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Ask a specific question about this device

Ask a specific question about this device

The PVDF Effort Sensor is intended to measure and output respiratory effort signals from a patient for archival in a sleep study. The sensor is an accessory to a polysomnography system which records and conditions the physiological signals for analysis and display, such that the data may be analyzed by a qualified sleep clinician to aid in the diagnosis of sleep disorders.

The PVDF Effort Sensor is intended for use on both adults and children by healthcare professionals within a hospital, laboratory, clinic, or nursing home, or outside of a medical facility under the direction of a medical professional.

The PVDF Effort Sensor does not include or trigger alarms, and is not intended to be used alone as, or a critical component of,

• an alarm or alarm system;
• an apnea monitor or apnea monitoring system; or
• life monitor or life monitoring system.

The PV01 PVDF Effort Sensor is a respiratory effort monitoring accessory designed for use during sleep studies to assess breathing patterns by measuring chest and abdominal wall movement. The device functions as an accessory to polysomnography (PSG) systems, enabling qualified sleep clinicians to analyze respiratory data for the diagnosis of sleep disorders.

The sensor consists of two main components: a PVDF (polyvinylidene fluoride) sensor module and an elastic belt. The sensor module contains two plastic enclosures connected by a piezoelectric PVDF sensing element encased in a silicone laminate. The PVDF material generates a tiny voltage that is output through the lead wire to the sleep amplifier. The change in voltage as the tension on the PVDF film fluctuates corresponds to the breathing of the patient. Since the PVDF material generates voltage, the sensor does not require a battery or power from the amplifier. The output signal is processed by the sleep recording system for monitoring and post-study analysis.

The PV01 PVDF Effort Sensor is intended for prescription use only by healthcare professionals in hospitals, sleep laboratories, clinics, nursing homes, or in home environments under medical professional direction. The device is designed for use on both adult and children participating in sleep disorder studies. The sensor is intended to be worn over clothes and not directly on the patient's skin.

The 510(k) clearance letter for the PV01 PVDF Effort Sensor does not contain the specific details required to fully address all aspects of your request regarding acceptance criteria and the study proving the device meets them. This document is a regulatory approval letter, summarizing the basis for clearance, not a detailed study report.

However, based on the provided text, here's an attempt to extract and infer the information:

Overview of Device Performance Study

The PV01 PVDF Effort Sensor underwent "comprehensive verification and validation testing" including "functional and performance evaluations" and "validation studies" to confirm it meets design specifications and is safe and effective. Additionally, "comparative testing against the Reference Device" was performed.

This suggests that the performance evaluation primarily focused on:

1. Safety Tests: Compliance with UL 60601-1 standards to ensure electrical and liquid ingress safety.
2. Usability and Validation Test: Assessment of user experience and comfort during a simulated sleep study.
3. Performance Comparison Test: Electrical signal output comparison to a legally marketed predicate device under simulated breathing conditions.
4. Temperature Range Test: Verification of signal output performance at extreme operating temperatures.

Acceptance Criteria and Reported Device Performance

Based on the "Summary of Tests Performed" section, the following can be inferred:

Missing Information and Limitations:

The provided FDA 510(k) clearance letter is a high-level summary and does not contain the granular details typically found in a full study report. Therefore, most of the following requested information cannot be extracted directly from this document.

1. Sample size used for the test set and data provenance:

   • Test Set Size: Not specified for any of the performance tests. For the usability test, it mentions "Participants" (plural), but no number. For the performance comparison test, it states "Both devices were placed on a rig," implying a comparison, but no human subject or case count.
   • Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The usability test mentions "participants," potentially implying prospective data collection, but this is a broad inference.

2. Number of experts used to establish the ground truth for the test set and their qualifications:

   • Not Applicable/Not Specified: The device is a "PVDF Effort Sensor" that measures and outputs respiratory effort signals. Its purpose is to provide raw physiological data for a "qualified sleep clinician to aid in the diagnosis of sleep disorders." The device itself does not provide a diagnosis or interpretation that would require expert ground truth labeling in the traditional sense of an AI diagnostic device (e.g., image-based AI). The performance assessment appears to be against expected signal characteristics and comparison to a known device, not against clinical ground truth established by experts.

3. Adjudication method for the test set:

   • Not Applicable/Not Specified: Given the nature of the device (a sensor outputting physiological signals) and the described tests, a formal adjudication process (like for interpreting medical images) is not mentioned or implied.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs. without AI assistance:

   • No: This type of study (MRMC for AI assistance) is not mentioned. The device is a sensor, not an AI interpretative tool designed to assist human readers directly. It provides raw data for clinicians to analyze.

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

   • Partially Yes (for the sensor itself): The "Performance Comparison Test" and "Temperature Range Test" assess the device's signal output performance independently without a human in the loop for interpretation. The "Safety Tests" are also standalone tests on the device's physical and electrical properties.

6. The type of ground truth used:

   • Physiological Simulation / Device Output Comparison: For the "Performance Comparison Test," the ground truth was essentially the simulated breathing patterns produced by a "rig" and the expected output signals of a known predicate/reference device.
   • User Feedback / Self-Reported Metrics: For the "Usability and Validation Test," the ground truth was the participants' subjective feedback on comfort and ease-of-use, and the absence of reported use errors or adverse events.
   • Compliance with Standards: For "Safety Tests," the ground truth was compliance with the specified clauses of the UL 60601-1 standard.

7. The sample size for the training set:

   • Not Applicable/Not Specified: The PV01 PVDF Effort Sensor is described as a passive hardware sensor ("generates a tiny voltage," "does not require a battery or power from the amplifier") that measures physical movement. It is not an AI/ML algorithm that requires a "training set" in the computational sense.

8. How the ground truth for the training set was established:

   • Not Applicable: As stated above, there is no mention or implication of a training set as this is a hardware sensor, not an AI/ML algorithm.

In summary, the provided document gives a high-level overview of the acceptance criteria met for regulatory clearance, primarily focusing on safety, basic functional performance relative to another device, and usability. It does not delve into the detailed statistical methodology and independent ground truth establishment typical of AI/ML device studies.

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The Portable Oxygen Concentrator provides a high concentration of supplemental oxygen to adult patients requiring respiratory therapy on a prescriptive basis. It may be used at home, in institution, vehicle, train, airplane, boats and other transport modalities. This device is to be used as an oxygen supplement and is not intended to be life sustaining or life supporting.

Users should follow their doctor's advice on setting the oxygen flow rate and should not adjust the flow rate without consulting a healthcare professional.

Note: Patients should regularly consult with their physician to evaluate the need for adjustments in their oxygen therapy settings.

The Portable Oxygen Concentrator is a Class II, low-risk medical device designed to provide a high-concentration oxygen supply (87%-95.5%) to adult patients requiring supplemental oxygen therapy as prescribed by a healthcare professional. It is intended for use at home, in institution, vehicle, train, airplane, boats and other transport modalities and complies with FAA regulations for in-flight use. The device is not intended for life-support or life-sustaining purposes.

The Portable Oxygen Concentrator utilizes Pressure Swing Adsorption (PSA) technology, which extracts oxygen from ambient air by selectively adsorbing nitrogen through molecular sieve beds. Oxygen is delivered through a pulse dose mechanism, synchronizing oxygen release with the patient's inhalation cycle to optimize efficiency and minimize waste.

The series consists of four models, each offering different pulse dose settings:

• W-R1 (MAX): 1, 2, 3, 4, 5, 6, S
• W-R1: 1, 2, 3, 4, 5, 6
• W-R2: 1, 2, 3, 4, 5
• W-R2 (Lite): 1, 2, 3, 4

The device operates in pulse flow mode and supports multiple power sources, including 100–240V AC (50–60Hz) and a rechargeable lithium-ion battery (14.4V / 6500mAh). While the hardware supports 13.0–16.8V DC input, DC operation is not currently supported, as no DC accessories are provided or authorized. A single battery charge provides up to 4.5 hours of continuous use, ensuring flexibility across various environments.

Designed for portability and efficiency, the W-R Series features a lightweight build (1.8 kg), low noise operation, and an intuitive LCD display. Its ergonomic and user-friendly design has been internationally recognized with six global design awards, including iF, Red Dot, and IDEA, for its usability, portability, and patient-centered innovation.

The device is suitable for operation within a temperature range of -5°C to 40°C (23°F to 104°F), humidity levels of 5% to 90% (non-condensing), and atmospheric pressure from 54kPa to 106kPa. It can function at altitudes up to 5,000 meters (16,400 feet).

The Portable Oxygen Concentrator consists of a casing, compressor, molecular sieve system, solenoid valve, battery, cooling fan, control board, and display screen.

Note: The device does not include a nasal cannula; patients should purchase one separately. The oxygen outlet follows international standards, and recommended cannula specifications can be found in Section 2.12: Cannula Use of the user manual.

The provided FDA 510(k) clearance letter is for a Portable Oxygen Concentrator. This device is not an AI/ML-enabled device. The information requested in the prompt (acceptance criteria, study details, sample size, ground truth, expert adjudication, MRMC studies, etc.) is typically associated with the rigorous evaluation of AI/ML software as a medical device (SaMD) or AI-enabled medical devices, especially those using diagnostic imaging.

Medical devices like portable oxygen concentrators are evaluated primarily on their physical performance characteristics, safety standards, and conformity to established regulations for mechanical and electrical safety. The clearance letter outlines the non-clinical tests performed (safety and performance testing, biocompatibility testing, electrical safety and EMC testing, battery safety testing, and software verification/validation), but these are not the types of studies that involve expert readers, ground truth consensus, or MRMC comparative effectiveness specific to AI diagnostics.

Therefore, I cannot extract the requested information (acceptance criteria in the context of an AI study, sample sizes for test/training sets, data provenance, expert adjudication, MRMC studies, standalone performance, or ground truth establishment relevant to AI/ML) directly from this document, as it pertains to a different type of medical device evaluation.

To directly answer your request based on the provided document, which is for a Portable Oxygen Concentrator (not an AI/ML diagnostic device):

The FDA 510(k) Clearance Letter for the Portable Oxygen Concentrator focuses on demonstrating substantial equivalence to a predicate device through:

• Same Intended Use: Providing supplemental oxygen to adult patients on a prescriptive basis for respiratory therapy.
• Similar Technological Characteristics: Utilizing breath detection, molecular sieve/pressure swing adsorption, and a pulse dose mechanism.
• Performance Data: Presenting specifications like oxygen concentration, pulse volumes, sound levels, and mechanical/electrical safety.
• Compliance with Recognized Standards: Adhering to various international IEC and ISO standards for medical electrical equipment, biocompatibility, and oxygen concentrators.

The "acceptance criteria" for a device of this type are generally meeting the performance specifications and safety standards outlined in the non-clinical testing section, and demonstrating that any differences from the predicate device do not raise new questions of safety or effectiveness.

Here's a breakdown of the closest equivalents to your requested categories, given the nature of the device and the document:

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

For a portable oxygen concentrator, acceptance criteria are generally related to its physical and performance specifications like oxygen purity, flow rates, noise levels, and battery life, rather than diagnostic accuracy metrics.

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The NeuroEars-Anna™ system provides information to assist in the nystagmographic evaluation, diagnosis, and documentation of vestibular disorders. Nystagmus of the eye is recorded using a head-mounted display equipped with eye-tracking cameras. These images are measured, recorded, displayed, and stored in the software. This information can then be used by trained medical professionals to assist in diagnosing vestibular disorders.

The NeuroEars-Anna™ system is intended for use in individuals aged 12 years and older, based on the physical compatibility of the FOVE VR headset (FOVE Inc., Japan). While the ANSI S3.45 standard does not define age-based limitations, the FOVE VR headset is generally suitable for individuals aged 12 and above. For improved fit, soft materials such as sponge pads may be used in cases where the headset does not conform properly to the user's face. This applies to both pediatric and adult patients. Any additional padding should be used only if it does not interfere with eye-tracking performance or measurement accuracy and must follow the manufacturer's instructions for proper use.

NeuroEars-Anna™ is a standalone software device that analyzes eye movements to assist medical professionals in the nystagmographic evaluation, diagnosis, and documentation of vestibular disorders. The NeuroEars-Anna™ software is intended to be used with off the shelf hardware including the HMD, PC, and monitors.

The NeuroEears-Anna™ software is designed to perform the following vestibular tests:

• Spontaneous Nystagmus Test
• Gaze-Evoked Nystagmus Test
• Head Shaking Nystagmus Test
• Fistula Nystagmus Test
• Dix-Hallpike Test
• Positional Test
• Smooth Pursuit Test
• Random Saccade Test
• Saccadometry Test
• Optokinetic Nystagmus Test
• Subjective Visual Vertical/Subjective Visual Horizontal (SVV/SVH)
• Caloric Test
• Video Frenzel

NeuroEars-Anna™ is a software program that analyzes eye movements recorded from an eye-tracking camera mounted on a head-mounted display (HMD) with eye-tracking specifications suggested by ANSI/ASA S3.45-2009 (Reaffirmed by ANSI April 16, 2024 version). The HMD devices used can be commercial products such as the FOVE0 (powerd by FOVE Inc., Japan), which meet these minimum eye-tracking specifications. The software is intended to run on a Microsoft Windows PC platform.

Here's a breakdown of the acceptance criteria and study information for NeuroEars-Anna™, based on the provided FDA 510(k) Clearance Letter:

1. Table of Acceptance Criteria and Reported Device Performance

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The NeuroOne OneRF® Trigeminal Nerve Ablation System is indicated for use in procedures to create radiofrequency lesions for the treatment of pain, or for lesioning nerve tissue for functional neurosurgical procedures.

OneRF® Ablation System for Trigeminal Nerve (TN) Ablation uses radiofrequency (RF) ablation to create lesion(s) in an area of nerve tissue that the surgeon has identified for ablation. The ablation site may be identified by diagnostic stimulation of the trigeminal nerve using the Trigeminal Nerve Radiofrequency (TN-RF) Probe to accurately locate the target area for ablation.

The subject device is identical to the sEEG-RF Probe cleared after FDA review of K231675. In K231675, the FDA reviewed and cleared the sEEG-RF Probe when used with the NeuroOne OneRF® Generator to form the OneRF® Ablation System. The OneRF® Ablation System is indicated to create radiofrequency lesions in nervous tissue for functional neurosurgical procedures.

In this new 510(k), we propose to market the identical sEEG-RF Probes to create lesion(s) in the trigeminal nerve "for the treatment of pain." This use for treatment of facial pain requires new accessories (Cannula and Tuohy Borst Adapter) for insertion/placement of the sEEG-RF Probe. When the sEEG-RF Probe is used to create lesion(s) in the trigeminal nerve, it will be marketed as the Trigeminal Nerve Radiofrequency (TN-RF) Probe. The TN-RF Probe and new accessories, when combined with the cleared (K231675) NeuroOne OneRF® Generator and accessories, will be referred to as the OneRF® Trigeminal Nerve Ablation System.

The OneRF® for TN Ablation System components/accessories consist of the following:

1. TN-RF Probe (with Stylet)
   • 16mm x 5 Contact TN-RF Probe Kit
   • 26.5mm x 8 Contact TN-RF Probe Kit
2. Insertion Components
   i. Insulated Cannula w/Stylet
   ii. Tuohy Borst Adapter (Adapter)
3. Stimulation Components
   i. Cable Assembly (5 or 8 connector pins) (CA)
4. Ablation Components
   i. Stylet
   ii. Temperature Accessory (TA)
   iii. Spacer Tubes
   iv. Radiofrequency Connector Box (RFCB)
   v. Equipment
   1. Generator
   2. Generator Interface Cable (GIC)
   3. Cart
   4. Foot Pedal (optional)
   5. Ground Pad

The provided document is a 510(k) Clearance Letter for a medical device. It does not describe a study that uses a test set, training set, or ground truth to evaluate algorithm performance. The clearance is based on the substantial equivalence of the "NeuroOne OneRF Trigeminal Nerve Radiofrequency Probes" to existing predicate devices, supported by non-clinical performance tests and biocompatibility assessments.

Therefore, I cannot provide the requested information in a table format as there are no relevant acceptance criteria or reported device performance metrics for an AI/algorithm-based study within the document.

Here's why each of your requested points cannot be answered from the provided text:

1. A table of acceptance criteria and the reported device performance: The document focuses on performance testing related to mechanical, dimensional, packaging integrity, and sterilization aspects of the physical device, not an AI algorithm's performance. The "Lesion Size Testing" states "Lesion sizes were proportional to time and temperature. Lesion size is comparable to predicate," but it doesn't provide specific quantitative acceptance criteria or detailed numerical results beyond this qualitative statement.
2. Sample size used for the test set and the data provenance: Not applicable. The studies are non-clinical, involving physical device testing, not data analysis on a test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. There is no ground truth established by experts for a test set in these non-clinical tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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-assisted diagnostic or interpretative device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

Summary of available information regarding performance testing:

The document outlines a series of non-clinical performance tests to support the substantial equivalence claim. These tests primarily verify the physical and functional integrity of the device and its components.

• Lesion Size Testing:
  • Overview: Measured lesion size as a function of temperature and time, for monopolar and bipolar configurations, and temperature control/manual modes.
  • Results: "Lesion sizes were proportional to time and temperature. Lesion size is comparable to predicate." (No specific numerical data or explicit acceptance criteria provided in the summary).
• Dimensional Verification of the Cannula:
  • Overview: Evaluated dimensional characteristics and compatibility between components.
  • Results: "Pass – The test results indicate that the Cannula meet the dimensional requirements."
• Mechanical Performance:
  • Overview: Verified specifications related to mechanical interaction between the TN-RF Probe, Cannula, and Tuohy Borst Adapter.
  • Results: "Pass – The test results indicate that the TN-RF Probe, Cannula, Tuohy Borst Adapter designs meet the mechanical performance requirements."
• Mechanical Integrity:
  • Overview: Evaluated mechanical integrity of the TN-RF Probe, Cannula, and Tuohy Borst Adapter.
  • Results: "Pass - The test results indicate that the TN-RF Probe, Cannula and Tuohy Borst Adapter designs meet the mechanical integrity requirements."
• TN-RF Probe Kit Package Integrity:
  • Overview: Tested the packaged device and labeling against conditions of packaging, shelf life, and distribution per ISO 11607-1, ISTA 3A, ASTM D4169, ASTM F1980, ASTM F2096, ASTM F88.
  • Results: "Pass - The test results indicate that the TN-RF Probe Kit (...) packaging designs meet the integrity requirements (i.e., seal strength, bubble leak, label inspection, and no damage that impacts device sterility)."
• Sterilization:
  • Overview: Validated ethylene oxide sterilization process to achieve a minimum SAL of 10⁻⁶ per ISO 11135.
  • Results: "Pass – All criteria passed and the new product/package configuration was adopted into the validated sterilization cycle."
• Usability – Summative Validation:
  • Overview: Performed in accordance with FDA guidance, "Applying Human Factors and Usability Engineering to Medical Devices," February 3, 2016.
  • Results: "Pass – The NeuroOne OneRF® TN-RF Ablation System has been found to be safe and effective for the intended users, uses, and use environments."
• Biocompatibility:
  • Overview: Tested sEEG-RF Probe for prolonged contact and Cannula w/stylet, Tuohy Borst Adapter for limited contact.
  • Results: "Passed" for all tested components. No testing for Temperature Accessory/Spacer Tubes/Stylet and Radio Frequency Connector Box as there is no direct or indirect patient contact.

The provided document specifically clarifies that the device is substantially equivalent, and the "conclusions drawn from the nonclinical testing demonstrate the device is as safe, as effective, and performs as well as the legally marketed device predicates, per 21 CFR 807.92(b)(3)." This is a traditional medical device clearance, not an AI/ML-driven software clearance.

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As a TENS device, the CP Relief Wand Rx - TENS/NMES is intended for use as an adjunctive therapy for pain management for medical purposes such as symptomatic relief of chronic intractable pain and relief of acute post surgical and post-traumatic pain.

As an EMS device, the CP Relief Wand Rx - TENS/NMES is intended for use for relaxation of muscle spasm, increasing local blood circulation, muscle re-education, prevention or retardation of disuse atrophy, prevention of venous thrombosis of the calf muscles immediately after surgery, and maintaining on increasing range of motion.

The CP Relief Wand Rx - TENS/NMES®("Wand") is a multitherapy medical device that combines the treatment capabilities of TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation).

The CP Relief Wand Rx - TENS/NMES is portable with self-contained electrodes. The device is powered by a standard non-rechargeable 9-volt alkaline battery. A charger is not used due to the low current drain and long battery life of the low power circuitry.

In operation, the electrode end of the CP Relief Wand Rx - TENS/NMES is positioned to touch the skin. The electrical pulses travel from one electrode, through the skin, through the underlying tissue, and back through the skin to the other electrode. Controls on the unit are provided for power, intensity, pulse width, and pulse polarity.

This FDA 510(k) clearance letter pertains to a TENS/NMES device, not an AI/ML-driven medical device. Therefore, the information typically found in a study proving an AI/ML device meets acceptance criteria (such as performance metrics, sample sizes for test/training sets, expert qualifications, and ground truth establishment) is not present in this document.

The document discusses the substantial equivalence of the "CP Relief Wand Rx - TENS/NMES" to predicate devices based on regulatory parameters, specifications, and the leveraging of performance testing from the primary predicate. It does not describe a new study specifically designed to assess the performance of the device against acceptance criteria in the context of an AI/ML model.

Therefore, I cannot provide the requested information for acceptance criteria and study details as they relate to an AI/ML device, as this document does not contain that type of data.

The document primarily focuses on:

• Substantial Equivalence: Arguing that the new device is as safe and effective as previously cleared devices.
• Expansion of Indications for Use: Adding EMS functionality, which is justified by comparison to a second predicate device that already has EMS indications.
• Performance Data (Leveraged from Predicate): Citing existing standards compliance from the primary predicate device, rather than new performance studies on an AI/ML algorithm.

If you have a document describing an AI/ML device and its validation study, I would be happy to analyze it for the requested information.

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The trophon2 is designed to provide High-Level Disinfection (HLD) of validated ultrasound transducers. High-Level Disinfection is achieved by surface exposure to a controlled dose of hydrogen peroxide mist delivered to a disinfection chamber contain the ultrasound probe.

The trophon2 system consists of a multiple use instrument combined with a single use disinfectant "trophon Sonex-HL", delivered from a multi-dose cartridge.

The trophon2 is suitable for use in general hospital and health care facilities by trained personnel.

The trophon Sonex-HL should be used with the following contact conditions:

• Minimum Operational Cycle Time: 4 minutes
• Minimum Concentration: 31.5%
• Minimum Disinfectant Dose: 1.0 g
• Minimum Chamber Temperature: 56°C

The trophon2 is a software-controlled device which provides High- Level Disinfection of validated ultrasound probes. The device consists of a sealed disinfection chamber and operates in conjunction with a multi-dose cartridge of concentrated hydrogen peroxide disinfectant, supplied as an accessory to the device. Pre-cleaned and dried ultrasound transducers are placed within the trophon2 chamber and disinfected by means of an automated disinfection and aeration cycle.

The provided text is a 510(k) clearance letter for a medical device called "trophon2". It focuses on proving the new version of trophon2 is substantially equivalent to a previously cleared version, primarily through non-clinical testing. This document does not describe a study involving an AI model for medical image analysis, nor does it detail a multi-reader multi-case (MRMC) study or expert adjudication for ground truth related to medical imaging.

The device, trophon2, is a High-Level Disinfection (HLD) system for ultrasound transducers, a piece of equipment for cleaning medical devices, not an AI diagnostic tool. Therefore, many of the requested categories (e.g., number of experts for ground truth, MRMC study, training set ground truth) are not applicable to the information provided in this regulatory document.

However, based on the non-clinical testing section, I can extract and present the acceptance criteria and reported device performance related to its disinfection capabilities.

Analysis of Acceptance Criteria and Device Performance for trophon2 (K250434)

The trophon2 device, as described in the 510(k) submission K250434, is a High-Level Disinfection (HLD) system for ultrasound transducers. The evaluation presented in the document is primarily a demonstration of its substantial equivalence to a previously cleared version of the trophon2 (K173865) by fulfilling specified non-clinical performance and safety standards.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the trophon2 are based on its ability to perform High-Level Disinfection effectively and safely, as well as adherence to relevant industry standards.

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

The document states that "Potency tests were conducted under worst case conditions" and "Simulated use testing was conducted under worst case conditions." However, specific sample sizes (e.g., number of tested devices, number of disinfection cycles, number of contaminated probes) for these non-clinical tests are not provided in the provided 510(k) summary. The data provenance is implied to be from Nanosonics Limited's internal testing in Australia, as the company is based in Macquarie Park, NSW, Australia. The document does not specify if the data was retrospective or prospective, though it pertains to performance testing of the device itself.

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

This question is not applicable to the provided document. The trophon2 is a disinfection device, not an AI model that interprets medical images. Therefore, the concept of "ground truth" established by medical experts for a test set, as is common in AI/ML medical devices, does not apply here. The "ground truth" for this device's performance is objective measurements of microbial kill, chemical residue levels, and functional parameters, validated against established standards (e.g., AOAC, ASTM, FDA guidance).

4. Adjudication method for the test set

This question is not applicable to the provided document, as it does not describe studies involving human readers or interpretation 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 to the provided document. The trophon2 is not an AI diagnostic tool, and no MRMC study or AI assistance for human readers is described.

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

This question is not applicable to the provided document. While the trophon2 is a software-controlled system, it is a physical device performing disinfection, not an algorithm providing diagnostic output. The "software verification and validation testing" mentioned refers to the functional correctness of the device's control software, not diagnostic performance.

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

The "ground truth" for the trophon2's performance is based on microbiological standards (e.g., complete kill of specific microorganisms), chemical concentration measurements, temperature parameters, and physical operational limits. This is established by well-defined laboratory testing protocols outlined in standards like AOAC and ASTM, and FDA guidance for liquid chemical sterilants/high-level disinfectants. It is a deterministic, objective ground truth based on the device's physical and chemical disinfection capabilities, not interpretive expert consensus or patient outcomes data for diagnosis.

8. The sample size for the training set

This question is not applicable to the provided document. The trophon2 is a hardware device with controlling software; it does not involve machine learning or a "training set" in the context of AI model development for diagnostic purposes. Its software is developed and validated through traditional software engineering principles.

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

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

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