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The Infrascanner Model 1000 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 hematoma. The device is indicated to assess patients for CT scans but should not serve as a substitute for these scans. The Infrascanner Model 1000 is indicated for use by physicians, or under the direction of a physician, who has been trained in the use of the device.

The system includes two components: the Sensor and a Personal Digital Assistant (PDA). The Sensor includes an 21 CFR 1040 Class I NIR 808nm diode laser and a silicon detector. The light to and from the laser and detector are optically coupled to the patient's head through two 19mm long disposable light guides. The light guides are long enough to reach through hair and contact the scalp. The light guides are placed 4 cm apart allowing detection of hematomas. The detector light passes through an optical bandpass filter centered at 808nm to minimize background light interference. Electronic circuitry is included to control laser power and the detector signal amplifier gain. The detector signal is digitized and transmitted via a Bluetooth wireless link to the PDA. The wireless link is also used to receive and set the hardware parameters of the Sensor. The PDA receives the data from the Sensor and automatically adjusts the settings of the Sensor to ensure good data quality. The data is further processed by the PDA and the results are displayed on the PDA screen.

Here's a breakdown of the acceptance criteria and the study that proves the Infrascanner Model 1000 meets them, based on the provided text:

Acceptance Criteria and Reported Device Performance

The core acceptance criteria for the Infrascanner Model 1000, as demonstrated by the clinical study, revolve around its ability to detect traumatic supratentorial hematomas of a specific size and depth.

• Software Requirements Specifications (SRS).
• Architecture Design Chart.
• Verification and Validation Plan (SVVP) based on IEEE Std 1059-1993 and FDA Guidance, with successful completion of all tests.
• Revision History Log. | Software: FMEA results showed no RPN > 100. SRS, Architecture Design Chart provided. SVVP followed IEEE and FDA guidance, all verifications and validation activities completed and tests passed successfully. Software versions: Firmware 2.18, System Software 2.006. |
  | Battery Testing (UL1642 compliance). | Battery testing conducted by CSA in accordance with UL1642 (passed). |

Study Details Proving Device Meets Acceptance Criteria

2. Sample size used for the test set and the data provenance:

• Test Set Sample Size: 383 subjects.
• Data Provenance:
  • Country of Origin: Not explicitly stated for all sites, but "four (4) sites US and one (1) site in India."
  • Retrospective or Prospective: Prospective. Subjects were enrolled and scanned with the Infrascanner Model 1000 within 30 minutes of receiving a CT scan.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Number of Experts: One
• Qualifications of Experts: An "independent radiologist blinded to the result of the Infrascanner Model 1000 measurements." Specific experience (e.g., years) is not provided.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

• Adjudication Method: None explicitly stated for the ground truth determination. The CT scans were interpreted by a single independent radiologist.

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:

• MRMC Study: No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This was a standalone device performance study against a CT ground truth, intended as an adjunctive device to clinical evaluation and CT, not as an AI-assisted reading tool for human readers.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

• Standalone Performance: Yes, the clinical study assessed the standalone performance of the Infrascanner Model 1000 (device's output: ΔOD > 0.2 indicates positive for hematoma) against the CT ground truth. The device results were considered "positive for hematomas if the maximum difference in optical density (ΔOD) for comparable skull regions was greater than 0.2."

7. The type of ground truth used:

• Type of Ground Truth: Imaging (CT scan) interpreted by an independent radiologist. Specifically, CT scans were evaluated for "location(s) and volume of hematomas."

8. The sample size for the training set:

• Training Set Sample Size: Not explicitly mentioned in the provided text. The clinical study described appears to be for device validation.

9. How the ground truth for the training set was established:

• Ground Truth Establishment for Training Set: Not described, as details of a training set are not provided. The non-clinical "Model laboratory testing" may have served as initial data for algorithm development and threshold setting, but this is distinct from a formal clinical training set with corresponding ground truth. The threshold of ΔOD > 0.2 appears to be derived from these lab tests, where "the Infrascanner Model 1000 is unable to reliably detect very small hematomas (

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