(211 days)
Not Found
No
The description focuses on the use of near-infrared spectroscopy (NIRS) and comparing regional differences in light absorbance to detect hematomas. There is no mention of AI, ML, or any learning algorithms being used for data analysis or interpretation. The performance study describes a clinical evaluation, not the training or testing of an AI/ML model.
No
The device is indicated for the detection of traumatic supratentorial hematomas and to assess patients for CT scans; it does not provide any treatment or therapy.
Yes
The "Intended Use / Indications for Use" states that the device is "indicated for the detection of traumatic supratentorial hematomas..." and "to assess patients for CT scans but should not serve as a substitute for these scans". This language clearly indicates that the device is used to identify a medical condition or to inform further diagnostic procedures, which directly aligns with the definition of a diagnostic device.
No
The device description explicitly states that the system consists of a "Class I NIR-based sensor" and uses "two disposable light guides," indicating the presence of hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- Device Description: The Infrascanner is described as a noninvasive device that uses near-infrared spectroscopy (NIRS) applied directly to the patient's head. It does not involve the collection or analysis of any specimens taken from the body.
- Intended Use: The intended use is for the detection of traumatic supratentorial hematomas by applying the device to the head. This is a direct measurement on the patient, not an analysis of a sample.
Therefore, the Infrascanner falls under the category of a non-invasive medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
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 Infrascamer is indicated for use by Physicians, or under the direction of a physician, who has been trained in the use of the device.
Product codes
OPT
Device Description
The device 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Near-infrared spectroscopy (NIRS)
Anatomical Site
Brain (supratentorial)
Indicated Patient Age Range
adult patients and pediatric patients aged 2 years and older
Intended User / Care Setting
Physicians, or under the direction of a physician, who has been trained in the use of the device.
acute hospital setting
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Duke University Global Neurosurgery studied the Infrascanner in Mbarara hospital in Uganda. The study evaluated 672 consecutive patients with confirmed or suspected head trauma who received a head CT scan. Overall Infrascanner and CT data were available for 387 patients.
After removing patients with small contusions outside of the Infrascanner, 138 patients had bleeding within the detection abilities of the Infrascanner. Of these 138 patients, 71 patients were randomly selected to receive measurements with both 100 mW and 200 mW Infrascanners.
The reference standard for hematoma detection was CT scan.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Phantom Testing: A skin color test was performed using a phantom head model. Test data were collected using filters to model three skin color groups for various hematoma size and depths. Measurements were made using the 100mW and 200mW scanners. The test data sets established that the Infrascanner Model 2500 had substantially equivalent performance between 200mW and 100mW laser power settings across a range of simulated hematoma sizes and depths and for light-skinned to very dark-skinned people.
Laser Power Performance Comparability Protocol: Five (5) Model 2500 scanners were used to perform optical density measurements across a range of different attenuations at 200mW and 100mW. The difference between models met the acceptance criteria and was less than 5% in absolute OD.
IEC Testing: IEC 60601-1; IEC 60601-1-2; AIM 7351731 RFID Immunity; and IEC 60825-1. All tests had acceptable results.
Clinical Performance:
Study Type: Clinical study
Sample Size: 387 patients (clinical data available), subgroup of 71 patients.
Key Results:
- For 345 patients with 138 hematomas within the detection range (measured by 100mW scanner): Sensitivity 91.3%, Specificity 39.1%, Positive Predictive Value 50.0%, Negative Predictive Value 87.1%.
- For 71 patient subgroup (measured with 100mW scanner): Sensitivity 100.0%, Specificity 36.6%, Positive Predictive Value 53.6%, Negative Predictive Value 100.0%.
- For 71 patient subgroup (measured with 200mW scanner): Sensitivity 96.7%, Specificity 43.9%, Positive Predictive Value 55.8%, Negative Predictive Value 94.7%.
Clinical data concluded that:
i) in patients with a detectable hematoma, the sensitivity of both laser power settings was equivalent,
ii) in patients with no hematomas, the specificity in both laser power settings was equivalent, and
iii) in three very dark skin individuals where measurements could not be collected with 100mW scanner, the proposed 200mW setting scanner was able to complete the measurements.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
100mW in 345 patients' group (Hematomas within detection range: 138):
Sensitivity: 91.3% (Cl 85.3-95.4)
Specificity: 39.1% (Cl 32.4-46.1)
Positive Predictive Value: 50.0% (Cl 43.7-56.3)
Negative Predictive Value: 87.1% (Cl 78.5-93.2)
100mW in 71 patient's subgroup (Hematomas within detection range: 30):
Sensitivity: 100.0% (Cl 88.4-100)
Specificity: 36.6% (Cl 22.1-53.1)
Positive Predictive Value: 53.6% (Cl 39.7-67.0)
Negative Predictive Value: 100.0% (Cl 78.2-100)
200mW in 71 patient's subgroup (Hematomas within detection range: 30):
Sensitivity: 96.7% (Cl 82.8-99.9)
Specificity: 43.9% (Cl 28.5-60.3)
Positive Predictive Value: 55.8% (Cl 41.3-69.5)
Negative Predictive Value: 94.7% (Cl 74.0-99.9)
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
December 12, 2024
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Infrascan, Inc. Baruch Ben Dor President & CEO 3508 Market Street, Suite 127 Philadelphia, Pennsylvania 19104
Re: K241389
Trade/Device Name: Infrascanner Model 2500 (Model 2500) Regulation Number: 21 CFR 882.1935 Regulation Name: Near Infrared (NIR) Brain Hematoma Detector Regulatory Class: Class II Product Code: OPT Dated: May 15, 2024 Received: November 12, 2024
Dear Baruch Ben Dor:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
2
Sincerely,
Image /page/2/Picture/3 description: The image contains the name "Patrick Antkowiak -S" in black text. The name is displayed against a white background. To the left of the name is a faded blue logo that appears to be "FDA".
for Jay Gupta Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional, and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K241389
Device Name Infrascanner Model 2500 (Model 2500)
Indications for Use (Describe)
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 Infrascamer is indicated for use by Physicians, or under the direction of a physician, who has been trained in the use of the device.
Type of Use (Select one or both, as applicable) | |
---|---|
Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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4
Traditional Premarket Notification Submission -510(k) Infrascanner Model 2500 510(k) Number K241389
Date Prepared: November 8, 2024
l. SUBMITTER
Infrascan, Inc. 3508 Market Street Philadelphia PA 19104
Contact Person
Baruch Ben Dor, PhD Infrascan, Inc. 3508 Market Street Philadelphia PA 19104 Tel: (610) 387-6784 bbendor@infrascanner.com
II. DEVICE
Name of Device: | Infrascanner Model 2500 |
---|---|
Common or Usual Name: | Near Infrared (NIR) Brain Hematoma Detector |
Classification Name: | 21 CFR § 882.1935 - Near Infrared (NIR) Brain Hematoma Detector |
Product Code OPT |
Regulatory Class: ||
lll. PREDICATE DEVICE
- Infrascan, Inc. Infrascanner Model 2500 cleared under K211617, Product Code: OPT
IV. DEVICE DESCRIPTION
The device 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.
V. INDICATIONS FOR USE
The Infrascanner is indicated for the detection of traumatic supratentorial hematomas of as small
5
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 substitute 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.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The Infrascanner Model 2500 is the same device as the predicate Model 2500 except for an upgrade of laser power from 100 mW to 200 mW to enable readings in very dark-skinned people. As illustrated in Table 1, the subject device has the same indication for use, technological characteristics, and principles of operation as its predicate device. The enhancement of increased laser power raises no new issues of safety or effectiveness as demonstrated by clinical performance data and bench data and is substantially equivalent.
| | Model 2500
K211617
(predicate) | Upgraded Model 2500
(subject device) | Equivalence |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Indications for Use | 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 substitute 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 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 substitute 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. | Identical |
| Target population | Brain injury victims more than 2
years old | Brain injury victims more than 2
years old | Identical |
| Method of
Measurement | Measures tissue hemoglobin
concentration using NIRS | Measures tissue hemoglobin
concentration using NIRS | Identical |
| Probe placement | Over frontal, temporal, parietal,
occipital regions of brain | Over frontal, temporal, parietal,
occipital regions of brain | Identical |
| Data processor | Microcontroller unit (MCU) | Microcontroller unit (MCU) | Identical |
Table 1: Substantial Equivalence
6
| | Model 2500
K211617
(predicate) | Upgraded Model 2500
(subject device) | Equivalence |
|-------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|-----------------------------|
| Communication
between patient-
contacting unit
and data
processor | Serial port protocol over wired
connection | Serial port protocol over wired
connection | Identical |
| System display | Built-in display | Built-in display | Identical |
| User interface | Membrane button- controlled
software | Membrane button- controlled
software | Identical |
| Power source | Rechargeable Lithium Polymer 3.7V
battery or 2 disposable AA batteries | Rechargeable Lithium Polymer 3.7V
battery or 2 disposable AA batteries | Identical |
| Power switch | Disposable Shield activated On/Off
electrical switch | Disposable Shield activated On/Off
electrical switch | Identical |
| Patient interface | Two disposable 1.6 mm PMMA
fibers, 4 cm from each other | Two disposable 1.6 mm PMMA
fibers, 4 cm from each other | Identical |
| Light source | 100 mW, 808 nm Diode Laser | 200 mW, 808 nm Diode Laser | Substantially
equivalent |
| Laser control and
safety | Pulsing with dedicated fuse for
overpower and pulsing failure | Pulsing with dedicated fuse for
overpower and pulsing failure | Identical |
| Detector + optical
filter | Silicon detector + 808 nm filter | Silicon detector + 808 nm filter | Identical |
| Signal processing,
control algorithm
and results display | Automatic algorithm to control
hardware, graphical and numerical
display. Hematoma detection
threshold of AOD = 0.2 | Automatic algorithm to control
hardware, graphical and numerical
display. Hematoma detection
threshold of AOD = 0.2 | Identical |
PERFORMANCE DATA VII.
The following clinical testing and non-clinical testing was conducted to demonstrate the appropriate substantial equivalence of the Infrascanner Model 2500 to the predicate.
Phantom Testing
A skin color test was performed using a phantom head model. Test data were collected using filters to model three skin color groups for various hematoma size and depths. Measurements were made using the 100mW and 200mW scanners. The test data sets established that the Infrascanner Model 2500 had substantially equivalent performance between 200mW and 100mW laser power settings across a range of simulated hematoma sizes and depths and for light-skinned to very dark-skinned people.
Laser Power Performance Comparability Protocol
Five (5) Model 2500 scanners were used to perform optical density measurements across a range of different attenuations at 200mW and 100mW. The difference between models met the acceptance criteria and was less than 5% in absolute OD.
7
IEC Testing
Other bench testing the following testing with acceptable results for all tests: IEC 60601-1; IEC 60601-1-2; AIM 7351731 RFID Immunity; and IEC 60825-1.
Clinical Performance
Duke University Global Neurosurgery studied the Infrascanner in Mbarara hospital in Uganda. The study evaluated 672 consecutive patients with confirmed or suspected head trauma who received a head CT scan. Overall Infrascanner and CT data were available for 387 patients. Table 2 includes the demographics and the injury description of the whole analyzed cohort of 387 patients.
N | % | ||
---|---|---|---|
Gender | Male | 341 | 88.1% |
Female | 46 | 11.9% | |
Age | Range (Mean) | 12-78 | |
(32.8) | |||
Glasgow Coma Scale | |||
(GCS) | Mild | 273 | 70.5% |
Moderate | 52 | 13.5% | |
Severe | 46 | 11.9% | |
Critical | 16 | 4.1% | |
Mortality by GCS | Mild | 3 | 1.1% |
Moderate | 4 | 7.7% | |
Severe | 8 | 17.4% | |
Critical | 11 | 68.8% | |
Mechanism of Injury | RTA | 298 | 77.0% |
Assault | 66 | 17.1% | |
Fall | 11 | 2.8% | |
Other | 6 | 1.6% | |
Accidental injury | 4 | 1.0% | |
Unknown | 2 | 0.5% | |
Mortality | No | 361 | 93.3% |
Yes | 26 | 6.7% | |
Face or Scalp | |||
Hematoma Present | No | 99 | 25.6% |
Yes | 283 | 73.1% | |
Visible Bleeding (Eye, | |||
Ear, Nose) | No | 170 | 43.9% |
After removing patients with small contusions outside of the Infrascanner, 138 patients had bleeding within the detection abilities of the Infrascanner. Of these 138 patients, 71 patients were randomly selected to receive measurements with both 100 mW and 200 mW Infrascanners. Table 3 presents the Infrascanner performance (sensitivity, specificity, positive and negative predictive values) for the above patient sub-groups: 345 patients with 138 hematomas within the detection range of the Infrascanner, measured by 100mW scanner, the selected 71 patients measured with 100mW and the same selected 71 patients measured with 200mW scanner. Three of the 71 patients had very dark skin.
8
| | 100mW in 345
patients' group | 100mW in 71
patient's subgroup | 200mW in 71
patient's subgroup |
|-------------------------------------|---------------------------------|-----------------------------------|-----------------------------------|
| Number of patients | 345 | 71 | 71 |
| Hematomas within
detection range | 138 | 30 | 30 |
| Sensitivity | 91.3% | 100.0% | 96.7% |
| Cl | 85.3-95.4 | 88.4-100 | 82.8-99.9 |
| Specificity | 39.1% | 36.6% | 43.9% |
| Cl | 32.4-46.1 | 22.1-53.1 | 28.5-60.3 |
| Positive Predictive
Value | 50.0% | 53.6% | 55.8% |
| Cl | 43.7-56.3 | 39.7-67.0 | 41.3-69.5 |
| Negative Predictive
Value | 87.1% | 100.0% | 94.7% |
| Cl | 78.5-93.2 | 78.2-100 | 74.0-99.9 |
Table 3: Infrascanner Detection Performance of Hematomas Within the Detection Range of the Device
Based on the results of this study, the clinical performance of the Infrascanner at 200mW laser power setting is substantially equivalent to the performance of the Infrascanner at 100mW laser power setting. The analysis of clinical data concluded that i) in patients with a detectable hematoma, the sensitivity of both laser power settings was equivalent, ii) in patients with no hematomas, the specificity in both laser power settings was equivalent, and iii) in three very dark skin individuals where measurements could not be collected with 100mW scanner, the proposed 200mW setting scanner was able to complete the measurements.
IX. CONCLUSION
Based on the same intended use, similar technological characteristics, acceptable performance testing, and clinical validation the modified device is substantially equivalent to the predicate and raises no additional or different questions of safety or effectiveness