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The Heated Breathing Tube is intended to be used for non-invasive respiratory therapy, such as CPAP/BiPAP therapy. It provides air connection between positive pressure ventilation, respiratory humidification therapy instrument, and ventilation mask, nasal cannula, trachea cannula etc. With the function of heating inside breathing tube, it can prevent condensation of the therapy air in the tube.

This device is single patient use only for adults.

The Compressor Nebulizer is mainly composed of the compressor and nebulizer kit(Optional). The compressor is mainly composed of shell, compressed motor, pump, fuse wire, air filter, power cord and plug (NB-1100,NB-1101,NB-1102,NB-1103 applicable), PCB (only model NB-1102,NB-1103applicable). The device is equipped with a nebulizer kit including Nebulizer Cup, Air Tube, Mouthpiece(Optional), Adult Mask(Optional), Child Mask(Optional) to easily delivery the medical aerosol. The Nebulizer kit is available in three models/configurations as below.

• NK-101: Nebulizer Cup, Air Tube, Adult Mask and/or Child Mask, Mouthpiece;
• NK-301: Nebulizer Cup, Air Tube, Adult Mask and/or Child Mask;
• NK-501: Nebulizer Cup, Air Tube, Mouthpiece
  This device operates on the Venturi principle. According to the principle of Venturi, the compressed air of the motor is used to form a high-speed air flow through the small pipe mouth. The negative pressure generated drives the liquid or other fluid to spray together on the barrier, and under the high-speed impact makes the droplets turn into mist particles to spray from the outlet trachea.

The provided FDA 510(k) clearance letter and summary pertain to a "Compressor Nebulizer" and a "Heated Breathing Tube," but the main body of the 510(k) summary and the comparative particle test tables focus on the "Compressor Nebulizer" (Model NB-1100, NB-1101, NB-1102, NB-1103) and its predicate "NE-C801 Nebulizer Compressor System." The "Heated Breathing Tube" mentioned in the clearance letter is inconsistent with the detailed submission summary. Therefore, the analysis will focus on the Compressor Nebulizer (JOYTECH NB-1103).

Based on the provided document, the acceptance criteria are implicitly derived from the comparative particle test results between the subject device (JOYTECH NB-1103) and the predicate device (OMRON NE-C801). The study aims to demonstrate substantial equivalence by showing that the differences in technological characteristics do not raise different questions of safety or effectiveness. The core of this demonstration lies in the comparative aerosol performance data.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria in a "pass/fail" format. Instead, it presents a comparison table and concludes that the devices are "Equivalent" or "Similar" for various parameters. For the aerosol performance metrics, the implication is that the subject device's performance should be comparable to, or within an acceptable range of, the predicate device's performance across different drug types and patient interfaces.

Given the structure, the reported device performance is the reported data in the comparative particle test tables. The "acceptance criteria" are implicitly that the subject device's performance metrics (MMAD, GSD, Respirable Dose, Respirable fraction, Total delivered Dose, Total delivered Dose fraction, Coarse Particle Fraction, Fine Particle Fraction, Ultra-Fine Particle Fraction) are comparable to (i.e., not significantly worse than) the predicate device.

Key Performance Metrics for Aerosol Performance (Based on Comparative Particle Test)

4. Adjudication Method for the Test Set

Since the ground truth is established through objective laboratory measurements rather than human interpretation, an adjudication method (like 2+1 or 3+1 for expert review) is not applicable.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. The study described is a non-clinical laboratory comparison of aerosol performance between the subject device and a predicate device. It assesses the physical characteristics of the aerosol produced, not human reader performance with or without AI assistance. This question is not applicable to this type of device and study.

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

This question typically applies to AI/software as a medical device (SaMD). The device in question is a Compressor Nebulizer, a physical medical device. Therefore, a standalone algorithm-only performance assessment is not applicable. The performance tested is the physical device's ability to generate aerosols.

7. The Type of Ground Truth Used

The ground truth for the device's performance (specifically aerosol characteristics) is established by objective, quantitative laboratory measurements of particle size, distribution, and drug delivery efficiency, as obtained using standard analytical methods (e.g., based on FDA guidance and potentially pharmacopeial standards for aerosol drug delivery systems). This is presented as "Particle Size characterization testing" on Page 13.

8. The Sample Size for the Training Set

The document describes non-clinical testing for a physical device, comparing its performance to a predicate device. There is no mention of a training set as this is not a machine learning or AI-based device. This question is not applicable.

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

As there is no training set for this device, this question is not applicable.

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VentStar Resus heated (N) (MP17030): VentStar Resus heated (N) with manual PEEP valve is a disposable breathing circuit for conveying breathing gas from a breathing gas source (resuscitation module) via the Fisher & Paykel MR850 humidifier to a patient.

The product allows short-term ventilation with humidified breathing gas and additional PEEP.

It can be connected to a breathing mask, a laryngeal mask, or an endotracheal tube via the patient port.

The product is suitable for patients with a maximum body weight of 10 kg (22 lb).

VentStar Autobreath heated (N) (MP17031): VentStar AutoBreath heated (N) with automatic PEEP valve is a disposable breathing circuit for conveying breathing gas from a breathing gas source resuscitation module) via the Fisher & Paykel MR850 humidifier to a patient.

The product allows automatic short-term ventilation with humidified breathing gas and additional PEEP.

The valve is controlled via the AutoBreath function of the resuscitation module. The product can be connected to a breathing mask, a laryngeal mask, or an endotracheal tube via the patient port.

The product is suitable for patients with a maximum body weight of 10 kg (22 lb).

The subject devices, VentStar Autobreath heated (N) (MP17031) and VentStar Resus heated (N) (MP17030), are two heated disposable single limp breathing circuits with humidifier chamber for connection to the humidifier MR850 by Fisher and Paykel (K073706), for neonatal patients with a maximum body weight of 10 kg for use with the Dräger BabyRoo TN300 (K230278) and Dräger Resuscitaire (K120642).

The VentStar Resus heated (N) MP17030 is equipped with a manual PEEP valve which enables the setting of a PEEP by the operator directly. The operator can control the inhalation and exhalation.

The VentStar Autobreath heated (N) MP17031 is equipped with an automatic PEEP valve. With the Autobreath function a respiratory rate can be adjusted on the resuscitation module and a machine controlled consistent inspiration rate can be applied to the patient.

The heated breathing circuits are intended for conveying breathing gases (air and/or oxygen) from a breathing gas source (resuscitation module) to the humidifier chamber and finally to the patient.

Both breathing circuits are designed for a flow range from 5 to 15 L/min.

The heating of the hoses is done by using electrical heating wires inside the wall of the hoses. These wires have specific electrical resistances to generate a specific heating power. The heating plate of the humidifier chamber is positioned at the heater of the humidifier.

The provided FDA 510(k) Clearance Letter for the VentStar Resus and Autobreath Heated Devices (K242769) outlines the regulatory approval process for these medical devices. However, it does not contain information related to software, artificial intelligence (AI), diagnostic studies, or the acceptance criteria for such studies.

The document pertains to the physical characteristics, safety, and functionality of heated disposable breathing circuits for neonatal ventilation. The performance data section refers to non-clinical testing covering mechanical, thermal safety, environmental conditions, electrical safety, electromagnetic compatibility, functional verification, and performance capacity and accuracy, all conducted against established medical device standards.

Therefore, I cannot fulfill your request to describe acceptance criteria and a study proving device performance related to AI, ground truth, expert consensus, sample sizes for training/test sets, or MRMC studies, as none of this information is present in the provided text.

The information primarily focuses on:

• Device Description: Heated disposable breathing circuits for neonatal patients.
• Intended Use: Conveying humidified breathing gas from a resuscitation module to a patient.
• Comparison to Predicate Devices: Demonstrating substantial equivalence based on physical and functional characteristics.
• Performance Data: References to compliance with various ISO and IEC standards for electrical safety, EMC, functional performance, and biocompatibility.

**To directly answer your numbered points based solely on the provided document: **

1. A table of acceptance criteria and the reported device performance: Not provided in the document in the context of diagnostic performance or AI. The performance section mentions compliance with various standards (e.g., IEC 60601-1, ISO 5367), implying that the acceptance criteria are adherence to these established engineering and safety standards, rather than diagnostic accuracy metrics.
2. Sample sizes used for the test set and the data provenance: Not applicable or not provided. The testing discussed is non-clinical (mechanical, electrical, etc.), not a data-driven diagnostic study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically defined for diagnostic AI models (e.g., expert reads of medical images) is not relevant to the described device testing.
4. Adjudication method: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable. This type of study is for evaluating human performance, often with AI assistance, in diagnostic tasks. The device is a breathing circuit, not a diagnostic AI tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as there is no mention of an algorithm or AI.
7. The type of ground truth used: Not applicable in the context of diagnostic accuracy. Ground truth for this device would be defined by engineering specifications and physical measurements (e.g., resistance levels, heating efficiency, material composition).
8. The sample size for the training set: Not applicable, as there is no AI/machine learning component mentioned.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document details the regulatory clearance of a physical medical device (breathing circuits) and its compliance with safety and performance standards for hardware, not a software/AI driven diagnostic tool. Therefore, the questions related to AI performance, ground truth establishment, and clinical study methodologies are not addressed by the provided text.

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The THERMALITE® CPAP Heated Tubing is a heated wire breathing tube intended to provide warmed and/or humidified breathing gases before they enter a patient's airway. It is indicated for single-patient reuse in the home and in clinical settings, such as hospitals, institutions, sleep laboratories, and sub-acute care facilities. It may be used with noninvasive ventilation for adult patients.
It is compatible with the Philips Respironics DreamStation 2 heated humidifiers.

The Exceleron Medical, LLC (Exceleron) THERMALITE® CPAP Heated Tubing (THERMALITE) is a heated tube that connects between a continuous positive airway pressure (CPAP) machine and the patient's interface, typically a CPAP mask. The THERMALITE is compatible with the Philips Respironics DreamStation 1 and DreamStation 2 heated humidifiers.
The THERMALITE has a unique design that helps prevent condensate from forming within the heated air stream during CPAP therapy by controlling the airflow temperature, creating an environment to maintain water in its vapor form. This condition of condensation is commonly known as "rainout," and is usually the result of temperature and humidity differentials between the device versus the surrounding air.
The THERMALITE is available in a three (3) or two (2) wire configuration.

The provided text is a 510(k) Premarket Notification for a medical device called "THERMALITE CPAP Heated Tubing." It details the device's characteristics, indications for use, comparison to a predicate device, and a summary of performance testing. However, it does not contain specific acceptance criteria values or detailed study results in the format typically requested for AI/ML device performance.

Therefore, many of the requested items cannot be fully answered with the provided text. I will answer what is available and indicate where information is missing.

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

The document lists various tests performed based on international standards and guidance documents. It states that "Test results indicated that the Exceleron THERMALITE complies with the applicable Standards and guidance documents" and "Test results indicated that the Exceleron THERMALITE complies with internal requirements, applicable Standards, and the guidance documents." However, it does not provide specific numerical acceptance criteria (e.g., "temperature must be within X +/- Y °C") or the exact reported performance values (e.g., "observed temperature was Z °C").

Acceptance Criteria and Reported Device Performance (as far as available in the text):

The purpose of the device is to provide "warmed and/or humidified breathing gases" and "prevent condensate from forming within the heated air stream during CPAP therapy by controlling the airflow temperature, creating an environment to maintain water in its vapor form." The predicate device description mentions "air passing through the tubing is warmed to or above the dew point (of the air existing the humidifier) reducing or eliminating water condensation and/or pooling of water in the breathing circuit 41 °C. The raising of the gas temperature does not exceed." This implies a performance target but no specific results for the subject device are given beyond general compliance. |

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

This information is not provided in the document. The document refers to "test results" and "verification and validation activities" but does not detail the sample sizes for these tests or the data provenance. These are bench tests on the device itself, not clinical studies with patient data.

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 question is not applicable as the device is a heated tubing for CPAP machines, not an AI/ML diagnostic or therapeutic device requiring expert interpretation of results or establishment of ground truth from clinical data. The "ground truth" for this type of device is established through engineering and performance specifications and testing against those specifications and relevant international standards.

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

This question is not applicable for the same reasons as #3. There is no clinical imaging or diagnostic data requiring adjudication.

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 question is not applicable. This is a physical medical device (heated tubing), not a software/AI device that would involve human readers or AI assistance.

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

This question is not applicable. This is a physical medical device.

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

The "ground truth" for this device is based on engineering specifications, compliance with international standards (e.g., ISO, IEC), and internal requirements for safety and performance (e.g., biocompatibility limits, electrical safety thresholds, EMC limits, and performance parameters for heating and humidification as defined in the standards). It is not derived from clinical expert consensus, pathology, or outcomes data in the way an AI/ML diagnostic device's ground truth would be.

8. The sample size for the training set

This question is not applicable. This is a physical medical device, not an AI/ML device that requires a training set.

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

This question is not applicable. See #8.

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The FT-615 is designed for symptomatic relief and management of chronic pain, and for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities and to strain from exercise or normal household work activities. It is also indicated for temporary relief of pain associated with dysmenorthea (menstrual cramps) when used with over-the-counter pain medication, it also provides a heat function intended to temporarily relief of minor aches and pains.

The subject device is a self-adhesive TENS device with 15 adjustable intensity levels for pain relief. Moreover, it also provides a heat function which can be used alone, or in conjunction with the TENS function simultaneously. TENS, Transcutaneous Electrical Nerve Stimulation, refers to the electrical stimulation of nerves through the skin which is an effective method of pain relief. It can be used for self-treatment. Any symptoms that could be relieved using TENS must be checked by your general practitioner who will also give you instruction on how to carry out a TENS self-treatment regime.

This FDA 510(k) premarket notification is for a medical device (HEATING TENS, Model FT-615), not an AI/ML powered device. Therefore, the information requested in your prompt regarding acceptance criteria and studies for AI/ML performance metrics (sample size for test/training sets, data provenance, number of experts, adjudication method, MRMC studies, standalone performance, ground truth type, how ground truth was established) is not applicable to this document.

The document discusses the device's substantial equivalence to a predicate device (HIVOX OTC Electrical Stimulator, FT610-B) based on non-clinical testing.

Here's a summary of the relevant information provided:

1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical):

2. Sample size used for the test set and the data provenance: Not applicable as this is not an AI/ML study. Performance was evaluated through non-clinical laboratory testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as this is not an AI/ML study.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable as this is not an AI/ML study.

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 is not an AI/ML study.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as this is not an AI/ML study. This is a physical device (TENS unit). The mentioned "software validation" refers to the intrinsic software of the device itself, not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable as this is not an AI/ML study. Ground truth was established by conformance to recognized medical device standards and internal requirements for safety and performance (e.g., electrical safety standards, biocompatibility standards, functional specifications).

8. The sample size for the training set: Not applicable as this is not an AI/ML study.

9. How the ground truth for the training set was established: Not applicable as this is not an AI/ML study.

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The Hudson RCI AQUATHERM® III Plus External Adjustable Electronic Heater is designed for use with the Hudson RCI Nebulizer Adaptor and the AQUAPAK® system to provide continuous heated aerosol for respiratory applications.

The AquaTherm devices are adjustable output temperature heaters. The AquaTherm Heater is placed between a nebulizer adaptor and a reservoir of sterile solution. When a gas flow is initiated to the nebulizer, sterile solution is drawn up from the reservoir and through the stainless-steel puncture pin in the center of the AquaTherm Heater. The solution is heated as it flows through the pin. The heated solution is then drawn into the nebulizer adaptor where it is aerosolized into the patient gas stream.

This document, K223100, is a 510(k) premarket notification for a medical device (Hudson RCI AquaTherm III Plus External Adjustable Electronic Heater) and, as such, focuses on demonstrating substantial equivalence to a predicate device rather than independently proving the device meets specific performance acceptance criteria through a clinical study or a similar robust evaluation of its diagnostic capabilities.

Therefore, the requested information regarding "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of diagnostic performance (e.g., accuracy, sensitivity, specificity, expert reads, MRMC studies, ground truth establishment) is not applicable to this document.

This FDA submission is for a heating device used with nebulizers, classified as a Class II device (Nebulizer, product code CAF). The purpose of a 510(k) is to demonstrate that the new device is as safe and effective as a legally marketed predicate device, primarily through non-clinical testing and comparison of technological characteristics.

Here's why the requested information is not present and what is provided:

1. No Diagnostic Acceptance Criteria or Performance Reporting: This is not a diagnostic AI device or a device that relies on interpreting data to provide a diagnosis. Its function is to heat sterile solution for aerosolization. Therefore, there are no metrics like sensitivity, specificity, AUC, or other diagnostic performance indicators to report in a table.

2. No Clinical Study on Efficacy/Accuracy: The submission demonstrates substantial equivalence through:

   • Comparison of Technological Characteristics: Showing similar design, intended use, operating principles, and materials to the predicate.
   • Non-Clinical Testing: This includes:
     • Biocompatibility: To ensure materials are safe for patient contact (even if indirect).
     • Packaging: To ensure the device remains sterile/intact until use.
     • Cleaning: To ensure proper reprocessing if applicable (though the device is non-sterile).
     • EMC Testing: To ensure electromagnetic compatibility and safety.
   • Compliance with Standards: Adherence to relevant ISO and IEC standards (e.g., for safety, quality, and electrical compatibility).

   This type of submission does not typically involve clinical trials or multi-reader studies to establish diagnostic accuracy or performance improvement for human readers.

3. No Test Set/Ground Truth Details: Since there's no diagnostic performance being evaluated, there are no test sets, data provenance, expert ground truth establishment, or adjudication methods described. "Ground truth" in this context refers more to established engineering and safety standards rather than medical diagnostic truth.

Summary of Relevant Information (from the document) despite the non-applicability of the full request:

• Type of Device: Hudson RCI AquaTherm III Plus External Adjustable Electronic Heater (a nebulizer heater).
• Purpose: To provide continuous heated aerosol for respiratory applications.
• Regulatory Pathway: 510(k) Premarket Notification.
• Predicate Device: Aero-Mist Nebulizer Heater/Pegasus Research Corporation (K880473).
• Demonstration of Safety and Effectiveness: Through non-clinical testing (Biocompatibility, Packaging, Cleaning, EMC Testing) and compliance to industry standards (ISO 10993 series, IEC 60601 series).
• Conclusion: The device is substantially equivalent to the predicate and does not raise new issues of safety or effectiveness.

In essence, the "acceptance criteria" for this device are its ability to meet the specified non-clinical performance and safety standards, and to be functionally and technologically similar to the legally marketed predicate device, rather than diagnostic accuracy metrics.

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VentStar Helix dual heated N Exten. Kit (MP02280): Inspiratory heated disposable breathing circuit with humidifier chamber for connection to a humidifier MR850 by Fisher & Paykel, for neonatal patients with a tidal volume of up to 100 mL, for conducting humidified breathing gas from humidifier to patient.

VentStar Helix heated (N) Plus (MP02608): Inspiratory heated disposable breathing circuit with humidifier chamber for connection to a humidifier MR850 by Fisher & Paykel, for neonatal patients with a tidal volume of up to 100 mL, for conducting humidified breathing gas from humidifier to patient.

The subject devices (VentStar Helix Dual Heated N Exten. Kit and VentStar Helix Heated (N) Plus), two inspiratory (and expiratory) heated disposable breathing circuits with humidifier chamber are designed for neonatal patients with a tidal volume of up to 100 mL, for conduction of humidified breathing gas from the humidifier to the patient. VentStar Helix Dual Heated N Exten. Kit is a dual heated breathing circuit and VentStar Helix Heated (N) Plus is a single heated breathing circuit to be connected to a humidifier MR850 by Fisher and Paykel, both tested for system compatibility and released for use with Dräger Babylog VN-Series ventilators.

Additionally, this submission comprises a neonatal humidifier chamber and a double connector for connection to the ventilators as accessories to the above mentioned medical devices.

This is a 510(k) premarket notification for breathing system heaters, not an AI/ML device. Therefore, the requested information about acceptance criteria for AI performance, sample sizes for test/training sets, ground truth establishment, expert consensus, MRMC studies, or standalone algorithm performance is not applicable.

The document discusses the substantial equivalence of the VentStar Helix Dual Heated N Exten. Kit (MP02280) and VentStar Helix Heated (N) Plus (MP02608) to previously cleared predicate devices. Substantial equivalence is determined by demonstrating that the new devices are as safe and effective as the predicate devices, despite some technological differences.

Here's the relevant information about the device's technical specifications and the non-clinical studies performed to demonstrate its safety and effectiveness:

1. Table of Acceptance Criteria and Reported Device Performance:

The document provides extensive comparison tables (Table 1 and Table 2) between the new devices and their predicate devices. These tables list various technical characteristics and performance parameters, indicating whether they are "Same," "Similar," or "Different" compared to the predicate. For characteristics marked "Different," numerical values are provided for both the subject device and the predicate device. These differences were evaluated through non-clinical testing to ensure they do not raise new questions of safety or effectiveness.

Due to the extensive nature of the comparison, which lists numerous parameters like hose diameter, length, resistance, compliance, leakage, volume, warm-up time, humidification output, and electrical data, a comprehensive reproduction of all "acceptance criteria" (which are implicitly the performance of the predicate device or established standards) and "reported device performance" in a single table format is beyond the scope of a short answer. However, the tables clearly highlight these comparisons.

For example, for VentStar Helix Dual Heated N Exten. Kit (MP02280) compared to predicate RT265 (K103767):

The document states that "Performance data related to each proposed modification has been tested and evaluated" and "High level summary reports included in this 510(k) demonstrate that the subject devices are substantially equivalent to the predicate device." This implies that the acceptance criteria are met if these differences do not negatively impact safety and effectiveness, as determined by the non-clinical testing against relevant standards.

2. Sample size used for the test set and the data provenance: Not applicable. This is not an AI/ML device that uses test sets of data in the common understanding for AI performance evaluation. The "test set" here refers to the physical devices and materials subjected to non-clinical laboratory testing. The provenance of these physical samples is from the manufacturer, Drägerwerk AG & Co. KGaA (Germany). The studies are prospective in the sense that they are conducted specifically for this 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically understood for AI/ML validation (e.g., expert annotations on medical images) is not relevant for this type of device submission, which relies on engineering and biocompatibility testing against established standards.

4. Adjudication method for the test set: Not applicable. This concept is not relevant for the type of non-clinical testing performed for this device.

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 an AI/ML device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML device.

7. The type of ground truth used: For this device, "ground truth" refers to the established requirements and performance limits defined by international consensus standards and the performance characteristics of the predicate devices. For example, specific thresholds for electrical safety, biocompatibility, resistance, and humidification output are defined by standards like IEC 60601-1, ISO 5367, and ISO 18562. The device's performance is measured against these objective, quantifiable benchmarks.

8. The sample size for the training set: Not applicable. This is not an AI/ML device.

9. How the ground truth for the training set was established: Not applicable.

Summary of Non-Clinical Studies and Standards:

The study that proves the device meets the acceptance criteria is a series of non-clinical tests covering various aspects:

• Mechanical Performance: Demonstrated conformance to ISO 5367 (Breathing sets and connectors) and ISO 80601-2-12 (Critical care ventilators).
• Thermal Safety: Implied by testing against the aforementioned standards and the device's function as a heated breathing circuit.
• Environmental Conditions: Not explicitly detailed beyond compliance with relevant standards.
• Electrical Safety and Electromagnetic Compatibility (EMC): Tested according to IEC 60601-1 (basic safety and performance) and IEC 60601-1-2 (EMC).
• Functional Verification and Performance Capacity and Accuracy: Demonstrated through compliance with ISO 5367, ISO 80601-2-12, ISO 5356-1 (Conical connectors), and ISO 80601-2-74 (Respiratory humidifying equipment).
• Biocompatibility Testing: Materials and completed products were evaluated through biological qualification safety tests as outlined in ISO 10993-1 ("Biological Evaluation of Medical Devices") and ISO 18562 series ("Biocompatibility evaluation of breathing gas pathways in healthcare"). Specific tests included:
  • Emissions of particulate matter (ISO 18562-2)
  • Emission of VOC with additional humidity (ISO 18562-3)
  • Leachables in condensate (ISO 18562-4)
  • Extraction (ISO 10993-18)
  • Material characterization (ISO 10993-18)
  • Cytotoxicity (ISO 10993-5)
  • Sensitization (ISO 10993-10)
  • Irritation (ISO 10993-10)

The "acceptance criteria" are implicitly defined by the requirements of these recognized consensus standards and the performance characteristics of the predicate devices, which the subject devices "meet all applicable requirements of" and are found to be "substantially equivalent" to. The testing demonstrates that despite some technological differences, no new safety or effectiveness concerns are raised compared to the predicate devices.

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The Infrared Heat (Model: E0221) is intended to emit energy in the red and infrared spectrum for use in the treatment of full face wrinkles.

The Infrared Heat, model: E0221, is an over-the-counter light emitting diode (LED) device that emits 630nm and 830nm light to treat wrinkles. The device uses three types of LEDs and has two modes to reach those two functions. The user can control the treatment time or automatically shut it off within a set time. The Infrared Heat components include the main unit device (a pad), an adjustable strap, a USB charging cord, goggles and a user manual. The user wears the device in the area which needs to treat, and the device will shut down automatically a 10-minute after finishing treatment.

The provided documentation does not describe a study that involves a test set, expert readers, or ground truth establishment in the context of an AI/ML device. The device in question, "Infrared Heat (Model: E0221)," is an LED device intended for the treatment of full face wrinkles. The submission is a 510(k) premarket notification, which seeks to demonstrate substantial equivalence to previously marketed predicate devices.

The document explicitly states: "Clinical testing was not needed for this 510(k). The non-clinical performance testing described above is sufficient to support that the device can be used safely and effectively."

Therefore, the information requested in the prompt (regarding acceptance criteria, test set, expert readers, ground truth, MRMC studies, standalone performance, training set details) is not applicable to the provided document. The evaluation of this device relies on non-clinical tests and comparison to predicate devices, rather than a clinical study involving human judgment of AI outputs.

The non-clinical tests performed relate to electrical safety, electromagnetic compatibility, photobiological safety, battery safety, biocompatibility, and software/usability testing, all in conformance with specific international standards (e.g., IEC, ISO). The comparison to predicate devices focuses on design principles, intended use, functions, materials, and compliance with standards.

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This home used device is designed to be used for adult and for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household work activities. In addition, it also provides a heat function intended to temporarily relieve minor aches and pains.

The FT-810R with a remote controller is a self-adhesive TENS device with 15 adjustable intensity level for pain relief. Moreover, it also provides a heat function which can be used in conjunction with the TENS function. TENS, Transcutaneous Electrical Nerve Stimulation, refers to the electrical stimulation of nerves through the skin which is an effective non-pharmacological method of pain relief. It can be used for self-treatment. Any symptoms that could be relieved using TENS must be checked by your general practitioner who will also give you instruction on how to carry out a TENS self-treatment regime.

TENS device works by passing electrical currents over the skin via a set of gel pads. As a transfer medium, the gel pads are subject to natural wear and tear and must be replaced when they stop providing sufficient contact or the main device no longer sticks to the skin completely. Failure to replace the gel pad may lead to skin irritation as a result of heightened current density in particular areas.

The provided text is a 510(k) summary for the Hivox Biotek Inc. Heating TENS (FT-810R) device. It details the device's characteristics, its comparison to predicate devices, and the non-clinical tests performed to demonstrate substantial equivalence. However, it explicitly states that "No clinical test data was used to support the decision of substantial equivalence."

Therefore, I cannot provide information on acceptance criteria based on human performance, nor can I describe a study that proves the device meets such criteria, because no clinical efficacy or human performance studies were conducted or presented for this 510(k) clearance. The clearance is based on demonstrating substantial equivalence to existing legally marketed predicate devices through engineering and safety testing.

The document focuses on non-clinical testing to ensure the device meets predefined acceptance criteria for safety and performance, primarily in comparison to its predicate devices.

Here's an analysis of the provided information, addressing your points where possible, and explicitly stating where information is not available:

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

The document mentions that "All the test results demonstrate the subject device, Heating TENS (FT-810R), meets the requirements of its pre-defined acceptance criteria and intended use, and its substantially equivalent to the predicate device." However, it does not explicitly list the specific quantitative acceptance criteria or the reported performance for each criterion in a consolidated table. Instead, it lists the types of non-clinical tests performed and implies that the device passed them by stating it "meets the requirements."

The "Table 1 – Comparison to Predicate Devices and Reference Device" does show comparisons of various technical specifications (e.g., maximum temperatureetting, output voltage, current, pulse width, frequency, maximum phase charge, maximum current density, maximum power density, etc.). While these are comparative performance metrics, they are not presented as explicit "acceptance criteria" with a target value + achieved value in the way you might see for clinical performance. The acceptance here is that it falls within a similar, safe, and effective range as the predicate devices.

For example, we can infer acceptance based on the comparison table:

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The Quantum PureFlow Standard Heat Exchanger is intended to be used with a compatible Heater/Cooler system to heat/cool blood during routine cardiopulmonary bypass (CPB) procedure up to 6 hours in duration. Devices are intended for adult patients.

The subject of the present Special 510(k) is the Quantum PureFlow Standard Heat Exchanger product family for inclusion of three additional variants with respect to the currently cleared (K220110) portfolio.

Quantum PureFlow Standard Heat Exchanger devices are designed to manage the temperature of blood during surgical procedures requiring cardiopulmonary bypass (CPB) for periods lasting less than 6 hours.

HX-S devices are designed to:

• keep circulating blood at a specific temperature, depending on the type of surgery being performed;
• maintain blood/patient thermoregulation during the CPB;
• rewarm blood at the conclusion of the CPB in order to restore normothermic patient condition.

Quantum PureFlow Standard Heat Exchangers have been designed to be powered by heatercooler systems that use

• Water
  or
• Glycol-based solution
  as Heat Transfer Fluid (HTF).

The provided text is an FDA 510(k) summary for a medical device called the "Quantum PureFlow Standard Heat Exchanger." It outlines the device's purpose, regulatory classification, and the comparison to an existing predicate device to demonstrate substantial equivalence.

However, the information requested in your prompt (Acceptance Criteria, Study Details, Sample Sizes, Expert Qualifications, Adjudication Methods, MRMC study, Standalone Performance, Ground Truth, Training Set Details) is typically related to the performance evaluation of AI/ML-based medical devices, particularly regarding diagnostic accuracy or clinical effectiveness.

The Quantum PureFlow Standard Heat Exchanger is a physical medical device (a cardiopulmonary bypass heat exchanger), not an AI/ML software device. Therefore, the types of studies and acceptance criteria described in your prompt (e.g., accuracy metrics, human reader improvement with AI, ground truth establishment by experts, training set details) are not applicable to this device.

The "Performance Data" section in the document (Page 5) does mention "NON-CLINICAL TESTING" and lists:

• Updating labeling and IFU according to ISO 15223-1:2021.
• Performance tests for new REF codes according to ISO 7199:2016.

This indicates that the acceptance criteria for this device would be related to meeting the standards outlined in ISO 7199:2016 for cardiopulmonary bypass heat exchangers (e.g., heat exchange efficiency, pressure drop, biocompatibility), as well as general safety and performance requirements for medical devices. The "study that proves the device meets the acceptance criteria" would be the non-clinical testing performed according to these standards.

In summary, none of the specific details you requested regarding AI/ML performance evaluation (such as number of experts for ground truth, MRMC study, sample sizes for test and training sets for an algorithm, etc.) are present in this document because it describes a hardware medical device, not an AI/ML software.

If this were an AI/ML device, the requested information would be crucial for understanding its validation and demonstrating its safety and effectiveness. Since it's a heat exchanger, the relevant "acceptance criteria" revolve around its physical performance (e.g., heat transfer rate, flow resistance) as per recognized standards (like ISO 7199), and the "study" would be bench testing to verify compliance with those standards.

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The Solex 7 Intravascular Heat Exchange Catheter connected to the CoolgardThermal Requlation System is indicated for use:

• · In cardiac surgery patients to achieve and/or maintain normothermia during surgery and recovery/intensive care. (Maximum use period: 4 days)
• · To induce, maintain and reverse mild hypothermia in neurosurgery patients in surgery and recoverylintensive care. (Maximum use period: 4 days)
• · In fever reduction, as an adjunct to other antipyretic therapy, in adult patients with cerebral infaction and intracerebral hemorrhage who require access to the central venous circulation and who are intubated and sedated. (Maximum use period: 7 days)

The Cool Line Catheter Model CL-2295A, when used with the ZOLL Thermal Regulation System, is indicated for use in fever reduction, as an adjunct to antipyretic therapy, in adult patients with cerebral hemorrhage who require access to the central venous circulation and who are intubated and sedated.

The ZOLL ICY Intravascular Heat Exchange Catheter Model IC-3893A, connected to the ZOLL Coolgard/Thermogard Thermal Regulation System, is indicated for use:

• · In cardiac surgery adult patients to achieve and/or maintain normothermia during surgery and recovery/intensive care, and
• · To induce, maintain and reverse mild hypothermia in neurosurqery and recovery/intensive care.

The ZOLL Quattro Catheter Model IC-4593, connected to a ZOLL Thermal Regulation System, is indicated for use:

• · In cardiac surgery adult patients to achieve and/or maintain normothermia during surgery and recoverylintensive care, and
• · To induce, maintain and reverse mild hypothermia in neurosurgery adult patients in surgery and recovery/intensive care.

The ZOLL Intravascular Temperature Management (IVTM™) System is comprised of an external heat exchange console (either the Thermogard HQ™ Console or the Thermogard XP® Console) and intravascular heat exchange catheters connected via a sterile heat exchanger and tubing circuit. These components together comprise a patient temperature regulation apparatus employing feedback control. The subject devices of this submission are the Thermogard HQ™ Console (TGHQ) and the Thermogard XP® Console (TGXP) for software changes due to the addition of the TrakLo functionality to both consoles.

Here's a breakdown of the requested information based on the provided text, regarding the "TrakLo" feature of the Thermogard XP Console and Thermogard HQ Console:

1. Table of acceptance criteria and the reported device performance

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

The document does not specify a numerical sample size for the test set for the TrakLo feature's non-clinical testing. It only states "Test methods validate the device for human factors per the intended use with the TrakLo feature" and "Test methods verify that the software meets software requirements." This suggests internal testing without a specified sample size for "human factors" or "software verification" in the context of clinical trials.

The data provenance for the non-clinical testing is implied to be internal testing conducted by ZOLL Circulation, Inc. The document does not mention details about country of origin or whether it was retrospective or prospective data in the context of this specific regulatory submission for the TrakLo feature.

It is important to note that the broader warnings regarding the "Cool Line Intravascular Heat Exchange Catheter" refer to a randomized controlled trial of 296 patients, but this clinical trial data is not related to the TrakLo feature, but rather to the initial clearance of the Cool Line device and its limitations for certain fever reduction indications.

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

The document does not provide information about the number or qualifications of experts used to establish ground truth for the non-clinical tests (Human Factors/Usability and Software Verification) related to the TrakLo feature.

4. Adjudication method for the test set

The document does not describe any adjudication method for the test set. For software and human factors testing, "adjudication" in the sense of expert consensus on clinical outcomes is typically not applicable. The testing would have followed internal protocols to assess functionality and usability.

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 for the TrakLo feature. The TrakLo feature is a software enhancement to an existing thermal regulation console, primarily affecting alarm behavior, not an AI-assisted diagnostic or interpretive tool that would involve human readers.

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

Yes, the performance of the TrakLo feature itself, as a software algorithm, was evaluated in standalone non-clinical testing. The "Software Verification" and aspects of "Human Factors / Usability" tests evaluate the algorithm's functionality and its interaction with the user interface, independent of a clinical human-in-the-loop scenario for diagnostic purposes. It's a control algorithm enhancement, not an AI for human interpretation.

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

For the TrakLo feature:

• Software Verification: The ground truth would be the defined software requirements and specifications. The tests verify that the code implements these requirements correctly.
• Human Factors / Usability: The ground truth would involve established human factors engineering principles and usability goals, likely assessed through user observation, task analysis, and error analysis against predetermined acceptance criteria related to usability.

8. The sample size for the training set

This information is not provided. The TrakLo feature is described as a software modification for improved utility in warming applications, preventing a "Lo alarm" under specific conditions. It doesn't appear to be an AI/machine learning model that would require a distinct "training set" in the conventional sense. It's an algorithmic change.

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

As described above, the concept of a "training set" and associated "ground truth" for training an AI model does not apply here based on the information provided. The TrakLo feature is an algorithmic change for alarm management under specific temperature conditions.

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