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510(k) Data Aggregation
(214 days)
iCertainty
The iCertainty System is intended for non-invasive two-dimensional imaging as an adjunctive method for evaluation of blood flow distribution (flow and perfusion) in tissues, up to a depth of 4-5mm.
The iCertainty System is a device used to image blood flow distribution (flow in vessels and perfusion in tissues) in real time. The device employs a mobile cart so that it can be configured in the appropriate orientation to properly image the tissue in an operating room environment without restrictions. When a practitioner elects to use imaging as an adjunct to evaluate blood flow distribution the device is moved into the appropriate position and an extension arm with an optical head unit (OHU, containing the lasers/camera equipment) is positioned over the patient as described in the instructions for use. The OHU is moved to a specified height (focused) over the target image area and the imaging is performed. The imaging can be performed as often as deemed necessary by the surgeon during the procedure to visualize blood flow distribution (blood flow in vessels and perfusion in tissues) in the target tissues being operated upon. The device employs a dual laser-based system with a camera imaging system. The two lasers (450nm and 785nm) illuminate the surface and blood flow distribution up to a depth of 4-5mm of the target tissue. A digital camera records the image in real time. All real-time blood flow distribution analyses are performed on a central computer within the device. Realtime images are displayed to the surgeon on an imaging display. Data entry is performed on a separate display and data entry keyboard. A sterile drape is used as an accessory to protect the sterile operating field from contamination during use.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly present a table of quantitative acceptance criteria for device performance. Instead, it details performance testing categories and states that the iCertainty system was evaluated to be "substantially equivalent to currently marketed perfusion flow imaging systems, and substantially equivalent to the PeriCam PSI (K120884)."
However, it does mention some performance aspects in comparison with predicate devices, which can be inferred as performance characteristics the device meets.
| Feature | Requirement (Implicit Acceptance Criteria) | Reported Device Performance (iCertainty) |
|---|---|---|
| Intended Use/Indications | Non-invasive two-dimensional imaging as an adjunctive method for evaluation of blood flow distribution (flow and perfusion) in tissues, up to a depth of 4-5mm. | Meets the stated intended use. Substantially equivalent to predicate in intended use. |
| Target Users | Surgeons, physicians, nurses, and other trained medical professionals. | Meets the target user profile. Substantially equivalent to predicate. |
| Targeted Anatomical Sites | Targeted surgical tissues exposed to the device field of view, including central organ and peripheral tissues. | Meets the targeted anatomical sites. Substantially equivalent to predicate. |
| Mechanism of Action | Use laser light to illuminate target tissues and analyze reflected light to generate blood perfusion images. | Employs a dual laser-based system (450nm and 785nm) with optical reflectance and laser speckle contrast analysis to process and image reflected patterns from blood, generating blood perfusion images up to a depth of 4-5mm. Substantially equivalent to predicate (PeriCam PSI) and similar to reference (Novadaq SPY) in underlying principles. |
| Imaging Distance | Comparable to predicate devices. | $32 \pm 3$ cm. Substantially equivalent to SPY (10cm) and comparable to PeriCam PSI (30cm). |
| Field of View | Comparable to predicate devices. | 9 cm x 9 cm. Comparable to PeriCam PSI (up to 24x24cm) and larger than SPY (5x7cm). |
| Depth of Penetration and Detection | Documented penetration and detection. | 4-5 mm documented penetration and 4-5 mm documented detection. Similar to SPY (5-6mm reported penetration), not comparable to PeriCam PSI (not reported). |
| Resolution and Contrast | Similar resolution and contrast to predicate devices. | Image Resolution: 112µm/pixel; Max: 1600 x 800 Data Points, 1600 x 800 pixels; Speckle Contrast: 0-1. Substantially equivalent to predicate. |
| Image Presentation | Display imaging that the user can interpret. | Visible color and MSPV (mean speckle perfusion value). Displays both visible light and perfusion image side-by-side. Substantially equivalent to predicate. |
| Imaging Depiction | Depict blood flow and perfusion. | Depicts blood flow and perfusion. Substantially equivalent to predicate. |
| User Interface | Functional and comparable to predicate devices. | Keyboard, Graphical User Interface, Buttons on Camera head. Substantially equivalent to predicate. |
| Mode of Use | Configurable for appropriate orientation for imaging. | Mobile cart with an extension arm for positioning over the patient. Substantially equivalent to predicate. |
| Setup | Adjustable arm stabilized for use, utilizing a computer. | Adjustable arm with laser and camera componentry mounted to a mobile cart with video screens, keyboard, and computer. Substantially equivalent to predicate. |
| Imaging Cycles | Multiple imaging episodes per evaluation. | 10 imaging cycles, limited by software. Substantially equivalent to predicate. |
| Size | Functional design that accommodates necessary components. | 81.3 x 81.3 x 198.1 cm, 221 kg (all-in-one device). Substantially equivalent to predicate. |
| Maintenance/Cleaning | Instructions for cleaning/disinfection. | Used with a sterile drape; user manual provides cleaning instructions. Substantially equivalent to predicate. |
| Biocompatibility | No patient contact; user contact materials are safe. | Does not come into contact with the patient. User-contact materials (arm, camera head, cart) are plastic and metal. Substantially equivalent to predicate. |
| Operating Conditions | Similar to predicate devices. | Temperature: 10°C to 30°C; Relative Humidity: 30-80% non-condensing; Atmospheric Pressure: 700hPA to 1060hPA. Substantially equivalent to predicate. |
| Power Supply | Operates on standard Mains power supply in the United States. | Operates on standard Mains power supply in the United States. Substantially equivalent to predicate. |
| Safety and EMC | Compliant with IEC 60601-1 and 60601-1-2. | Compliant with IEC 60601-1 and 60601-1-2. Substantially equivalent to predicate. |
| Sterile Barrier | Compatibility with sterile barrier/drape. | Tested for sterile barrier/drape compatibility. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: 40 patients.
- Data Provenance: The study involved evaluation of human anatomy (hand, forearm, and ankle). The document does not explicitly state the country of origin, but given the FDA 510(k) submission, it is likely that the study was conducted in the US or in a region acceptable to US regulatory standards. The study appears to be prospective as it involved "Evaluation of human anatomy... demonstrated that the iCertainty images blood flow distribution."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not specify the number of experts or their qualifications used to establish ground truth for the human evaluation on the 40 patients. It only states that the evaluation "demonstrated that the iCertainty images blood flow distribution (flow and perfusion)."
4. Adjudication method for the test set
The document does not specify an adjudication method like 2+1, 3+1, or none.
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
The document mentions "Assessment of Clinical Data: Evaluation of human anatomy (hand, forearm and ankle from 40 patients) demonstrated that the iCertainty images blood flow distribution (flow and perfusion)." This suggests a clinical evaluation. However, the document does not report a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with AI assistance versus without AI assistance, nor does it provide an effect size for such improvement. The iCertainty system is described as an "adjunctive method," implying it assists evaluation, but the study described is focused on the device's ability to image blood flow, not on reader performance with or without the device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The document implies that the device provides images for a human operator to interpret ("Realtime images are displayed to the surgeon on an imaging display"). The described clinical assessment is about the device's ability to "image blood flow distribution," rather than the performance of an algorithm to make a diagnosis or assessment on its own. Therefore, it does not explicitly state that a standalone (algorithm only) performance study was conducted. The device is intended as an "adjunctive method," strongly suggesting human-in-the-loop operation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the human clinical evaluation on 40 patients, the document states it "demonstrated that the iCertainty images blood flow distribution (flow and perfusion)." It does not explicitly define the "ground truth" method used for this human evaluation. Given the nature of blood flow imaging, it's possible that comparison was made against physiological expectations or qualitative assessment by clinicians, but the specific method (e.g., expert consensus on other gold standard imaging, direct physiological measurement) is not detailed.
For the animal studies, it states: "In vivo blood flow and perfusion was evaluated through animal studies investigating skin/epidermis, static solid organ, vascular and moving solid organs in normal and diseased state." This indicates a comparative approach to normal vs. diseased states to assess the device's ability to detect different perfusion levels, but the exact "ground truth" (e.g., histological confirmation of disease, other perfusion measurement techniques) specific to the animal study is not explicitly mentioned.
8. The sample size for the training set
The document does not specify the sample size for the training set for any algorithms used in the iCertainty system.
9. How the ground truth for the training set was established
Since the document does not specify a training set, it also does not provide information on how the ground truth for any training set was established.
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