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The Evolve DS (delivery system) delivers INOMAX® (nitric oxide for inhalation) therapy gas into the inspiratory limb of the patient breathing circuit in a way that provides a constant concentration of nitric oxide (NO), as set by the user, to the patient throughout the inspired breath. It uses a specially designed Injector Module, which enables tracking of the gas delivery system waveforms and the delivery of a synchronized and proportional dose of NO. It may be used with ventilators and respiratory care devices for which the Evolve DS has been validated. The Evolve DS provides continuous integrated monitoring of inspired NO2 and NO with a comprehensive alarm system. The Evolve DS also provides monitoring and alarms for the drug delivery system.

The Evolve DS incorporates a battery that provides up to 4 hours of uninterrupted NO delivery in the absence of external power. The Evolve DS also incorporates an integrated electronic blender that functions as a backup delivery device to provide an adjustable INOmax dose with user supplied oxygen to a manual resuscitator or gas delivery system. The electronic blender incorporates a separate control and delivery pathway that serves as a redundant mechanism for nitric oxide delivery in the event of a main system fault.

The Evolve DS must only be used in accordance with the indications, warnings and precautions described in the nitric oxide drug packaging inserts and labeling and is indicated for use in term and near-term (>34weeks gestation) neonates with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension. The Evolve DS is indicated for a maximum of 14 days use. The primary targeted clinical setting is the Neonatal Intensive Care Unit (NICU), and secondary targeted clinical setting is the transport of neonates.

The EVOLVE Nitric Oxide (NO) Delivery System (DS) is used for administration and monitoring of INOMAX (nitric oxide for inhalation). It is comprised of a main delivery device (EVOLVE), an electronic blender (eINOblender) for backup use, and a Cart which holds the EVOLVE as well as INOMAX drug cylinders, an oxygen cylinder and miscellaneous parts.

The EVOLVE Nitric Oxide Delivery System utilizes Technology component technology to deliver Nitric Oxide gas to the patient. The components consist of a main delivery device (EVOLVE), an electronic blender (eINOblender) for backup use, and a Cart which holds the EVOLVE as well as INOMAX drug cylinders, an oxygen cylinder and miscellaneous parts. In this revision of the EVOLVE Nitric Oxide Delivery System, the changes to the device includes the labeling for compatibility with respiratory care devices.

The provided FDA document describes a 510(k) premarket notification for the EVOLVE Nitric Oxide Delivery System. This submission is for an updated version of a previously cleared device (K240410 and K222930), primarily focusing on expanded labeling for compatibility with additional ventilator and breathing devices.

Therefore, the document does not contain information about acceptance criteria and a study that proves the device meets those criteria in the context of device performance, as it pertains to a labeling update for compatibility. Clinical studies were explicitly stated as "not applicable to this submission."

Here's a breakdown of what can be extracted based on your request, and what cannot:

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

This information is not provided in the document. The filing is for a change in labeling for compatibility with more ventilator devices, not for demonstrating new performance criteria for the core device. It implicitly relies on the original clearance for the device's performance specifications.

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

• Sample size for test set: Not explicitly stated as a numerical value for patients or cases. The "test set" in this context refers to the additional ventilator and breathing devices with which compatibility was tested.
• Data Provenance: The testing was "conducted across all platforms to demonstrate that the EVOLVE Nitric Oxide Delivery System performs within published specifications." This suggests laboratory or bench testing rather than clinical data from a specific geographic region or a prospective/retrospective study on human subjects.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

This information is not provided. The testing described is focused on the device's functional performance and compatibility with other medical equipment, not on clinical interpretations that would require expert consensus for ground truth.

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

This information is not provided, as the nature of the "test set" does not involve clinical judgment 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 information is not applicable/provided. The device described is a nitric oxide delivery system, not an AI-assisted diagnostic or therapeutic device that would involve human readers or image interpretation.

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

This information is not applicable/provided for the same reasons as above. The device doesn't involve an algorithm in the sense of AI for diagnostic or interpretive tasks.

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

The "ground truth" for the compatibility testing appears to be the published specifications of the EVOLVE Nitric Oxide Delivery System and the functional operation of the connected ventilator devices. The testing aimed to demonstrate that the EVOLVE system "performs within published specifications" when used with the additional ventilators.

8. The sample size for the training set:

This is not applicable/provided. The submission is not for a machine learning or AI-based device that would typically have a training set.

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

This is not applicable/provided.

Summary of what is available from the document:

• Device Name: EVOLVE Nitric Oxide Delivery System
• Purpose of Submission: Updated labeling for compatibility with additional ventilator and breathing devices.
• Testing Conducted: "Ventilator / Gas Delivery System Validation Test Protocol" was used to validate hazard mitigation and demonstrate performance within published specifications across various ventilator platforms. This was the same protocol used in previous clearances (K222930 and K240410).
• Clinical Studies: Explicitly stated as "not applicable to this submission."
• Predicate Device: EVOLVE Nitric Oxide Delivery System (K240410). The current device is considered substantially equivalent.

In conclusion, the supplied document does not describe the types of performance studies (e.g., diagnostic accuracy, clinical effectiveness) and associated acceptance criteria that would typically involve many of the points in your request. Instead, it focuses on technical compatibility validation for a medical device.

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The Evolve DS must only be used in accordance with the indications, contraindications, warnings and precautions described in the nitric oxide drug packaging inserts and labeling and is indicated for use in term and near-term (>34weeks gestation) neonates with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension. The Evolve DS is indicated for a maximum of 14 days use. The primary targeted clinical setting is the Neonatal Intensive Care Unit (NICU), and secondary targeted clinical setting is the transport of neonates.

The EVOLVE Nitric Oxide (NO) Delivery System (DS) is used for administration and monitoring of INOMAX (nitric oxide for inhalation). It is comprised of a main delivery device (EVOLVE), an electronic blender (eINOblender) for backup use, and a Cart which holds the EVOLVE as well as INOMAX drug cylinders, an oxygen cylinder and miscellaneous parts.

This submission is for an updated labeling for compatibility with additional ventilator and breathing devices for the EVOLVE Nitric Oxide Delivery System, not a new device or a software-driven diagnostic. Therefore, the detailed information about acceptance criteria, device performance, sample sizes, expert involvement, and ground truth establishment typically required for AI/ML device studies is not available in this document.

The document primarily focuses on demonstrating substantial equivalence to a previously cleared device (K222930) by evaluating the impact of new ventilator compatibility labeling.

Here's an analysis based on the provided text, addressing the requested points where information is available or applicable:

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

The document does not provide a specific table of acceptance criteria and reported device performance in the context of an algorithmic diagnostic. Instead, it refers to the performance of the overall EVOLVE Nitric Oxide Delivery System, which is a hardware-based medical device.

The "Summary of Non-Clinical Tests" section mentions:
"The Mallinckrodt Ventilator / Gas Delivery System Validation Test Protocol was used to validate the hazards identified from risk input were mitigated. Testing was conducted across all platforms to demonstrate that the EVOLVE DS performs within published specifications. Ultimately, the requirements necessary for the operation of the EVOLVE Nitric Oxide Delivery System passed."

This indicates that the acceptance criteria were likely related to the device working within its published specifications when interfaced with the new ventilators, and the reported device performance was that it "passed" these requirements. However, specific quantitative metrics are not provided.

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

This information is not applicable and therefore not provided in the document. The study was a non-clinical validation test of device compatibility, not a clinical study on patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable. The "ground truth" here would be the functional performance of the device and its compatibility with ventilators, established through engineering and technical validation rather than expert clinical consensus on diagnostic outcomes.

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

This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies with human readers to resolve discrepancies in diagnoses or interpretations. This was a non-clinical validation.

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, an MRMC comparative effectiveness study was not done. The submission is not for an AI device or a diagnostic requiring human reader interpretation.

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

No, a standalone algorithm performance study was not done. This device is a hardware delivery system, not an algorithm.

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

The "ground truth" used for this non-clinical validation was the functional performance of the device and its compatibility with the listed ventilators according to its published specifications and safety requirements. This would be established through engineering tests and measurements, rather than clinical ground truth types like pathology or expert consensus.

8. The sample size for the training set

This information is not applicable. There is no training set as it's not an AI/ML device.

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

This information is not applicable, as there is no training set.

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The Evolve System with the Transform Applicator employs RF technology and EMS-TENS technology for the treatment of selected medical conditions.

The Transform Applicator in RF mode is intended for the temporary relief of minor muscle aches and pain, temporary relief of muscle spasm, and temporary improvement of local blood circulation.

The Transform Applicator in EMS mode is intended for:

• . Relaxation of muscle spasms
• . Prevention or retardation of disuse atrophy
• . Increasing local blood circulation
• Muscle re-education
• Maintaining or increasing range of motion ●
• Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis ●

The Transform Applicator in TENS mode is intended for:

• Symptomatic relief and management of chronic, intractable pain
• . Post-surgical acute pain
• . Post-trauma acute pain

Additionally the Transform Applicator in sequential RF/EMS mode is intended for:

• . Non-invasive lipolysis (breakdown of fat) of the abdomen.
• Reduction in circumference of the abdomen ●

The Evolve System with the Transform Applicator is designed to deliver non-thermal RF energy and electro-muscle and transcutaneous nerve stimulation for the treatment of different body areas for various medical applications. The Evolve System software controls and regulate the different applied energies in accordance with the user system preprograming and treatment settings. The subject device platform system is identical to the FDA-cleared Evolve System platform (K210877).

The Evolve System includes the following components:

• LCD display touch screen, ●
• Audio loudspeaker,
• 48V AC/DC power supply, ●
• Real time controller, distributor card and 2 RF generators, .
• . Fans

The System operates while connected to the Transform Applicator.

The purpose of this submission is to add non-invasive lipolysis (breakdown of fat) of the abdomen and reduction in circumference of the abdomen to the indications.

The provided text describes the regulatory clearance of "The Evolve System with the Transform Applicator" and includes information about its performance data to demonstrate safety and efficacy. However, it does not present acceptance criteria in a formal table or describe a multi-reader multi-case (MRMC) comparative effectiveness study, nor does it explicitly define "acceptance criteria" for the clinical study results.

Based on the information provided, here's an attempt to answer your questions, interpreting some elements from the clinical study summary:

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

The document doesn't explicitly define "acceptance criteria" with numerical thresholds for performance. Instead, it states that "The success criteria for the percentage of subjects were met, with the correct identification rate exceeding 70%" for the photographic assessment. For the primary outcome (circumference measurement), it broadly states "Each of these measures independently demonstrated reduction in fat, and findings were consistent and strongly correlated with each other."

Without explicit pass/fail criteria from the submission, we can infer the "reported device performance" based on the study outcomes:

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

• Sample Size for Test Set: 44 subjects.
• Data Provenance: Prospective, multi-site, single-arm clinical study. The country of origin of the data is not specified in the provided text.

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

• Number of Experts: Three blinded evaluators were used to assess the "before and after 3 months photographs."
• Qualifications of Experts: The qualifications of these experts are not explicitly stated (e.g., radiologist with 10 years of experience). They are only referred to as "blinded evaluators."

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

The document states that "Three distinct measurements were used to evaluate fat reduction: circumference measurement by measurement tape (primary endpoint), fat thickness caliper measurement, and fat layer ultrasound measurement. Each of these measures independently demonstrated reduction in fat, and findings were consistent and strongly correlated with each other." It also mentions that "Before and after 3 months photographs were assessed by three blinded evaluators."

The method for reconciling differences between the three evaluators for the photographic assessment, or if simple majority or consensus was used, is not specified. Therefore, the adjudication method is unclear from the provided text.

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

The provided text describes a single-arm clinical study evaluating the Evolve System with the Transform Applicator. It does not describe an MRMC comparative effectiveness study involving human readers or AI assistance. The study focuses solely on the device's performance in achieving non-invasive lipolysis and circumference reduction.

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

This device is not an AI algorithm but a physical device that delivers RF and EMS energy. Therefore, the concept of "standalone (algorithm only)" performance does not directly apply here in the way it would for a software-as-a-medical-device (SaMD) or AI-powered diagnostic tool. The study assesses the device's effect on patients.

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

The ground truth for the efficacy evaluation was based on clinical measurement and observation data:

• Circumference measurement by measurement tape (primary endpoint)
• Fat thickness caliper measurement
• Fat layer ultrasound measurement
• Assessment of before and after photographs by three blinded evaluators.
• Patient-reported comfort and satisfaction.

8. The sample size for the training set

The provided text describes a clinical study validating the device's effectiveness. It does DNOT refer to a "training set" in the context of an AI/ML model. The 44 subjects are part of the performance data or test set for demonstrating the device's clinical efficacy.

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

As there is no training set discussed in the context of an AI/ML model, this question is not applicable based on the provided document. The study is a clinical validation of a physical medical device.

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e Volve PACS, is a software device used for viewing and manipulating medical images and other healthcare related electronic records. Digital imaging units (including DR, CR, CT, MR, US, RF, and 2D/3D mammography), other computed and direct radiographic devices, secondary capture devices, document and film scanners, imaging gateways, other imaging devices and healthcare related electronic records can be displayed, processed, managed, stored and communicated across computer networks using this software.

e Volve PACS, can be integrated with a facility's existing Electronic Medical Records System (EMR), Hospital Information System (HIS), Practice Management System, Radiology Information System (RIS) and Dictation System. eVolve PACS, may also be integrated with the facility's Teleradiology Provider's systems. These integrations provide seamless operation and access for Providers and other caregivers to the entire spectrum of a patient's radiology records from the Provider's orders, to images of the exam, to completion data all the way to the interpretations (results/reports).

Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretation on the eVolve PACS. Mammographic images may only be interpreted using an FDA cleared display that offers at least 5 MP resolution and meets other technical specifications reviewed and accepted by the FDA. eVolve PACS is not intended for diagnostic review or other diagnostic uses on mobile devices.

eVolve PACS, uses web-based technology and a secure operating system. This means that virtually any computer at any location can use an Internet browser to access eVolve PACS (and RIS) systems. Whether on-site or from another location, physicians can manage, edit, view and move diagnostic exams quickly and efficiently. As part of eVolve PACS support, eVolve PACS Inc., performs virtually all the system maintenance. eVolve PACS, has been designed to be expandable, with storage beginning at 2 TB and growing to 25 TB onboard or 256 TB expansion.

eVolve PACS is an implementation of an IHE (Integrating the Healthcare Enterprise) compliant Image Archive and Report Repository. This includes the capabilities:

• To store and retrieve various kinds of DICOM Objects such as:
  • Images from multiple modalities,
  • Grayscale Presentation States [GSPS], which specifies the presentations of images as gray scaling, zoom, text and graphical annotations,
  • Key Objects [KO], which specifies a particular selection of images for a specified reason and with an attached note,
  • Structured Reports [SR].
• To process HL7 notification messages from the Order Filler, about Procedure Scheduling, Procedure Updates and Patient Information Updates,
• To process DICOM Modality Performed Procedure Step [MPPS] messages from modalities and forward them to the Order Filler.

eVolve PACS is a server application. Its Web-based User Interface is intended for system configuration and monitoring by system administrators.

eVolve PACS, was developed with special emphasis on its telerad features for those facilities that use teleradiology either full time or for night reads.

The provided text describes the eVolve PACS system and its comparison to a predicate device for 510(k) clearance. However, it explicitly states that clinical testing was not necessary and that "Successful Bench Testing should be sufficient in demonstrating substantial equivalence." Therefore, there is no information in the document regarding a study involving acceptance criteria as typically understood for clinical performance, human readers, ground truth establishment, or effect sizes for AI assistance.

The document focuses on non-clinical performance data, primarily validation testing to ensure the device functions as intended and meets technical standards.

Here's a breakdown based on the information provided, highlighting what is not available from the text:

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

• Medical image management and processing system
• Web-based system architecture
• Log-on user ID & password security
• Remote monitoring functionality
• Standard image viewing layouts (up to 4x4)
• WW/WL functionality
• Zoom in/Zoom out
• Hounsfield Measurement
• Linear and angle measurements
• Series Comparison
• Scout line display
• MPR/MIP capabilities
• Stack mode
• Gray scale invert
• Filters
• Rotate
• Key Image selection
• DICOM Print
• Windows print
• Query/Retrieve
• Lossless streaming image compression
• Thumbnails selection tools
• Reporting Interface with template support, digital signature, and MS office formats (PDF, rtf, text, Docx)
• Link to Hospital Information System (HIS)
• Link to Radiology Information System (RIS)
• Electronic patient record (through Broker Software)
• HIPAA Compliant
• PACS Server
• Radiology Workstation
• Basic Image Viewer
• Mobile app viewer | Demonstrated Through:
• Comparison table showing "Yes" for all listed features/functions for both subject and predicate devices.
• "Validation testing indicated that as required by the risk analysis, designated individuals performed all verification and validation activities and that the results demonstrated that the predetermined acceptance criteria were met." |
  | Compliance with Standards:
• DICOM Set (PS 3.1 - 3.20 (2016))
• IEC 60812 Edition 3.0 2018-08 (FMEA)
• ANSI AAMI IEC 62304:2006/A1:2016 (Medical device software life cycle processes)
• FDA Guidance on Cyber Security: Content of Premarket Submissions for Management of Cybersecurity in Medical Devices (Oct 2, 2014)
• FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May 11, 2005) | "eVolve PACS, and the device has met all the requirements listed in the Standards except for inapplicable requirements." |
  | Safety and Effectiveness Profile (Comparable to predicate device) | "Based on the performance as documented in the Validation Testing, eVolve PACS, was found to have a safe and effectiveness profile that is similar to the predicate device." |

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

• Not Applicable / Not Provided: The document states "Clinical testing is not necessary to show substantial equivalence for the subject device. Successful Bench Testing should be sufficient in demonstrating substantial equivalence." Therefore, no patient test set was used. The non-clinical testing refers to "Validation Test Plan" results but does not specify a "sample size" in terms of clinical cases or data provenance.

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

• Not Applicable / Not Provided: No clinical test set requiring expert ground truth was used.

4. Adjudication method for the test set

• Not Applicable / Not Provided: 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

• No, not done: The device is a PACS system, not an AI-assisted diagnostic tool. No MRMC study was performed, and no AI assistance is mentioned.

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

• No, not done (and not applicable): The eVolve PACS is a software device for viewing and managing medical images, not an algorithm providing diagnostic outputs. It is explicitly stated that it "does not intend to replace the skills and judgment of a qualified physician/radiologist."

7. The type of ground truth used

• Not Applicable / Not Provided: No clinical ground truth (expert consensus, pathology, outcomes data) was used, as no clinical study was deemed necessary. The "ground truth" for the non-clinical validation was likely the expected functional behavior and compliance with technical standards.

8. The sample size for the training set

• Not Applicable / Not Provided: No machine learning or AI models are described as being part of this device, therefore, no training set data would be relevant or provided.

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

• Not Applicable / Not Provided: No machine learning or AI models are described.

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The Evolve System with the T3 Applicator employs RF technology or EMS-TENS technology for the treatment of selected medical conditions.

The T3 Applicator in RF mode is intended for the temporary relief of minor muscle aches and pain, temporary relief of muscle spasm, and temporary improvement of local blood circulation.

The T3 Applicator in EMS mode is intended for:

• Relaxation of muscle spasms
• Prevention or retardation of disuse atrophy
• Increasing local blood circulation
• Muscle re-education
• Maintaining or increasing range of motion
• Immediate post surgical stimulation of calf muscles to prevent venous thrombosis

The T3 Applicator in TENS mode is intended for:

• Symptomatic relief and management of chronic, intractable pain
• Post-surgical acute pain
• Post-trauma acute pain

The RF treatment mode and EMS/TENS mode should not be used in combination or sequentially.

The Evolve System with the T3 Applicator is designed to deliver non-thermal RF energy and electro-muscle and transcutaneous nerve stimulation for the treatment of different body areas for various medical applications. The Evolve System software controls and regulate the different applied energies in accordance with the user system preprograming and treatment settings. The subject device platform system is identical to the FDA-Cleared Evolve System platform (a.k.a EmBody System and the subject of K183450). The same platform system was recently FDA-Cleared for the use with the Tone Applicator (subject of K201285).

The Evolve System supports the placement of the following components:

• LCD display touch screen,
• Audio loudspeaker,
• 48V AC/DC power supply,
• Real time controller, distributor card and 2 RF generators,
• Fans

The System operates while connected to the T3 Applicator.

The Evolve System with the T3 Applicator is intended for temporary relief of minor muscle aches and pain, muscle spasm, and improved local blood circulation (RF mode), as well as relaxation of muscle spasms, prevention of disuse atrophy, increased local blood circulation, muscle re-education, maintaining/increasing range of motion, and immediate post-surgical stimulation of calf muscles to prevent venous thrombosis (EMS mode), and symptomatic relief of chronic, intractable, post-surgical, and post-trauma acute pain (TENS mode).

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document states that Non-Clinical (Bench) Performance Data was conducted to demonstrate the device performs as expected and meets design requirements. This included various bench tests (e.g., accuracy of RF output, electrode temperature sensors, thermal build-up, ex-vivo tissue thermal profile, safety and thermal profile testing, EMS/TENS output specifications).

However, the document explicitly states "Clinical Performance Data: Non-Applicable." This implies that there was no clinical test set using human subjects or patient data. The evaluation for substantial equivalence relies on non-clinical bench testing and comparison to predicate devices, rather than a clinical study with a test set of patient data. Therefore, questions regarding sample size, data provenance (e.g., country of origin, retrospective/prospective) for a clinical test set are not applicable here.

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

Since no clinical test set was conducted, the concept of "ground truth" derived from expert consensus on patient data (e.g., from radiologists, pathologists) is not applicable to this submission. The "ground truth" for the non-clinical bench tests would be the established engineering and safety standards and design specifications against which the device's performance was measured.

4. Adjudication Method for the Test Set:

Not applicable, as no clinical test set was conducted.

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

No, an MRMC comparative effectiveness study was not done. The submission explicitly states "Clinical Performance Data: Non-Applicable," making any evaluation of human reader improvement with or without AI assistance irrelevant in this context. The device is a physical therapeutic system, not an AI-assisted diagnostic tool.

6. Standalone (Algorithm Only) Performance Study:

Not applicable. This device is a physical therapeutic system, not an algorithm or AI. Its performance is tied directly to its hardware functionality and energy delivery.

7. Type of Ground Truth Used:

For the non-clinical performance data, the "ground truth" was based on:

• Engineering and Design Requirements: The device was tested to verify that its performance meets its own design requirements.
• Consensus Standards: The device's performance was evaluated against recognized consensus standards for medical electrical equipment, such as ANSI AAMI ES 60601-1, IEC 60601-1-2, IEC 60601-2-10, IEC 60601-1-6, and IEC 60601-2-2.
• Predicate Device Specifications: The device's technical specifications and performance characteristics were compared directly to those of legally marketed predicate devices to establish substantial equivalence.

8. Sample Size for the Training Set:

Not applicable. This device is not an AI/ML algorithm that requires a training set. Its functionality is based on established physical principles of RF and EMS/TENS technology.

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

Not applicable, as there is no training set for this device.

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The EVOLVE System with the Tone Applicator is an electro-muscle and transcutaneous nerve stimulation device for the treatment of different body areas.

The EVOLVE System with Tone Applicator is designed to operate in two modes - EMS and TENS.

In EMS mode it is used for:

• Relaxation of muscle spasms
• Prevention or retardation of disuse atrophy
• Increasing local blood circulation
• Muscle re-education
• Maintaining or increasing range of motion
• Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis

And in TENS mode is intended for

• Symptomatic relief and management of chronic, intractable pain
• Post-surgical acute pain
• Post-trauma acute pain

The EVOLVE System in combination with Tone Applicator (manufactured by InMode Ltd.), is a computerized device intended to employ EMS (Electrical Muscle Stimulation) and TENS (Transcutaneous Electrical Nerve Stimulation) technologies for various medical applications.

The EVOLVE System with the Tone Applicator consists of an AC/DC power supply unit, controller and user interface including an LCD touch screen. The Tone Applicator is connected to the console via a cable, each of the subject device applicator units consist of a designated cable and of a connection port to be directly connected to one of the four connectors positioned on the rear side of the console. Up to four Tone Applicator units can be connected to the console simultaneously.

The delivery of the electrical energy is controlled by a Start/Stop button positioned on the LCD screen.

The System supports the following components:

• LCD display touch screen .
• Audio loudspeaker ●
• . 48V AC/DC power supply
• Controller
• . Fans

The System operates while connected to the Tone Applicator.

The provided document is a 510(k) summary for the InMode Ltd. EVOLVE System with the Tone Applicator. This type of submission to the FDA focuses on demonstrating substantial equivalence to a predicate device, rather than proving independent effectiveness through extensive clinical trials. Therefore, the information typically found in a study demonstrating acceptance criteria for the device's performance (especially related to clinical efficacy or AI model performance) is largely absent.

The "acceptance criteria" discussed in this document primarily refer to compliance with recognized consensus standards for safety and basic performance (bench testing) and demonstrating similar characteristics to a predicate device. There is no mention of an AI model within this submission, nor are there any clinical effectiveness studies, MRMC studies, or details on establishing ground truth for AI algorithms.

However, I can extract the information related to the device's performance based on the provided text, focusing on the available "acceptance criteria" (which are regulatory conformity and bench testing results) and the performance data for those criteria.

Based on the provided FDA 510(k) summary (K201285), here's an analysis of the "acceptance criteria" and the "study" proving the device meets them:

Crucial Caveat: This 510(k) summary does not describe an AI/ML model or its performance. The "acceptance criteria" and "study" described here pertain to the safety and basic functional performance of a medical device (an electro-muscle and transcutaneous nerve stimulator) demonstrating substantial equivalence to a legally marketed predicate device. Therefore, many of the requested points related to AI/ML model evaluation (e.g., sample sizes for training/test sets, expert adjudication of ground truth, MRMC studies) are not applicable and will not be found in this document.

1. Table of Acceptance Criteria and Reported Device Performance

The "acceptance criteria" here are framed as compliance with recognized consensus standards and meeting design requirements through bench testing. The "reported device performance" is the confirmation that these tests were passed and the design requirements were met. The table below summarizes the key performance specifications and their acceptance against the predicate device.

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

• Sample Size: This is a medical device safety and performance submission, not an AI/ML model evaluation. Therefore, there are no "test set" sample sizes in the sense of patient data for clinical performance evaluation. The "tests" performed are bench tests and compliance with recognized standards.
• Data Provenance: The "data" comes from mandated bench testing and compliance documentation. There is no mention of patient data, clinical studies, or data provenance (e.g., country of origin, retrospective/prospective) in the context of efficacy testing. The document explicitly states "Clinical Performance Data: Non-Applicable."

3. Number of Experts Used to Establish Ground Truth and Qualifications:

• Not Applicable. This submission does not involve an AI/ML model where "ground truth" adjudicated by experts is typically needed. The "ground truth" for this device's performance is established by direct physical measurements during bench testing and adherence to engineering and safety standards.

4. Adjudication Method for the Test Set:

• Not Applicable. As there is no clinical or image-based "test set" requiring expert interpretation or labeling, no adjudication method (e.g., 2+1, 3+1) was used.

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

• Not Applicable. No MRMC study was done, as this is not an AI-assisted diagnostic device, nor is it reporting on human reader performance. The document states "Clinical Performance Data: Non-Applicable."

6. Standalone (Algorithm Only) Performance:

• Not Applicable. There is no AI algorithm being evaluated. The device functions as a physical muscle/nerve stimulator.

7. Type of Ground Truth Used:

• Technical Specifications and Compliance with Standards. The "ground truth" for this device's acceptance is its adherence to a specified design and its ability to pass established engineering, electrical safety, EMC, and specific performance standards for muscle/nerve stimulators (e.g., IEC 60601 series). This is verified through direct measurement and documentation from bench testing.

8. Sample Size for the Training Set:

• Not Applicable. There is no AI/ML model for which a "training set" would be used.

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

• Not Applicable. As there is no AI/ML model, there is no training set or associated ground truth establishment process.

In summary: The provided document is a regulatory submission demonstrating substantial equivalence for a physical medical device. It focuses on engineering specifications, safety compliance, and bench testing, not on the performance of a software algorithm or clinical efficacy requiring a test set, ground truth experts, or training data for AI.

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The SLENDERTONE® Evolve Abs, Type 735 is indicated for the improvement of abdominal muscle tone, for strengthening of abdominal muscles, and for the development of a firmer abdomen.

The SLENDERTONE® Evolve Abs, Type 735 is a portable neuromuscular electrical stimulator intended to deliver electrical stimulation to the abdominal muscles. The device includes a control unit, abdominal garment, 3 adhesive gel pads (electrodes), USB cable and instructions for use. It contains twelve pre-installed programs.

The control unit is connected to the abdominal belt garment via three magnetic connectors. The control unit contains the primary controls for operation of the device and push buttons are available for switching the unit on or off and to increase or decrease the stimulation intensity. The SLENDERTONE® Evolve Abs, Type 735 contains an Organic Light-Emitting Diode (OLED) display which indicates status relating to battery charge and stimulation. Power is derived from a 3.7V Li-Po rechargeable battery pack and the unit can be recharged by using the supplied USB cable.

The SLENDERTONE® Evolve Abs, Type 735 is rated as IP22 for ingress protection. The user has no access to the wiring or connectors within the garment. For purposes of hygiene, the garment may be cleaned and instructions for garment care are included in the user manual.

The provided document is a 510(k) summary for the SLENDERTONE® Evolve Abs, Type 735, a powered muscle stimulator. It does not contain information about a clinical study or acceptance criteria based on human performance or AI performance.

Instead, the document focuses on demonstrating substantial equivalence to a predicate device (SLENDERTONE® Corefit Abs8, Type 734) by comparing technological characteristics and citing compliance with safety standards.

Therefore, I cannot provide the requested information regarding acceptance criteria, reported device performance, sample sizes for test/training sets, ground truth establishment, expert involvement, or MRMC studies for this specific device based on the given text.

The document states:

• Indications for Use: Improvement of abdominal muscle tone, strengthening of abdominal muscles, and development of a firmer abdomen.
• Performance Data (Safety Standards): The device complies with several international safety standards (IEC 60601-1, IEC 60601-1-6, IEC 60601-1-2, IEC 60601-2-10, IEC 60601-1-11, and IEC 62133 for batteries). These standards typically involve engineering and electrical safety tests, not clinical efficacy studies for the stated indications.
• Conclusion: The device is considered substantially equivalent to the predicate device, and any differences in technological characteristics do not raise new issues of safety or effectiveness.

To answer your request, a clinical study demonstrating the efficacy of this specific device for its indications would be required, which is not present in this 510(k) summary. The document explicitly states "Performance data has demonstrated that the SLENDERTONE® Evolve Abs, Type 735 is as safe and effective as the predicate device and is substantially equivalent," but this "performance data" refers to compliance with electrical and safety standards, not a clinical trial proving its effectiveness in improving muscle tone or firmness.

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Components of the Signature Orthopaedics hip replacement range are intended to replace a hip joint where bone stock is sufficient to support the implant. When a surgeon has selected prosthetic replacement as the devices are indicated for:

• · Non-inflammatory degenerative joint disease including osteoarthritis or avascular necrosis
• · Inflammatory joint disease including rheumatoid arthritis
• · Correction of functional deformity including congenital hip dysplasia
• · Traumatic injury involving the hip joint including traumatic arthritis or femoral head or neck fracture
• · Failed previous hip surgery including internal fixation, reconstruction, hemiarthroplasty, surface replacement, or total replacement

Signature Orthopaedics' Origin, Aria, Remedy, TSI and Pegasus femoral stems and Logical acetabular cups are intended for cementless fixation only. Signature Orthopaedics' Evolve, Cemented TSI (both CoCr and HNSS variants) and Cemented Origin femoral stems are intended for cemented fixation only.

Signature Orthopaedics' constrained liner components are indicated particularly for patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease or intraoperative instability.

Signature Orthopaedics' Evolve UniPolar Head and BiPolar Head are intended for hemi-hip arthroplasty only, where the natural acetabulum does not require replacement. The Evolve UniPolar Head are indicated for bone fractures or pathologies involving only the femoral head/neck and/or proximal femur, such as:

• · Acute femoral head or neck fracture
• Fracture dislocation of the hip
• · Avascular necrosis of the femoral head
• Non-union of femoral neck fractures
• · Certain high subcapital and femoral neck fractures in the elderly
• · Degenerative arthritis involving only the femoral head

The purpose of this 510(k) application is to extend the compatibility of the subject devices between Signature Orthopaedics and Encore Medical components. The subject devices themselves have not undergone any changes.

The provided document is a 510(k) premarket notification for hip replacement prostheses. It details the device name, regulation, and a claim of substantial equivalence to previously marketed predicate devices. However, it does not describe specific acceptance criteria and a study demonstrating the device meets those criteria, as typically found in clinical performance sections of submissions for new or significantly modified devices.

Instead, this document focuses on extending the compatibility of existing subject devices with other components. The core argument for substantial equivalence is that the devices themselves have not undergone any changes, only their compatibility with other components has been extended. Therefore, the "performance testing" described refers to engineering evaluations to ensure that the performance remains equivalent to predicate devices when used in these new combinations.

As such, many of the requested items related to acceptance criteria, clinical studies, sample sizes, ground truth establishment, expert adjudication, and MRMC studies are not present or not applicable in this specific FDA clearance document, as it's not a de novo clearance or a submission for a novel AI/software as a medical device (SaMD).

Here's an analysis based on the information provided, with an emphasis on what is not present given the nature of the document:

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

No explicit "acceptance criteria" table for a clinical performance study is provided. The document states that "engineering evaluations concluded that the performance of the subject devices will remain at least equivalent to the predicate devices when used in combinations as per the expanded compatibility." The performance testing listed appears to be bench testing rather than clinical study.

Performance Testing (Engineering Evaluations/Bench Testing):

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

Not applicable for a clinical study. The testing described appears to be bench/laboratory testing of the physical hip prostheses components. The document does not specify sample sizes for these engineering evaluations, nor does it refer to patient data (e.g., country of origin, retrospective/prospective).

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 mention of experts establishing a ground truth for a test set, as this is not a clinical or AI/SaMD performance study.

4. Adjudication method for the test set

Not applicable. No adjudication method is mentioned as there is no test set in the context of a clinical performance study.

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

No. This document does not pertain to an AI/SaMD device, and therefore no MRMC study or AI assistance evaluation was conducted.

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

No. This document does not pertain to an AI/SaMD device, and therefore no standalone algorithm performance study was conducted.

7. The type of ground truth used

Not applicable in the context of clinical "ground truth." The "ground truth" for these engineering evaluations would be the established performance characteristics and safety criteria defined by the relevant ISO and ASTM standards (e.g., specific fatigue limits, wear rates, pull-out forces), against which the tested devices' physical properties are measured.

8. The sample size for the training set

Not applicable. There is no mention of a training set as this is not an AI/SaMD device.

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

Not applicable. There is no mention of a training set.

In summary: This FDA 510(k) clearance document for hip replacement prostheses makes a claim of substantial equivalence based on the fact that the actual devices have not changed, only their compatibility with other components has been extended. The "performance testing" referenced is a series of engineering/bench tests against international standards (ISO and ASTM) to ensure that the performance of the components remains equivalent to predicate devices in these extended combinations. It is not a clinical study involving patients, human readers, or AI/software performance.

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The Evolve breast pump is intended to be used by lactating women to express and collect milk from their breasts.

The Evolve Breast Pump, the subject device, is an electrically powered breast pump from an external AC-DC power supply or internal, rechargeable batteries; the device is provided non-sterile. The subject device is a cordless version of the predicate device.

The Evolve Breast Pump is intended to be used by lactating women to express and collect mills from their breasts. Pumping can be performed on one breast (single pumping) or on both breasts of a lactating woman at the same time (double pumping). The breast pump is designed as a multi-user breast pump and is available as a cordless model powered by an internal, rechargeable Lithium lon battery or an external AC-DC power supply.

The Evolve Breast Pump utilizes a DC-powered motor driving a reciprocating-type vacuum pump and an electromechanical solenoid which are controlled electronically to provide vacuum (suction) capability that extracts and collects milk from breasts of lactating women.

The Evolve Breast Pump has a backlit, LCD display. The subject device also has soft-touch buttons for the user to power the device on/off, switch between two different pumping modes - stimulation and expression – and to control vacuum speed and strength within each of the modes. Multiple vacuum speed and strength settings are available in both pumping modes.

The Evolve Breast Pump is intended for repeated use by multiple users in the home environment.

The Evolve Breast Pump requires Hygeia's Personal Accessory System for users to express and collect milk from their breasts.

The provided text is related to an FDA 510(k) premarket notification for a medical device: an Evolve Breast Pump. This document is a regulatory submission demonstrating substantial equivalence to a legally marketed predicate device, not a study proving device performance against acceptance criteria for an AI/ML powered device.

Therefore, the requested information about acceptance criteria, study design for AI, sample sizes, ground truth establishment, expert adjudication, MRMC studies, or standalone algorithm performance cannot be extracted from this document, as it pertains to a different type of medical device submission and evaluation.

The document discusses the following:

• Device: Evolve Breast Pump (K200406)
• Predicate Device: Hygeia Evolve Breast Pump (K190465)
• Key Modification: Addition of an internal rechargeable Lithium Ion battery for cordless operation.
• Performance Data Summary:
  • Risk Analysis (ISO 14971:2007)
  • Electrical Safety (IEC 60601-1:2005 with AAMI/ANSI ES60601-1:2005/(R)2012 and A1:2012 deviations)
  • Electromagnetic Compatibility (IEC 60601-1-2: 2014)
  • Performance Testing: Measurement of vacuum and cycles for minimum and maximum settings in both single and double pumping modes, and for stimulation and expression modes. It also verified battery energy capacity and operation time.
• Conclusion: The performance testing demonstrates that the Evolve Breast Pump is substantially equivalent to the predicate device.

This submission focuses on engineering and safety performance rather than the diagnostic or predictive performance that would be associated with AI/ML devices. Therefore, the specific questions regarding AI/ML performance metrics, ground truth, and expert adjudication are not applicable to this document.

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