(117 days)
The HomMed Model Sentry patient monitor system is for spot checking of adult or pediatric patient's systolic, diastolic and mean arterial (MAP) blood pressures, pulse rate, SpO2 oximetry and oral temperature. The device will provide fast, reliable NIBP measurements on patients when using the appropriate blood pressure cuff. The oximetry function operates with all OEM (BCI) oximetry sensors, providing SpO2 and pulse rate on all patients from pediatric to adult patients. The electronic thermometry is intended for oral temperature measurements and is only compatible with the Welch Allyn thermometry probes and probe covers. The device is intended for use in clinical environments by health care providers and for home use by patients with retrospective review by health care providers.
HomMed Model Sentry patient monitor provides a manually initiated sequence of automatic patient measurements. The Sentry patient monitor consists of a small tabletop NIBP monitor with a desktop Features include an NIBP cuff hose connection, an SpO2 sensor interface, a oral charger. temperature probe interface and holder, display of patient systolic, diastolic, and mean arterial pressure, interval timer, SpO2, pulse rate, pulse strength, temperature via an LED display.
The HomMed Model Sentry is the existing presently marketed BCI Mini-Torr Plus noninvasive blood pressure (NIBP) monitor with oximeter and electronic thermometer options with certain defeatures implemented via software toggle off/on function controls. The BCI Mini-Torr Plus monitor has a FDA 510(k) approval, Number K983796.
The provided text describes a 510(k) submission for the HomMed Model Sentry patient monitor. However, the document explicitly states that no additional performance testing was conducted for the HomMed Model Sentry. Instead, its performance is considered equivalent to its predicate device, the BCI Model 6004, which had already met applicable FDA requirements.
Therefore, the HomMed Model Sentry itself did not undergo a study to prove it meets specific acceptance criteria. Its acceptance is based on the substantial equivalence principle, drawing upon the pre-existing performance data of the BCI Model 6004.
Given this, I cannot provide an answer that fully addresses all points of your request as the specific performance study for the HomMed Model Sentry, and thus its unique acceptance criteria and study details, are not present in the provided text.
However, I can extract the relevant information regarding the basis for its acceptance:
1. A table of acceptance criteria and the reported device performance
Since no new performance testing was conducted for the HomMed Model Sentry, there are no specific new acceptance criteria or reported device performance metrics unique to this device in the provided text. The device's acceptance is based on the performance of its predicate device, the BCI Model 6004. The HomMed Model Sentry is stated to perform "within its specifications and functional requirements," which are implicitly those of the BCI 6004.
- Acceptance Criteria (Implicit, based on predicate): Compliance with guidelines and standards referenced in FDA reviewer's guides for respiratory devices and electronic EMC, electrical, mechanical durability, safety (operator and patient), and thermometers.
- Reported Device Performance (Implicit, based on predicate): The Sentry "performed within its specifications and functional requirements" and its performance "remains unchanged" from the BCI 6004.
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, as no new testing was performed for the HomMed Model Sentry. The predicate device's testing details are not provided.
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, as no new testing was performed for the HomMed Model Sentry.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no new testing was performed for the HomMed Model Sentry.
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 device is a patient monitor, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable, as no new testing was performed for the HomMed Model Sentry. The device is an integrated patient monitor with hardware and software elements, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable, as no new testing was performed for the HomMed Model Sentry. The predicate device's testing would have used established reference methods for vital sign measurements (e.g., direct arterial line for NIBP, calibrated temperature probes for temperature).
8. The sample size for the training set
Not applicable, as no new testing was performed for the HomMed Model Sentry, and the device is not described as having an AI component that would require a "training set" in the typical machine learning sense.
9. How the ground truth for the training set was established
Not applicable, as no new testing was performed for the HomMed Model Sentry, and the concept of a "training set" is not relevant to the described device.
§ 870.1130 Noninvasive blood pressure measurement system.
(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).