(87 days)
The OTIS 1B Optical Coherence Tomography System is indicated for use as an imaging tool in the evaluation of excised human tissue microstructure by providing two-dimensional, cross-sectional, real-time depth visualization, with image review manipulation software for identifying and annotating regions of interest.
The Perimeter OTIS 1B is based on optical coherence tomography (OCT) imaging which is similar to ultrasound, but uses non-ionizing, low-power optical radiation to produce high resolution, sub-surface images of a tissue sample. Due to the extremely high velocity of light, optical echoes (reflected and backscattered light from the sample) cannot be measured directly using a photodetector. Instead, OCT devices use an interferometer to compare a reference beam of light to the backscattered light returning from the tissue sample. The features in an OCT image are created by changes in the optical properties (namely scattering, absorption, and index of refraction) of the sample.
The Perimeter OTIS 1B collects and displays OCT images of human tissue with comparable image quality to other previously 510(k)-cleared OCT imaging systems and, specifically, the Perimeter OTIS 1.0 System (K160240). Like its predicate, the Perimeter OTIS 1B has automated the OCT scanning of the specimen surface, standardizing the image collection process.
The Perimeter OTIS 1B includes a white light image (e.g., photograph) of the specimen, to assist the clinician in viewing the OCT images with a reference to the white light image and the OCT image scan position. The Perimeter OTIS 1B also includes user interface options, such as the ability to "scroll" through the OCT images, across a specimen's surface, as well as to zoom and pan in more closely to examine areas of interest, as desired.
Here's an analysis of the provided text regarding the acceptance criteria and study details for the Perimeter OTIS 1B Optical Coherence Tomography System:
Important Note: The provided document is a 510(k) summary, which is designed to demonstrate substantial equivalence to a predicate device rather than providing detailed clinical efficacy data as might be found in a full scientific study publication. As such, information regarding comprehensive clinical performance, multi-reader multi-case studies, and detailed ground truth methodology for training datasets is not present in this document. The FDA's letter explicitly states, "The safety and effectiveness of this device for diagnostic analysis (i.e. differentiating normal versus specific abnormalities) in any tissue microstructure or specified disease has not been evaluated." This indicates that the device's primary claim relates to its imaging capabilities, not its diagnostic ability.
1. Table of Acceptance Criteria and Reported Device Performance
Based on the document, the "performance" primarily refers to the technical specifications and equivalency to the predicate device. Direct acceptance criteria for clinical performance (e.g., sensitivity, specificity for a specific diagnostic task) are not explicitly stated or demonstrated, aligning with the FDA's "diagnostic analysis" disclaimer.
| Acceptance Criteria (Implied / Technical Specification) | Reported Device Performance (OTIS 1B) |
|---|---|
| Functional Equivalence | Identical to OTIS 1.0 (K160240) |
| Measurement Technique | Optical Coherence Tomography |
| Center Wavelength (NIR: 700 – 1400 nm) | 1325 ± 20 nm |
| Optical Source | Super Luminescent Diode |
| Optical Radiation Safety | Safe for Indicated Use, Class 1 Laser |
| Lateral Resolution (Nominal) | ≤ 50 μm (20 μm) |
| Lateral Range (x-axis): Single B-scan | (1.7 mm) 2 mm |
| Lateral Range (x-axis): WF-OCT Scan | 500 mm [250 2 mm-strips] |
| Axial Resolution (Nominal) [free space units] | ≤ 15 μm (11.7 ± 2.0 μm) |
| In-depth tissue range [free space units] | 1.5 mm in tissue [minimum of 2.2 mm in free space (7mm)] |
| Patient Applied Part | No Patient Applied Part |
| Input Devices: Keyboard, Pointing | Yes, Yes |
| Input Devices: Foot pedal (optional) | No |
| Electrical Voltage Frequency | 108-132 V, 60 Hz [North America Use] |
| Image Quality for Tissue Microstructure | Sufficient to identify excised tissue microstructure features as compared to histopathology, at a level comparable to other OCT imaging systems. |
| Usability | Validated per IEC 62366:2007, with representative users in actual and simulated use environments. |
| Safety (Laser, Electrical, EMC) | Successfully demonstrated the safety in its intended environment. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not specify a distinct "test set" sample size in terms of number of patients or samples. The performance evaluation primarily focuses on the device's technical specifications and the ability to visualize tissue microstructure comparably to histopathology and other OCT systems. It does not provide quantitative data on a specific clinical test set.
- Data Provenance: Not explicitly stated for specific test data used for device performance comparisons. The device is for "excised human tissue."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- The document states that the device's image quality was evaluated "as compared to histopathology." It does not specify the number of experts, their qualifications, or their role in establishing "ground truth" for a test set in a diagnostic performance study. The comparison is likely a general technical assessment of image features against histological features, rather than a formal ground truth process for a specific diagnostic outcome.
4. Adjudication Method for the Test Set
- Not applicable/Not described. There is no mention of a formal adjudication method for a diagnostic test set in the document.
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
- No MRMC study described. The document does not mention any multi-reader multi-case study, nor does it discuss AI assistance or human reader improvement. The device is an imaging tool for visualizing microstructure, not an AI-powered diagnostic aide.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. The device is an imaging system, not an algorithm performing diagnostic analysis. The document states the device provides imaging for human evaluation and annotation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The ground truth for assessing image quality was stated as "histopathology." This implies that the features observed in the OCT images were qualitatively compared to corresponding features in standard histopathological slides.
8. The Sample Size for the Training Set
- Not applicable / Not described. The OTIS 1B is an imaging system based on physical principles (Optical Coherence Tomography). It is not an AI/ML algorithm that requires a "training set" in the conventional sense. Its "training" would be in its engineering and design to meet optical and mechanical specifications, rather than a data-driven training process.
9. How the Ground Truth for the Training Set was Established
- Not applicable / Not described. As mentioned above, the device is not an AI/ML algorithm that uses a training set with established ground truth labels in the typical sense.
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.