(210 days)
The intended use statement for the device is to measure heart rate, respiration rate, invasive pressure, non-invasive pressure, arrhythmia(only for adults), temperature, SpO2 and central apnea. The device will produce visual and aural alarms if any of the above parameters vary beyond preset limits and produce timed or alarm recordings.
The SC 6000 and SC 6000P Portable patient monitors with neonatal monitoring enhancement are software enhanced versions of the SC 6000 and SC 6000P Portable patient monitors. The software modifications have been undertaken to expand the Intended Patient Population from pediatric and adults to also include neonatal patients.
The provided text describes the Siemens SC 6000 & SC 6000 P Neonatal Monitoring Enhancement, which is a software upgrade to expand the intended patient population of existing monitors to include neonatal patients. The filing is a 510(k) submission, comparing the enhanced device to a predicate device (Siemens SIRECUST 1261).
Here's an analysis of the provided information against your requested criteria:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria here are implicitly the specifications of the predicate device, as the submission aims to demonstrate substantial equivalence. The reported device performance is the specifications of the SC 6000 & SC 6000 P.
| Parameter | Acceptance Criteria (Predicate Device: SIRECUST 1261 Specification) | Reported Device Performance (SC6000 & SC6000 P Specification) |
|---|---|---|
| ECG & Heart Rate | ||
| Available leads | I, II, III, aVR, aVF, aVL, V | I, II, III, aVR, aVF, aVL, V |
| Measuring range | 15 - 300 bpm | 15 - 300 bpm |
| Accuracy | ± 10% for 15 - 300 bpm | ± 5% for 15 - 200 bpm |
| ± 8% for 201 - 300 bpm | ||
| Respiration | ||
| Method | Impedance pneumography | Impedance pneumography |
| Measuring range | 2 - 155 breaths per min. | 2 - 155 breaths per min. |
| Measuring accuracy | ± 3 bpm | ± 3 bpm |
| Apnea Detection? | Yes | Yes |
| SpO2 | ||
| Measuring method | Absorption-spectrophotometry | Absorption-spectrophotometry |
| Measuring range | 1 - 100% | 1 - 100% |
| Pulse Rate | 30 - 300 bpm | 30 - 300 bpm |
| SpO2 Accuracy (Range 70 - 100%) | ± 2% | ± 2% |
| SpO2 Accuracy (Range 0 - 69%) | not specified | not specified |
| Pulse Rate Accuracy | ± 10% | ± 10% |
| Temperature | ||
| Measurement Range | -5° C to 50° C | 0° C to 50° C |
| Accuracy (Range 30 - 50°C) | ± 0.1°C | ± 0.1°C |
| Accuracy (Range 0 - 30°C) | ± 0.2°C | ± 0.2°C |
| Non Invasive Blood Pressure (NBP) | ||
| Parameter display | Systolic, Diastolic, Mean | Systolic, Diastolic, Mean |
| Measuring method | Oscillometric technique | Oscillometric technique |
| Measurement range (heart rate) | 40-240 bpm | 40-240 bpm |
| Measurement range (systolic) | 30-130 mmHg | 30-130 mmHg |
| Measurement range (mean) | 20-110 mmHg | 20-110 mmHg |
| Measurement range (diastolic) | 10-100 mmHg | 10-100 mmHg |
| Initial inflation pressure | 110 mmHg +/- 15 mmHg | 110 mmHg +/- 15 mmHg |
| Static cuff accuracy | ± 3 mmHg | ± 3 mmHg |
| Invasive Blood Pressure (IBP) | ||
| Measuring method | resistive strain gauge transducer | resistive strain gauge transducer |
| Measuring range | -50 to + 399 mmHg | -50 to + 399 mmHg |
| Accuracy (exclusive of transducer) | ± 2 mmHg | ± 2 mmHg |
| Transducer specifications | Siemens-approved transducers with a resistance of 200 to 3000 Ω and an equivalent pressure sensitivity of 5uV/V/mmHg + 10% | Siemens-approved transducers with a resistance of 200 to 3000 Ω and an equivalent pressure sensitivity of 5uV/V/mmHg ± 10% |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The provided text mentions "validation results and other information in this submission" but does not specify the sample size, data provenance (country of origin), or whether the data was retrospective or prospective for any test sets used.
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)
The document does not provide any information regarding the number of experts used, their qualifications, or how ground truth was established for a test set. This type of information is typically related to clinical trials or performance testing involving human interpretation, which is not detailed here.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not provide any information about an adjudication method. This is relevant for studies where multiple experts assess data, and discrepancies need to be resolved.
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
This is not applicable. The device is a patient monitoring system, not an AI-assisted diagnostic tool that human readers would use to interpret cases. The submission is for a software enhancement to expand the patient population, focusing on technical specifications for vital sign monitoring.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The provided text describes a "software enhanced version" of existing patient monitors. The performance metrics presented (e.g., accuracy of heart rate, SpO2, blood pressure) are inherently "standalone" in the sense that the device outputs these measurements automatically. The "validation results" mentioned implicitly refer to testing the device's ability to accurately measure these parameters without human intervention in the measurement process itself. However, the document does not explicitly describe a study designed to evaluate standalone algorithm performance in isolation from the hardware.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Given that this is a patient monitoring device, the ground truth for parameters like heart rate, respiration rate, SpO2, and blood pressure would typically be established using reference medical devices or gold standard measurement techniques. For example:
- Heart Rate/Respiration: Manually counted by trained personnel, or derived from reference ECG/respiration waveforms.
- SpO2: Measured by a highly accurate reference oximeter or blood gas analysis.
- Blood Pressure: Measured directly via arterial line (for invasive) or by a validated reference oscillometric or auscultatory method (for non-invasive).
However, the document does not explicitly state the type of ground truth used for its validation. It refers to "validation results," but doesn't detail the methodology.
8. The sample size for the training set
The document does not mention any training set or its sample size. This is common for 510(k) submissions for non-AI devices, where performance is often evaluated against engineering specifications and predicate device equivalence rather than machine learning model training.
9. How the ground truth for the training set was established
As no training set is mentioned (see point 8), there is no information on how its ground truth was established.
§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.