography (PSG) systems. The RIP Belts measure respiratory effort signals based on Respiratory Inductance Plethysmography (RIP) technology, which is the gold standard technology for respiratory effort belts.
Two RIP belts are used to measure the respiratory effort of the patient. One belt is placed around the patient's abdomen and the other around the patient's thorax. Both abdomen and thorax belts are identical.
The Nox RIP Belt Cables are used to connect between the respiratory effort sensor (RIP belts) and the applicable sleep recorder/polysomnography (PSG) system.
There are two product groups for the Nox RIP Belt Cables; RIP Belt Cables and Third Party RIP Belt Cables.
The RIP Belt Cables are designed for use with Nox recorders only. Those are abdomen cables only because the thorax belt is attached directly to the Nox recorders.
The Third Party RIP Belt Cables are designed for use with third party recorders. The Third Party RIP Belt Cables come in pairs for abdomen and thorax.

The provided document is a 510(k) premarket notification for Nox RIP Belts and Nox RIP Belt Cables. The core of this submission is to demonstrate substantial equivalence to a predicate device, not necessarily to set new performance acceptance criteria through a clinical study in the same way an AI-driven diagnostic might.

Therefore, the acceptance criteria and study described here are focused on demonstrating that the new devices perform equivalently to the predicate, and comply with relevant safety standards.

Here's an attempt to extract the information you requested, based on the provided text, while noting the differences in context for a traditional medical device accessory vs. an AI diagnostic:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a submission for device accessories (RIP belts and cables) demonstrating substantial equivalence to a predicate, the "acceptance criteria" are primarily related to meeting performance specifications and safety standards, and showing clinical equivalence to the predicate's signal quality. There aren't specific metrics like sensitivity/specificity for disease detection.

• ISO 14971 (Risk Management)
• ISO 15223-1 (Symbols)
• AAMI/ANSI/ES 60601-1 (Basic Safety & Essential Performance)
• IEC 60601-1-2 (EMC)
• AAMI/ANSI/IEC 62366 (Usability Engineering)
• 21 CFR 898 (for Third Party RIP Belt Cables) |
  | Functional | Conformance to design input/specifications. | Verification testing: Design output conforms to design input, fulfilling all physical characteristics, performance, functional, interface, packaging, labeling, safety, and reliability requirements. |
  | Usability | Minimize use errors and risks. | Usability testing resulted in all usability goals passed. |
  | Signal Quality | Clinically equivalent signal to predicate. | Signal integrity tests (signal-to-noise ratio, signal range, bandwidth, linearity) for new devices compared to predicate (QDC-PRO AND NOX-RIP) demonstrated clinical equivalence. |
  | Risk Management | Risks appropriately managed. | Risk analysis performed according to ISO 14971; appropriate measures implemented and their effectiveness verified/validated. |
  | Material/Physical Equivalence | Materials do not raise new safety/effectiveness concerns. | Verification testing and risk analysis show minor differences in material do not raise new questions about safety and effectiveness (for RIP Belt Cables). |
  | Connector Equivalence | Different connectors do not raise new safety/effectiveness concerns. | Verification testing, signal integrity comparison, and risk analysis show different connectors do not raise new questions about safety and effectiveness (for RIP Belt Cables). |

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

The document does not specify a "test set" in the context of patient data or clinical images for an algorithm. The testing described is primarily bench testing, engineering verification, and validation against product requirements and standards.

• Sample Size for Test Set: Not applicable in the context of patient-specific data for algorithm performance. The "samples" would be the manufactured devices (RIP Belts and Cables) themselves. The number of devices tested is not specified, but it implies a statistically sound sample for verification and validation activities.
• Data Provenance: Not applicable for patient data. The provenance of the testing results is "thorough internal testing" conducted by Nox Medical ehf.

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

Not applicable. As a medical device accessory focused on signal measurement and equivalence to a predicate, the "ground truth" is established by direct physical/electrical measurements against known standards and the predicate device's performance, rather than expert interpretation of a clinical finding.

4. Adjudication Method for the Test Set

Not applicable. There is no expert adjudication mentioned, as the nature of the device (respiratory effort sensors) involves direct measurement and comparison, not subjective interpretation.

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 device is a sensor and cable accessory, not an AI diagnostic tool that assists human readers.

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 with standalone performance. It measures respiratory effort signals, which are then used by sleep/polysomnography (PSG) systems, presumably to be interpreted by healthcare professionals.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The "ground truth" for the performance evaluation of these accessories primarily consists of:

• Engineering Specifications and Standard Compliance: Adherence to established ISO and IEC standards for medical devices (e.g., electrical safety, EMC, risk management, usability).
• Predicate Device Performance: The QDC-PRO AND NOX-RIP (K124062) device serves as the benchmark for "clinical equivalence" of signal quality. New devices' signals were compared against the predicate's signals using metrics like signal-to-noise ratio, signal range, bandwidth, and linearity.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" as this device does not involve machine learning or AI.

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

Not applicable. There is no training set for this type of device.

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