(287 days)
The Infrascanner is indicated for the detection of traumatic supratentorial hematomas of greater than 3.5 mL in volume that are less than 2.5 cm from the brain surface, as an adjunctive device to the clinical evaluation in the acute hospital setting of patients 18 years old or greater with suspected traumatic supratentorial intracranial hematoma. The device is indicated to assess patients for CT scans but should not serve as a substitute for these scans. The Infrascanner is indicated for use by Physicians, or under the direction of a physician, who has been trained in the use of the device.
The Infrascanner Model 2000 is a noninvasive device, which uses near-infrared spectroscopy ("NIRS") to provide early information about the possible development of traumatic supratentorial intracranial hematomas in patients presenting to hospitals with head trauma This technology involves comparing regional differences in absorbance of NIR light. The application of NIRS to hematoma evaluation is based on the principle that intracranial hemoglobin concentration will differ where a hematoma is present, compared to hemoglobin concentrations in normal intracranial regions. The system consists of a Class I NIR-based sensor. The sensor is optically coupled to the patient's head through two disposable light guides in a "hairbrush" configuration. Examination with the Infrascanner is performed through placement of the sensor on designated areas of the head that represent the most common locations for traumatic hematoma. The examination is designed to be performed within two minutes.
Acceptance Criteria and Study for InfraScan's Infrascanner Model 2000
The acceptance criteria for InfraScan's Infrascanner Model 2000 are not explicitly stated as numerical performance metrics in the provided 510(k) summary. Instead, the submission focuses on demonstrating substantial equivalence to its predicate device, the Infrascanner Model 1000 (K080377). The study conducted was primarily a bench testing and comparability study rather than a clinical trial with specific performance targets.
The key acceptance criterion, implicitly, is that the Infrascanner Model 2000 functions as intended and is as safe and effective as the predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implicit from Substantial Equivalence Basis) | Reported Device Performance (as per 510(k) Summary) |
|---|---|
| Function as Intended: The device should perform its intended function of detecting traumatic supratentorial hematomas. | "Bench testing demonstrated that the Infrascanner Model 2000 functioned as intended." |
| Similar Performance to Predicate Device: Performance in detecting hematomas should be comparable to the Infrascanner Model 1000 across relevant parameters (depth, size, skin tone). | "Testing comparing the Infrascanner Model 2000 and its predicate was conducted using a multilayer brain hematoma model... Results with the multilayer model for both the Model 2000 and the predicate were consistent with the expected result observed in clinical testing of the predicate. Performance was substantially similar for both models across a range of depths and sizes of hematomas similar to those seen in the clinical setting, and for light and dark skin types." |
| Comparability of Optical Densities: The device should demonstrate comparable performance across the range of optical densities observed clinically. | "Additional laboratory testing demonstrated the comparability of the device and its predicate over the range of optical densities observed in the clinical setting." |
| Safety and Effectiveness: No new issues of safety or effectiveness should be raised by the minor technological differences. | "The minor technological differences between the Infrascanner Model 2000 and its predicate device raise no new issues of safety or effectiveness. Performance data demonstrate that the Infrascanner Model 2000 is as safe and effective as the Infrascanner Model 1000." |
2. Sample Size Used for the Test Set and Data Provenance
The provided 510(k) summary does not specify a "test set" in the traditional sense of a patient cohort. The study described is primarily a bench test using a multilayer brain hematoma model. Therefore, there are no details about:
- Sample size used for the test set (human subjects): Not applicable for this type of testing.
- Data provenance: The "data" comes from the performance of the device on the multilayer brain hematoma model. No country of origin is mentioned for this model or its development. The testing is retrospective in the sense that it's evaluating a developed device against a model, not prospectively on new patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable as the "test set" was a physical model (multilayer brain hematoma model) rather than patient data requiring expert interpretation for ground truth.
4. Adjudication Method
This information is not applicable as the "test set" was a physical model, not patient data requiring adjudication of diagnostic results.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed according to the provided text. The study focused on demonstrating the functional equivalence of the new device to its predicate through bench testing, not on human reader performance with or without AI assistance.
6. Standalone Performance Study
Yes, a standalone performance evaluation of the algorithm (device) was indeed done. The "bench testing" and "testing comparing the Infrascanner Model 2000 and its predicate" using a multilayer brain hematoma model represent a standalone evaluation of the device's ability to detect hematomas in a controlled environment, without human interpretation as part of the primary measurement.
7. Type of Ground Truth Used
The ground truth used for the testing was primarily the physical characteristics of the multilayer brain hematoma model, specifically the presence, depth, and size of simulated hematomas within the model. This is an engineered ground truth within a simulated environment.
8. Sample Size for the Training Set
The provided 510(k) summary does not mention a training set nor any machine learning or AI components that would typically require one. The description of the technology ("Near-infrared spectroscopy ('NIRS') to provide early information about the possible development of traumatic supratentorial intracranial hematomas... based on the principle that intracranial hemoglobin concentration will differ where a hematoma is present") suggests a biophysical measurement device, not one that relies on a trained algorithm in the modern sense.
9. How the Ground Truth for the Training Set Was Established
As no training set is mentioned or implied, this information is not applicable.
§ 882.1935 Near Infrared (NIR) Brain Hematoma Detector.
(a)
Identification. A Near Infrared (NIR) Brain Hematoma Detector is a noninvasive device that employs near-infrared spectroscopy that is intended to be used to evaluate suspected brain hematomas.(b)
Classification. Class II (special controls). The special controls for this device are:(1) The sale, distribution, and use of this device are restricted to prescription use in accordance with § 801.109 of this chapter;
(2) The labeling must include specific instructions and the clinical training needed for the safe use of this device;
(3) Appropriate analysis/testing should validate electromagnetic compatibility (EMC), electrical safety, and battery characteristics;
(4) Performance data should validate accuracy and precision and safety features;
(5) Any elements of the device that may contact the patient should be demonstrated to be biocompatible; and,
(6) Appropriate software verification, validation, and hazard analysis should be performed.