Search Results

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

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.

Ask a specific question about this device

Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters patients.

Intended use: For monitoring, recording, and alarming of multiple physiological parameters of adults, pediatrics, and neonates in health care facilities.

EASI 12-lead ECG is only for use on adult and pediatric patients.

ST Segment monitoring is restricted to adult patients only.

The transcutaneous gas measurement (tcp02 / tcpCO2) is restricted to neonatal patients only.

The Philips Medical Systems, M1275B Component Compact Monitor is a multi-parameter module.

The provided document, K020531 for the Philips Medical Systems M1275B Component Compact Monitor, does not contain detailed information about acceptance criteria or a specific study proving the device meets those criteria in the format typically required for AI/algorithm performance.

This 510(k) submission primarily focuses on establishing substantial equivalence to a previously cleared predicate device (K013199) rather than presenting a detailed performance study as one might expect for a novel AI/ML device. The document describes a traditional medical device (a multi-parameter monitor) and its updated multi-parameter module.

Here's a breakdown of the available information based on your requested criteria:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not provide a specific table of acceptance criteria with corresponding performance metrics. Instead, it states:

"Verification, validation, and testing activities establish the performance, functionality, and reliability characteristics of the new device with respect to the predicate. Testing involved system level tests, performance tests, and safety testing from hazard analysis. Pass/Fail criteria were based on the specifications cleared for the predicate device and test results showed substantial equivalence. The results demonstrate that Component Compact Monitor meets all reliability requirements and performance claims."

This indicates that the acceptance criteria were the existing specifications and performance of the predicate device. The performance reported is that the new device met these predicate specifications and achieved substantial equivalence.

Regarding items 2-9, which are typically relevant for AI/ML performance studies, the document does not contain this information because it is not an AI/ML device submission. It's a hardware medical device. Therefore, the following information is not applicable or not provided in this 510(k) submission:

2. Sample size used for the test set and the data provenance: Not applicable. Performance was likely assessed through bench testing, simulated scenarios, and potentially limited clinical verification against existing monitors, but specific "test sets" of patient data as understood in AI/ML are not described.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physiological monitor would be established by physical measurements and calibrated equipment.

4. Adjudication method for the test set: Not applicable.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No. This is a hardware monitor, not an interpretive AI system that human readers would use in conjunction with.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: The device itself is standalone in terms of its monitoring function, but this refers to a different context (AI algorithm performance) and is therefore not applicable to the information provided.

7. The type of ground truth used: For a multi-parameter monitor measuring physiological parameters (ECG, blood pressure, etc.), the ground truth would be established by comparison to other validated medical devices, calibrated sensors, and established physical measurement principles. The document states "Pass/Fail criteria were based on the specifications cleared for the predicate device," implying the predicate device's performance served as the benchmark.

8. The sample size for the training set: Not applicable, as this is not an AI/ML device requiring a training set.

9. How the ground truth for the training set was established: Not applicable.

In summary:

This 510(k) submission for the Philips M1275B Component Compact Monitor, Release A.02, with M3001A Multi-Parameter Module, is for a traditional medical device (a physiological monitor). Its "acceptance criteria" and "proof" primarily revolve around demonstrating substantial equivalence to a previously cleared predicate device (K013199) and meeting the existing specifications and performance standards of that predicate. The document explicitly states that "Pass/Fail criteria were based on the specifications cleared for the predicate device and test results showed substantial equivalence." The type of detailed performance study and ground truth establishment described in your request is specific to AI/ML devices and is therefore not found in this submission.

Ask a specific question about this device