(85 days)
The 3444 Reusable Finger Sensor is used with BCI oximetry to noninvasively measure oxygen saturation (SpOz), pulse rate and plethysmographic pulse waves. The 3444 sensor is recommended for patients weighing more than 15 kg and patients with limited activity.
The 3444 Reusable Finger Sensor is not recommended for prolonged use unless skin integrity is checked frequently and the measurement site is changed accordingly.
The Reusable Finger Sensor is for use with BCI International monitors and with monitors that contain BCI International oximelry or are licensed to use BCI International sensors.
The BCI 3444 Reusable Oximetry Finger Sensor is an updated version of an existing finger sensor, the 3044, legally marketed by BCI International. This updated finger sensor is designed to work with all BCI oximeters. The sensor is made up of three major parts, the cable with the molded connector, the top part of the shell containing the LEDs and the bottom part of the shell containing the photo detector.
This submission describes the BCI 3444 Reusable Finger Sensor, an updated version of an existing finger sensor (BCI 3044), designed to work with BCI oximeters for noninvasive measurement of oxygen saturation (SpO2), pulse rate, and plethysmographic pulse waves.
Here's a breakdown of the requested information:
1. Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Specification) | Reported Device Performance |
|---|---|
| Standard deviation for SpO2 measurement range of 70-100% ≤ 2 | 1.73 |
| Standard deviation for SpO2 measurement range of 50-69% ≤ 3 | 2.50 |
| Sensor intensity (Red & IR light) | Passed (Performed the same as predicate device) |
| Drop test | Passed |
| 4 kV Hi-Pot test | Passed |
| Surface temperature test | Passed |
| Operational test at extreme temperatures (0°F & 140°F) | Passed |
| Maximum difference in readings when compared to predicate device (3044) | A count of one (maximum difference between 89 sets of measurements) |
2. Sample Size Used for the Test Set and Data Provenance
The document describes two main clinical/comparison studies for the test set:
- Clinically controlled desaturation studies: The sample size for these studies is not explicitly stated as a number of subjects. It mentions "data collected from the studies" but does not quantify the number of subjects or measurements.
- Comparison with predicate device (3044): 89 sets of measurements were compared on subjects. The provenance of this data (e.g., country of origin, retrospective or prospective) is not explicitly stated, but the context of "clinically controlled desaturation studies" suggests a prospective, controlled clinical setting.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not mention the use of experts to establish a "ground truth" in the traditional sense for the clinical studies. Instead, it relies on a co-oximeter (OSM-3) as the reference standard for blood oxygen level measurements during the controlled desaturation studies. Therefore, this section is not applicable as expert review was not the method for ground truth.
4. Adjudication Method for the Test Set
Since a co-oximeter was used as the reference standard and there's no mention of expert review, there was no adjudication method described for the test set. The comparison was statistical against the reference device.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The study focuses on the device's accuracy against a reference standard and its equivalence to a predicate device, not on human reader performance with or without AI assistance.
6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done
The clinical desaturation studies and the comparison with the predicate device represent a standalone assessment of the BCI 3444 sensor (in conjunction with a BCI oximeter). The performance metrics (standard deviation) are for the device system's accuracy as compared to a co-oximeter, without human intervention in interpreting the output of the device under test beyond standard clinical usage.
7. The Type of Ground Truth Used
The primary ground truth used for the clinical desaturation studies was measurement from a co-oximeter (OSM-3), which is a gold standard for blood gas analysis. This is a form of direct physiological measurement providing objective outcome data.
8. The Sample Size for the Training Set
The document does not provide information regarding a training set. This is a medical device submission for an updated sensor, not an AI or machine learning algorithm. Therefore, the concept of a "training set" as typically understood in AI/ML is not applicable here. The performance evaluation relies on comparing the new device against a predicate and a reference standard.
9. How the Ground Truth for the Training Set Was Established
As there is no mention of a training set (as this is not an AI/ML device), this section is not applicable.
§ 870.2310 Apex cardiograph (vibrocardiograph).
(a)
Identification. An apex cardiograph (vibrocardiograph) is a device used to amplify or condition the signal from an apex cardiographic transducer and to produce a visual display of the motion of the heart; this device also provides any excitation energy required by the transducer.(b)
Classification. Class II (performance standards).