Search Results

Continuous, non-invasive functional arterial oxygen saturation and pulse rate monitoring in patients weighing >10 kg

The Flexi-Stat(tm) SpO2 Sensor is an electro-optical sensor that functions without skin penetration, electrical contact, or heat transfer. The sensor uses optical means to determine the light absorption of functional arterial hemoglobin by being connected between the patient and the oximeter. The sensor contains three optical components: two light emitting diodes (LED) that serve as light sources and one photodiode that acts as a light detector. The optical components are housed in a durable ear clip housing. The sensor cable is terminated in a DB-9 style connector.

This document describes the Flexi-Stat SpO2 Ear Sensor, an accessory to a pulse oximeter, and its clearance for market based on substantial equivalence to a predicate device. This is primarily a descriptive summary of the device and its testing rather than a detailed study report. Therefore, specific details typically found in a robust study publication are limited.

Here's an attempt to extract the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria or a detailed "reported device performance" table with numerical metrics beyond the general statement of equivalence. It states that the device was found to be "equivalent to predicate device accuracy claims." The predicate device is the Nellcor Dura-Y ear sensor (K944760). Without the predicate device's specific accuracy claims, it's impossible to quantify the acceptance criteria or performance from this document alone.

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

• Sample Size for the Test Set: Not explicitly stated. The document mentions "clinical hypoxia studies" but does not provide the number of subjects or data points.
• Data Provenance:
  • Country of Origin: Not explicitly stated, though Elekon Industries, USA, Inc. is located in Torrance, CA, USA. The clinical studies were conducted in an "independent research lab," the location of which is not specified.
  • Retrospective or Prospective: "Clinical hypoxia studies" implies a prospective study design, as subjects would be intentionally exposed to hypoxic conditions for the purpose of the study.

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

Not applicable in the context of this device. The ground truth for SpO2 accuracy was established by comparing the device readings to "arterial blood samples analyzed on a laboratory co-oximeter." This is a direct physiological measurement, not an expert consensus on interpreting images or clinical signs.

4. Adjudication Method for the Test Set

Not applicable. The ground truth was based on objective laboratory co-oximetry measurements of arterial blood samples. There was no need for expert adjudication of subjective assessments.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. This document describes the performance testing of a medical device (SpO2 ear sensor), not an AI algorithm. Therefore, an MRMC comparative effectiveness study comparing human readers with and without AI assistance is not relevant to this submission.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, in a sense. The SpO2 Ear Sensor itself is the "algorithm" (or the sensing and output component). Its performance in determining SpO2 and pulse rate was evaluated directly against a gold standard (co-oximetry for SpO2, pulse rate simulator for pulse rate) in a standalone manner, without requiring human interpretation of its raw output. The pulse oximeter to which it connects would then display these values, but the sensor's accuracy is evaluated independently.

7. The Type of Ground Truth Used

• For SpO2 Accuracy: "Arterial blood samples analyzed on a laboratory co-oximeter." This is considered a physiological measurement/outcome data, which is a gold standard for blood oxygen saturation.
• For Pulse Rate Accuracy: "Bench testing with a pulse rate simulator." This is a simulated/bench-test ground truth.

8. The Sample Size for the Training Set

Not applicable. This device is a hardware sensor, not a machine learning algorithm that requires a training set. Its "training" is in its design and manufacturing.

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

Not applicable, as there is no training set for a hardware sensor.

Ask a specific question about this device

The Datex-Ohmeda TruSat Pulse Oximeter and Accessories is indicated for spotchecking and continuous monitoring of functional oxygen saturation and pulse rate, including monitoring during conditions of clinical patient motion or low perfusion. These devices are intended for use with adult, pediatric and neonatal patients in both hospital and non-hospital environments.

The TruSat is the next generation in the Datex-Ohmeda Pulse Oximeter family of products. The Datex-Ohmeda 3800 Series and 3900 Series Pulse Oximeters and Accessories with TruTrak Plus Enhancements and the Datex-Ohmeda TruSat Pulse Oximeter and Accessories are substantially equivalent in design concepts, technologies and materials. The TruSat was validated through rigorous testing that, in part, support the compliance of the TruSat to the above mentioned standards. Additionally, the software for the TruSat was developed following a robust software development process and was fully specified and validated.

The provided text does not contain detailed information regarding acceptance criteria, a specific study proving device performance, sample sizes for test or training sets, data provenance, expert ground truth establishment, or adjudication methods for the Datex-Ohmeda TruSat Pulse Oximeter.

The document is a 510(k) summary for premarket notification, primarily focusing on establishing substantial equivalence to previously cleared devices and compliance with relevant standards. It mentions "rigorous testing" and "fully specified and validated" software but does not elaborate on the specifics of these tests in a way that would allow for a detailed answer to your request.

Therefore, I cannot provide the requested table or detailed information on the study as the input text does not contain this data.

The summary states:

• "The TruSat was validated through rigorous testing that, in part, support the compliance of the TruSat to the above mentioned standards."
• "Additionally, the software for the TruSat was developed following a robust software development process and was fully specified and validated."

These statements indicate that testing and validation occurred, but they do not provide the detailed output or methods of those tests to answer your specific questions about acceptance criteria or study specifics.

Ask a specific question about this device

The Flexi-Site SpO2 Ear Sensor is indicated for continuous, non-invasive functional arterial oxygen saturation and pulse rate monitoring in patients weighing > 30 kg.

The Flexi-Site SpO2 Sensor is an electro-optical sensor that functions without skin penetration, electrical contact, or heat transfer. The sensor uses optical means to determine the light absorption of functional arterial hemoglobin by being connected between the patient and the oximeter. The sensor contains three optical components: two light emitting diodes (LED) that serve as light sources and one photodiode that acts as a light detector. The optical components are housed in a durable silicone casing. The sensor cable is terminated in a Hypertronics style connector.

Here is an analysis of the provided text regarding the acceptance criteria and the study that proves the Flexi-Site SpO2 Ear Sensor meets those criteria:

Device Acceptance Criteria and Performance

While the document explicitly states the "Accuracy (Ams) for the Flexi-Site was 3.84% across the range of 70%-100% SaO2", it does not provide a pre-defined acceptance criterion for this metric. The listed value of 3.84% is simply the result obtained from the performance testing. In a typical regulatory submission, there would be a target accuracy value (e.g., "Accuracy Ams shall be less than 4%"). However, based on the provided text, the 3.84% value implicitly met the FDA's unstated or assumed requirements for substantial equivalence to the predicate devices.

Study Details

1. Sample size used for the test set and the data provenance:

   • Sample Size: Not explicitly stated. The document mentions "clinical hypoxia studies," but does not provide the number of subjects or data points included in these studies.
   • Data Provenance: The studies were "clinical hypoxia studies conducted in an independent research lab." While the country of origin is not specified, clinical hypoxia studies typically involve human subjects whose oxygen levels are carefully controlled. The phrasing "clinical hypoxia studies" implies a prospective study design where data was collected specifically for this purpose.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Number of Experts: Not applicable. The ground truth was established by laboratory co-oximetry, not by expert consensus.
   • Qualifications of Experts: Not applicable.

3. Adjudication method for the test set:

   • Adjudication Method: Not applicable. The ground truth was established by direct comparison to arterial blood samples analyzed on a laboratory co-oximeter, a gold standard measurement, which does not typically involve expert adjudication in the same way imaging or subjective diagnostic tasks might.

4. 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: No. This device is an SpO2 sensor, which provides automated measurements, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study is not relevant.
   • Effect Size: Not applicable.

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

   • Standalone Performance: Yes, implicitly. The performance data presented (Accuracy Ams of 3.84%) refers to the device's measurement accuracy compared to a reference standard, without any explicit mention of human interpretation or intervention in the measurement process itself. The SpO2 sensor is an automated measurement device.

6. The type of ground truth used:

   • Ground Truth Type: Arterial blood samples analyzed on a laboratory co-oximeter. This is considered a gold standard for blood oxygen saturation measurement.

7. The sample size for the training set:

   • Sample Size: Not applicable. As an electro-optical sensor, the device's operation is based on established physical principles for light absorption by hemoglobin. It's not a machine learning or AI device that requires a training set in the conventional sense. Its "training" is in its design and calibration, not in learning from a large dataset.

8. How the ground truth for the training set was established:

   • Ground Truth Establishment: Not applicable, as no training set was used in the machine learning sense. The device's fundamental operating principles and calibration would be based on well-understood physiological and optical science.

Ask a specific question about this device

Ask a specific question about this device