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The Flex Coils are designed to produce diagnostic images of human anatomies and are used as general purpose coils. The Flex Coils are receive-only coils designed to be used with 1.5T MR1 systems manufactured by GE Healthcare to provide images of various parts of human body including shoulder, elbow, wrist, knee, hip and ankle. Large flex coil can be used for scanning large anatomy and small flex coil can be used for scanning smaller anatomy. The flexible coil is wrapped around the anatomy of interest, such as an elbow or knee or can be used for planar imaging.

The 1.5T 4CH Flex Coils are receive-only coils designed to provide images of various parts of human body. The flexible coil is wrapped around the anatomy of interest, such as an elbow or knee or can be used for planar imaging.
The 1.5T 4CH Flex coils are available in two models – 1.5T 4CH Large Flex coil and 1.5T 4CH Small Flex Coil, and are designed for use with GE 1.5T MR systems.
1.5T 4CH Flex coils are General Purpose receive only coils with 4 elements and integrated preamplifiers.
1.5T 4CH Flex coils are based on phased array technique for combining the images from 4 different channels. Coils are tuned to the proton frequency of 63.86MHz.

Here's an analysis of the provided text regarding the acceptance criteria and study for the GE Healthcare 1.5T 4CH Flex Coil, structured to address your specific points:

Acceptance Criteria and Device Performance

Study Information:

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

   • Test Set Sample Size: Not explicitly stated as a numerical count of patients or images. The text mentions "sample clinical images" were obtained.
   • Data Provenance: The study involved "Internal scans within GE Healthcare facility." This indicates the data was likely prospective and collected specifically for this filing. The country of origin is implicitly India ("Wipro GE Healthcare Pvt Ltd, Bangalore, INDIA").

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 filing focuses on technical and safety equivalence, with clinical images used internally for verification rather than a formal clinical trial with expert interpretation for ground truth.

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

   • This information is not provided. Given the nature of the "internal scans" for "sample clinical images" and the absence of explicit expert review processes, it's highly probable that a formal adjudication method was not used in the context typically seen in AI device studies. The primary goal was to demonstrate image production and quality consistent with the predicate, not diagnostic accuracy against a ground truth.

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:

   • No, an MRMC comparative effectiveness study was not done. This submission is for a medical device (MRI coil), not an AI-assisted diagnostic tool. The document explicitly states: "The subject of this premarket submission, 1.5T 4CH Flex Coil did not require external clinical studies to support substantial equivalence."

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

   • Not applicable. This device is an MRI coil, which is a component of an imaging system, not a standalone algorithm or AI. Its performance is evaluated on its ability to acquire images, not to perform interpretations.

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

   • For the "sample clinical images" obtained from internal scans, the concept of a formal "ground truth" (e.g., pathology, expert consensus on disease presence) in the context of diagnostic accuracy is not applicable or stated. The "ground truth" for the coil's performance was likely related to the expected image quality and signal-to-noise ratio compared to engineering specifications and the predicate device, demonstrated through visual inspection of the images themselves rather than an independent diagnostic gold standard.

7. The sample size for the training set:

   • Not applicable. This is a hardware device (MRI coil), not a machine learning algorithm that requires a training set.

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

   • Not applicable. (See point 7).

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Infant radiant Warmers provide infrared heat in a controlled manner to infants who are unable to maintain thermoregulation based on their own physiology. Infant radiant Warmers may be used to facilitate the newborn's transition to the external environment or to rrovide a controlled open microenvironment.

The Lullaby™ Warmer is a radiant warmer which provides a micro-environment for a premature, new born baby which otherwise might have very little chance of survival as it will not be able to maintain, by itself, its core body temperature. The Lullaby™ Warmer provides a means for the care giver to monitor the baby continuously by giving timely feedback via the different alarm systems and servo controlled thermal feedback mechanism while maintaining a pre-set temperature and thus ensures that the neonate slowly develops the internal organs to enable it to maintain its body temperature.

The Lullaby™ Warmer is an infant radiant warmer. The provided documents detail its premarket notification (510(k)) summary, indicating that it did not require clinical studies for substantial equivalence. Therefore, the device does not rely on a study demonstrating how it meets acceptance criteria based on human expert performance or clinical outcomes. Instead, its acceptance is based on non-clinical tests and compliance with recognized standards.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document explicitly states: "The subject of this premarket submission, Lullaby™ Warmer, did not require clinical studies to support substantial equivalence."
Therefore, there was no "test set" in the context of clinical data, no sample size of patients, and no data provenance from human subjects for this device's 510(k) submission. Acceptance was based on engineering and performance verification testing of the device itself.

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

Not applicable. As no clinical studies were required, there was no test set involving human subjects where expert ground truth was established for the device's performance with patients. Ground truth in this context would relate to engineering specifications and performance benchmarks, which are established by design and testing engineers.

4. Adjudication method for the test set

Not applicable. There was no clinical test set 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

Not applicable. The Lullaby™ Warmer is an infant radiant warmer, not an AI-powered diagnostic or assistive device that would involve human readers or AI assistance.

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

Not applicable. The Lullaby™ Warmer is a physical medical device, not an algorithm. Its performance is demonstrated through its functional capabilities, safety features, and compliance with manufacturing and performance standards.

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

The "ground truth" for the Lullaby™ Warmer's acceptance is based on engineering specifications, technical performance benchmarks, and compliance with recognized voluntary standards. This includes verification that the device maintains a pre-set temperature, provides timely feedback via alarm systems, and operates within specified electrical, mechanical, and safety parameters.

8. The sample size for the training set

Not applicable. There was no "training set" in the context of machine learning or clinical data. The device's design and manufacturing process would involve internal testing and validation against specifications.

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

Not applicable. As no training set (in the machine learning sense) was used, no ground truth needed to be established for it. The "ground truth" for the device's functionality is its adherence to its design specifications and the regulatory requirements for infant radiant warmers.

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The Lullaby The LED Phototherapy System is used for the treatment of indirect hyperbilirubinemia in term and pre-term infants, in a hospital environment - NICUs, PICUs and Well-baby Nurseries - administered by trained, professional medical staff, on the order of a licensed medical practitioner.

The Lullaby 10 LED Phototherapy System is intended for use under the direct supervision of a licensed healthcare practitioner.

The Lullaby The LED Phototherapy System device is not intended to be operated in mobile vehicles including ambulances or other vehicles associated with health care facilities.

The Lullaby™ LED Phototherapy System is intended for the treatment of neonatal hyperbilirubinemia, commonly known as neonatal jaundice, in a hospital. The system can be used for infants in a bassinet, incubator, open bed or radiant warmer. The lamp unit emits blue light, which falls within the phototherapy therapeutic spectrum range. The Lullaby™ LED Phototherapy System consists of a lamp unit with 10 blue LED lamps mounted on a roll stand. The lamp unit consists of a lightweight plastic light enclosure. It can be adjusted vertically and tilted if required. The light enclosure can be tilted up to approximately 90° from the horizontal about it pivot axis. The height of the pedestal can be adjusted to change the vertical position of the lamp unit. The base of the Lullaby™ LED Phototherapy System is designed to slide conveniently under a bassinet, incubator, open bed, or radiant warmer. The lamp unit is designed as a table top style to place directly on the incubator

This 510(k) premarket notification describes the Lullaby™ LED Phototherapy System, a device intended for the treatment of neonatal hyperbilirubinemia.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document compares the proposed Lullaby™ LED Phototherapy System with its predicate device, the Lullaby™ Phototherapy System (K071828), to establish substantial equivalence. The performance factors listed act as the de facto acceptance criteria.

Note on "Acceptance Criteria": In the context of a 510(k) for a substantially equivalent device, the "acceptance criteria" are typically met by demonstrating that the new device performs as well as or better than the predicate device for key performance characteristics, or that any differences do not raise new questions of safety or effectiveness. The table above uses the predicate device's performance as the benchmark for these criteria.

2. Sample Size and Data Provenance

The document states: "The subject of this premarket submission, Lullaby™ LED Phototherapy System, did not require clinical studies to support substantial equivalence." Therefore, there is no patient-specific test set or associated sample size for demonstrating clinical performance. The evaluation was based on non-clinical testing and engineering verification.

The data provenance for the non-clinical tests would be internal to Wipro GE Healthcare Private Ltd. and performed during the device's development and testing phases in India (based on the submitter's address).

3. Number and Qualifications of Experts for Ground Truth

Since no clinical studies were conducted and the device's substantial equivalence was based on non-clinical engineering and performance testing, there were no experts used to establish ground truth for a test set in a clinical context. The determination of substantial equivalence was made by the FDA's Office of Device Evaluation based on the provided technical documentation.

4. Adjudication Method

As there was no clinical test set requiring expert interpretation or consensus, there was no adjudication method used in this context.

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

No MRMC comparative effectiveness study was done. The submission explicitly states that clinical studies were not required.

6. Standalone (Algorithm Only) Performance

This device is a physical medical device (phototherapy system), not an algorithm or AI software, therefore, the concept of "standalone (algorithm only) performance" does not apply. The performance evaluation focused on the physical characteristics and functionality of the system itself.

7. Type of Ground Truth Used

The "ground truth" for this submission was established through engineering verification and performance testing. This involved:

• Testing of electrical, mechanical, and safety parameters.
• Reliability testing.
• System design verification protocols.
• Compliance with voluntary standards.

The results of these tests demonstrated that the device met all design requirements and performance claims, allowing it to be deemed substantially equivalent to the predicate.

8. Sample Size for the Training Set

This device is not an AI/ML algorithm that requires a training set. Therefore, there is no training set sample size to report.

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

As there is no training set, this question is not applicable.

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The Mini Telemetry system is intended to transmit fetal heart rate and uterine activity signals from an ambulatory mother to a fetal or maternal fetal monitor during the ante partum period and during labor. The system allows ultrasound fetal heart rate, FECG, MECG and uterine activity signals to be monitored individually or in combination.

The Mini Telemetry system is intended for use under the direct supervision of a licensed healthcare practitioner in a defined coverage area.

The Mini Telemetry device is not intended to be operated in mobile vehicles including ambulances or other vehicles associated with health care facilities.

The Mini Telemetry System provides a wireless means of transmitting heart rate and uterine activity signals from an ambulatory mother to a fetal or maternal/fetal monitor. It includes receiver (RX 2051412-004) and transmitter (TX 2051411-004) subsystems.

The system monitors fetal heart rate through ultrasound Doppler technology, ECG (Fetal ECG or Maternal ECG), and uterine activity (TOCO or IUPC) signals individually or in combination.

The transmitter stays along with mother acquiring data from transducers and transmitting it to the remote Receiver placed next to the monitor in the room. The Mini Transmitter is carried by the mother using the strap mechanism. One end of the transducers are connected to the transmitter and the other end comes in contact with the mother to acquire data.

This system acquires and transmits data wirelessly to the receiver.

The Mini Telemetry system itself is an accessory to the main fetal/maternal fetal monitor.

The Mini Telemetry system is compatible with the following Corometrics brand monitors:
CORO 170 Series fetal monitors K993751 / K991905
CORO 120 Series Maternal fetal monitors K0332252
CORO 250 Series Maternal fetal monitors K050583

Here's an analysis of the provided text regarding the acceptance criteria and study for the Mini Telemetry System, presented in the requested format:

It's important to note that this document is a 510(k) Summary for a Premarket Notification, which seeks to demonstrate substantial equivalence to a predicate device rather than proving novel effectiveness. Therefore, the "study" described focuses on verification and validation activities against standards and internal requirements, not a clinical trial proving new medical efficacy or superiority.

Acceptance Criteria and Device Performance Study for Mini Telemetry System

This submission pertains to the Mini Telemetry System, a device intended to transmit fetal heart rate and uterine activity signals wirelessly from an ambulatory mother to a fetal or maternal/fetal monitor. The submission demonstrates substantial equivalence to a predicate device (Corometrics Model 330 Fetal Maternal Telemetry System K910260) through non-clinical testing and adherence to recognized standards.

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) for substantial equivalence and not a clinical efficacy study, the "acceptance criteria" are primarily regulatory and performance standards, and the "reported device performance" is the successful demonstration of compliance.

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

The document describes "Design verification of Mini Telemetry System" with "several protocols that include electrical, mechanical, safety Testing, reliability, and system design verification protocols."

• Sample Size: The specific sample sizes for each test protocol (e.g., number of devices tested, duration of reliability tests) are not detailed in the provided summary. It states "testing on unit level, system level."
• Data Provenance: The nature of these tests suggests they are prospective, non-clinical engineering and performance tests conducted by the manufacturer, Wipro GE Healthcare Private Ltd. The country of origin for these tests is not explicitly stated but can be inferred to be associated with India, where the submitter is located, and potentially other GE Healthcare facilities.

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

• Not Applicable: This submission relies on engineering and performance standards, and comparison to a predicate device. It does not involve a "test set" in the context of diagnostic performance requiring expert-established ground truth. The acceptance criteria are based on established regulatory standards and the performance of the predicate device.

4. Adjudication Method for the Test Set

• Not Applicable: There was no clinical "test set" requiring adjudication by human experts to establish ground truth for algorithm performance.

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

• No: A MRMC comparative effectiveness study was not conducted. This is a 510(k) for substantial equivalence based on non-clinical testing and comparison to a predicate, not demonstrating improved human reader performance with AI assistance. The device itself is a telemetry system, not an AI-driven diagnostic aid.

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

• The device being assessed is a telemetry system, not an "algorithm" in the sense of an AI or diagnostic algorithm operating on complex data. Its core function is to acquire and transmit signals. Therefore, the concept of "standalone algorithm performance" as typically applied to AI/diagnostic tools is not directly applicable. The device's performance (signal acquisition, transmission fidelity, safety) was evaluated in its standalone operational capacity through the various engineering and performance tests mentioned.

7. The Type of Ground Truth Used

• The "ground truth" for the verification and testing activities consisted of:
  • Recognized International and National Standards: e.g., IEC 60601 series, ISO 10993, FCC regulations.
  • Predicate Device Performance: The Corometrics Model 330 Fetal Maternal Telemetry System (K910260) served as the benchmark for demonstrating "substantial equivalence" in function, indications for use, and technological characteristics.
  • Internal Design Requirements: The device was tested against its own pre-defined functional, safety, reliability, and performance specifications.

8. The Sample Size for the Training Set

• Not Applicable: This device is a classic medical device hardware and software system for signal transmission, not a machine learning or AI-based system that requires a "training set" in the conventional sense.

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

• Not Applicable: As there is no "training set" for an AI or machine learning model, this question is not relevant to this submission.

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The device is intended for use by a qualified physician for ultrasound evaluation of Cardiac (adult and pediatric), Peripheral Vascular. Fetal/Obstetrics. Abdominal (including GYN), Pediatric, Small Organ (including breast, testes, thyroid), Neonatal Cephalic, Adult Cephalic, Intra operative (abdominal, thoracic and peripheral), Musculo-skeletal Conventional, Urology (including prostate). Transrectal and Transvaginal.

The VividTM P3 is a high performance, mobile Color Doppler Ultrasound Imaging system. This system is designed for cardiovascular applications and including abdominal neonatal/pediatrics & intra-operative. It is integrated with keyboard control panel, LCD type video display and interchangeable electronic-array transducers.

The provided text is a 510(k) Premarket Notification Submission for the GE VIVID P3 ultrasound system. It outlines the device's technical specifications and intended uses, primarily to demonstrate substantial equivalence to previously cleared predicate devices.

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly present a table of quantitative acceptance criteria with corresponding performance metrics for the VIVID P3. Instead, it focuses on demonstrating that the VIVID P3 is substantially equivalent to its predicate devices by sharing the same fundamental scientific technology and conforming to applicable medical device safety standards. The "performance" reported is primarily the list of clinical applications and operating modes for which the device and its various transducers ("4C", "E8Cs", "8L", "8C", "5Cs", "3S", "11L", "T739", "6S") are intended and "previously cleared by FDA".

The device performance is implied through compliance with and application of:

• Acoustic output evaluation (Summary of Non-Clinical Tests)
• Biocompatibility evaluation (Summary of Non-Clinical Tests)
• Cleaning and disinfection effectiveness evaluation (Summary of Non-Clinical Tests)
• Thermal, electrical, electromagnetic, and mechanical safety standards (Summary of Non-Clinical Tests)
• Voluntary standards as detailed in Sections 9, 11, 15, and 17 of the premarket submission (Summary of Non-Clinical Tests) - These specific standards are not detailed in the provided excerpt.
• Application of quality assurance measures: Risk Management, Requirement Reviews, Design reviews, Unit level testing (Module Verification), Integration Testing (System level verification), Final acceptance testing (Validation), Performance testing (Verification), and Safety testing (Verification).

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

The document explicitly states: "The subject of this premarket submission, VIVID P3, did not require clinical studies to support substantial equivalence."

Therefore, there is no test set or associated sample size for clinical performance evaluation mentioned. The provenance of any data used for non-clinical tests (acoustic output, biocompatibility, etc.) is not specified, nor is whether it was retrospective or prospective.

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

Since no clinical studies were required or performed to establish substantial equivalence based on clinical performance, there is no mention of experts establishing ground truth for a test set in clinical scenarios.

4. Adjudication Method for the Test Set:

Not applicable, as no clinical studies with a test set requiring expert adjudication are mentioned.

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

Not conducted or mentioned. The submission states that clinical studies were not required to support substantial equivalence. Therefore, there is no effect size reported for human readers improving with or without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

Not applicable. The VIVID P3 is an ultrasound imaging system with various transducers, not a standalone algorithm. Its performance is demonstrated through its hardware and software capabilities as a whole system, benchmarked against predicate devices in terms of safety and technical specifications, not typically through standalone algorithmic metrics.

7. Type of Ground Truth Used:

For the purpose of this 510(k) submission, the "ground truth" for the device's acceptability is its substantial equivalence to existing, legally marketed predicate devices (GE Logiq e/i & Vivid e - K072797, GE Logiq P5/A5 K060993, GE Logiq P6 K073297, GE Vivid S5/S6 K092079) and its conformity to recognized medical device safety standards. This is established through non-clinical testing and internal quality assurance measures rather than clinical outcome data or pathology. The "ground truth" for its intended uses is that these uses were "previously cleared by FDA" for the predicate devices or previous iterations of GE's ultrasound systems.

8. Sample Size for the Training Set:

Not applicable. This document describes a medical device submission based on substantial equivalence, not an AI or machine learning model that would typically involve training sets for performance evaluation.

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

Not applicable, as there is no training set mentioned in this context.

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