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TeleMon is indicated for use in the monitoring, recording, and alarming of multiple physiologic parameters in adult and pediatric patients to gain information for treatment, to monitor adequacy of treatment, or to exclude causes of symptoms.

TeleMon is a prescription devices for use in healthcare facilities by trained healthcare professionals. TeleMon is not intended for home use.

The Agilent M2636B TeleMon B Monitor is an upgraded version of the current M2636A TeleMon, which is an extension device for the M2600A Telemetry System. The modification in this submission is the addition of audible alarms, the display of pulse and PVC rate numerics, a software upgradeable NBP module with improved measurement time, and the addition WaveViewer functionality to the M2636A TeleMon B Monitor, a multi-parameter monitor as an extension to the M2600A Telemetry System. The new device will be known as the M2636B TeleMon B Monitor.

The provided text is a 510(k) summary for the Agilent M2636B TeleMon B Monitor. It describes an upgrade to an existing device and primarily focuses on demonstrating substantial equivalence to previously cleared devices rather than providing detailed acceptance criteria or a specific study proving the device meets those criteria in the way one might find for a novel device with specific performance metrics.

However, based on the available information, here's an attempt to extract and infer the closest information to your requested categories:

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

The document does not provide a table with specific, quantitative acceptance criteria and corresponding reported device performance values in the typical sense of a clinical or performance study.

Instead, the acceptance criteria are implicitly tied to the performance specifications of the predicate devices. The document states:

"Pass/fail criteria are based on the specifications cleared for the predicate devices to demonstrate substantial equivalence."

This implies that the M2636B TeleMon B Monitor is expected to perform at least as well as, or within the accepted specifications of, the legally marketed predicate devices, particularly the M2636A TeleMon Monitor.

The "reported device performance" is not explicitly quantified but is implicitly stated to be in compliance with the predicate device's performance through the substantial equivalence argument. The modifications (audible alarms, display of pulse and PVC rate numerics, improved NBP module, WaveViewer functionality) are presented as additions/improvements, not as changes to core performance that would necessitate new, specific performance studies beyond ensuring they integrate safely and effectively within the existing framework.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify a "test set" in the context of a clinical study with a sample size. The testing activities mentioned are primarily related to design controls, system-level tests, integration tests, safety tests, interference testing, and hardware testing. These are typically engineering verification and validation activities, not clinical trials with patient data.

Therefore, there is no information on:

• Sample size used for a test set.
• Data provenance (country of origin, retrospective/prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable, as no clinical "test set" requiring expert-established ground truth is described in the provided text. The submission focuses on substantial equivalence based on engineering and performance specifications relative to predicate devices.

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

Not applicable, as no clinical "test set" requiring adjudication for ground truth is described.

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. This device is a multi-parameter patient monitor, not an AI-assisted diagnostic tool that would involve human readers or an MRMC study to assess diagnostic improvement.

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

Not applicable. This device is not an algorithm for medical image analysis or a similar application where standalone algorithm performance would be assessed in isolation. It is a monitoring device that presents physiological data to healthcare professionals.

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

Not applicable, as there is no mention of a study involving ground truth in the context of clinical performance data. The "ground truth" for this device's performance would be its accurate measurement and display of physiological parameters as defined by its technical specifications and comparison to established medical standards (e.g., accuracy of ECG, NBP measurements) which are implicitly covered by its predicate devices.

8. The sample size for the training set

Not applicable. The document does not describe any machine learning or AI components that would require a "training set."

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

Not applicable. As no training set is described, there is no information on how its ground truth would be established.

Summary of Study (as described in the 510(k) context):

The "study" described in this 510(k) is primarily focused on design controls, verification, validation, and testing activities to ensure the new M2636B TeleMon B Monitor meets the safety, performance, and reliability characteristics established for its predicate devices.

The key statement regarding this "study" is:

"Verification, validation, and testing activities will be successfully conducted prior to commercialization to establish the safety, performance, and reliability characteristics of the M2636B TeleMon B Monitor. Testing involves system level tests, integration tests, safety tests from hazard analysis, interference testing, and hardware testing. Pass/fail criteria are based on the specifications cleared for the predicate devices to demonstrate substantial equivalence."

This indicates an engineering and regulatory compliance approach to demonstrating equivalence, rather than a clinical trial with specific patient-based performance metrics against a clinical ground truth. The acceptance is based on meeting the established specifications of the M2636A TeleMon Monitor (K001436) and other predicate devices in terms of functionality and safety.

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The M1205A OmniCare Component Monitoring System is intended for monitoring, recording, and alarming of multiple physiological parameters for adult, neonatal and pediatric patients in the hospital environment. There was no change to the intended use statement.

HP M1205A OmniCare Component Monitoring System Rev. E (Rev. D is not used for this product) is a modification of OmniCare Model 24 Rev. C. Modification of the device was limited to three of 29 functional blocks of software that comprise the OmniCare Model 24 Product (originally cleared under K950821). Changes to the OmniCare Model 24 device software were confined to the ECG/ Respiration, CO2 and SpO2/PLETH functional blocks. Modification was accomplished by reusing and leveraging software originally developed for CMS Rev. D (K941811). No new software was designed for this device. For that reason, the modification and this notification are nearly identical to that of the previously modified CMS device.

Analysis of K960934 for Acceptance Criteria and Study Details

Based on the provided text for K960934, the information regarding acceptance criteria and detailed study methodology is very limited. This 510(k) summary primarily focuses on describing the nature of the modification to an existing device rather than presenting a new, comprehensive validation study with explicit performance metrics.

Here's an attempt to extract and infer information based on the provided text, along with a clear indication of what is not present:

1. Table of Acceptance Criteria and Reported Device Performance

Critique: The summary does not explicitly state quantitative acceptance criteria for specific performance metrics (e.g., accuracy, precision, sensitivity, specificity for alarm detection or parameter measurement). Instead, it relies on the concept of "substantial equivalence" and the reuse of previously validated software. The "reported device performance" is a general statement of equivalence and the fact that validation was performed, not specific data points.

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

• Sample Size for Test Set: Not specified. The document mentions "device validation" and "validation results," but no details on the number of patients, data points, or scenarios used in the testing.
• Data Provenance: Not specified. It's unclear if the validation involved clinical data, simulated data, or a combination. The country of origin and whether the data was retrospective or prospective are also not mentioned.

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

• Not applicable/Not specified. Given the nature of a multi-parameter physiological monitor, ground truth would typically be established by calibrated reference devices and expert clinical assessment during the validation process (e.g., confirming the accuracy of displayed parameters against a gold standard). However, the number of experts, their qualifications, and their role in establishing "ground truth" for a test set are not detailed in this summary.

4. Adjudication Method for the Test Set

• Not applicable/Not specified. Since there's no mention of specific human-reviewed "ground truth" or a test set requiring adjudication in the context of diagnostic interpretation, an adjudication method is not described.

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

• No. This type of study is typically conducted for diagnostic imaging devices or algorithms where human readers interpret medical images. For a physiological monitoring system, an MRMC study is generally not relevant or performed. The focus is on the accuracy of the measurements and alarms.

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

• Implied, but not explicitly detailed. The validation mentioned ("OmniCare Model 24 was thoroughly validated in R&D and in the SQE department") would inherently involve testing the device's algorithms and sensors "standalone" to ensure they accurately measure and display physiological parameters and trigger alarms. However, the summary does not provide specifics of such a study or its results.

7. The Type of Ground Truth Used

• Inferred: Reference device measurements and clinical assessment. For physiological monitoring, ground truth is usually established by comparing the device's readings (ECG, SpO2, CO2 values) against highly accurate, calibrated reference instrumentation or direct clinical observations made by qualified personnel. The summary does not explicitly state the type of ground truth used.

8. The Sample Size for the Training Set

• Not applicable/Not specified. This device is described as a "modification" by reusing and leveraging software from a previous 510(k) cleared device (K941811). This suggests that the core algorithms were already developed and validated. If machine learning was involved (which is not indicated for this type of device at that time), a training set would be relevant, but it's not mentioned here as a new development.

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

• Not applicable/Not specified. As there's no mention of a new training set, the method of establishing its ground truth is not discussed.

Conclusion regarding K960934:

The provided 510(k) summary for K960934 is a class 2 device (predicate device modification) clearance, not a de novo clearance requiring extensive new clinical trial data. It primarily emphasizes that the changes to the software are minor (three out of 29 functional blocks) and that this modified software was already leveraged from another cleared device (K941811). Therefore, the validation relies heavily on the premise of substantial equivalence to the original OmniCare Model 24 (cleared under K950821) and the previous validation of the reused software.

This type of summary is typical for minor modifications where new, extensive validation studies with explicit acceptance criteria tables and detailed performance metrics are often not required, as the performance is assumed to be substantially equivalent to the already cleared predicate. The "study" referenced is the "validation results" that supported the claim of substantial equivalence, but the specifics of that validation are not provided in this summary.

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