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The OtoSight Middle Ear Scope is intended for use as an imaging tool for real-time visualization of the human tympanic membrane and fluid or air within the middle ear space. In the presence of middle ear Scope is used to visualize the fluid density. The OtoSight Middle Ear Scope is also used to provide surface images of the ear canal and tympanic membrane. It is indicated for use in children and adults.

The OtoSight Middle Ear Scope is a multiple use, non-sterile device which provides a surface view of the eardrum, equivalent to the functionality of a video otoscope. Additionally, the OtoSight Middle Ear Scope provides a view through the surface to visualize the contents of the middle ear using Low-Coherence Interferometry (LCI). LCI is an implementation of OCT which. rather than generating 2-D or 3-D images, is limited to the generation of a one-dimensional in-depth density profile displayed over time, which reveals the optical reflective property of the tympanic membrane (TM), as well as the content(s) which are present behind the TM.

The OtoSight Middle Ear Scope has a form factor which allows for ease of imaging the middle ear by the clinician, who will utilize disposable speculum tips and position the OtoSight Middle Ear Scope in the external ear canal in the same way routinely utilized for the current gold standard otoscopy. A push-button on the handheld is used to put the device into active recording mode, capturing both surface and LCI images simultaneously. Scan data is saved on the device with the option to export a summary of the scan over a Wi-Fi network.

The device incorporates a battery that provides 7 hours of use under a typical usage scenario to facilitate convenient use in a practice.

The provided text describes a 510(k) submission (K222655) for the PhotoniCare OtoSight Middle Ear Scope. This submission is a Special 510(k) for a modification to an already cleared device (K191804). Special 510(k)s are used for changes that do not affect the intended use or fundamental scientific technology of a device, where the new design is validated through design controls.

Therefore, the study described in this document is primarily focused on non-clinical performance testing to demonstrate that the modified device remains safe and effective and substantially equivalent to its predicate, rather than a clinical study establishing the device's diagnostic performance from scratch. Clinical studies to establish the diagnostic performance (e.g., accuracy in detecting fluid vs. air in the middle ear) would typically have been performed for the original predicate device (K191804).

Based on the provided text, here's an analysis of the acceptance criteria and study details:

Nature of the Study: This submission is a Special 510(k), indicating that the device has undergone relatively minor changes (addition of battery operation). The "study" described is a series of non-clinical performance tests to ensure the modified device remains safe and effective and substantially equivalent to the original cleared device. It is not a clinical diagnostic performance study demonstrating efficacy in disease diagnosis.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and data provenance:

• For the non-clinical performance tests listed, the "sample size" refers to the number of devices or test conditions used for engineering verification and validation, not patient data. The document does not specify exact numbers of devices tested but generally refers to "appropriate bench testing methods."
• Data Provenance: The document does not discuss the provenance of data in terms of country of origin or retrospective/prospective for patient data, as this 510(k) focuses on engineering changes and compliance with safety standards rather than clinical performance data. The device itself is manufactured by PhotoniCare, Inc. in Champaign, Illinois, USA.

3. Number of experts used to establish the ground truth for the test set and qualifications of those experts:

• This information is not applicable to the non-clinical performance tests described. Ground truth for diagnostic accuracy would be established during clinical studies, which are not the focus of this Special 510(k) submission.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

• Not applicable to the non-clinical performance tests.

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:

• Not applicable. The OtoSight Middle Ear Scope is an imaging tool for visualization, not an AI-assisted diagnostic device where human readers would interpret AI outputs. This document discusses engineering changes and safety compliance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Not applicable. The device is an imaging tool, not a standalone algorithm. The "LCI" (Low-Coherence Interferometry) part of the device processes optical signals to generate a one-dimensional in-depth density profile. Its performance is evaluated through its ability to provide this visualization, not as a diagnostic algorithm independent of human interpretation.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• For the non-clinical tests described, the "ground truth" or reference standard would be the specified engineering tolerances, recognized safety standards (IEC 60601 series, IEC 62133-2), and design inputs/user needs established for the device. For example, for battery performance, the ground truth would be that the battery operates for "up to 7 hours" under typical usage, or that it complies with the specified standard.

8. The sample size for the training set:

• Not applicable. This submission is for device modification, not for the development of a machine learning algorithm requiring a "training set."

9. How the ground truth for the training set was established:

• Not applicable. See point 8.

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The TOMi Scope is intended for use as an imaging tool for real-time visualization of the human tympanic membrane and fluid or air within the middle ear space. In the presence of middle ear fluid, the TOM Scope is used to visualize the fluid density. The TOMi Scope is also used to provide surface images of the ear canal and tympanic membrane. It is indicated for use in children and adults.

Model 34R TOMi Scope is a multiple use, non-sterile device which provides a surface view of the eardrum, equivalent to the functionality of a video otoscope. Additionally, the TOMi Scope provides a view through the surface to visualize the contents of the middle ear using Low-Coherence Interferometry (LC). LCI is an implementation of OCT which, rather than generating 2-D or 3-D images, is limited to the generation of a onedimensional in-depth density profile displayed over time, which reveals the optical reflective property of the tympanic membrane (TM), as well as the content(s) which are present behind the TM. The TOMi Scope has a form factor which allows for ease of imaging the middle ear by the clinician, who will utilize disposable specula tips and position the TOMi Scope in the external ear canal in the same way routinely utilized for the current gold standard otoscopy. A push-button on the handheld is used to put the device into active recording mode, capturing both surface and LCI images simultaneously.

Here's a breakdown of the acceptance criteria and study information for the PhotoniCare TOMi Scope, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: 26 subjects (combined adult and child subjects).
• Data Provenance: The study was conducted at a "single site clinical study involving both Pediatric and Otolaryngology clinics." The country of origin is not explicitly stated, but given the FDA submission, it is highly likely to be the United States. The study was prospective as it involved collecting new images from human subjects to illustrate the device's ability.

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

The document mentions that "a trained reader" assessed the readability of the images (Endpoint 2). However, it does not specify the number of trained readers used, nor does it detail their specific qualifications (e.g., years of experience, medical specialty).

4. Adjudication Method for the Test Set

The document does not specify an adjudication method (e.g., 2+1, 3+1). It only mentions assessment by "a trained reader."

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

No, a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance was not mentioned in the provided text. The study focused on the device's ability to acquire and produce readable images, not on its impact on human reader performance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done

The TOMi Scope is described as an "imaging tool for real-time visualization." The clinical study focused on its ability to "collect images" and their "imageability" by "a trained reader." This suggests it's a device that provides images for human interpretation, rather than an AI algorithm making independent diagnoses. Therefore, a standalone (algorithm only) performance study as typically understood for AI-based diagnostic devices was not performed or reported in this context. The "software" is mentioned for the user interface, not as a diagnostic algorithm.

7. The Type of Ground Truth Used

The ground truth for the clinical study was based on the readability of the images by a trained reader. This is a form of expert consensus/interpretation of the device's output. The document doesn't indicate the use of pathology or outcomes data as ground truth for these specific endpoints.

8. The Sample Size for the Training Set

The document does not specify a sample size for a training set. The TOMi Scope is described as an optical imaging device utilizing Low-Coherence Interferometry (LCI) and video otoscopy for visualization. While it has software for the user interface, there is no mention of machine learning or deep learning components that would typically require a distinct training set in the context of diagnostic algorithms.

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

Since no specific training set for an AI algorithm is mentioned, the method for establishing its ground truth is not applicable based on the provided information.

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