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The OTIS 2.0 Optical Coherence Tomography System is indicated for use as an imaging tool in the evaluation of excised human tissue microstructure by providing two-dimensional, real-time depth visualization, with image review manipulation software for identifying and annotating regions of interest.

The Perimeter OTIS™ 2.0 is an imaging tool for use on excised human tissue. The Perimeter OTIS™ 2.0 is based on optical coherence tomography (OCT) imaging, and it 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™ 2.0 collects and displays OCT images of human tissue with comparable image quality to other previously 510(k)-cleared OCT imaging systems and, specifically, the predicate Perimeter OTIS 1B System (K171560). Like its predicate, the Perimeter OTIS™ 2.0 has automated the OCT scanning of the specimen surface, standardizing the image collection process.

The Perimeter OTIS™ 2.0 includes a white light image (photograph) of the specimen, to assist the clinician in viewing the OCT images with a reference to the photograph and the OCT image scan position. The Perimeter OTIS™ 2.0 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.

The Perimeter OTIS™ 2.0 Optical Coherence Tomography System is compared to its predicate device, the Perimeter OTIS™ 1B. The provided text, however, does not directly state specific acceptance criteria (e.g., numerical performance metrics like sensitivity, specificity, accuracy) for the device's ability to identify tissue microstructure features, nor details of a study with such specific performance metrics. Instead, it focuses on demonstrating substantial equivalence in terms of technology, intended use, and image quality compared to the predicate device.

Here's a breakdown of the information that can be extracted or inferred from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of predetermined acceptance criteria with corresponding performance results in terms of identifying tissue microstructure features. It primarily emphasizes that the OTIS™ 2.0 can obtain OCT images with sufficient image quality to identify excised tissue microstructure features, at a level comparable to other OCT imaging systems, including the predicate device, OTIS 1B.

2. Sample Size Used for the Test Set and Data Provenance

The document states: "Perimeter validated that the OTIS™ 2.0 can obtain OCT images with sufficient image quality to identify excised tissue microstructure features, at a level comparable to other OCT imaging systems, including the predicate device, OTIS 1B."

However, it does not specify the sample size for the test set used in this validation, nor does it mention the country of origin of the data or whether the study was retrospective or prospective.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

The document does not specify the number of experts used to establish ground truth for image quality or feature identification, nor does it detail their qualifications.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method used for establishing ground truth for the test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

The provided text does not mention a multi-reader multi-case (MRMC) comparative effectiveness study and therefore does not report any effect size of human readers improving with or without AI assistance. The device description focuses on its imaging capabilities and user interface for review and annotation, not on direct assistance to human interpretation in a comparative effectiveness study.

6. Standalone (Algorithm-only) Performance Study

The document describes the device as an "imaging tool in the evaluation of excised human tissue microstructure" with "image review manipulation software for identifying and annotating regions of interest." This implies a human-in-the-loop system. The text does not describe a standalone (algorithm-only) performance study for automated identification or diagnosis without human input.

7. Type of Ground Truth Used

The ground truth used for validation was "sufficient image quality to identify excised tissue microstructure features." This suggests an assessment of the visual clarity and detail in the images, allowing for the potential identification of microstructural features. However, the exact nature of this "ground truth" (e.g., expert consensus on image quality, comparison to histological slides, etc.) is not explicitly detailed.

8. Sample Size for the Training Set

The document does not provide information on the sample size for a training set. The validation described focuses on the device's ability to produce images of "sufficient image quality" comparable to existing OCT systems, rather than a machine learning model that would require a distinct training set.

9. How the Ground Truth for the Training Set Was Established

Since there is no mention of a training set, the document does not describe how ground truth for a training set was established.

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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.

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.

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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

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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