(76 days)
The Nellcor OxiMAX adhesive forehead reflectance sensor, model MAX-FAST, is indicated for single-patient use when continuous noninvasive arterial oxygen saturation and pulse rate monitoring are required for adult or pediatric (≥ 10 kg) patients.
The OxiMAX MAX-FAST Adhesive Forehead Sensor is a disposable adhesive sensor for the forehead. MAX-FAST may be used on mechanically ventilated patients and on patients in supine position. MAX-FAST may be used continuously up to two days with appropriate site inspections, and will allow a maximum of four site changes and/or inspections with the removal of adhesive layers.
The OxiMAX MAX-FAST sensor contains a memory chip carrying information about the sensor which the oximeter needs for correct operation.
The OxiMAX MAX-FAST adhesive forehead sensor was cleared as part of the OxiMAX Pulse Oximetry System (510(k) #K012891). This forehead sensor was labeled for adults. The labeling has been updated to add pediatric use.
Let's break down the information provided about the K021089 submission for the OxiMAX MAX-FAST Adhesive Forehead Sensor.
Based on the provided document, this 510(k) submission is not about proving a new device meets acceptance criteria through a new effectiveness study. Instead, it's a resubmission for a labeling change to an already cleared device. The original device (OxiMAX MAX-FAST adhesive forehead sensor) was cleared as part of the OxiMAX Pulse Oximetry System (510(k) #K012891) and was labeled for adults. This K021089 submission updates the labeling to add pediatric use (≥ 10 kg).
The document explicitly states:
- "No design modifications have been made to the OxiMAX MAX-FAST adhesive forehead sensor. Only labeling has been revised."
- "The OxiMAX MAX-FAST adhesive forehead sensor was cleared as part of the OxiMAX Pulse Oximetry System (510(k) #K012891). This forehead sensor was labeled for adults. The labeling has been updated to add pediatric use."
Therefore, the information you're asking for regarding acceptance criteria, performance studies, sample sizes, ground truth establishment, expert adjudication, and MRMC studies related to meeting new acceptance criteria is not present in this specific K021089 document. This filing refers back to the original K012891 for device performance.
To answer your request thoroughly, I would need the K012891 submission document, which would contain the original performance study details that led to its clearance.
However, I can extract the information that is implicitly available or directly stated based on the nature of this submission:
1. Table of Acceptance Criteria and Reported Device Performance
As this is a labeling update, no new acceptance criteria or reported device performance studies are presented in K021089. The device's performance for adults would have been established in the predicate K012891 submission. For the pediatric expansion, the FDA typically assesses if the existing performance data and technological characteristics are sufficient to support the expanded indication without new testing, or if bridging data is required. The lack of new study data in this submission implies the FDA found the existing data (likely from K012891) sufficient for the pediatric expansion (≥10kg).
2. Sample size used for the test set and the data provenance
- Sample Size: Not applicable/Not provided in this document as no new performance study was conducted.
- Data Provenance: Not applicable/Not provided in this document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable/Not provided in this document as no new performance study was conducted.
4. Adjudication method for the test set
- Not applicable/Not provided in this document as no new performance study was conducted.
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 oxygen sensor, not an AI-assisted diagnostic tool requiring MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This device is an oxygen sensor, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable/Not provided in this document as no new performance study was conducted. For pulse oximeters, the typical ground truth involves co-oximetry (blood gas analysis) for SaO2 measurements.
8. The sample size for the training set
- Not applicable/Not provided in this document as no new performance study was conducted. This device is hardware; any "training" would have been for the original algorithm development in K012891, not a new study here.
9. How the ground truth for the training set was established
- Not applicable/Not provided in this document as no new performance study was conducted.
Summary of K021089 specific to your questions:
The K021089 submission is a regulatory update to expand the indications for use of an already cleared device (OxiMAX MAX-FAST Adhesive Forehead Sensor) to include pediatric patients (≥10 kg). No new performance data, studies, or acceptance criteria are presented in this document. The substantial equivalence determination relies on the existing performance data from the predicate device (K012891) and the fact that no design modifications were made.
§ 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).