(115 days)
The Salter Labs Oral/Nasal Thermal Airflow Sensor is used as a cannula accessory with existing recording devices and data acquisition systems in a sleep laboratory setting to support the diagnostic recording of nasal and/ or oral airflow. The subject device itself performs no diagnostic functions, and only supports the diagnostic recording of ariflow for use as an accessory component to a polysomnography recorder.
The target population is adult and pediatric patients during a sleep study in a sleep laboratory.
The Salter Labs Thermal Airflow Sensor is composed of a Thermistor as the element which changes resistance as aiflow from the patient is delivered across the element of the themistor. The thermistor elements are located directly underneath the nares and in the airflow of the mouth. In both cases the element is kept from touching the skin in the patient in order to be the most effective change in temperature.
The thermistor will be mounted in the Cannula to position the thermistor properly under the nares and in the airflow path of the mouth. The thermistor will be covered with a heat shrink tubing to protect it from moisture from the patient.
The thermistor will require a battery source in order to derive a current flow through the circuit. This battery source will be located in a small container called a signalconditioning unit. This unit has circuitry that will remove noise, display a smooth signal and is an added feature test for wire continuity.
This 510(k) summary for the Salter Labs Oral/Nasal Thermal Airflow Sensor (K080922) does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and a specific study proving the device meets them. This document is a summary for regulatory clearance based on substantial equivalence to a predicate device, not a detailed technical report of a performance study with specific acceptance criteria.
However, based on the provided text, I can infer some information and highlight what is missing.
Here's a breakdown of the available and missing information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Inferred from Substantial Equivalence Claim) | Reported Device Performance (Inferred from Substantial Equivalence Claim) |
|---|---|
| Same intended use as predicate device | The device has the same intended use as the Braebon Medical Corp. Airflow Sensor (K981445). |
| Same operating principle as predicate device | The device operates on the same principle as the predicate device (thermistor element changes resistance as airflow is delivered). |
| Same technology as predicate device | The device uses the same technology as the predicate device. |
| Similar manufacturing processes to predicate device | The device uses similar manufacturing processes as the predicate device. |
| Equivalent performance in all operating ranges (to predicate device) | The device has equivalent performance in all operating ranges to the predicate device. |
- Missing: Specific quantitative acceptance criteria (e.g., accuracy, precision, response time, specified drift, signal-to-noise ratio) are not provided. The document relies on qualitative equivalence to a predicate device. If a performance study was conducted, the detailed results against specific metrics are not included in this summary.
2. Sample size used for the test set and the data provenance
- Missing: This information is not provided in the 510(k) summary. Given that this is a substantial equivalence submission, it's possible no direct clinical or bench testing beyond what's needed to simply demonstrate equivalence to the predicate (which might not involve a "test set" in the sense of a standalone performance study) was required or reported in this summary. If any testing was done, the sample size and data provenance are not disclosed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Missing: Not applicable as a formal "ground truth" establishment for a test set in a human-in-the-loop diagnostic performance study is not described. The device is an accessory for diagnostic recording, not a diagnostic device itself.
4. Adjudication method for the test set
- Missing: Not applicable for the reasons stated above.
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
- Missing: Not applicable. This device is a thermal airflow sensor, not an AI-powered diagnostic tool. No MRMC study is mentioned.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Missing: The document states, "The subject device itself performs no diagnostic functions, and only supports the diagnostic recording of airflow for use as an accessory component to a polysomnography recorder." This implies it provides raw data rather than performing an "algorithm-only" interpretation or diagnosis. No standalone performance data is presented in this document. The "equivalent performance in all operating ranges" likely refers to bench testing or basic functional comparison against the predicate, not a clinical standalone study.
7. The type of ground truth used
- Missing: Not explicitly stated as a formal "ground truth" was likely not established for a clinical diagnostic performance study of the sensor itself. For a device like this, "ground truth" for proving performance would typically involve a reference standard for airflow measurement (e.g., spirometry, pneumotachograph) or comparison against the established performance of the predicate device under controlled conditions. This detail is not in the summary.
8. The sample size for the training set
- Missing: Not applicable. This is a hardware sensor, not a machine learning model, so there is no "training set."
9. How the ground truth for the training set was established
- Missing: Not applicable for the same reason as above.
Summary of Study (Based on the 510(k) Summary):
The document does not describe a particular "study" that proves the device meets specific acceptance criteria in the way one might expect for a diagnostic device. Instead, it relies on a "Substantial Equivalence" claim.
The implicit "study" is a comparison to a predicate device (Braebon Medical Corp. Airflow Sensor K981445). The "proof" is the assertion from Salter Labs that their device is substantially equivalent based on:
- Same intended use.
- Same operating principle (thermistor changes resistance with airflow).
- Same technology.
- Similar manufacturing processes.
- Equivalent performance in all operating ranges.
The 510(k) process for this type of accessory device often involves demonstrating that the new device functions reliably and similarly to a legally marketed predicate, rather than conducting extensive de novo clinical or performance trials with strict, quantitative, pre-defined acceptance criteria published in the summary. The "equivalent performance in all operating ranges" statement without specific data means that the FDA reviewed internal company data (not provided in this summary) and agreed that the new device performs at a similar level to the predicate, making it substantially equivalent.
§ 868.2375 Breathing frequency monitor.
(a)
Identification. A breathing (ventilatory) frequency monitor is a device intended to measure or monitor a patient's respiratory rate. The device may provide an audible or visible alarm when the respiratory rate, averaged over time, is outside operator settable alarm limits. This device does not include the apnea monitor classified in § 868.2377.(b)
Classification. Class II (performance standards).