(124 days)
The HomMed Sentry III Patient Monitor System with Card Reader is intended for in home and/or healthcare facility applications under physician orders. The Card Reader with the HomMed Sentry III Patient Monitor System allows patients to use multiple Sentry III monitors or multiple patients to use the same Sentry III monitor. The use of the system is to allow retrospective review of certain patient physiological functions. The HomMed Sentry III Patient Monitor System with Card Reader can measure and display patient data including noninvasive blood pressure, pulse rate, oral temperature, oximetry, and weight. Additionally, the patient vital signs data can be communicated to a central review station via a pager network with a backup landline telephone modem for telephone communication with the central pager network if necessary.
The HomMed Sentry III Patient Monitor System with Card Reader is a portable patient vital signs monitoring system which allows patients to use multiple Sentry III monitors or multiple patients to use the same Sentry III monitor. The system measures noninvasive blood pressure, pulse rate, oral temperature, oximetry, and weight. In addition, the system has optional glucometry and spirometer measuring capabilities. The Sentry III Patient Monitor with Card Reader acquires the patient vital signs data and displays it. The data can also be transmitted via the communication system through the Skytel Pager Network to a central station for storage with retrospective display and analysis. The Card Reader with the HomMed Sentry III Patient Monitor System allows patients to use multiple Sentry III monitors or multiple patients to use the same Sentry III monitor.
The provided text describes the HomMed Sentry III Patient Monitor System with Card Reader but does not contain the specific details required to fully address your request regarding acceptance criteria and a definitive study demonstrating direct device performance against those criteria.
The document is a 510(k) summary indicating substantial equivalence to a predicate device and compliance with general standards, rather than detailing a specific clinical performance study with clear acceptance criteria and resulting data.
Therefore, I can only provide information based on what is available in the text and indicate where information is missing.
Here's an attempt to answer your questions based on the provided text, highlighting what is present and what is not:
HomMed Sentry III Patient Monitor System with Card Reader
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided text, specific numerical acceptance criteria (e.g., accuracy ranges for NIBP, SpO2, etc.) and corresponding detailed device performance results are NOT explicitly stated in a table format. The document focuses on demonstrating substantial equivalence and compliance with general standards.
However, the text implies that the device performs:
| Parameter / Criterion | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Overall Performance | Substantial equivalence to predicate device (HomMed Sentry III Patient Monitor System) and compliance with relevant standards. | "The performance of each component of the HomMed Sentry III Patient Monitor System with Card Reader has been confirmed to be equivalent to the predicate device HomMed Sentry III Patient Monitor System." |
| "The HomMed Sentry III Patient Monitor System with Card Reader performs consistent with guidelines and standards found in the FDA reviewer's guides for respiratory devices and electronic thermometers." | ||
| "The test results demonstrated that the Sentry III System with Card Reader is in compliance with the guidelines and standards referenced in the FDA reviewer's guides and that it performed within its specifications and functional requirements." | ||
| NIBP (Systolic, Diastolic, MAP) | Accurate, reliable measurements on pediatric to adult patients. | "The device will provide fast, reliable measurements on patients ranging from children (pediatrics) to adults when using the appropriate blood pressure cuff." (Implied to meet expectations based on substantial equivalence) |
| Pulse Oximetry (SpO2, Pulse Rate) | Accurate, reliable measurements on pediatric to adult patients. | "The pulse oximetry works with Sentry III Patient Monitor System pulse oximetry probes provided by HomMed, providing Sp02 and pulse rate on all patients from pediatric to adult." (Implied to meet expectations based on substantial equivalence) |
| Oral Temperature | Accurate measurements. | "The electronic thermometry requires use of the Welch Allyn oral thermometry probe and probe covers. It provides only oral temperature information." (Implied to meet expectations based on substantial equivalence) |
| Weight | Accurate measurements. | Measured via an electronic scale. (Implied to meet expectations based on substantial equivalence) |
| EMC, Electrical, Mechanical Durability, Safety, Temp/Humidity | Compliance with applicable standards. | "EMC, electrical, mechanical durability, safety (operator and patient), and temperature/humidity testing has been completed demonstrating compliance with applicable standards." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a sample size for a test set or clinical study. It mentions "testing has been completed" to demonstrate compliance with standards and guidelines, but details about the nature of this testing (e.g., number of subjects, whether it was a clinical trial, or internal lab testing) and its provenance (e.g., country of origin, retrospective/prospective) are not provided.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This information is not provided in the document. Given that the document focuses on substantial equivalence and engineering/compliance testing rather than a de novo clinical validation study with expert-established ground truth, it's unlikely this type of detail would be present.
4. Adjudication Method for the Test Set
The document does not mention any adjudication method for a test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
A MRMC comparative effectiveness study is not mentioned in the document. This type of study would typically assess the impact of AI assistance on human reader performance, which is not the focus of this 510(k) summary for a patient monitoring system.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The HomMed Sentry III Patient Monitor System is a device that provides measurements for human review. While it implicitly performs "standalone" measurement capture (e.g., NIBP, SpO2 algorithmically determine values from raw physiological signals), the document does not explicitly detail an "algorithm only" performance study in the context of an AI-driven standalone assessment. The focus is on the device's ability to capture and transmit vital signs.
7. The Type of Ground Truth Used
The document does not explicitly state the "type of ground truth" used for performance validation. Instead, it relies on:
- Comparison to a predicate device: The HomMed Sentry III Patient Monitor System.
- Compliance with established standards and guidelines: "FDA reviewer's guides for respiratory devices and electronic thermometers," EN 60601-1, IEC 601-1-2, ISO 10993-5, 10-11.
For individual measurements (e.g., blood pressure, SpO2), the implicit ground truth would be established using reference standard measurement devices during engineering and performance testing.
8. The Sample Size for the Training Set
The document does not mention a training set sample size. This device is a vital signs monitor, not typically an AI/machine learning device that requires a distinct "training set" for model development in the way an imaging AI algorithm would. Its underlying algorithms for vital sign extraction are likely well-established and pre-programmed, not "trained" in the modern ML sense.
9. How the Ground Truth for the Training Set Was Established
As there is no mention of a training set, there is no information on how its ground truth would have been established.
In summary: The provided text is a 510(k) summary for a patient monitor system, demonstrating substantial equivalence to a predicate device and compliance with relevant safety and performance standards. It successfully obtains FDA clearance based on these aspects. However, it does not detail specific acceptance criteria in a quantitative table or provide specifics about clinical study designs, sample sizes, expert ground truth establishment, or AI-specific performance metrics (like MRMC studies), which are more commonly found in submissions for diagnostic AI algorithms.
§ 870.2700 Oximeter.
(a)
Identification. An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.(b)
Classification. Class II (performance standards).