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NOxBOXi Nitric Oxide Delivery System is intended for use by healthcare professionals for the delivery and monitoring of a constant (user set) concentration of nitric oxide (NO) and the monitoring of NO2 and O2 in the inspiratory ventilator lines of a patient undergoing nitric oxide therapy (iNO).

The NOxBOXi Nitric Oxide Delivery System includes:

• The NOxBOXi head unit, which delivers NO gas while in the intelligent delivery mode.
• Continuous monitoring and alarms for NO, O2 and NO2.
• The integrated NOxMixer which provides a backup NO delivery capability that is intended to deliver a continuous flow of NO, mixed with O2, for iNO therapy and provides a continuous treatment option during transit and transfer conditions within hospitals.

The NOxBOXi Nitric Oxide Delivery System must only be used in accordance with the indications, contraindications, warnings and precautions described in the nitric oxide drug packaging inserts and labeling (currently neonates). Refer to this material prior to use.

The NOxBOXi Nitric Oxide Delivery System (NOxBOXi) simultaneously delivers Nitric Oxide (NO) medical gas, while monitoring Nitric Oxide, Nitrogen Dioxide and Oxygen levels in the inspiratory limb of a ventilator for patients undergoing inhaled Nitric Oxide Therapy.

The system is designed for use by healthcare professionals to administer treatment to patients undergoing inhaled Nitric Oxide (iNO) therapy. The NOxBOXi will deliver nitric oxide in a synchronous manner to a single patient.

An integrated component to the NOxBOXi, the NOxMixer is intended to deliver a continuous flow of Nitric Oxide from the NOxBOXi, mixed in line with Oxygen (O₂) for use in iNO therapy. The NOxMixer will be used in conjunction with manually bagging a patient.

The NOxBOXi includes the NOxBOXi Head Unit, a NOxFLOW sample line, two NO feed hoses, two regulators (connector type dependent on the gas supplier), a test circuit, NO, O3 & NO2 monitors, power supply, drainage syringe, Operating Manual & Technical Guide.

Optional accessories include 4 separate NOxKITs (22mm, 12 mm, & 10mm), one way valve for HFOV (High Frequency Oscillatory Ventilation), bagging kits (hyperinflation & selfinflating) and circuit reducers (22f - 15m).

This submission is for the addition of compatibility claims for specific ventilators and is not related to product changes. It also introduces a new accessory, a modified sample line. There are no changes to the indications for use of the product and there are no significant design changes.

This document is a 510(k) premarket notification for the NOxBOXi Nitric Oxide Delivery System, specifically for adding compatibility claims for additional ventilators and introducing a new accessory. The submission states that there are no changes to the product itself, its indications for use, or its general design. Therefore, the device specifications and acceptance criteria are those of the previously cleared predicate device, K201339.

Here's a breakdown of the requested information based on the provided text:

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

Since this submission is for adding compatibility claims and an accessory without product changes, the acceptance criteria and reported device performance are identical to the predicate device (K201339) and relate to its general operational specifications. The document compares the subject device (K220898) with the predicate (K201339) and explicitly states "No Change" for all performance parameters. Therefore, the acceptance criteria and performance are as listed below:

The study that proves the device meets these acceptance criteria is referenced as a series of non-clinical performance data and compliance to international standards and FDA guidance documents. The submission states, "Testing for this submission was limited to the aspects that could be affected by including compatibility with additional ventilators and introduction of a new accessory. No additional usability testing was conducted for this submission. No clinical testing was required to support substantial equivalency of this medical device." The previous clearances (K171696 and K201339) would have established the initial performance.

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 primarily refers to "non-clinical performance data" and testing for compatibility with additional ventilators and a new accessory. It does not specify a "test set" in the context of clinical trials or expert review of cases. The testing conducted appears to be engineering and validation testing rather than human subject testing.

• Sample size for compatibility testing: Not explicitly stated as a number of specific ventilators, but a list of manufacturers is provided (e.g., Bio-Med Devices, Bunnel, Carefusion, Drägerwerk, Hamilton Medical, Philips Respironics, etc.). It implies that various models from these manufacturers were tested for compatibility.
• Data provenance: Not explicitly stated. The manufacturer is "NOxBOX Ltd.", suggesting the testing could have occurred in the UK or other locations where the manufacturer operates. The submission correspondent is in Austin, Texas, USA. Given the context of FDA submission, the data would need to be acceptable to the US regulatory body, but the origin itself isn't specified.
• Retrospective or prospective: Not applicable for this type of non-clinical engineering and validation testing.

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 submission describes non-clinical engineering and validation testing, not a study involving expert review of cases for ground truth establishment.

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

This section is not applicable as the submission describes non-clinical engineering and validation testing, not a study involving expert review of cases for ground truth establishment.

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

This section is not applicable. The NOxBOXi Nitric Oxide Delivery System is a medical device for delivering and monitoring nitric oxide, not an AI-assisted diagnostic tool involving human readers.

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

This section is not applicable in the context of an "algorithm only" performance. The device is hardware with integrated software for delivery and monitoring, not an AI algorithm performing a standalone task. Its performance is inherent to its design and validated through engineering tests.

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

For the non-clinical performance evaluation, the "ground truth" would be established by:

• Reference standards/equipment: Calibration gases, calibrated flow meters, pressure sensors, and gas analyzers that provide highly accurate measurements of NO, NO2, and O2 concentrations, flow rates, and pressures.
• Engineering specifications: The device's design specifications for accuracy, delivery ranges, and alarm thresholds serve as the targets for "ground truth".
• Standardized test methods: Compliance with international standards (e.g., ISO 80601-2-55 for respiratory gas monitors) and FDA guidance documents implies validated test methodologies where the "true" values are known or traceable to national/international standards.

8. The sample size for the training set

This section is not applicable. The document does not describe a machine learning algorithm that requires a "training set" of data. The device's functionality is based on established engineering principles and calibrated sensors/actuators.

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

This section is not applicable for the reasons stated in point 8.

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NOxBOXi Nitric Oxide Delivery System is intended for use by healthcare professionals for the delivery and monitoring of a constant (user set) concentration of nitric oxide (NO) and the monitoring of NO2 and O2 in the inspiratory lines of a patient undergoing nitric oxide therapy (iNO).

The NOxBOXi Nitric Oxide Delivery System includes:

· The NOxBOXi head unit, which delivers NO gas while in the intelligent delivery mode.

· Continuous monitoring and alarms for NO, O2 and NO2.

• The integrated NOxMixer which provides a backup NO delivery capability that is intended to deliver a continuous flow of NO. mixed with O2, for iNO therapy and provides a continuous treatment option during transit and transfer conditions within hospitals.

The NOxBOXi Nitric Oxide Delivery System must only be used in accordance with the indications, warnings and precautions described in the nitric oxide drug packaging (currently neonates). Refer to this material prior to use.

The NOxBOXi Nitric Oxide Delivery System (NOxBOXi) simultaneously delivers Nitric Oxide (NO) medical gas, while monitoring Nitric Oxide, Nitrogen Dioxide and Oxygen levels in the inspiratory limb of a ventilator for patients undergoing inhaled Nitric Oxide Therapy.

The system is designed for use by healthcare professionals to administer treatment to patients undergoing inhaled Nitric Oxide (iNO) therapy. The NOxBOXi will deliver nitric oxide in a synchronous manner to a single patient.

An integrated component to the NOxBOXi, the NOxMixer is intended to deliver a continuous flow of Nitric Oxide from the NOxBOXi, mixed in line with Oxygen (O2) for use in iNO therapy. The NOxMixer will be used in conjunction with manually bagging a patient.

The NOxBOXi includes the NOxBOXi Head Unit, a NOxFLOW sample line, two NO feed hoses, two regulators (connector type dependent on the gas supplier), a test circuit, NO, O₂ & NO₂ monitors, power supply, drainage syringe, Operating Manual & Technical Guide.

Optional accessories include 4 separate NOxKITs (22mm, 12 mm, & 10mm), one way valve for HFOV (High Frequency Oscillatory Ventilation), bagging kits (hyperinflation & selfinflating) and circuit reducers (22f - 15m).

This submission is for the addition of compatibility claims for specific ventilators and is not related to product changes. There are no changes to the indications for use of the product and there are no significant design changes.

This document describes a Special 510(k) submission (K201339) for the NOxBOXi Nitric Oxide Delivery System. This submission is specifically for adding compatibility claims for additional ventilators and does not involve product changes or changes to the indications for use. Therefore, the validation and acceptance criteria primarily refer to the original K171696 clearance.

Here's the breakdown of the requested information based on the provided text:

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

The document does not explicitly present a table of acceptance criteria with corresponding reported device performance values in the typical format of a clinical study or performance verification. Instead, it refers to broad categories of performance and compliance with standards. The "Comparison of Characteristics With Changes From Device Cleared in K171696" table shows that no changes were made to the core technical parameters of the device concerning its primary functions (NO administration, monitoring accuracy, battery backup, etc.). The acceptance criterion for this specific submission (K201339) is that the device, with the added ventilator compatibility, continues to meet safety and effectiveness standards, as demonstrated by non-clinical testing.

The acceptance criteria for the original device (K171696) can be inferred from the tests performed:

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

For the K201339 submission, the testing was limited to non-clinical bench testing to verify compatibility with additional ventilators. There is no mention of a human patient test set or sample size in this document for this specific submission. The provenance is internal testing performed by the manufacturer or their agents. The nature of this submission is purely technical validation without clinical data.

For the original K171696, while biological and performance standards were met, specific "sample sizes" for patient data are not detailed, as these are typically bench and engineering tests rather than clinical trials with patient cohorts.

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

This information is not provided in the document. Given that the testing for this submission was non-clinical (ventilator compatibility), the "ground truth" would have been established through engineering and performance specifications, likely by the manufacturer's R&D and quality assurance teams, rather than medical experts for clinical ground truth.

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

This information is not provided and is generally not applicable to the type of non-clinical, bench testing described for this device. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in clinical reading studies, which were not performed for this submission.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a nitric oxide delivery system, not an AI-assisted diagnostic or therapeutic tool for which such studies would be relevant. The document explicitly states: "No clinical testing was required to support substantial equivalency of this medical device."

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

This question is not applicable as the NOxBOXi system is a medical device for delivering and monitoring nitric oxide, not an algorithm or AI system. It operates with a "human-in-the-loop" as healthcare professionals operate and monitor the device.

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

For the specific K201339 submission, the "ground truth" for ventilator compatibility was established through engineering specifications and verification testing to ensure that the device's interaction with the additional ventilators did not compromise their functionality or the safety and effectiveness of the NOxBOXi system. This is based on objective measurements and compliance with applicable standards, not clinical ground truth like pathology or outcomes data.

For the core device (K171696), the ground truth for its performance characteristics (e.g., accuracy of gas delivery and monitoring) would have been established against calibrated reference standards and established measurement methodologies during verification and validation testing.

8. The sample size for the training set

This information is not applicable as the device is not described as an AI/machine learning system that requires a training set.

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

This information is not applicable as the device is not described as an AI/machine learning system that requires a training set and associated ground truth.

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The Earlens Contact Hearing Aid transmits amplified sound by vibrating the eardrum through direct contact. It is indicated for individuals 18 years and older with a mild to severe sensorineural hearing impairment who can benefit from amplification. The device can provide the full spectrum of amplification that includes 125 Hz - 10,000 Hz.

The Earlens Hearing Aid consists of several components including a Processor worn behind the pinna, an Ear Tip that is placed in the external ear canal, and a Tympanic Lens that is placed in the anterior sulcus near the tympanic membrane. Sound waves are received by the two directional microphones on the Processor and converted into electrical signals, digitally processed, amplified and sent to the Ear Tip through a cable. The Ear Tip houses a transmit coil, which converts the electrical signal containing the amplified sound into electromagnetic energy. This energy is transmitted to a receive coil on the Tympanic Lens. Both data and power are sent from the transmit coil to the receive coil by resonant inductive coupling. The receive coil converts the electromagnetic energy back into electrical signals, thereby activating the microactuator of the Tympanic Lens to transmit sound vibrations to the umbo.

The Tympanic Lens is placed deep in the ear canal and adiacent to the tympanic membrane by a trained ENT physician through a non-invasive and non-surgical procedure. The Tympanic Lens makes contact with the umbo of the tympanic membrane and is intended to remain in the ear for greater than 30 days.

An Audiologist uses the Earlens Fitting software (ELF) to prescribe the gain and overall output of the Processor based on the recipient's hearing profile.

A Charger is provided to the recipient to recharge the Lithium-Ion battery of the Processor daily.

The provided document describes the Earlens Contact Hearing Aid, a Class II device intended for individuals with mild to severe sensorineural hearing impairment. The submission is a 510(k) premarket notification, seeking to demonstrate substantial equivalence to a predicate device, the Wireless Earlens Light Driven Hearing Aid (K153634). The core change in the new device is the replacement of an infrared light link with resonant inductive coupling for transmitting power and data from the Ear Tip to the Tympanic Lens.

The document includes a section on "NON-CLINICAL PERFORMANCE TESTING" and "CLINICAL PERFORMANCE TESTING." These sections detail the testing performed and demonstrate that the device meets acceptance criteria.

Here's an analysis of the requested information:

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

The document states that the device passed all acceptance criteria, but it does not explicitly list the specific acceptance criteria for each test in a tabular format. Instead, it generally states compliance or desirable outcomes.

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

• Sample Size for Clinical Test Set: 30 subjects.
• Data Provenance: The document does not explicitly state the country of origin or whether the study was retrospective or prospective. However, given that it's a "human factors study to assess whether sound variability would be reduced... when they were refitted," it implies a prospective study design.

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

The document describes a "human factors study" and assessments including objective measures (MEPO, aided sound field thresholds) and subjective questionnaires. It does not mention the use of experts to establish a "ground truth" in the context of diagnostic interpretation or classification. The assessments performed are direct measurements of device performance and wearer experience, not interpretations requiring expert consensus.

4. Adjudication method for the test set

Not applicable. The study is evaluating the performance of a hearing aid and the experience of its users, not a diagnostic classification that would require adjudication of expert opinions.

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 not a study involving human readers or AI assistance in diagnostic interpretation. It is a clinical performance study of a hearing aid device.

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

This is not an AI-driven diagnostic algorithm. It is a physical medical device (hearing aid). Therefore, a "standalone algorithm performance" is not relevant in the typical sense for AI devices. However, the non-clinical tests (electrical safety, EMC, biocompatibility, mechanical integrity, etc.) can be considered "standalone" device performance without active human interaction during measurement, demonstrating the device's inherent characteristics.

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

The clinical study does not appear to rely on a "ground truth" in the diagnostic sense. Instead, it uses:

• Objective measurements: Maximum Equivalent Pressure Output (MEPO), aided sound field thresholds, aided word recognition.
• Subjective feedback: Subjective questionnaires regarding sound variability.

The "truth" for these measures is derived directly from the physical characteristics of the sound produced by the device and the subjective experience reported by the human subjects.

8. The sample size for the training set

Not applicable. This device is a hearing aid, not an AI/machine learning model that requires a training set.

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

Not applicable, as no training set for an AI/machine learning model was used.

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The wireless Earlens Light Driven Hearing Aid (a.k.a. Earlens Hearing Aid) transmits amplified sound by vibrating the eardrum through direct contact. It is indicated for individuals 18 years and older with a mild to severe sensorineural hearing impairment who can benefit from amplification. The device can provide the full spectrum of amplification that includes 125 Hz - 10,000 Hz.

Not Found

The provided text is a 510(k) Premarket Notification from the FDA for a hearing aid device. It details the regulatory approval of the "Wireless Earlens Light Driven Hearing Aid" and its indications for use.

Crucially, this document does not contain information about acceptance criteria or a study proving the device meets those criteria, as typically seen in submissions for AI/ML-based diagnostic devices. This document is a regulatory approval letter for a hardware device (a hearing aid) based on substantial equivalence to predicate devices, not performance against specific, quantifiable metrics often associated with AI/ML evaluations.

Therefore, I cannot extract the requested information from the provided text. The questions posed in your request ("multi reader multi case (MRMC) comparative effectiveness study," "standalone (i.e. algorithm only without human-in-the-loop performance)," "training set," "ground truth establishment") are typically relevant to the performance evaluation of AI/ML software, not the regulatory approval of a physical medical device like a hearing aid based on predicate equivalence.

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The EarLens™ Contact Hearing Device transmits amplified sound by vibrating the eardrum through direct contact. It is indicated for individuals 18 years and older with a mild to severe sensorineural hearing impairment who can benefit from amplification. The device can provide the full spectrum of amplification that includes 125 Hz - 10,000 Hz.

The EarLens™ Contact Hearing Device (CHD) transmits amplified sound to compensate for hearing impairment by direct vibration of the tympanic membrane (eardrum). The EarLens™ CHD is composed of an external Audio Processor, which includes a Behind-the-Ear (BTE) Unit and an Ear Tip, a Tympanic Membrane Transducer (TMT), the EarLens™ Fitting Software (ELF), and a Charger with a Power Adapter. In this device, light is used to wirelessly transmit both signal and power from the Audio Processor to the TMT. The BTE sits behind the outer ear, housing the rechargeable battery, digital signal processor (DSP), microphones and drive electronics. The Ear Tip contains the light emitter and directs the light signal down the ear canal. The TMT resides at the end of the ear canal on the skin around the tympanic membrane. The TMT receives the light signal and converts it into direct vibration of the umbo of the tympanic membrane. The EarLens™ Charger charges two BTEs at the same time when connected to either the wall power adapter or from the internal battery contained in the Charger. The CHD is patientmatched for single patient use. The ELF enables the hearing professional to program the device specific to the patient's hearing needs. The EarLens™ Impression System is provided to the physician to enable the collection of a deep ear canal impression to create patient-matched TMTs for each patient.

The EarLens™ Contact Hearing Device (CHD) has undergone extensive testing to ensure its safety and effectiveness. Both non-clinical (bench) studies and clinical studies were conducted to support its performance and establish acceptance criteria.

The acceptance criteria and reported device performance are as follows:

1. Table of Acceptance Criteria and Reported Device Performance

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