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ClearMate™ is intended to be used by emergency department medical professionals as an adjunctive treatment for patients suffering from carbon monoxide poisoning. The use of ClearMate" enables accelerated elimination of carbon monoxide from the body by allowing isocapnic hyperventilation through simulated partial rebreathing.

This device is intended to induce isocapnic hyperventilation in patients to speed up elimination of carbon monoxide (CO). Isocapnic hyperventilation can be defined as large increases in patient minute volume with minimal changes in arterial partial pressure of carbon dioxide (CO2). This device replaces CO2 levels in the airway, thereby maintaining CO2 levels in the blood that ultimately causes hyperventilation. This pneumatic device initially provides 100% supplemental oxygen (O2) at minute volumes selected based on patient weight. If the patient minute volume demand is more than the preset supplement O2 volume, this device supplies a mixture of 94%/6% (O2/CO2), which maintains CO2 levels in the airway to enable isocapnic breathing by partial simulated rebreathing (of CO2). This device consists of:

1. The subject of this De Novo, the Control unit ("briefcase"), connects to sources of O2 and CO2 (neither gas is supplied with this device). The unit includes pressure gauges to read the source gas pressures. Internal components control supplemental gas flowrates, gas concentrations, and CO2 diversion away from the gas delivery pathway should O2 pressures be insufficient. This unit weighs about 2 kg and is pneumatically driven (i.e., no electronics).
2. Two breathing circuits, which are not the subject of this De Novo, can attach to the gas outlet ports of the control unit. These circuits are constructed of reservoir bags (21 CFR 868.5320, Class I), oxygen cannulas (21 CFR 868.5340, Class I), masks (21 CFR 868.5550, cleared under K953107), valves (21 CFR 868.5870, cleared under K142402), resuscitation bags (21 CFR 868.5915, cleared under K912203), and/or tubing (21 CFR 868.5925, cleared under K161420).
3. Hoses for source gas connections and a device stand for steadying the device, which are a subject of this De Novo.

Here's a breakdown of the acceptance criteria and the study information for the ClearMate device, based on the provided text:

Acceptance Criteria and Device Performance

Study Information

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

The document primarily discusses preclinical (animal and bench) and clinical literature review, rather than a single prospective "test set" for the device itself in the traditional sense of an AI/algorithm.

• Bench Testing:

  • Breathing Circuit Performance: 10 samples of spontaneously breathing circuits and 10 samples of non-spontaneously breathing circuits (20 samples total).
  • Control Unit Performance: 10 control units.
  • Use Life Performance: 5 device samples.
  • Data Provenance: Retrospective, conducted by the applicant (Thornhill Research, Inc.) presumably in Canada (given the contact address is in Scottsdale, AZ, but the company is Thornhill Research, Inc., which is Canadian). This is inferred as internal testing presented to the FDA.

• Animal Studies:

  • Fisher JA et al. (1999): Dog model (specific N not provided in the summary). Provenance: Published U.S. study.
  • Krech T et al. (2001): Mechanically ventilated sheep (specific N not provided in the summary). Provenance: Published U.S. study.

• Human Clinical Literature Review (considered as evidence of effectiveness):

  • Anand et al. (2017): 13 healthy volunteers (chronic smokers). Provenance: Published study (journal name "PLOS One" suggests an international publication, DOI:10.1371/journal.pone.0170621).
  • Rucker et al. (2002): 14 healthy volunteers. Provenance: Published U.S. study.
  • Takeuchi et al. (2000): Healthy human volunteers (specific N not provided in the summary). Provenance: Published U.S. study.
  • Katznelson et al. (2008): Specific N not provided in the summary (anesthetic agents study). Provenance: Published study.
  • Katznelson et al. (2011): 44 obese elective surgical patients (anesthetic agents study). Provenance: Published study.
  • Wu et al. (2015) - external study, not used for efficacy but for safety: 319 patients in treatment group, 320 in control group. Provenance: Chinese study, published in "Chinese Journal of Clinicians."

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

This device is not an AI/algorithm requiring expert-established ground truth for a test set in the diagnostic sense. The "ground truth" for its performance is derived from:

• Bench Testing: Engineering specifications and physical measurements. Experts involved would be engineering and quality control personnel. Their specific qualifications are not detailed, but they would be presumed to be qualified engineers/technicians.
• Animal Studies: Scientific observation and measurement by researchers/veterinarians.
• Human Clinical Studies: Clinical endpoints (e.g., COHb levels, elimination half-life, cerebral blood flow) measured by medical professionals and researchers. The peer-review process for these published studies implicitly involves expert clinicians and scientists.

4. Adjudication Method for the Test Set:

Not applicable, as this is not an AI/diagnostic algorithm using expert review for a "test set." For the literature review, the FDA's internal review team served as the adjudicators of the existing scientific evidence.

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

No, an MRMC comparative effectiveness study, in the context of human reader performance with/without AI assistance, was not performed. The device is a physical therapeutic device, not a diagnostic AI system intended to assist human readers.

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

Yes, the device itself is the "standalone" component. Its performance was evaluated independently through bench testing (as detailed in item #2) and animal studies. The human clinical studies also assess the device's effect on physiological markers when used therapeutically.

7. The Type of Ground Truth Used:

• Bench Testing: Device specifications, physical properties, engineering standards, and direct measurement of gas concentrations, flow rates, and pressures.
• Animal Studies: Physiological measurements (e.g., COHb levels, cardiac output, oxygen delivery) directly measured from the animal subjects.
• Human Clinical Studies (for effectiveness): Physiological measurements (e.g., COHb levels, elimination half-life, cerebral blood flow) obtained from human volunteers or patients using established medical measurement techniques.
• Human Clinical Study (Wu et al. for safety, but with limitations on efficacy): Clinical outcomes adjudicated by medical personnel based on consciousness, continence, disappearance of CO poisoning signs, EEG findings, and BI (Barthel Index) scores.

8. The Sample Size for the Training Set:

Not applicable. This is a physical medical device, not an AI model requiring a training set in the machine learning sense. The device's design is based on scientific principles of isocapnic hyperventilation, not data training.

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

Not applicable (as above). The design and performance targets for the ClearMate device are based on established physiological principles and engineering requirements, not on a "ground truth" derived from a training dataset for an AI algorithm.

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The MOVES® SLC™ is a portable computer controlled, electrically powered emergency ventilator intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation.

a. Suction
The MOVES® SLC™ suction pump is intended for aspiration and removal of fluids, tissue (including bone), gases, bodily fluids or infectious materials from wounds or from a patient's airway or respiratory support system.

b. Supplementary Oxygen
The MOVES® SLC™ is intended to provide supplemental oxygen enriched air to patients that require supplemental oxygen.

c. Patient Monitoring
The MOVES® SLC™ is intended to monitor physiological parameters of patients and provide these parameters to a health care provider for interpretation in the form of physiological data and system alarms. Physiological data and system alarms will be available to the care provider from the monitor.

The MOVES® SLC™ (SLC) is an upgraded version of the cleared MOVES® SLC™ device (K140049), a portable multifunction patient support and monitoring system with the following capabilities:

• Computer controlled, electrically powered circle ventilator intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation.
• Delivery of oxygen-enriched air that may be supplied from an external oxygen source or generated internal to the system with the on-board oxygen concentrator.
• Patient monitoring functions including the following patient parameters: Pulse Rate, Noninvasive BP (NIBP), Invasive BP (IBP), SPO2, Temperature, Respiration Rate, CO2, and O2.
• Suction/aspirator pump for medical suction procedures where secretions, blood and other body fluids must be removed through the application of continuous negative pressure.

The MOVES® SLCTM is capable of operating under battery power or external AC supply. It includes a handle and mounting equipment that allows it to attach to a stretcher.

The provided text is a 510(k) summary for the MOVES® SLC™ medical device, which is an emergency ventilator with additional functions. This document describes the device, its indications for use, and its comparison to predicate devices to demonstrate substantial equivalence. However, it does not include detailed acceptance criteria and a study proving the device meets those criteria in the format requested.

Specifically, the document:

• Does not provide a clear table of acceptance criteria and reported device performance. It offers a comparison table of features and characteristics between the MOVES® SLC™ and predicate devices, including some performance specifications like frequency range, tidal volume, and SPO2 accuracy, but these are comparative, not acceptance criteria.
• Does not mention anything about sample sizes used for test sets, data provenance, number of experts, adjudication methods, multi-reader multi-case (MRMC) studies, or standalone algorithm performance. This is because the device is a piece of hardware (ventilator, monitoring, suction, oxygen concentrator) and not an AI/software device that would typically involve such studies for regulatory clearance.
• Does not discuss a training set or how ground truth for a training set was established. This is irrelevant for a hardware medical device of this type.
• States that "Testing was conducted in accordance with all referenced standards and regulations, and to validate all system requirements" and a "Summary of Performance Testing" section mentions that "The results of performance testing demonstrate that the characteristics the MOVES® SLC™ are substantially equivalent to the identified predicates in terms of ventilator characteristics, patient monitoring performance, ability to delivery supplemental oxygen, and provide airway suction." However, it does not explicitly detail the specific performance test results against a defined set of acceptance criteria.

Therefore, I cannot extract the requested information as it is not present in the provided document. The document focuses on demonstrating substantial equivalence to existing predicate devices based on features, characteristics, and compliance with general medical device standards, rather than proving performance against specific acceptance criteria through clinical studies involving human readers or AI algorithms.

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MADM™ is intended to deliver volatile anesthetic to a patient when placed in either circle or open anesthetic circuits. It vaporizes Isoflurane and Sevoflurane and delivers the vaporized anesthetic agent into the inspiratory limb of the breathing circuit.

MADM™ is also intended to monitor respiratory rate, CO2, and the anesthetic gases Isoflurane and Sevoflurane. It is intended to be connected to a patient breathing circuit for monitoring of patients to whom it is delivering volatile anesthetic gases.

The MADM™ system is a portable vaporizer capable of delivering anesthetic to the inspiratory limb of a breathing circuit. Unlike other in-line vaporizers, MADMTM can be inserted into a circle system where some exhaled anesthetic is rebreathed. The MADM™ system measures the anesthetic concentration of incoming gas and reduces the anesthetic output to ensure the anesthetic concentration of gas delivered to the patient is as set on the dial.

MADM™ includes an internal battery backup capable of powering the device for 20 minutes, and an optional external battery base with hot swappable batteries capable of powering the system for over two hours. Anesthetic is stored in custom single agent anesthetic canisters.

This document is a 510(k) premarket notification summary for the Thornhill Research Inc. MADM™ device. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study proving acceptance criteria for its performance metrics.

However, based on the provided text, we can extract the following information regarding performance testing and acceptance criteria:

1. Table of Acceptance Criteria and Reported Device Performance:

The document broadly states that the device meets the acceptance criteria of international standards for anesthetic delivery accuracy and gas sensing accuracy. However, specific numerical acceptance criteria (e.g., ±X% accuracy) and the reported performance values are not explicitly provided in this summary. The summary states:

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

The document mentions "Performance testing" and "Safety and Performance Testing" but does not specify the sample size for any test sets used. It also does not provide information on data provenance (e.g., country of origin, retrospective or prospective nature of the data). This level of detail is typically found in the full test reports, which are not included in this summary.

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

The summary does not mention the use of experts to establish ground truth for a test set. The performance testing described appears to be engineering and laboratory-based testing against established standards and internal system requirements, rather than clinical studies requiring expert consensus on subjective outcomes.

4. Adjudication Method for the Test Set:

Since there is no mention of experts or a "test set" in the context of expert review, no adjudication method is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done as this device is an anesthesia gas machine and monitor, not an interpretive diagnostic imaging or AI-driven system that would typically involve human readers. The document focuses on the device's standalone performance compared to standards and predicates.

6. Standalone Performance:

Yes, a standalone performance evaluation was done. The "Summary of Performance Testing" section details various tests conducted on the MADM™ device by itself to validate its system requirements and compliance with standards. This includes:

• Performance testing across the intended environmental operating range.
• Battery Longevity testing.
• Anesthetic delivery accuracy.
• Disturbance analysis.
• Anesthetic compatibility evaluation.
• Biocompatibility Evaluation.

The conclusion states that the performance characteristics demonstrate substantial equivalence and meet acceptance criteria of international standards.

7. Type of Ground Truth Used:

The ground truth used for the performance testing appears to be based on:

• International standards and regulations: Compliance to AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60601-2-13, ISO 80601-2-55.
• System requirements: The device's internal design specifications and functional requirements.
• Physical measurements/instrumentation: For accuracy (anesthetic delivery, gas sensing) and longevity (battery).
• Chemical/material compatibility testing: For anesthetic compatibility.

8. Sample Size for the Training Set:

The concept of a "training set" is typically applicable to machine learning or AI models that learn from data. The MADM™ device, as described, is a physical medical device (vaporizer, monitor) with embedded controls, not an AI system. Therefore, the notion of a "training set" is not relevant in this context, and no information about one is provided.

9. How the Ground Truth for the Training Set Was Established:

As there is no "training set" in the context of this device, this question is not applicable. The device's design and operation are based on engineering principles and validated through testing against established physical and safety standards.

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The MOVES® SLC™ is a portable computer controlled electrically powered emergency transport ventilator intended to provide continuous or intermittent ventilatory support for the care of adults who require mechanical ventilation.

MOVES® SLC™ is intended to deliver high inspired oxygen concentrations to spontaneously breathing patients who require elevated inspired oxygen.

MOVES® SLC™ is intended to be used in a transport or emergency setting on adult patients who weigh between 40kg and 120kg.

MOVES® SLC™ provides the following supplemental functions for patients that it is ventilating or supplying with supplemental oxygen:

• Suction a.
  The MOVES® SLC™ suction pump is intended for aspiration and removal of fluids, tissue (including bone), gases, bodily fluids or infectious materials from wounds or from a patient's airway or respiratory support system.

• Supplementary Oxygen b.
  The MOVES® SLCTM is intended to provide supplemental oxygen enriched air to patients that require supplemental oxygen.

• c. Patient Monitoring
  The MOVES® SLC™ is intended to monitor physiological parameters of patients and provide these parameters to a health care provider for interpretation in the form of physiological data and system alarms. Physiological data and system alarms will be available to the care provider from the monitor.

The MOVES® SLC™ (SLC) is an upgraded version of the cleared MOVES® device (K093261), a portable multifunction patient support and monitoring system with the following capabilities:

• . Computer controlled, electrically powered circle ventilator intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation.
• Delivery of oxygen-enriched air that may be supplied from an external oxygen . source or generated internal to the system with the on-board oxygen concentrator.
• Patient monitoring functions including the following patient parameters: Pulse . Rate, Noninvasive BP (NIBP), Invasive BP (IBP), SPO2, Temperature, Respiration Rate, CO2, and O2.
• Suction/aspirator pump for medical suction procedures where secretions, blood . and other body fluids must be removed through the application of continuous negative pressure.
  The MOVES® SLCTM is capable of operating under battery power or external AC supply. It includes a handle and mounting equipment that allows it to attach to a stretcher.

The provided text is a 510(k) summary for the Thornhill Research Inc. MOVES® SLC™ medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting extensive clinical studies to establish new safety and effectiveness.

Therefore, the document does not contain the kind of detailed information about acceptance criteria and study designs (like sample sizes for test and training sets, expert qualifications, adjudication methods, or MRMC studies) that would be present in a submission establishing de novo safety and effectiveness for a novel device or AI algorithm.

The document mainly describes the device, its intended use, and states that performance testing was conducted to demonstrate substantial equivalence to predicate devices and compliance with relevant standards.

Here's a breakdown of the information available in the document regarding acceptance criteria and performance, as much as can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a specific table of quantitative acceptance criteria with corresponding performance metrics. Instead, it relies on demonstrating substantial equivalence to existing predicate devices.

The "Summary of Performance Testing" section states:

"The results of performance testing demonstrate that the characteristics SLC are substantially equivalent to the identified predicates in terms of ventilator characteristics, patient monitoring performance, ability to delivery supplemental oxygen, and provide airway suction."

And the "Determination of Substantial Equivalence" section reiterates:

"Where differences in performance or technology exist, it has been demonstrated that they do not adversely impact safety or effectiveness. In addition, SLC has been tested to comply with relevant recognized consensus safety and performance standards as well as voluntary standards (detailed above)."

The acceptance criteria, implicitly, are that the device's performance characteristics for ventilation, patient monitoring, oxygen delivery, and suction must be substantially equivalent to those of its predicate devices and comply with all referenced standards and regulations.

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

This information is not provided in the 510(k) summary. The testing mentioned is "performance testing" and likely refers to engineering, bench, and potentially animal testing, rather than human clinical trials with specific patient sample sizes. The provenance of any data (country, retrospective/prospective) is also not mentioned.

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

This information is not applicable/provided. The document describes a medical device (ventilator, monitor, concentrator, suction pump), not an AI algorithm requiring expert-established ground truth on a test set (e.g., for image classification or diagnosis).

4. Adjudication Method for the Test Set

This information is not applicable/provided for the reasons stated above.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a MRMC comparative effectiveness study was not conducted or reported in this 510(k) summary. This type of study is typically performed for AI-powered diagnostic aids where the impact on human reader performance is being evaluated.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

The MOVES® SLC™ is a hardware medical device with integrated software/control. It is not an "algorithm only" device in the sense of a standalone AI diagnostic tool. Therefore, the concept of "standalone performance" for an algorithm without human-in-the-loop is not applicable in this context. The performance testing refers to the overall device's functionality.

7. The Type of Ground Truth Used

Given that this is a hardware device primarily demonstrating substantial equivalence and compliance with standards, the "ground truth" would be established through a combination of:

• Engineering specifications and measurements: Comparing output parameters (e.g., ventilator pressures, flow rates, oxygen concentration, monitoring accuracy) against known physical standards or the specifications of predicate devices.
• Performance against predicate device specifications: Ensuring that the MOVES® SLC™ meets or exceeds the demonstrated performance of its predicate devices for the various functions.
• Compliance with recognized consensus standards: Meeting the benchmarks set by standards like IEC 60601 series, EN-794-3, ISO 8359, and ASTM E1112-00.

There is no mention of expert consensus, pathology, or outcomes data being used as "ground truth" in the context of this 510(k) summary.

8. The Sample Size for the Training Set

This information is not applicable/provided. The MOVES® SLC™ is not described as a device that uses machine learning or an AI algorithm that requires a "training set" of data. Its control system and functionalities are based on established engineering principles and algorithms, not data-driven machine learning models that are "trained."

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

This information is not applicable/provided as there is no mention of a training set for an AI algorithm.

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The MOVES™ is a portable computer controlled electrically powered emergency transport ventilator intended to provide continuous or intermittent ventilatory support for the care of adults who require mechanical ventilation.

The MOVES™ is intended to deliver high inspired oxygen concentrations via the MOVES™ O2 mask to spontaneously breathing patients who require elevated inspired oxygen.

MOVESTM is intended to be used in a transport or emergency setting on adult patients who weigh between 40 and 120kg.

MOVES™ provides the following supplemental functions for patients that it is ventilating or to whom it is delivering elevated inspired oxygen:

a. Suction
The MOVES™ suction pump is intended for aspiration and removal of fluids, tissue (including bone), gases, bodily fluids or infectious materials from wounds or from a patient's airway or respiratory support system.

b. Supplementary Oxygen
The MOVESTM is intended to provide supplemental oxygen enriched air to patients that require supplemental oxygen.

C. Patient Monitoring
The MOVESTM is intended to monitor physiological parameters of patients and provide these parameters to a health care provider for interpretation in the form of physiological data and system alarms. Physiological data and system alams will be available to the care provider from the monitor.

The MOVES™ is a portable multifunction patient support and monitoring system with the following capabilities:

• Computer controlled, electrically powered circle ventilator intended to provide . continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation.
• . Delivery oxygen-enriched air that may be supplied from an external oxygen source or generated internal to the system with the on-board oxygen concentrator.
• Patient monitoring functions including the following patient parameters: Pulse . Rate, Noninvasive BP (NIBP), Invasive BP (IBP), SPO2, Temperature, Respiration Rate, CO2, and O2.
• Suction/aspirator pump for medical suction procedures where secretions, blood . and other body fluids must be removed through the application of continuous negative pressure.
  The moves is capable of operating under battery power or external AC supply. It includes a handle and mounting equipment that allows it to attach to a stretcher.

The provided 510(k) summary for the MOVES™ device does not contain specific acceptance criteria in quantitative terms (e.g., minimum sensitivity, specificity, or error rates) or detailed results of a study designed to prove the device meets such criteria. Instead, it relies on a comparison to predicate devices and adherence to recognized standards.

Here's an analysis based on the information provided, outlining what is or isn't present regarding acceptance criteria and performance studies:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria for device performance. Instead, it claims substantial equivalence to predicate devices and compliance with various IEC, ISO, ASTM, and ANSI/AAMI standards. The "reported device performance" is described qualitatively as meeting "all of its performance requirements" and being "substantially equivalent" to predicate devices.

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

This information is not provided in the document. The summary refers to "performance testing" but does not detail the methodology, sample sizes (e.g., number of test subjects, test scenarios, or data points), or provenance of any data used in such testing.

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

This information is not applicable as the document does not describe a study involving expert-established ground truth for a test set. The validation approach is based on demonstrating equivalence to existing devices and compliance with technical standards.

4. Adjudication Method for the Test Set

This information is not applicable as the document does not describe a study requiring a test set with adjudicated ground truth.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done or at least not described in this 510(k) summary. The device is not an AI-assisted diagnostic tool that would typically involve human readers.

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

This concept is not applicable in the context presented. The MOVES™ is a medical device for patient support and monitoring, not an algorithm being evaluated for standalone diagnostic or assistive performance. The "performance testing" mentioned refers to the device's functional operation.

7. The Type of Ground Truth Used

The concept of "ground truth" as typically understood in AI/imaging studies (e.g., pathology, expert consensus) is not directly applicable here. For this type of device, the "ground truth" would be the engineering specifications and performance capabilities of the device as measured against recognized standards and the performance of predicate devices. For example, a ventilation parameter's accuracy would be verified against a reference standard or precision instrument, not an expert opinion.

8. The Sample Size for the Training Set

This information is not provided and is not applicable in the context of this device. The MOVES™ device is not described as utilizing machine learning or AI that would require a "training set" in the conventional sense. Its "computer-controlled" nature implies programmatic logic rather than learned models.

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

This information is not applicable as there is no mention of a "training set" or a machine learning component requiring one.

In summary: The 510(k) process for the MOVES™ device focused on demonstrating substantial equivalence to already cleared predicate devices and compliance with relevant industry standards. The summary does not provide specific quantitative acceptance criteria or detailed results from a clinical or performance study with defined sample sizes, expert involvement, or ground truth establishment in the way one would expect for an AI/diagnostic software submission. The "performance testing" mentioned is general and aimed at confirming functional operation and safety against established standards and predicate device performance.

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