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510(k) Data Aggregation
(259 days)
Adults K080377
The Infrascanner is indicated for the detection of traumatic supratentorial hematomas of as small as 3.5mL and as deep as 2.5 cm from brain surface, but not both at the same time, as an adjunctive device to the clinical evaluation in the acute hospital setting of adult patients and pediatric patients aged 2 years and older with suspected traumatic supratentorial intracranial hematoma. The device is indicated to assess patients for CT scans but should not serve as a subsitute for these scans, the device should only be used to rule in subjects for the presence of hematoma, never to rule out. 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 device is a noninvasive device, which uses near-infrared spectroscopy ("NIRS") to provide early information about the possible development of traumatic supratentorial 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.
Here's a breakdown of the acceptance criteria and study information for the Infrascanner device, based on the provided text:
1. Acceptance Criteria and Reported Device Performance
The provided text doesn't explicitly state "acceptance criteria" as a separate, pre-defined set of thresholds. Instead, it presents the diagnostic performance metrics observed in a clinical study for different age groups, comparing them to a predicate adult population performance. This suggests that the reported performance itself serves as evidence of meeting an implicit acceptance standard for substantial equivalence.
Here's a table summarizing the reported device performance for diagnosing traumatic supratentorial hematomas:
| Metric | 2-12 Years Old (Reported Performance) | 12-18 Years Old (Reported Performance) | Adults (Predicate K080377 Performance) |
|---|---|---|---|
| Sensitivity | 88.9% (65.3% to 98.6% CI) | 85.7% (42.1% to 99.6% CI) | 74.6% (62.1% to 84.7% CI) |
| Specificity | 72.3% (65.6% to 78.3% CI) | 73.4% (65.2% to 80.5% CI) | 81.6% (76.9% to 85.7% CI) |
| PPV | 22.2% (17.8% to 27.4% CI) | 14.0% (9.7% to 19.6% CI) | 44.3% (37.8% to 51.1% CI) |
| NPV | 98.6% (95.2% to 99.6% CI) | 99.0% (94.3% to 99.8% CI) | 94.2% (91.4% to 96.2% CI) |
Note on Acceptance Criteria: The text highlights that "Bench data demonstrate the subject device performance in pediatric subjects is substantially equivalent to the performance in adult subjects of the predicate." This implies that the observed pediatric performance, being comparable or better than the predicate's adult performance, met the criteria for substantial equivalence.
2. Sample Size and Data Provenance
Test Set Sample Size:
- Enrolled: 464 patients
- Met Inclusion for Primary Data Analysis: 344 patients
- 2-12 Years Old: 220 patients
- 12-18 Years Old: 146 patients
- Hematomas Detected on HCT: 10.5% of enrolled (approx. 49 patients)
- Qualifying Hematomas: 4.7% of enrolled (approx. 22 patients)
Data Provenance:
- Country of Origin: The clinical study was carried out in "Emergency Departments large urban quaternary care academic medical centers." While a specific country isn't explicitly stated, the context of an FDA submission for a US market device strongly suggests the study was conducted in the United States.
- Retrospective or Prospective: The wording "A clinical study was carried out in the Emergency Departments... 464 patients were enrolled..." indicates this was a prospective clinical study.
3. Number of Experts and Qualifications for Ground Truth
The document does not explicitly state the number of experts used to establish ground truth or their specific qualifications (e.g., "radiologist with 10 years of experience").
However, it does state that the ground truth for hematoma presence was determined by "evidence of a hematoma on HCT" (referring to Head CT scans). This implies that radiologists and/or emergency physicians would be involved in interpreting these CT scans, but their numbers and specific experience levels are not detailed in this summary.
4. Adjudication Method for the Test Set
The document does not describe a specific adjudication method (e.g., 2+1, 3+1, none) for the test set.
The ground truth relies on Head CT scans, which are generally considered the gold standard for diagnosing intracranial hematomas. It's common practice for CT scan interpretations to either be from a single-reader clinical report or, in research settings, to involve multiple readers and/or consensus, but this detail is not provided here.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The document does not describe a multi-reader multi-case (MRMC) comparative effectiveness study evaluating the effect of human readers improving with AI vs. without AI assistance.
The Infrascanner is described as an "adjunctive device to the clinical evaluation," but the study presented focuses on the device's standalone diagnostic performance rather than its impact on human reader performance in a controlled MRMC setting.
6. Standalone (Algorithm Only) Performance
Yes, a standalone (i.e., algorithm only without human-in-the-loop performance) study was clearly done. The sensitivity, specificity, PPV, and NPV values provided in the table are direct measures of the Infrascanner device's performance in detecting hematomas when applied to patients, without specifying human intervention affecting these metrics. The device's output (presence/absence of hematoma) is compared directly to the CT scan ground truth.
7. Type of Ground Truth Used
The primary ground truth used for the clinical study was Head CT scans (HCT). The text states: "...10.5% had evidence of a hematoma on HCT, and 4.7% had qualifying hematomas." This is a definitive imaging modality for diagnosing intracranial hematomas.
8. Sample Size for the Training Set
The document does not provide any information about the sample size for a training set. The descriptions focus on the clinical validation study (test set) and bench testing. Given that this is a 510(k) submission and the device uses near-infrared spectroscopy, it's possible the device relies on underlying physical principles and signal processing rather than a "trained" machine learning algorithm in the typical sense that would require a large annotated training set. However, if there was any internal algorithm development or optimization done using data, the size and nature of such a training set are not mentioned here.
9. How Ground Truth for the Training Set Was Established
Since no information on a training set is provided, there is no information on how its ground truth was established.
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(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.
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