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For central monitoring of adult, pediatric, and neonatal patients; and where the clinician decides to monitor cardiac arrhythmia of adult, pediatric, and neonatal patients and/or ST segment of adult patients to gain information for treatment, to monitor adequacy of treatment, or to exclude causes of symptoms.

The Philips Drug Calculator Software served by the Philips IntelliVue application server software (M2387A Application Server Software). The modification is primarily a software based change that incorporates the Rule of Six algorithm for IV drug computations in 100 mL IV bags.

The provided text describes a 510(k) premarket notification for the Philips Drug Calculator Software. However, the documentation focuses primarily on the regulatory aspects of substantial equivalence and does not contain the specific details required to answer all questions about acceptance criteria and a dedicated study proving device performance against those criteria.

Here's what can be extracted and what information is missing:

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

The document does not explicitly list acceptance criteria or specific reported device performance in a quantitative manner. It states:

• "Verification testing activities were conducted to establish the performance and reliability characteristics of the new device with respect to the predicate."
• "Pass/Fail criteria were based on the specifications cleared for the predicate devices and test results showed substantial equivalence."

This indicates that internal specifications and the performance of predicate devices served as benchmarks, but the actual criteria and performance metrics are not detailed.

Missing Information for 2-9:

The provided text focuses on the 510(k) summary for the Philips Drug Calculator Software, emphasizing its substantial equivalence to previously cleared devices. It states that "Verification testing activities were conducted to establish the performance and reliability characteristics of the new device with respect to the predicate," and that "Pass/Fail criteria were based on the specifications cleared for the predicate devices and test results showed substantial equivalence."

However, the document does not provide the detailed information requested regarding sample sizes, data provenance, expert involvement, adjudication methods, details of comparative effectiveness studies (MRMC), standalone performance, types of ground truth, or training set specifics. The document is a regulatory submission summary, not a detailed study report.

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The HP ORVue Intra-Op [M2510A] Intraoperative Recording System is indicated for use in healthcare facilities by healthcare professionals whenever there is a need for a anesthesia record. This product is indicated for all patients requiring a anesthesia record. The specific medical indication for use of this device is:

• This device is a prescription device.
• This device is not intended to contact the patient.
• This device is used continuously in Operating Theatres during Anesthesia
• The Recording of calculations (Fluid, Hemodynamic, Renal, Oxygenation and Ventilation) indicated for any patient who will have medication administered and which requires dose computation.
• The physiological purpose is indirect. The device is intended to gather and store patient information during Anesthesia, and to document computed calculations as needed by care providers.

The HP ORVue Intra-Op [M2510A] Intraoperative Recording System is a product that provides documentation of all anesthesiarelevant information, replacing parts (or all) of the paperchart of the anesthesia protocol in the operating theatre. ORVue Intra-Op [M2510A] is easily adaptable to different types of anesthesia by means of multiple anesthesia-specific configurations designed to automate the charting process and address the needs of health care providers. It is capable of providing the following six reports: Anesthesia Report One Time, Anesthesia Report Continuous, Billing Report, QA Report, Graphics Report, Notes Report, whereas the anesthesia report contains the following information : Medication trends (Drugs/Gases and Infusions/Transfusions), Parameter trends, List of entries, IV/IA lines, Surgical information, Anesthesia information, Equipment used, Transfusions administered, Anesthesia times, Personnel involved, Discharge location. Summary of anesthesia, Post-op orders, Space for additional notes. It is also capable of accessing data automatically from other HP and Non-HP devices/systems (such as Infusion pumps, computer systems (Database) and medical devices).

The provided text describes the HP ORVue Intra-Op [M2510A] Intraoperative Recording System, a device for documenting anesthesia-related information. However, it does not contain the specific details required to complete all sections of your request regarding acceptance criteria and a study proving device performance.

Specifically, the document is a 510(k) premarket notification letter, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study with specific performance metrics and acceptance criteria.

Here's what can be inferred and what information is missing based on your request:

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

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 for test set: Not mentioned.
• Data provenance: Not mentioned.

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 mentioned.

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

• Not mentioned. The document primarily discusses software validation and substantial equivalence, not a performance study with a test set.

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

• MRMC study: Not mentioned. This device is an intraoperative recording system, not an AI diagnostic tool that would typically involve human readers. Its primary function is documentation and calculation.
• Effect size of human improvement with AI: Not applicable for this device as described.

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

• The document states, "All of the processes for safe software development that were used to develop original device were followed and the software was fully validated." This implies internal software testing, but details on standalone performance (e.g., specific metrics for calculation accuracy) are not provided in this excerpt. The calculations themselves are stated to be "identical" to previously cleared devices, suggesting reliance on the established performance of those predicate devices.

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

• For the "Recording of Calculations" functionality, the ground truth for the calculations would likely be the mathematical algorithms and formulas themselves, validated against established medical science or engineering principles, similar to the predicate devices. The document explicitly states the calculations are "identical" to already cleared devices, suggesting their accuracy was established through comparison with these existing, validated systems.

8. The sample size for the training set

• Not applicable. This device is not described as an AI/ML device that requires a training set in the typical sense for learning patterns from data. Its functionality involves executing predefined calculations and recording. "Software validation" refers to ensuring the software performs its intended functions correctly, not training a model.

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/ML model. The "ground truth" for the software validation would be the specifications and requirements for the calculations and recording functions, which are verified through testing to ensure the software performs as designed.

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