(217 days)
TS-SP3-GE The sensor is a reusable sensor intended for use for continuous non-invasive arterial oxygen saturation (SpO2) and pulse rate monitoring. Patient weight range: 15-30 kg (33-66 pounds)
TS-SP3-MC The sensor is a reusable sensor intended for use for continuous non-invasive arterial oxygen saturation (SpO2) and pulse rate monitoring. Patient weight range: 15-30 kg (33-66 pounds)
TS-SP-D The sensor is a reusable sensor intended for use for continuous non-invasive arterial oxygen saturation (SpO2) and pulse rate monitoring. Patient weight range: 15-30 kg (33-66 pounds)
Pulse oximeter sensors connecting to patient monitors
Here's a breakdown of the acceptance criteria and study information for the TruSignal® SpO2 PediTip Sensors, based on the provided text:
Important Note: The provided document states that clinical studies were NOT required for this device to support substantial equivalence. Instead, the manufacturer relied on the non-clinical tests and the established equivalence of materials and electro-optical components to a predicate device. Therefore, many of the typical questions regarding clinical study design (sample size, expert qualifications, adjudication, MRMC studies, ground truth for training data) do not apply directly to this specific submission.
Acceptance Criteria and Reported Device Performance
Since clinical studies were not performed, specific acceptance criteria in terms of SpO2 accuracy (e.g., A_rms values) are not explicitly stated for the device itself in this submission. Instead, the acceptance criteria focused on demonstrating equivalence to the predicate device in non-clinical tests.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Safety | Performed equal to or better than the predicate device. |
| Mechanical Durability | Performed equal to or better than the predicate device. |
| Electromagnetic Compatibility | Performed equal to or better than the predicate device. |
| Current Transfer Ratio | Performed equal to or better than the predicate device. |
| Crosstalk | Performed equal to or better than the predicate device. |
| Substantial Equivalence | Concluded to be as safe, as effective, and performance is substantially equivalent to the predicate device (TruSignal® SpO2 FingerTip Sensors, K101871). |
Study Information (Non-Clinical Equivalence Demonstration)
As mentioned, no clinical studies were conducted for the TruSignal® SpO2 PediTip Sensors in this submission. The "study" described is a series of non-clinical tests to demonstrate that the new sensor geometry did not adversely affect performance compared to its predicate device. This approach is based on the fact that the new device has identical materials and electro-optical components to the predicate.
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Sample size used for the test set and the data provenance:
- Test Set Size: Not applicable in terms of patient data. The "test set" here refers to the device units subjected to non-clinical tests. The exact number of units is not specified, but it would have been a sample of the TruSignal® SpO2 PediTip Sensors.
- Data Provenance: Not applicable for patient data. The non-clinical tests would have been performed by GE Healthcare, likely at their R&D or manufacturing facilities. The specific country of origin for these tests is not explicitly stated in the provided text, but the submitter is GE Healthcare Finland Oy.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. As no clinical studies were performed, there was no need for experts to establish ground truth from patient data. The "ground truth" for the non-clinical tests would be the established performance characteristics of the predicate device against which the new device was compared.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. No clinical data requiring adjudication by experts.
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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 a pulse oximeter sensor, not an AI-assisted diagnostic tool requiring human reader studies.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable in the context of an algorithm. This device is a sensor. Its standalone performance was evaluated through the non-clinical tests (safety, mechanical durability, etc.) to ensure it functioned as expected on its own and comparably to the predicate.
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The type of ground truth used:
- For the non-clinical tests, the "ground truth" was derived from predefined engineering specifications, regulatory standards, and the known performance characteristics of the legally marketed predicate device (TruSignal® SpO2 FingerTip Sensors, K101871).
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The sample size for the training set:
- Not applicable. There is no AI/machine learning algorithm involved that would require a training set in the typical sense.
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How the ground truth for the training set was established:
- Not applicable for the same reasons as above.
§ 870.2700 Oximeter.
(a)
Identification. An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.(b)
Classification. Class II (performance standards).