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Quest is designed to provide ECG information and data to qualified medical personnel for the purpose of assessing the patient's cardiac response to exercise. It is to be used in hospitals, clinics, or physician offices by a qualified and licensed physician, or by trained staff under the direct supervision of that physician.

Stress-test or exercise electrocardiography is used a) when the diagnosis of coronary artery disease is suspected, b) to determine the physical performance characteristics of a patient, c) for post myocardial infarction assessment, or d) for cardiac rehabilitation. The test involves the recording of the electrocardiogram during dynamic or, occasionally, isometric exercise. The diagnostic value of exercise testing primarily concerns either ST segment depression present in myocardial ischemia, or elevation seen in infarcts (in comparison to P-Q segment as the isoelectic line). In addition it is important to consider the patient's blood pressure response and physical symptoms. Disease assessment is most prominent in, but not limited to, adult patients.

This instrument can also serve as an adult resting interpretive electrocardiograph with the addition of Burdick's resting interpretive program.

This instrument is not intended to interpret any exercise test results but is to be used as an aid for the physician to determine normal or abnormal response of the patient to exercise.

Quest is not intended for long term monitoring of patient ECG signals. Specifically it does not substitute Quest is not intended for folly will and ices recognized by AAMI EC13 especially in the area of alarms.

This instrument (QUEST ) is a computerized exercise stress testing system which provides a method for dynamic exercise evaluation performed by the patient who walks on a treadmill in which the speed and elevation can be adjusted (automatically or manually) to suit a variety of graded exercise protocols, or when the patient pedals an electronically braked bicycle ergometer. If the test subject is unable to walk, isometric exercise can be performed using a handheld dynamometer, or by injecting the patient with heart rate stimulants to stress the myocardial system. In each case this instrument is used to present real-time ECG waveforms and calculations to qualified medical personnel while providing automatic or manual control of the exercise equipment. Paper reports are commonly produced.

It contains a viewing screen of sufficient size to accommodate easy reading of important patient and test parameters such as heart rate, test time, ECG waveforms and ST indications. To minimize distractions to the operators and patients during tests, no alarms are used and user-defined prompting encourages timely entry and recording of important test data (such as blood pressure).

Paper test records can be obtained from the thermal recording system incorporated into the design. Formats for the test summaries and data obtained during the test are selectable, enhancing its usage for a variety of test facilities. The ability to produce print records of ECG waveforms during exercise and recovery are continuously made available to the users.

Processing of the incoming ECG signal from the (10) electrode sites results in a real time display, heart rate determination, ST measurement indices and values, ectopic beat detection, pacemaker detection, and optionally, interpretation of the resting ECG signals. Further calculations support exercise such as METS, target heart rate, calories, distance, and protocol timers.

Interfaces are provided to enable connection to Burdick's T600 treadmill, an Ergomed 840 Bike ergometer, standard electronically braked bike ergometers, non-invasive blood pressure equipment, oximetry devices supporting serial communications protocols, and computer communications equipment such as printers, fax/modems and networks. The measurement devices typically return a value to be displayed on-screen and Quest is not involved in making the actual measurements. In addition, analog outputs provide a selection of ECG signals, ergometer speed and grades, and exercise data (heart rate, workload, etc.). A digital QRS pulse output is available as a trigger typically used for echocardiography, nuclear imaging equipment, or pulmonary gas exchange equipment.

The computer system is based on an industry standard computer chip and uses a standard software operating system. Custom circuits are fabricated by Burdick and integrated with standard assemblies purchased from outside suppliers

The provided text is a 510(k) summary for the Burdick Quest Exercise Stress System, which focuses on demonstrating substantial equivalence to existing devices. It does not contain information about acceptance criteria or a study that proves the device meets specific performance metrics.

Specifically, the document:

• Describes the device's function and intended use.
• Compares its functionalities and technical specifications to predicate devices (Quinton Q4500 Stress Test System and Burdick E350i Electrocardiograph) to establish substantial equivalence.
• Mentions compliance with the AAMI Standard for Diagnostic Electrocardiographs for ECG acquisition parameters (Leads acquired, Frequency response, Input impedance, Patient isolation, Sensitivity). This is the closest it comes to "acceptance criteria," but it lists the type of specification, not the actual numerical criteria or performance results proving compliance.

Therefore, I cannot extract the requested information as it is not present in the provided text. The document is primarily a regulatory filing to show equivalence, not a performance study report with detailed acceptance criteria and validation results.

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The Burdick 200 Pulse Oximeter provides SpO2, Pulse Rate, and Pulse Strength measurements. It may be used in the hospital or clinical environment, during emergency land or air transport, or for in home use.

The intended patient population is neonates to adults. The oximeter permits patient monitoring with adjustable alarm limits as well as visual and audible alarm signals.

The Oximeter has three modes of operation: Clinician Mode, Home-use Mode, and Sleep Study Mode.

The Clinician Mode aids the health care professional in monitoring patient activity.

The Home Use Mode permits the home-use caregiver to monitor a patient within the home environment.

The Sleep Study Mode allows the health care professional to record sleep study data which may be later transferred to a PC and analyzed.

The Burdick 200 is a hand held stand alone Pulse Oximeter designed to detect (SpO2) Oxygen saturation, pulse rate, and pulse strength on any patient from neonates to adults and output the measurements.

The Burdick 200 consists of two units, a hand held pulse oximeter and a table top charger base. Nine probes of various sizes and configurations are available to accommodate the spectrum of body sizes and sites.

This 510(k) summary does not contain sufficient information to answer all the requested questions about acceptance criteria and device performance studies. The document primarily focuses on establishing substantial equivalence to a predicate device and briefly mentions some functional and environmental tests performed due to minor dimensional and material changes.

Here's an attempt to extract and infer information based on the provided text:

Acceptance Criteria and Device Performance Study Summary

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information: Precise numerical acceptance criteria for SpO2 accuracy, pulse rate accuracy, or specific environmental limits are not provided in this summary.

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

The document describes tests performed on "a modified unit" (singular).

• Sample Size: 1 unit (a modified Burdick 200 Oximeter).
• Data Provenance: Not explicitly stated, but the functional and environmental testing appears to be conducted on the Burdick 200 Oximeter itself, likely in a controlled laboratory environment. It is not patient or clinical data, but rather device performance data.

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

This information is not provided in the document. The tests described are functional and environmental, likely based on engineering specifications and laboratory measurements rather than expert clinical assessment of patient data.

4. Adjudication Method for the Test Set

This information is not provided in the document. Given the nature of the tests (functional and environmental), an adjudication method in the context of expert review of clinical cases would not be applicable.

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

No MRMC comparative effectiveness study was done. This document describes a 510(k) for a standalone medical device (pulse oximeter), not an AI-assisted diagnostic tool. Therefore, a study to measure the effect size of human readers with vs. without AI assistance is not relevant or included.

6. Standalone (Algorithm Only) Performance Study

The document does describe functional tests of the device itself, which operates as a standalone algorithm/device.

• Standalone Performance Study Done: Yes, functional tests were performed as described under "TESTS."
• Details:
  • A "functional test was performed on the unit prior to environmental testing to establish that the unit to be tested was operating properly."
  • "Following the environmental test an expanded functional test was performed."
  • The "software accomplishing these measurements and calculations was developed by BCI International for their model 3302 and is used by Burdick Inc. in their model 200 in an unaltered form." This implies reliance on the already established performance of the BCI 3302's algorithm.

However, detailed performance metrics (e.g., accuracy, precision, bias) of the SpO2 and pulse rate measurements against a gold standard are not reported in this summary. The summary focuses on showing that the modified unit functions properly and withstands environmental stress, preserving the performance characteristics of the predicate device.

7. Type of Ground Truth Used

For the functional tests, the ground truth would typically be established by comparison to:

• Known input signals: For SpO2 and pulse rate measurements, this would involve using calibrated simulators or reference devices that provide known oxygen saturation and pulse rate values.
• Engineering specifications/reference standards: For environmental tests, the "ground truth" is adherence to specified environmental conditions and the device's ability to maintain functionality within those conditions.

The document does not explicitly state the specific ground truth methods or devices used but implies comparison to "normal established limits" and "established limits." Given it's a 510(k) seeking equivalence, the ground truth for overall device performance is implicitly based on the predicate device's established performance.

8. Sample Size for the Training Set

This information is not applicable as the document describes a hardware device (pulse oximeter) with embedded software, not a machine learning model that requires a "training set" in the conventional AI sense. The software's calculations are based on established physiological principles and algorithms, not machine learning trained on large datasets.

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

This information is not applicable for the same reasons as #8. The "ground truth" for the software's functionality would have been established during the development and validation of the BCI 3302 software, likely using physiological models and clinical studies, but these details are not provided here.

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The Burdick Eclipse 4 performs the same functions and meets the same performance standards as the Marquette MAC PC. This version of the Burdick GRI interpretative program and Marquette s interpretative program used in the MAC PC both provide adult and pediatric resting ECGs on patients ranging in age from birth to 99 years. Both programs analyze 10 seconds of data simultaneously from the 12 standard leads and identify essentially the same set of abnormalities.

Here's an analysis of the provided text regarding the acceptance criteria and study for the K94681 device, an enhancement to an ECG interpretative program:

This submission (K94681) is specifically about a pediatric enhancement to an existing ECG interpretative program. The core claim is that this enhancement performs the same functions and meets the same performance standards as another established device (Marquette MAC PC) with its pediatric interpretation.

Since this is an enhancement to an existing program and a claim of equivalence, the "acceptance criteria" are implicitly tied to demonstrating that the pediatric interpretation performs comparably to a predicate device.

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

The document does not explicitly state quantitative "acceptance criteria" in the typical sense (e.g., "sensitivity must be >X%"). Instead, the primary acceptance criteria appear to be:

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: The underlying basis for the pediatric criteria (developed by Dr. MacFarlane) is "a large study of 2,196 neonates, infants and children." This number likely refers to the dataset used to develop or validate the pediatric criteria itself, which is then incorporated into the Burdick Eclipse 4. It's not explicitly stated as a separate "test set" for the K94681 submission, but rather the foundation for the expert criteria being adopted.
• Data Provenance: The criteria were developed at the University of Glasgow, Department of Cardiology, Glasgow Royal Infirmary (GRI), Glasgow, Scotland. This indicates the data originated from Scotland.
• Retrospective or Prospective: Unspecified.

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)

The ground truth or "pediatric criteria" was "developed by Dr. Peter MacFarlane." The text implies he was the primary expert involved in its development, drawing on his extensive experience: "Dr. MacFarlane has been involved in computerized ECG interpretation since its inception in the 1960s." It's not specified if other experts were involved in the development of the GRI criteria or in establishing a "ground truth" for a specific test set related to this 510(k) submission.

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

The document does not describe an adjudication method for a specific test set. The pediatric criteria itself was developed by a single expert (Dr. MacFarlane) based on a large study. The submission focuses on the incorporation of this established criteria and its functional equivalence to a predicate device.

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

• Was an MRMC study done? No. The document does not describe an MRMC study involving human readers with and without the AI (interpretive program) assistance. The focus is on the program's standalone functional and performance equivalence.
• Effect size: Not applicable, as no such study was described.

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

Yes, implicitly. The submission focuses on the "pediatric enhancement to the interpretative program" and states it "performs the same functions and meets the same performance standards as the Marquette MAC PC." This implies a comparison of the algorithm's performance (standalone) to that of the predicate device's algorithm, specifically in identifying "essentially the same set of abnormalities."

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

The ground truth for the underlying pediatric criteria is expert-developed criteria based on a large clinical study. Dr. MacFarlane, a long-standing expert in computerized ECG interpretation, developed these criteria based on data from 2,196 pediatric patients. This is essentially expert consensus or expert-defined criteria derived from clinical observation.

8. The sample size for the training set

The text states the GRI pediatric criteria is "based on a large study of 2,196 neonates, infants and children." This 2,196 sample size likely represents the dataset used to develop and train (in a broader sense of "training" a set of expert rules or algorithms) the pediatric criteria. It's not explicitly labeled as a "training set" in the context of modern machine learning, but it served that function for the development of the expert system.

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

The ground truth for this "training set" (the 2,196 patients) was established through the expertise and extensive clinical research of Dr. Peter MacFarlane and potentially his team at the University of Glasgow. He "developed" the criteria, implying he analyzed the data from these patients to define the diagnostic rules and parameters that constitute the pediatric interpretation logic. This would involve a deep understanding of pediatric electrophysiology and ECG patterns.

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