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510(k) Data Aggregation
(153 days)
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
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Endpoint 1: Obtain data illustrating the clinical use of the PhotoniCare TOMi Scope to collect bilateral images of human TM and underlying middle ear space from at least 25 combined adult and child subjects. | Achieved: The study successfully collected images from 26 subjects (both adult and child subjects), meeting this endpoint. |
| Endpoint 2: Obtain data illustrating TOMi Scope imageability of human middle ears, wherein at least 80% of TOMi Scope images collected are considered readable by a trained reader. | Achieved: This endpoint was successfully achieved, indicating that at least 80% of images were readable. (The exact percentage above 80% is not specified in the document). |
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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