Search Results

The Flexi-Stat SpO2 Sensor is indicated for continuous, non-invasive functional arterial oxygen saturation and pulse rate monitoring in adult, pediatric, and neonatal patients.

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 adhesive film. The sensor cable is terminated in a DB-9 style connector, with an adapter cable for Datexcompatible models.

The provided text describes a 510(k) summary for the Flexi-Stat SpO2 Sensor. However, it does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and a detailed study description. The document focuses on demonstrating substantial equivalence to a predicate device rather than providing a comprehensive clinical study report with specific acceptance criteria.

Based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document broadly states that the device was "found to be equivalent to predicate device accuracy claims." It does not provide specific numerical acceptance criteria (e.g., A_rms values, bias, precision) or the detailed performance metrics of the Flexi-Stat against those criteria. The predicate device's accuracy claims are not specified in this document.

Ask a specific question about this device

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 Flexi-Stat SpO2 Sensor is indicated for continuous, non-invasive functional arterial oxygen saturation and pulse rate monitoring in patients weighing >20 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 rigid, spring-loaded clip. The sensor cable is terminated in a DB-9 style connector, with an adapter cable for Datex-compatible models.

The provided document describes a 510(k) summary for the Flexi-Stat SpO2 Sensor, indicating its substantial equivalence to a predicate device for continuous, non-invasive functional arterial oxygen saturation and pulse rate monitoring. However, the document does not contain detailed information regarding acceptance criteria or a specific study that proves the device meets those criteria in a format that allows for the extraction of all the requested information.

Here's an analysis of what can and cannot be extracted from the provided text, based on your questions:

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

• Sample Size for 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 specified. It mentions studies conducted "in an independent research lab," but the location of this lab is not given.
  • Retrospective or Prospective: Not specified, but "clinical hypoxia studies" typically imply a prospective design where the device is tested on subjects under controlled conditions.

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)

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified. The "ground truth" was established by "arterial blood samples analyzed on a laboratory co-oximeter," which implies laboratory personnel or medical professionals were involved in sample collection and analysis, but their qualifications are not detailed.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

• Adjudication Method: Not applicable/not specified. For an SpO2 sensor, the "ground truth" is typically a direct physiological measurement (co-oximetry) rather than an interpretation requiring adjudication among human experts.

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 Comparative Effectiveness Study: No. This type of study is not relevant for an SpO2 sensor, which provides direct physiological measurements rather than aiding human readers in interpreting images or complex data. The device itself is a measurement tool, not an AI-assisted diagnostic aid for interpretation.

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

• Standalone Performance: Yes, in terms of the device's measurement accuracy. The clinical hypoxia studies directly compared the Flexi-Stat's measurements to the co-oximeter’s results, indicating its performance as a standalone measurement device. There is no "human-in-the-loop" aspect to analyze beyond a clinician using the device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

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

8. The sample size for the training set

• Sample Size for Training Set: Not applicable/not specified. The device is a traditional electro-optical sensor, not an AI/ML algorithm that requires a "training set" in the machine learning sense. Its design and calibration would be based on engineering principles and physiological models, not data-driven training.

9. How the ground truth for the training set was established

• How Ground Truth for Training Set was Established: Not applicable. As mentioned, this is not an AI/ML device that uses a "training set" with established ground truth in the typical sense.

Summary of what the document implies about the study:

The document indicates that Elekon Industries, USA, Inc. conducted "clinical hypoxia studies in an independent research lab" where the Flexi-Stat SpO2 Sensor was "compared to arterial blood samples analyzed on a laboratory co-oximeter." The conclusion was that the device was "found to be equivalent to predicate device accuracy claims." This suggests a prospective, controlled clinical study designed to assess the accuracy of the SpO2 sensor against a gold standard (co-oximetry) under varying oxygen saturation levels induced by hypoxia. However, specific details such as the number of subjects, the range of SpO2 values tested, the statistical methods used, or the actual accuracy data (e.g., bias, precision, A-rms values) are not provided in this summary. The assessment focuses on demonstrating substantial equivalence to a predicate device, rather than detailing the full performance characteristics of the new device.

Ask a specific question about this device

The Flexi-Stat SpO2 Sensor is indicated for continuous, non-invasive functional arterial oxygen saturation and pulse rate monitoring in patients weighing ≥ 30 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 adhesive film. The sensor cable is terminated in a DB-9 style connector, with an adapter cable for Datexcompatible models.

Here's a summary of the acceptance criteria and study information for the Elekon Flexi-Stat SpO2 Sensor based on the provided 510(k) submission:

Acceptance Criteria and Device Performance

Note: The document does not provide specific numerical targets for SpO2 accuracy (e.g., standard deviation or root mean square error) within a defined range. Instead, it refers to equivalence to predicate device accuracy claims.

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" without specifying the number of subjects or data points.
   • Data Provenance: The studies were conducted in an "independent laboratory." The country of origin is not specified but given the submitter is "Elekon Industries, USA, Inc." it's likely they were conducted in the USA or a region with comparable regulatory standards. The study appears to be prospective, involving induced hypoxia, rather than retrospective.

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

   • Not applicable/Not specified for SpO2 accuracy. The ground truth for SpO2 accuracy was established by "arterial blood samples analyzed on a laboratory co-oximeter." There is no mention of experts interpreting these co-oximeter results; rather, the co-oximeter itself provides the objective measurement.

3. Adjudication method for the test set:

   • Not applicable. The ground truth was based on objective laboratory measurements (co-oximetry) of arterial blood samples, not subjective assessments requiring expert adjudication.

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:

   • Not applicable. This device is an SpO2 sensor, which provides a direct physiological measurement, not an AI-assisted diagnostic tool that requires human interpretation.

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

   • This is a standalone device in the sense that its performance, as an accessory to a pulse oximeter, is evaluated based on its direct measurements compared to a gold standard (co-oximetry), without requiring a human-in-the-loop to interpret its output for the accuracy study. The sensor outputs a numerical SpO2 value.

6. The type of ground truth used:

   • Objective measurement (Laboratory Co-Oximetry): Arterial blood samples were analyzed on a laboratory co-oximeter to provide the gold standard for arterial oxygen saturation.

7. The sample size for the training set:

   • Not applicable. As a medical device (sensor) that measures a physiological parameter, there is no "training set" in the machine learning sense for the core SpO2 measurement algorithm itself, which is based on established electro-optical principles. The performance testing focuses on validation.

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

   • Not applicable, as there is no training set in the context of this device's SpO2 measurement function.

Ask a specific question about this device

The Flexi-Stat SpO2 Sensor is indicated for continuous, non-invasive functional arterial oxygen saturation and pulse rate monitoring. The Flexi-Stat SpO2 Sensor is indicated for use in patients weighing >30 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 finger clip housing. The sensor cable is terminated in a DB-9 style connector, with an adapter cable for Datex-compatible models.

Here's a breakdown of the acceptance criteria and study information for the Elekon Flexi-Stat SpO2 Sensor, based on the provided text:

Acceptance Criteria and Device Performance

Study Details

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

• Sample Size: Not explicitly stated. The text mentions "clinical hypoxia studies" without specifying the number of subjects.
• Data Provenance: Clinical hypoxia studies conducted in an independent research lab. The country of origin is not specified, but the submission is from Elekon Industries, USA, Inc.

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified. However, the ground truth was "arterial blood samples analyzed on a laboratory co-oximeter," implying that experts in laboratory co-oximetry would have been involved in analyzing these samples.

4. Adjudication method for the test set:

• Not applicable. The ground truth was established through direct comparison with arterial blood samples analyzed on a co-oximeter, not through expert consensus 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:

• Not applicable. This device is an SpO2 sensor, not an AI-assisted diagnostic tool for which MRMC studies are typically performed. The study focused on the sensor's accuracy compared to a reference standard.

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

• Yes, in essence. The performance testing described is standalone for the device. The Flexi-Stat SpO2 sensor's readings were compared directly to the ground truth from arterial blood samples without human interpretation being part of the device's measurement process, though human operators would connect and read the oximeter display. The focus was on the sensor's accuracy.

7. The type of ground truth used:

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

8. The sample size for the training set:

• Not applicable / Not specified. This device is a physiological sensor, not a machine learning algorithm that typically requires a distinct training set. The performance testing validates its function.

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

• Not applicable. As a non-AI physiological sensor, there isn't a "training set" in the machine learning sense. The ground truth for performance evaluation was established by comparing sensor readings to concurrently drawn and analyzed arterial blood samples using a laboratory co-oximeter.

Ask a specific question about this device

The Flexi-Stat SpO2 Sensor is indicated for continuous, non-invasive functional arterial oxygen saturation and pulse rate monitoring in adult, pediatric, and neonatal patients.

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 foam and Velcro wrap. The sensor cable is terminated in a DB-9 style connector, with an adapter cable for Datex-compatible models.

This submission describes the Flexi-Stat SpO2 Sensor, an accessory to a pulse oximeter for continuous, non-invasive functional arterial oxygen saturation and pulse rate monitoring. The summary provided primarily focuses on the substantial equivalence of the Flexi-Stat SpO2 Sensor to existing predicate devices, rather than detailed acceptance criteria and supporting studies for a novel or significantly modified device. Therefore, some information requested, particularly regarding specific numerical acceptance criteria and a detailed study design as might be seen for a new algorithmic device, is not explicitly present in the provided text.

Here's the breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Specific numerical acceptance criteria (e.g., accuracy ranges for SpO2 measurements) are not explicitly stated in the provided text for the Flexi-Stat SpO2 Sensor itself. Instead, the document states: "The Flexi-Stat was compared to arterial blood samples analyzed on a laboratory co-oximeter and found to be equivalent to predicate device accuracy claims." This implies that the acceptance criteria for the Flexi-Stat SpO2 Sensor were to meet or be equivalent to the accuracy claims of its predicate devices.

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

• Sample Size: This information is not explicitly stated in the provided text. The document mentions "clinical hypoxia studies" but does not give the number of subjects.
• Data Provenance: The studies were described as "clinical hypoxia studies conducted in an independent research lab." No specific country of origin is mentioned, but the company is US-based. It is a prospective study as clinical hypoxia studies involve actively inducing hypoxia in subjects under controlled conditions.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable to this type of device and study. The ground truth was established using an objective measurement from a laboratory co-oximeter and arterial blood samples, not through expert consensus on interpretations.

4. Adjudication Method for the Test Set

This information is not applicable. The ground truth was based on objective laboratory measurements (co-oximetry of arterial blood samples), not on expert interpretation requiring adjudication.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for devices involving human interpretation (e.g., radiology AI), not for objective physiological measurement devices like an SpO2 sensor where the output is a direct numerical reading.

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

Yes, the accuracy assessment described ("The Flexi-Stat was compared to arterial blood samples analyzed on a laboratory co-oximeter") represents a standalone performance evaluation of the device's measurement capabilities. There is no human intervention mentioned in the process of generating the SpO2 values from the Flexi-Stat sensor and comparing them to the ground truth.

7. The Type of Ground Truth Used

The ground truth used was objective physiological measurement:

• "arterial blood samples analyzed on a laboratory co-oximeter"

8. The Sample Size for the Training Set

This information is not applicable as the Flexi-Stat SpO2 Sensor is not a machine learning or AI-based device that typically requires a "training set" in the conventional sense. Its function is based on electro-optical principles, not learned patterns from data.

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

This information is not applicable for the reasons mentioned above.

Ask a specific question about this device