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The Clear Moves Aligner is a series of clear, lightweight, plastic appliances indicated for the correction of dental malocclusion in patients with permanent dentition (i.e. all second molars). Clear Moves Aligner positions teeth by way of continuous gentle force.

Clear Moves Aligners are comprised of a series of clear, thin, thermoformed removable aligner trays that are designed to correct tooth malocclusions without the use of conventional wire and bracket orthodontic technology. They are made of biocompatible thermoformable plastics, either from a copolyester or a composite of copolyester and polyurethane. They are provided non-sterile and are customized for each patient according to the dental clinician's prescription. The dental health professional (dentist/orthodontist) provides physical or scanned impressions of the patient's teeth to Clear Moves Aligners. A treatment plan using commercially available treatment planning software of either the scanned impression or a scan of the physical impression is sent to the clinician for approval. Upon approval, molds are then created with 3D-printing technology and the clear aligners are thermoformed on the molds and laser marked with patient identifying information and treatment step. The finished, customized aligners are provided to the dental health care professional who provides them to the patient, confirming fit and design. The aligner trays are held in place by pressure and can be removed by the patients at any time.

This document is a 510(k) Premarket Notification from the FDA for a dental device called "Clear Moves Aligners." This type of submission is for demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving safety and efficacy from scratch through extensive clinical trials. Therefore, the information provided focuses on comparisons to existing devices and bench testing, rather than detailed human clinical study data with specific acceptance criteria, expert ground truth, or MRMC studies that would be typical for more novel or higher-risk medical devices.

Based on the provided text, here's a breakdown of the requested information:

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

The document does not explicitly state "acceptance criteria" in terms of specific performance metrics for the device itself (e.g., accuracy of tooth movement in millimeters). Instead, the "performance" described is about demonstrating that the manufacturing process is valid and the materials are biocompatible, and that the device is "substantially equivalent" to predicate devices.

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

The document explicitly states: "In vivo Animal and Human Clinical performance testing are not required for this device category." Therefore, there is no test set of clinical patient data in the traditional sense, for which sample sizes or data provenance (country, retrospective/prospective) would be applicable concerning the device's clinical performance. The "test sets" mentioned would be for biocompatibility testing (material samples) and mechanical bench testing (prototype aligners/molds). These details are not provided in terms of specific sample numbers or origins within this document.

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

Not applicable. As no human clinical performance testing was required or conducted for this 510(k) submission, there was no "ground truth" derived from expert consensus on patient outcomes/diagnoses related to the device's effectiveness. Ground truth for bench testing would typically involve engineering specifications or physical measurements.

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

Not applicable. No clinical test set requiring adjudication was used.

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

Not applicable. This device is a physical orthodontic aligner, not an AI-powered diagnostic or assistive tool. While software is used for treatment planning, the submission focuses on the aligner itself and does not include an MRMC study comparing human performance with and without AI assistance.

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

Not applicable. This is not an AI algorithm being submitted for standalone performance. The software mentioned (Ortho Analyzer) is a pre-existing, referenced device used for treatment planning, not for autonomous diagnosis or treatment execution.

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

For the compliance requirements:

• Biocompatibility: Ground truth would be established by validated test methods (e.g., ISO standards) and comparison to known safe materials.
• Manufacturing Process Validation: Ground truth would be established by engineering specifications, CAD models, and precise measurements comparing the manufactured parts to the digital design.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that requires a "training set" for an algorithm to learn from data.

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

Not applicable, as no training set for an AI algorithm was used.

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The Clear Moves Aligners are indicated for the treatment of tooth malocclusion in patients with permanent dentition (i.e. all second molars). The Clear Moves Aligners position teeth by way of continuous gentle force.

The Clear Moves Aligner is a series of clear, light weight thermoformed plastic aligners designed to be worn in sequence to facilitate the movement of the teeth to the final desired position. The sequential aligners introduce increments that move teeth by way of gentle continuous force. The aligners are to be worn 20 to 22 hours a day and are to be removed for eating and for cleaning. Generally the typical wear time for each aligner is a two weeks duration prior to being replaced by the next aligner in sequence.

A digital or traditional mold impression of the patient's dentition is provided by a dental health professional (e.g. orthodontist or dentist). From the digital data of the patient's dentition, a specialized orthodontic CAD/CAM software is used to develop treatment plan. Using the software, dental technicians design a series of intermediate models corresponding to each stage of treatment, gradually realigning the patient's teeth according to the dental health profession's prescription.

The prescribing doctor reviews and approves the model scheme and treatment plan before the molds/models are produced.

Once approved. the specialized orthodontic software is used to generate standard format 3D files which are used to physically produce each model/mold in the treatment plan for aligner fabrication. Space Maintainers Laboratories produces the aligner trays by thermal forming a plastic sheet over each model in the treatment plan. The trays are provided to the dental health care professional who provides them to the patients in sequential stages, confirming fit and design. The dental health professional monitors treatment from the moment of the first aligner is delivered to when the final aligner is finished and treatment is complete. The aligners are held in place by pressure and can be removed by the patient at any time.

Based on the provided text, the device in question is the "Clear Moves Aligners," which is an orthodontic device. The FDA document K240038 is a 510(k) premarket notification, indicating that the manufacturer is seeking substantial equivalence to a legally marketed predicate device rather than outright approval based on a clinical efficacy study.

Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the demonstration of substantial equivalence to a predicate device, rather than a clinical trial demonstrating efficacy of the aligners themselves beyond what is already established for this class of device.

The document states multiple times that "there was no clinical testing necessary to support this device" due to the well-established clinical performance of sequential aligners and the device's equivalence to its predicate.

Here's an analysis of the provided information concerning the acceptance criteria for substantial equivalence and the "study" (non-clinical testing and comparison) proving this:

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

The "acceptance criteria" for this 510(k) submission are based on demonstrating substantial equivalence to a predicate device (K223141 STR8 Clear Aligners and another reference predicate). This means showing that the new device has the same intended use and similar technological characteristics, or if there are differences, that those differences do not raise new questions of safety or effectiveness.

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

• Test Set (Non-Clinical Performance Data):
  • Manufacturing Validation: The document states "An internal manufacturing validation was performed to demonstrate the dimensional accuracy of the manufacturing for Clear Moves Aligner." and "all the aligners including in the study passed and were deemed an excellent fit." However, it does not specify the sample size (number of aligners or manufacturing runs) used for this internal validation.
  • Biocompatibility & Physical Properties: The data provenance for these tests is the "material manufacture." This implies the tests were conducted by the supplier of the Zendura FLX material, not SML. No country of origin is specified for these tests. These are presumably prospective tests performed on the material and (for cytotoxicity) the final product.
  • Clinical Performance Data: The document explicitly states: "The clinical performance of sequential aligners (product code NXC) has been well established since the first device of this category was cleared by the FDA in 1998. The Clear Moves aligners have equivalent indication and method of use to its predicate, therefore there was no clinical testing necessary to support this device." Thus, there is no clinical "test set" in the context of a new human clinical study performed for this specific device.

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)

• Manufacturing Validation: "A trained physician" evaluated the final aligner fitness. The exact number of physicians or their specific qualifications (e.g., years of experience) are not specified, beyond being "trained."
• Other Data: Given that no new clinical study was conducted for this device, the concept of "experts establishing ground truth for a test set" involving human patients does not directly apply to this 510(k) submission's safety and effectiveness demonstration beyond the general scientific and regulatory consensus on the predicate.

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

• Manufacturing Validation: The document mentions "a trained physician" evaluated the fit. It does not mention any adjudication method (e.g., multiple readers, consensus, etc.). If only one physician was involved, the adjudication method would implicitly be "none" in terms of multiple expert reviews.
• Other Data: Not applicable as no multi-reader evaluation was performed for the device's performance given the nature of the submission.

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

• No MRMC Study: The document explicitly states "there was no clinical testing necessary to support this device." Therefore, no MRMC comparative effectiveness study was done.
• No AI Assistance Element: This device (aligners) is a physical medical device, not an AI software intended to assist human readers (e.g., radiologists interpreting images). The software mentioned is for treatment planning, not for image interpretation by clinicians requiring AI assistance.

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

• Manufacturing Validation: An "internal manufacturing validation" was done, assessing dimensional accuracy and fit. This is a standalone performance test of the manufacturing process and aligner product, but not an "algorithm" in the sense of AI.
• Software: The Guidenia Ortho+ software is mentioned as FDA-cleared (K162850), implying it has its own standalone performance characteristics for the purpose of treatment planning, but this submission isn't validating that software itself, only confirming its cleared status.

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

• Manufacturing Validation: The "ground truth" for the manufacturing validation implicitly involved predefined engineering tolerances (0.150mm) for dimensional accuracy and a trained physician's assessment of "excellent fit" as an acceptance criterion.
• Substantial Equivalence: The primary "ground truth" for this 510(k) submission is the established safety and effectiveness profile of the predicate device (STR8 Clear Aligners, K223141) and the established clinical practice for sequential aligners in general.

8. The sample size for the training set

• No new training set data: Since no new clinical study was performed for this 510(k), there is no "training set" of patient data in the typical sense of an efficacy trial.
• Manufacturing Process/Software: The software used (Guidemia Ortho+) and the manufacturing processes would have their own internal validation/training data, but these details are not provided in this 510(k) summary as SML is not validating the software itself, only using a cleared one, and the manufacturing process details are proprietary.

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

• Not applicable for this 510(k) context: As explained above, no new clinical training set was established. The ground truth for the predicate device's initial clearance and the general understanding of orthodontic aligners is based on historical clinical data and expert consensus over many years in the field of dentistry and orthodontics.

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Smart Moves Complete is indicated for the treatment of tooth malocclusion in patients with permanent dentition (i.e. all second molars). Smart Moves Complete positions teeth by way of continuous gentle force.

Smart Moves Complete consists of a series of doctor-prescribed, thin, clear plastic removable orthodontic appliances (aligners). The aligners gently move the patient's teeth in small increments from their original state to a more optimal, treated state. Smart Moves Complete is intended as an alternative to conventional bracket technology and fixed appliances for the treatment of patients with malocclusion.

The provided text describes a 510(k) premarket notification for "Smart Moves Complete," an orthodontic aligner system. It details the device's indications for use, design, manufacturing, and comparison to a legally marketed predicate device. The submission explicitly states that no clinical studies were performed to support the device as the indications for use are equivalent to the predicate device, and thus, no comparative effectiveness study (such as MRMC) was done, nor was there a standalone algorithm performance evaluation.

Therefore, the requested information regarding acceptance criteria and a study proving the device meets them, specifically within the context of AI/algorithm performance evaluation, cannot be extracted from this document as it pertains to a medical device that does not incorporate AI and relies on equivalence to a predicate device through non-clinical performance data.

The relevant sections of the document state:

• "No clinical studies are included in the submission" (page 4)
• "Clinical Performance Data: There was no clinical testing performed to support the medical device as the indications for use is equivalent to the predicate device. The substantial equivalence is supported by non-clinical testing and the comparative table, so this is not required." (page 9)

Given this, I cannot provide the detailed information requested about acceptance criteria and a study proving the device meets them, as it relates to AI/algorithm performance, because such a study was not conducted or presented in this 510(k) submission.

The document focuses on demonstrating substantial equivalence based on:

• Same intended use as the predicate device.
• Similar technological characteristics, with a detailed comparison table (pages 5-6) highlighting similarities in product code, regulation number, regulation name, indications for use, device description, mode of action, anatomy location, size, manufacturing method, biocompatibility, hardness, and dental tooth alignment software description.
• Non-clinical performance testing (page 8-9) for materials and manufacturing process, including biocompatibility, software verification and validation (though this refers to the design software for aligners, not an AI algorithm for diagnostic or treatment planning), tensile strength, elongation, tensile stress, modulus, load, water absorption, durometer, and process flow validation. These tests are about the physical properties and manufacturing consistency of the aligners, not AI performance.

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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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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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