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510(k) Data Aggregation
(102 days)
The OTIS 1.0 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-section, real-time depth visualization.
The Perimeter Optical Tissue Imaging System (OTIS) 1.0 is an imaging tool for use on excised human tissue. The Perimeter OTIS 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 collects and displays OCT images of human tissue with comparable image quality to other previously 510(k)-cleared OCT imaging systems. However, rather than requiring the clinician to move his/her hand to collect "point-by-point" images, the Perimeter OTIS has automated the OCT scanning of the specimen surface, standardizing the image collection process.
The Perimeter OTIS also 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. In addition, the Perimeter OTIS 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.
The provided document is a 510(k) premarket notification FDA letter for the Perimeter OTIS™ 1.0 Optical Coherence Tomography System. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a comprehensive study report with specific performance metrics.
Based on the provided text, there is NO explicit table of acceptance criteria or specific quantitative performance metrics reported for the device's ability to "differentiate normal versus specific abnormalities" or for "diagnostic analysis." In fact, the FDA letter specifically states a limitation regarding this:
"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."
Therefore, many of the requested details about acceptance criteria and study results cannot be fully extracted from this document, as the device's diagnostic performance for differentiating abnormalities was not evaluated in this submission.
However, I can extract information related to the device's technical performance and usability as presented for the 510(k) submission, and the general approach to validating the device for its indicated use.
Here's an attempt to answer the questions based solely on the provided text, highlighting what is available and what is explicitly stated as not evaluated:
Acceptance Criteria and Device Performance (Based on available information)
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category (Implied by the document) | Specific Acceptance Criteria (Explicitly stated or derivable) | Reported Device Performance (as stated in the document) |
|---|---|---|
| Intended Use | The device is to be an imaging tool for evaluating excised human tissue microstructure by providing 2D, cross-section, real-time depth visualization. | "The OTIS 1.0 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-section, real-time depth visualization." (Stated as the intended use, implying it meets this functionality) |
| Image Quality / Microstructure Identification | Obtain OCT images with sufficient image quality to identify tissue microstructure features comparable to other OCT imaging systems. | "Perimeter validated that the OTIS can obtain OCT images with sufficient image quality to identify tissue microstructure features as compared to histopathology, at a level comparable to other OCT imaging systems." (No quantitative metrics provided, only a qualitative statement of comparability.) |
| Resolution (Technical Specifications) | Lateral Resolution: As good as or better than predicate devices (≤ 50 μm). Axial Resolution: As good as or better than predicate devices (≤ 15 μm). | Lateral Resolution: ≤ 50 μm (Matches predicate and meets/exceeds typical spec for this technology). Axial Resolution: ≤ 15 μm (Matches predicate and meets/exceeds typical spec for this technology). |
| Tissue Penetration (Technical Specifications) | In-depth tissue range: As good as or better than predicate devices (1.5 mm in tissue). | 1.5 mm in tissue [minimum of 2.2 mm in free space (7mm)] (Matches predicate devices). |
| Laser Safety Classification | Meet laser safety standards, aiming for lowest possible classification. | Class 1 Laser (per IEC 60825-1:2014), requiring no special optical safety precautions. (This is safer than predicate Class 3R lasers, indicating improved safety performance). |
| Electrical Safety & EMC | Comply with relevant IEC standards for electrical safety and electromagnetic compatibility. | "External laser, electrical, and EMC testing successfully demonstrated the safety of the Perimeter OTIS in its intended environment." (Implicitly means it met the acceptance criteria defined by these standards, e.g., IEC 60601-1 and IEC 60601-1-2). |
| Usability | Demonstrate usability per IEC 62366. | "Perimeter validated the usability of the OTIS per IEC 62366:2007 – Application of usability engineering to medical devices. Testing was performed with representative users in actual and simulated use environments." (Implies successful completion of usability validation based on the standard's criteria, though specific metrics are not given.) |
| Software Life Cycle Management | AAMI ANSI IEC 62304 compliance. | The device was designed and developed under design controls per 21 CFR 820.30 and complied with AAMI ANSI IEC 62304. |
| Risk Management | ISO 14971 compliance. | The device was designed and developed under design controls per 21 CFR 820.30, in addition to risk management, ISO 14971:2007. |
Crucial Qualification: The document 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 means the submission does not include studies on the device's diagnostic accuracy or clinical utility for differentiating pathologies. Its evaluation is focused on its role as an imaging tool to visualize microstructure.
2. Sample size used for the test set and the data provenance:
- Test Set Size: Not explicitly stated in the document. The statement "Perimeter validated that the OTIS can obtain OCT images with sufficient image quality to identify tissue microstructure features as compared to histopathology" implies a test set was used, but its size is not provided.
- Data Provenance: The document refers to "excised human tissue." It does not specify the country of origin of this data or if the studies were retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided. The document mentions comparison to "histopathology" as the ground truth, which implies expert pathology review, but details on the number and qualifications of pathologists are absent.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not specified.
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 involving human readers with AI assistance was performed or reported. This device is an imaging tool, not one that incorporates AI for diagnostic assistance. The focus of the 510(k) was on comparing technical and functional equivalence to predicate OCT imaging systems.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No standalone algorithm performance for diagnostic purposes was done or reported. The device generates images for human interpretation. The "Perimeter validated that the OTIS can obtain OCT images with sufficient image quality to identify tissue microstructure features as compared to histopathology" refers to the image quality generated by the device, not an automated diagnostic algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Histopathology was used as the ground truth for evaluating the image quality's ability to identify tissue microstructure features.
8. The sample size for the training set:
- Not applicable / Not specified. This document describes a 510(k) submission for an imaging device based on established OCT technology, not a new AI/machine learning algorithm that requires distinct training and test sets in the conventional sense. The "development" and "validation" refer to device engineering and performance against specifications, not AI model training.
9. How the ground truth for the training set was established:
- Not applicable / Not specified. As noted above, this context is not relevant to the type of device and submission described.
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