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The intended use of this software is to measure: heart rate, respiration rate, invasive blood pressure, noninvasive blood pressure, cardiac output, gaseous carbon dioxide level, temperature, artial oxygen concentration and pulse rate in neonatal patients and to detect ventilator performance and electroencephalograph waveforms. The software will produce visual and aural alarms if any of these parameters vary beyond preset limits.

The 960/1260/1280 Series Neonatal Monitoring is an enhanced software version of the 960/1260/1280 Series monitors. The enhanced version increases the patient population to include neonates along with the pediatric and adult patient covered by earlier versions of these products. The enhanced software (version VH4-HXE) is fully compatible with previously sold versions of these monitors. A retrofit will be offered to the owners of units with the previous revision software (version VGx-HXE and VHx-HXE) where x is the revision number. The Neonatal Monitors use the same hardware with enhanced software to accommodate the neonatal population of patients.

The provided text describes a 510(K) submission for an enhanced software version of the Siemens Sirecust 960/961, 1260/1261, and 1280/1281 Series Neonatal Monitors. The enhancement specifically increases the patient population to include neonates.

However, the document does not contain specific acceptance criteria tables, reported device performance metrics, or details of a study that directly proves the device meets such criteria for the enhanced software version. Instead, it relies on demonstrating substantial equivalence to a predicate device (Siemens Neonatal Monitor Model 404N, K844187/A).

Here's an analysis based on the information provided, highlighting what is present and what is missing:

1. Table of acceptance criteria and the reported device performance

• Missing from the document. The document states:
  • "The Neonatal Monitors use the same hardware with enhanced software to accommodate the neonatal population of patients."
  • "The performance specifications for the neonatal applications are identical to the performance specifications of the Siemens Medical Systems Neonatal Monitor Model 404N (reference 510(K) K844187/A)"
• Implication: The acceptance criteria are implicitly those established for the predicate device, Model 404N. The reported performance is asserted to be "identical" to the predicate device, suggesting a claim of equivalence rather than a new empirical performance evaluation with defined acceptance criteria. Specific numerical performance metrics (e.g., accuracy, precision for heart rate, respiration, BP, etc., in neonates) are not provided in this document.

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

• Missing from the document. There is no mention of a specific clinical "test set" or data used to evaluate the enhanced software's performance in neonates.
• The argument for substantial equivalence relies on the software being "the same" as the predicate device's software, and the enhanced version is "fully compatible with previously sold versions of these monitors." This suggests that new clinical data specific to the neonatal population for this enhanced software might not have been generated for this 510(K) submission.

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)

• Missing from the document. No information is provided regarding experts, ground truth establishment, or clinical studies for this specific submission.

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

• Missing from the document. No information is provided as no specific "test set" or clinical study with adjudication 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 physiological monitor, not an AI-assisted diagnostic tool for human readers. No MRMC study is mentioned or relevant to this type of device.

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

• The document implies a standalone performance assertion based on equivalence. It states: "The performance specifications for the neonatal applications are identical to the performance specifications of the Siemens Medical Systems Neonatal Monitor Model 404N". This suggests that the standalone performance is considered equivalent to the predicate device, which would have had its own standalone performance validated. However, details of this specific device's standalone performance in neonates (other than claiming it's "identical" to the predicate) are not provided.

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

• Missing from the document for this submission. For a physiological monitor, "ground truth" would typically come from highly accurate reference measurement devices or established clinical standards. However, the document relies on the predicate device's established ground truth and performance validation.

8. The sample size for the training set

• Not applicable / Missing from the document. This submission is for an enhanced software version for a physiological monitor, not a machine learning model requiring a distinct training set in the typical sense. If the software involved algorithms, their development would have been part of the Siemens Product Planning Process, but specific training set sizes are not mentioned.

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

• Not applicable / Missing from the document. As above, this is generally not relevant for this type of device in the context of this 510(K) summary.

Summary of Device Acceptance & Study Evidence from the Provided Text:

The provided document details a 510(K) submission based on substantial equivalence to an existing predicate device (Siemens Neonatal Monitor Model 404N).

The core argument is that:

• The enhanced software is the "same as the software used in the predicate device" (Model 404N) and has the "same intended use."
• "The performance specifications for the neonatal applications are identical to the performance specifications of the Siemens Medical Systems Neonatal Monitor Model 404N."
• "The 960/1260/1280 Series Neonatal Monitoring is an enhanced software version of the 960/1260/1280 Series monitors. The enhanced version increases the patient population to include neonates along with the pediatric and adult patient covered by earlier versions of these products."

Therefore, the "study" proving the device meets acceptance criteria is implicitly the original validation study of the predicate Model 404N, combined with a demonstration that the enhanced software for the Sirecust series maintains identical performance specifications and uses the same core software for neonatal applications. The document does not describe new, specific clinical studies or performance evaluations for this enhanced software version. It primarily relies on regulatory precedent and a direct comparison to an already cleared device.

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