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Measures and displays long-term "body temperature" as calibrated to the equivalent oral temperature standard.
Will not provide valid data in ambient temperatures greater than patient body temperature.
Requires 30 minute warm-up before achieving accurate readings.
Will not operate while exposed directly to sun or other forms of radiant heat.
Measures and displays patient temperature as calibrated to the equivalent oral temperature standard. The APM-2000 Ambulatory Patient Transcutaneous Temperature Monitor is an element of the Sabratek Corporation APM-2000 System.

The document describes the Sabratek APM-2000 Ambulatory Patient Transcutaneous Temperature Monitor, which is an electronic thermometer that measures and displays patient transcutaneous temperature. It has a digital display with a resolution of ± 0.1 F, a warm-up time of 30 minutes, and an accuracy of 0.3° F over a range of 95° F-105° F. It uses a skin surface probe and is powered by a battery.

The document provided is a 510(k) summary for the Sabratek APM-2000 Ambulatory Patient Transcutaneous Temperature Monitor. It outlines substantial equivalence to predicate devices but does not contain detailed information about a study proving the device meets specific acceptance criteria in the format requested.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in a separate section with pass/fail metrics. Instead, it compares the Sabratek APM-2000's parameters to those of predicate devices. The implication is that meeting or being comparable to the predicate's performance makes the device acceptable for market.

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

The document briefly mentions "Non-clinical tests included comparison with temperature standard." However, it does not provide any specific information regarding:

• The exact sample size used for any test set.
• The data provenance (e.g., country of origin, retrospective or prospective nature).

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

The document states that non-clinical tests compared the device with a "temperature standard." It does not mention the involvement of human experts in establishing ground truth for any test set. The ground truth appears to be based on an objective measurement standard.

4. Adjudication Method:

Since no human experts are mentioned in establishing ground truth for a test set, there is no adjudication method described.

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

The document does not describe an MRMC comparative effectiveness study. This device is a transcutaneous temperature monitor, not an AI diagnostic tool that would typically involve human readers to interpret outputs. Therefore, there's no discussion of human readers improving with or without AI assistance.

6. Standalone Performance Study:

The "Non-clinical tests included comparison with temperature standard" can be interpreted as a standalone performance evaluation of the device. However, the details are extremely limited. It does not provide metrics like sensitivity, specificity, or any specific numerical outcomes beyond the accuracy claim.

7. Type of Ground Truth Used:

The ground truth used for the device's evaluation was a "temperature standard." This implies a reference thermometer or a calibrated temperature source.

8. Sample Size for the Training Set:

The document does not mention a training set or any machine learning/AI components that would require one. The APM-2000 appears to be a traditional electronic measurement device.

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

Since there is no mention of a training set, there is no information on how ground truth for a training set was established.

Conclusion:

The K983355 510(k) summary focuses on demonstrating substantial equivalence to predicate devices based on device specifications and a general statement about non-clinical testing against a "temperature standard." It does not provide the detailed study information typically associated with proving a device meets specific acceptance criteria through a rigorous clinical or performance study, especially not for AI/ML-enabled devices that require such extensive validation. The lack of information on sample sizes, expert involvement, and specific study designs is characteristic of 510(k) summaries for less complex devices where performance is primarily demonstrated through comparison with well-established predicate technology.

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Provides controlled delivery of fluids, blood and blood products and can be used in enteral, epidural, subcutaneous, arterial and intravenous applications.

Linear Peristaltic Infusion Pump

Here's an analysis of the provided text regarding the Sabratek 4040 Infusion Pump, focusing on acceptance criteria and the supporting study:

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided information, the key performance characteristic highlighted and compared is the Flow Accuracy.

It's important to note that the document primarily focuses on demonstrating substantial equivalence to predicate devices, rather than setting explicit acceptance criteria for a new device against a predefined benchmark. The "acceptance criteria" here are derived from the performance of the predicate devices. The Sabratek 4040 meets or exceeds the flow accuracy of both predicate devices.

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

The document states: "Non-clinical tests included accuracy testing and comparison with Sabratek's stated accuracy claim and recording of data."

• Sample Size: Not specified. The document does not provide any details regarding the number of units tested, the number of measurements taken, or specific test protocols that would allow for the determination of sample size.
• Data Provenance: The document does not explicitly state the country of origin. Given the submission is to the U.S. FDA, it is highly likely that the testing was conducted domestically (US) or by a manufacturer associated with US regulatory requirements. There is no information to indicate if the data was retrospective or prospective, but for device approval, it would typically be prospective testing specifically for the submission.

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

• Not applicable. This device is an infusion pump, and its "ground truth" for performance is established through objective engineering and metrological measurements (e.g., flow rate calibration, volume dispensed) rather than subjective expert interpretation (like a radiologist reading an image). There would be no need for medical experts to establish a "ground truth" for the device's accuracy performance.

4. Adjudication Method for the Test Set

• Not applicable. As the "ground truth" is based on objective measurements, there would be no subjective interpretations requiring adjudication.

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

• No. An MRMC study is not relevant for an infusion pump. This type of study is typically used for diagnostic or screening devices where human readers interpret medical images or data, and the AI's impact on their performance is evaluated.

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

• Yes, implicitly. The "accuracy testing" mentioned is a standalone performance test of the device itself. The infusion pump operates without human intervention in its core pumping and accuracy functions. The stated performance of "+/-5%" for Flow Accuracy is a standalone performance metric of the device.

7. The Type of Ground Truth Used

• Engineering/Metrological Measurements. The ground truth for infusion pump accuracy is objective and quantifiable. It involves precisely measuring the volume of fluid dispensed over a given time and comparing it to the programmed flow rate. This would involve calibrated equipment and measurement standards.

8. The Sample Size for the Training Set

• Not applicable. This device is a mechanical/electronic infusion pump, not an AI/ML-based device. Therefore, there is no "training set" in the context of machine learning. The device's performance is based on its engineering design, calibration, and manufacturing specifications.

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

• Not applicable. As stated above, there is no training set for this device.

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The Sabratek Patient Home Monitoring System (PHMS), is a physiological data monitoring and communications system intended for use predominately in alternate care settings.

The system consists of three major components as shown in Fig.1. The Ambulatory Patient Monitor (APM-2000) is an ambulatory device that monitors physiological data of the ambulatory patients. The Virtual Hospital Room Communicator (VHRC) is a data storage and transfer device that resides in a patient's home or at an alternate care center. The VHRC has the capability to detect and monitor the APM-2000. A number of peripheral devices such as a Scale, Non Invasive Blood Pressure device (NIBP), Oral Temperature probe and other devices can also be connected to the VHRC. Sabratek has selected peripheral devices with current agency rulings of substantial equivalence for use with the VHRC is accessible by a standard telephone line (POT). The Remote Device Access Software (RDAS) is a Microsoft Windows 95/NT applications program. The program interacts with the Virtual Hospital Room Communicator (VHRC) via modem and standard telephone line. The program collects the data stored in the VHRC and presents the information for review by the caregivers. The program can also control the functions of the APM-2000 and monitor the functions of other devices connected to the VHRC.

The Sabratek Patient Home Monitoring System (PHMS) is a physiological data monitoring and communications system. The device itself is not a diagnostic tool but gathers various physiological data. Therefore, the "acceptance criteria" discussed here relate to the device's technical specifications and engineering performance rather than diagnostic accuracy.

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Acceptance Criteria:

The document states: "NON-CLINICAL TESTING CONCLUSIONS: Engineering bench testing Verification and Validation testing. The Sabratek Patient Home Monitoring System (PHMS) is equivalent in safety and efficacy to its predicate devices."

This indicates that the Sabratek PHMS underwent Engineering bench testing Verification and Validation testing to demonstrate its equivalence in safety and efficacy to predicate devices. The details of these tests are not provided in the summary.

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

The document does not provide details on the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). This information would typically be found in detailed verification and validation reports, which are not included in this summary.

3. Number of Experts and Qualifications for Ground Truth:

The document does not mention the use of experts to establish ground truth for a test set. This is consistent with the nature of the device, which is for physiological data monitoring rather than diagnostic interpretation. The acceptance criteria focus on technical performance metrics (e.g., accuracy of respiration rate, ECG recording capability).

4. Adjudication Method for the Test Set:

No adjudication method is mentioned, as the reported testing appears to be non-clinical engineering bench testing focusing on technical specifications rather than human interpretation or diagnostic accuracy.

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

No MRMC comparative effectiveness study was done. The device is a monitoring system and does not involve human readers interpreting data from the device in a comparative effectiveness study scenario to improve diagnostic accuracy.

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

The evaluation described as "Engineering bench testing Verification and Validation testing" implies a standalone performance assessment of the device's ability to accurately measure and record physiological data according to its specifications, without human intervention in the primary data acquisition and processing steps that define these metrics. However, the document does not explicitly state "standalone performance."

7. Type of Ground Truth Used:

The ground truth for the device's performance, such as respiration rate accuracy or ECG recording capability, would have been established through calibrated instruments and reference standards during the engineering bench testing. For example, a known, precisely controlled respiration rate would be used to test the device's respiration rate measurement, or a calibrated signal generator for ECG. The document implicitly relies on the technical specifications and performance of the listed component sensors (e.g., Pro-Tech 1246 for respiration, Nonin OEM II for pulse oximetry, AND Medical for NIBP) which themselves would have been validated against their respective ground truths.

8. Sample Size for the Training Set:

The document does not refer to a "training set" as the device is a hardware system for physiological monitoring, not an AI/machine learning algorithm requiring a separate training set.

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

Not applicable, as there is no mention of a training set for an AI/machine learning algorithm.

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