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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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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

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

The Evolve Breast Pump, is an electrically powered breast pump from an external AC-DC power supply; the device is provided non-sterile. The Evolve Breast Pump is intended to be used by lactating women to express and collect milk 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 Evolve breast pump is designed as a multi-user breast pump and available in a corded model (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 for user 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 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 describes a 510(k) premarket notification for the Evolve Breast Pump (K190465), comparing it to a predicate device, the Hygeia EnDeare Breast Pump (K081932).

However, the document does not contain information about specific acceptance criteria or a study proving the device meets those criteria in the context of diagnostic performance (e.g., sensitivity, specificity, accuracy) which would typically be relevant for AI/ML devices. This is a breast pump, not a diagnostic device.

Instead, the "acceptance criteria" for a breast pump would relate to its functional performance, electrical safety, electromagnetic compatibility, and software/firmware robustness. The "study" proving it meets these criteria refers to the non-clinical performance data provided to the FDA.

Based on the provided text, here's an attempt to answer your questions, interpreting "acceptance criteria" and "study" in the context of a breast pump's regulatory submission:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not explicitly state "acceptance criteria" in a tabulated format with corresponding performance for each criterion. Instead, it describes general performance specifications that were met. Below is a reconstruction based on the information provided, focusing on the functionality of the breast pump.

The document states, "Specifications were met and within required, acceptable range for pump operation, cycle rate, and vacuum pressure."

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

The document does not specify a "test set" in the context of patient data or clinical imaging for AI/ML. For this medical device (a breast pump), the "testing" involves hardware and software performance.

• Sample Size: Not applicable in the traditional sense of patient data. Testing was performed on the device itself.
• Data Provenance: Not applicable. The testing was non-clinical, likely conducted by the manufacturer in a lab environment.

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

Not applicable. The ground truth for a breast pump's performance is objective measurement against engineering specifications (e.g., vacuum pressure, cycle rate, electrical safety standards). It does not involve expert interpretation of medical data.

4. Adjudication Method for the Test Set

Not applicable. This is not a diagnostic device requiring adjudication of expert interpretations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is a breast pump, not an AI-assisted diagnostic device. No human readers or AI assistance are involved in its primary function.

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

Not applicable. While the device contains firmware/software, the "standalone" performance concept typically applies to AI algorithms whose output is a diagnosis or risk assessment. Here, the "standalone" performance would be the pump's mechanical and electronic function, which was tested.

7. The Type of Ground Truth Used

The "ground truth" for the performance data in this submission is based on:

• Engineering Specifications and Measurements: Direct physical measurements of vacuum (mmHg) and cycle rates (CPM) against predefined ranges.
• Regulatory Standards: Compliance with international and national standards for electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), and risk management (ISO 14971).
• Software Verification & Validation Best Practices: Adherence to FDA guidance for software in medical devices.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device that requires a "training set" of data in the typical sense. The firmware/software development process would involve iterative testing and refinement, but not "training" on a dataset to learn patterns.

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

Not applicable, as there is no "training set" in the context of AI/ML. The firmware's functionality is designed and verified against established engineering principles and requirements, not learned from a dataset with pre-established ground truth labels.

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Signature Orthopaedics' Evolve UniPolar Head is intended for hemi-hip arthroplasty only, where the natural acetabulum does not require replacement. The Evolve UniPolar Head is 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 Evolve™ UniPolar Head is a metallic (per ISO 5832-12) ball with a tapered bore. The head connects to a femoral stem from Signature Orthopaedics' range via taper sleeve. The taper sleeve is manufactured from cobalt-chromium alloy per ISO 5832-12, and includes a 12/14 taper. The head's outer surface is highly polished to articulate against the patient's natural acetabulum as part of a hip hemi-arthroplasty.

This document is a 510(k) premarket notification for the Evolve™ UniPolar Head, a hip prosthesis. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than presenting a novel device requiring extensive clinical studies with acceptance criteria and ground truth evaluations typically seen for AI/ML devices or new technologies.

Therefore, many of the requested items related to acceptance criteria, ground truth, expert adjudication, MRMC studies, and standalone performance for AI/ML are not applicable to this type of submission.

Here's a breakdown of the information that can be extracted, and where the requested information is not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Acceptance Criteria:

The "study" proving the device meets the acceptance criteria is a series of non-clinical tests and engineering evaluations. These are outlined in the "Performance Testing" section:

• Range of motion analysis
• Component connection strength and fretting corrosion testing
• Femoral stem fatigue testing

The report states that these tests were conducted "to verify that the performance of the Evolve™ UniPolar Head is adequate for anticipated in-vivo use." The conclusion is that "Non-clinical testing results support the substantial equivalence claim. The Evolve UniPolar Head is expected to perform adequately during clinical use."

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

• Not applicable / Not provided. This document details a 510(k) submission for a traditional medical device (hip prosthesis) based on mechanical and material engineering testing, not a data-driven device like AI/ML. There is no "test set" in the sense of a dataset for an algorithm. The "data" provenance would refer to the origin of the materials and manufacturing, and the engineering tests are conducted in a lab setting.

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)

• Not applicable / Not provided. Ground truth, in the context of expert consensus, is not relevant for the mechanical and material testing performed for this device. The "ground truth" for these tests is the physical measurement and observation of the device's behavior under simulated conditions.

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

• Not applicable / Not provided. Adjudication methods are used to resolve discrepancies in human expert labeling or diagnosis for ground truth establishment, which is not part of this device's testing.

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

• Not applicable. This is a physical medical device, not an AI/ML diagnostic aid. MRMC studies are not relevant.

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

• Not applicable. This is a physical medical device. There is no algorithm to evaluate in standalone mode.

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

• Engineering/Physical Ground Truth: The "ground truth" for the performance testing is based on established engineering principles, material science standards (e.g., ISO 5832-12), and physical measurements obtained from laboratory testing (e.g., range of motion, connection strength, fretting corrosion, fatigue). Outcomes data might be considered relevant in post-market surveillance for long-term device performance but is not part of this premarket submission.

8. The sample size for the training set

• Not applicable / Not provided. This device does not involve a "training set" in the context of machine learning. The design and manufacturing processes are refined through engineering development, which could be seen as an iterative "training" process in product design, but not through statistical learning from a data set.

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

• Not applicable / Not provided. As there is no "training set" in the ML sense, there is no ground truth needing establishment for it. The "ground truth" for design decisions and manufacturing quality would be established through engineering specifications, material standards, and quality control processes.

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The Evolve HPD 980/ 1470nm Multiwavelength Diode Laser (Evolve Dual) (and its delivery accessories used to deliver optical energy) are indicated for use in general surgical applications for incision, excision, ablation, cutting, vaporization, hemostasis, and coagulation of soft tissue contact or non-contact, open or closed endoscopic applications where incision, tissue dissection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors and lesions, tissue vaporization, hemostasis and/or coagulation may be indicated.

The device is intended for delivery of laser light to soft tissue in the contact and non contact mode during surgical procedures including via endoscopes. The Evolve HPD Multiwavelength 980/ 1470 Diode Laser is generally indicated for use in incision, excision, vaporization, ablation, hemostasis or coagulation of soft tissue in ear, nose and throat and oral surgery (otolaryngology), arthroscopy, gastroenterology, general surgery, dermatology, plastic surgery, podiatry, urology, gynecology, neurosurgery (peripheral nervous system), pulmonary surgery, cardiothoracic surgery, dental applications, and endovenous occlusion of the saphenous veins in patients with superficial vein reflux. The Multiwavelength laser is further indicated for laser assisted lipolysis.

The device is specifically indicated for use as follows:
Ear, Nose and Throat and Oral Surgery (Otolaryngology)
Arthroscopy
Gastroenterology
General Surgery, Dermatology, Plastic Surgery and Podiatry
Urology
Gynecology
Neurosurgery
Cardiac Surgery
Pulmonary Surgery
Dental Applications

The Biolitec Medical Device, Inc. Evolve HPD 980/ 1470nm Multiwavelength Diode Laser contains the same identical components as the cleared Biolitec, Inc. Evolve HPD 980/ 1470nm Multiwavelength Diode Laser (K112013).

The provided document is a 510(k) summary for the Evolve® HPD 980/ 1470nm Multiwavelength Diode Laser. It explicitly states that the device is determined to be substantially equivalent to a predicate device (K112013).

In the context of 510(k) submissions, the acceptance criteria for a new device are typically met by demonstrating that it is as safe and effective as a legally marketed predicate device. This is primarily done by showing identical or highly similar technological characteristics, intended use, indications for use, and principles of operation, and by demonstrating compliance with relevant voluntary consensus standards.

Therefore, the "study that proves the device meets the acceptance criteria" in this case is the substantial equivalence determination by the FDA, based on a comparison to the predicate device and compliance with established standards. There is no clinical study, comparative effectiveness study, or standalone algorithm performance study described in these documents that would provide information on sensitivity, specificity, or other performance metrics typically associated with AI/software devices.

Here's the breakdown of why certain requested information cannot be provided from this document:

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

   • Acceptance Criteria (Implied by Substantial Equivalence): The device must be "as safe and effective" as the predicate device (Evolve HPD 980/ 1470nm Multiwavelength Diode Laser, K112013). This implicitly means it must perform within the same safety and effectiveness parameters as the predicate.
   • Reported Device Performance: The document states, "The Evolve HPD 980/ 1470mm Multiwavelength Diode Laser is as safe and effective for these Indication for Use as the cleared predicate device." and "The Evolve HPD 980/ 1470nm Multiwavelength Diode Laser has the identical same intended uses, indications, technological characteristics, and principles of operation as its predicate device." No specific quantitative performance metrics (e.g., accuracy, sensitivity, specificity, or other clinical outcomes) are provided for either device.

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

   • Not applicable / Not provided: No test set or clinical study data is described in this 510(k) summary. The submission relies on demonstrating substantial equivalence to a predicate device through technological and intended use comparisons, and compliance with recognized standards.

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)

   • Not applicable / Not provided: No test set or ground truth establishment is described.

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

   • Not applicable / Not provided: No test set or adjudication process is described.

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: No MRMC study was done, nor is this device an AI-assisted device. The device is a multiwavelength diode laser for general surgical applications.

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

   • No: This is a physical medical device (laser), not an algorithm or software. Therefore, a standalone performance assessment in the sense of an algorithm is not applicable.

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

   • Not applicable / Not provided: No ground truth used for a performance study is described as no performance study was conducted for this 510(k). The "ground truth" for this submission is the established safety and effectiveness of the existing predicate device.

8. The sample size for the training set

   • Not applicable / Not provided: This is not a machine learning or AI device. No training set is involved.

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

   • Not applicable / Not provided: No training set is involved.

In summary, this 510(k) submission for the Evolve® HPD 980/ 1470nm Multiwavelength Diode Laser is based on demonstrating substantial equivalence to a predicate device and compliance with relevant voluntary consensus standards. It does not involve performance studies in the context of diagnostic or AI devices, and therefore, most of the requested information regarding independent performance testing, sample sizes, and ground truth is not present in the provided text.

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The device is intended for delivery of laser light to soft tissue in the contact and non contact mode during surgical procedures including via endoscopes. The Evolve HPD Multiwavelength 980/ 1470 Diode Laser (up to 150W) is generally indicated for use in incision, excision, vaporization, ablation, hemostasis or coagulation of soft tissue in ear, nose and throat and oral surgery (otolaryngology), arthroscopy, gastroenterology, general surgery, dermatology, plastic surgery, podiatry, urology, gynecology, neurosurgery (peripheral nervous system), pulmonary surgery, cardiothoracic surgery, dental applications, and endovenous occlusion of the saphenous veins in patients with superficial vein reflux. The Multiwavelength laser is further indicated for laser assisted lipolysis. Power from 151W to 200W is indicated in the vaporization of the prostate to treat Benign Prostatic Hyperplasia (BPH).

The device is specifically indicated for use as follows:

Ear, Nose and Throat and Oral Surgery (Otolaryngology)
Arthroscopy
Gastroenterology
General Surgery, Dermatology, Plastic Surgery and Podiatry
Endovenous Occlusion of the Saphenous Veins in Patients with Superficial Vein Reflux Associated with Varicose Veins and Varicosities
Urology
Gynecology
Neurosurgery
Cardiac Surgery
Pulmonary Surgery
Dental Applications
Powers from 151W to 200W

The Evolve HPD 980/ 1470nm Multiwavelength Diode Laser contains the same basic components as the cleared Ceralas 150W 980/ 1470mm Diode Laser (K090164). The purpose of this submission is to increase the energy from 150W to 200W for application in the vaporization of the prostate to treat Benign Prostatic Hyperplasia. (BPH)

The provided text is a 510(k) summary for the Evolve® HPD 980/ 1470nm Multiwavelength Diode Laser. It primarily focuses on demonstrating substantial equivalence to predicate devices and expanding the power range for a specific indication. The document does not contain the level of detail typically found in a clinical study report that would establish specific acceptance criteria and detailed performance metrics.

Therefore, many of the requested fields cannot be directly extracted or inferred from this document. However, based on the information provided, here's what can be answered:

Acceptance Criteria and Device Performance:

The document states that the device complies with several voluntary consensus standards, implying that meeting these standards served as acceptance criteria for certain aspects (e.g., electrical safety, electromagnetic compatibility, biocompatibility).

Study Details:

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

   • The document mentions "studies using 200W 980nm lasers on human cadaver prostates" and "50W 1470nm lasers on prostates of patients with bladder outlet obstruction." However, specific sample sizes for these studies are not provided.
   • Provenance: "human cadaver prostates" and "prostates of patients." The country of origin is not specified but given it's a US FDA submission, US data is implied or preferred, but not explicitly stated.
   • Retrospective or prospective: Not specified.

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

   • This information is not provided in the document. The document refers to "published clinical data" and "studies," but doesn't detail the methodology for establishing ground truth within those studies.

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

   • This information is not provided.

4. 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 device is a surgical laser, not an AI diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable and was not performed.

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

   • This device is a surgical laser, and its performance is inherently tied to its use by a human in a surgical setting. Therefore, a "standalone algorithm only" performance study is not applicable. The "performance data" refers to the physical effects of the laser (ablation rates).

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

   • For the ablation studies on prostates, the "ground truth" would likely involve objective measurements of tissue ablation, such as volume of tissue removed, depth of penetration, or other physical/histological evaluations of the treated tissue. The document does not explicitly state the specific type of measurement.

7. The sample size for the training set:

   • The document primarily relies on "published clinical data" and studies on cadaver/patient prostates. There is no mention of a "training set" in the context of an algorithm or AI model, as this is a hardware device.

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

   • As there is no "training set" in the context of an AI model for this hardware device, this question is not applicable. The "ground truth" related to the laser's physical performance (e.g., ablation rates) would be established through direct measurement and observation in experiments.

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