(117 days)
Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Intended for monitoring, recording and alarming of multiple physiological parameters of adults, pediatrics and neonates in patient transport and hospital environments.
The picoSAT II SpO2 pulse oximetry module for use in host patient monitors.
The Philips Medical Systems picoSAT II SpO2 pulse oximetry module (K030973) is intended for monitoring, recording, and alarming of multiple physiological parameters (SpO2 and pulse rate) in adults, pediatrics, and neonates within hospital and patient transport environments.
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
| Item | Acceptance Criteria (Specification) | Reported Device Performance (Provided as Specification) |
|---|---|---|
| SpO2 Accuracy (functional) over range of 70% to 100% for neonates through adults (reusable probes) | Not explicitly stated as "acceptance criteria", but implied by device specification. | M1191A and M1192A: ± 2.5% |
| M1193A and M1195A: ± 3.0% | ||
| M1194A: ± 3.0% (adult only) | ||
| SpO2 Accuracy (functional) over range of 70% to 100% for adults and neonates (disposable probes) | Not explicitly stated as "acceptance criteria", but implied by device specification. | M190xA and Nellcor®: ±3.0% |
| Perfusion Indicator | >0.3 indicates that >95% of the time signals are good enough for valid measurements. At 0, no measurement is made. | An indicator of SpO₂ signal quality |
0.3 indicates that >95% of the time
signals are good enough for valid
measurements.
At 0, no measurement is made. (This is a description, and implies the device meets this rule.) |
| NBP cuff inflation detection suppression of SpO2 INOPs & parameter output | SpO₂ and pulse rate parameter output and the SpO₂ Non-pulsatile and Pleth Non-pulsatile INOPS are suppressed for adjustable period of 30 s to 60 s when picoSAT II SpO2 pulse oximetry module detects that an NBP measurement is in progress. SpO2 EXTD. UPDATE INOP generated after 30 s of suppression. | SpO₂ and pulse rate parameter output and the
SpO₂ Non-pulsatile and Pleth Non-pulsatile
INOPS are suppressed for adjustable period
of 30 s to 60 s when picoSAT II SpO2 pulse
oximetry module detects that an NBP
measurement is in progress. SpO2 EXTD.
UPDATE INOP generated after 30 s of
suppression. (This is a description, and implies the device meets this rule.) |
| Technical alarm conditions (INOPS) | Generates various specified technical alarm conditions (SpO₂ EQUIP MALF, SpO₂ TEST SIGNAL, etc.). | Generates the following technical alarm
conditions:
SpO₂ EQUIP MALF
SpO₂ TEST SIGNAL
SpO₂ SENSOR MALF
NO SpO₂ SENSOR
SpO₂ INTERFERENCE
SpO₂ LEARNING
SpO₂ NOISY SIGN.
SpO₂ NON-PULSAT.
SpO₂ ERRATIC
SpO₂ EXTD. UPDATE
SpO₂ LOW PERF (This means it is designed to achieve this.) |
| SpO2 Algorithm | Philips FAST SpO2 algorithm motion and low perfusion tolerant (Implied by specification) | Philips FAST SpO2 algorithm
motion and low perfusion tolerant |
| SpO2 displayed range | 0% to 100% (Implied by specification) | 0% to 100% |
| SpO2 parameter resolution | 1% (Implied by specification) | 1% |
| Pulse Rate parameter range & resolution | 30 bpm to 300 bpm ±2% or 1 bpm whichever is greater (Implied by specification) | 30 bpm to 300 bpm ±2% or 1 bpm whichever is
greater |
| FAST SpO2 parameter averaging | 5 s to 20 s (Implied by specification) | 5 s to 20 s |
| SpO2 parameter data update period | 1 s (Implied by specification) | 1 s |
| Pleth wave height requirement | 32 pixels, minimum (Implied by specification) | 32 pixels, minimum |
| Input power | 1.8 V to 11.5 Vdc, 300 mW max (Implied by specification) | 1.8 V to 11.5 Vdc, 300 mW max |
| Serial data interface | 3/5 V logic levels, switchable, 8-bit word with stop, start & parity bit (Implied by specification) | 3/5 V logic levels, switchable
'
8-bit word with stop, start & parity bit |
2. Sample Size Used for the Test Set and Data Provenance
The document states that "Clinical validation studies were also conducted," but does not provide any specific sample sizes for the test set or the data provenance (e.g., country of origin, retrospective or prospective nature of the data).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
This information is not provided in the document.
4. Adjudication Method for the Test Set
This information is not provided in the document.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not mentioned in the document. The document focuses on the technical specifications and clinical validation of the device itself, not a comparison of human reader performance with and without AI assistance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, a standalone performance evaluation of the algorithm is implied. The document states "Clinical validation studies were also conducted" in the context of establishing the performance characteristics of the new device (the picoSAT II module, which includes the Philips FAST SpO2 algorithm). The specifications for SpO2 accuracy (e.g., ± 2.5%, ± 3.0%) are direct measurements of the device's ability to accurately determine SpO2 levels.
7. The Type of Ground Truth Used
The type of ground truth used for the clinical validation studies is not explicitly stated, but for SpO2 accuracy measurements, it is conventionally established through co-oximetry readings of arterial blood samples, which is considered the gold standard for blood oxygen saturation. While not explicitly mentioned, this is the expected method for establishing ground truth in pulse oximetry validation studies.
8. The Sample Size for the Training Set
This information is not provided in the document. The document refers to "Philips FAST SpO2 algorithm," implying a pre-existing or internal development and training process, but details are not disclosed in this summary.
9. How the Ground Truth for the Training Set Was Established
This information is not provided in the document. Similar to the test set, it would likely involve co-oximetry readings of arterial blood samples if applicable to the algorithm's development.
§ 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).