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Indicated for use whenever there is a need for monitoring, transport monitoring, recording, and alarming of the physiological parameters arterial oxygen saturation (SpO2) and pulse rate of adult, pediatric and neonatal patients in a hospital environment by health care professionals.

X2 (M3002A) Multi-Measurement Module is indicated for transport monitoring outside hospitals.

The SpO2 measurement is based on the absorption of light, which is emitted through human tissue (i.e. index finger). Two light sources transmit red and infrared light through the human tissue. The ratio of the different absorption of the red and infrared light is calculated. The saturation value is defined by the percentage ratio of the oxygenated hemoglobin [HbO₂] to the total amount of hemoglobin [Hb] (SpO2 = [HbOz]/({Hb]+[HbO2]). Out of calibration curves, which are based on controlled hypoxia studies with healthy non-smoking adult volunteers over a specified saturation range (SaO2 from 70%-100%), the ratio determines the SpO2 value. The measurement accuracy of SpO2 in the range of 70% to 100% is between 2% and 4% RMS dependent on the Philips sensor type. The measurement accuracy of pulse rate in the range of 30 bpm to 300 bpm is 2% or 1 bpm (whichever is greater).

The modification is a hardware and firmware improvement and reduces the manufacturing costs.

Here's an analysis of the acceptance criteria and study details for the picoSAT IIP408 SpO2 pulse oximetry module, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: 10 volunteers
• Data Provenance: Controlled hypoxia studies with healthy non-smoking adult volunteers. Since the submitter is Philips Medizin Systeme Böblingen GmbH (Germany), it's highly likely the study was conducted in Germany or a similar Western country, but the specific country of origin is not explicitly stated. The study was prospective in nature due to it being a "controlled desaturation study."

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

• Number of Experts: Not applicable in this context.
• Qualifications of Experts: The ground truth was established by a CO-Oximeter as a reference, not human experts. CO-Oximeters are laboratory-grade instruments used for highly accurate blood gas analysis, including oxygen saturation.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

• Adjudication Method: Not applicable. The ground truth was established by instrumental reference (CO-Oximeter) rather than human expert interpretation requiring adjudication.

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

• MRMC Study Done: No. This device is a pulse oximeter, not an AI-assisted diagnostic tool that would involve human readers interpreting cases.

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

• Standalone Study Done: Yes, essentially. The accuracy of the SpO2 measurement is a direct output of the device's hardware and firmware, compared against a reference standard. There is no human "in-the-loop" for the direct SpO2 measurement process itself.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

• Type of Ground Truth: Instrumental reference – a CO-Oximeter was used to provide SaO2 (arterial oxygen saturation) reference values.

8. The Sample Size for the Training Set

• Sample Size: Not explicitly stated as a distinct "training set" in the context of machine learning model development. For traditional medical device calibration (as described here), "calibration curves" are developed. While the text mentions "Out of calibration curves, which are based on controlled hypoxia studies with healthy non-smoking adult volunteers over a specified saturation range (SaO2 from 70%-100%), the ratio determines the SpO2 value," it does not specify a separate sample size for developing these curves, implying some overlap or that the 10 volunteers may have contributed to this process. It explicitly states "at least 20 data samples per volunteer" for the validation study.

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

• Ground Truth Establishment: The "calibration curves" (analogous to a training process for establishing the device's core functionality) were "based on controlled hypoxia studies with healthy non-smoking adult volunteers over a specified saturation range (SaO2 from 70%-100%)." This implies that during these hypoxia studies, a reference method (likely a CO-Oximeter, similar to the validation) was used to establish the true SaO2 values against which the device's internal light absorption ratios were mapped to create the SpO2 output.

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The EsteLuxTM System with the LuxVTM handpiece is intended for the treatment of inflammatory acne (acne vulgaris).

The EsteLux Pulsed Light System with the LuxVTTM handpiece accessory is a light-based medical device designed for treatment of inflammatory acne.

The provided text focuses on the 510(k) summary for the Palomar LuxV™ Handpiece, outlining its classification, intended use, and substantial equivalence to predicate devices for the treatment of inflammatory acne. However, it does not contain information about acceptance criteria, specific study designs, sample sizes for test or training sets, ground truth establishment, expert qualifications, or MRMC studies. The document primarily serves as a regulatory submission for market clearance based on substantial equivalence, rather than a detailed report of a performance study with specific acceptance criteria.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them because the necessary information is not present in the provided text.

Specifically, the document states: "The differences in the specifications of the EsteLux LuxVIM and the ClearTouch do not result in different performance or raise new questions of safety or efficacy. In addition, clinical data was provided to support the safety and efficacy of the LuxV handpiece." This indicates that clinical data was provided, but the details of that data, including the points you've requested, are not included in this 510(k) summary.

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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.

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