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The Tomey "ConfoScan" Confocal Microscope is intended for use in carrying out a visualization of the cell layers of the anterior parts of the eye.
The Tomey "ConfoScan" Confocal Microscope is intended for use as a diagnostic tool for looking at the cell layers of the anterior parts of the eye.

The Tomey "ConfoScan" Confocal Microscope is a scanning slit microscope system that is used to carry out a visualization of the cell layers of the anterior parts of the eye. The prime attributes of a Confocal Microscope include both improved contrast and spatial resolution over more conventional microscopy. The improved image rendition is accomplished in the Tomey "ConfoScan" Confocal Microscope by the introduction conjugate scanning slits into the viewing and illuminating light paths of the microscope. By illuminating and viewing an object through restricted apertures, it is possible to eliminate the contributions of scattered light from other regions in the object plane that can degrade contrast and spatial resolution.

The provided text describes the Tomey ConfoScan Confocal Microscope, but it does not contain explicit acceptance criteria or a detailed study proving the device meets specific performance criteria. Instead, it focuses on demonstrating substantial equivalence to predicate devices.

Here's a breakdown based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance

No explicit acceptance criteria are provided in terms of performance metrics (e.g., sensitivity, specificity, accuracy, resolution targets). The document highlights characteristics of the ConfoScan and compares them to predicate devices, implying these characteristics are accepted by virtue of being similar or equivalent to already approved devices.

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The ImageScape is intended to be used to capture, store and manipulate digital images of the retina taken by fundus camera.
The ImageScape is intended to capture, store, and manipulate digital images of the retina taken by a fundus camera.

The ImageScape consists of: (1) a digital camera; (2) an imaging board; (3) a personal computer; (4) a monitor; and (5) Tomey's Windows-based image processing software. The ImageScape is used during ophthalmic procedures such as digital angiography during which the patient's retina is viewed through a slit lamp with a fundus camera. Images are transferred to the ImageScape's imaging board, located in the ImageScape's personal computer, and stored in the computer's Random Access memory ("RAM") and hard drive. As the images accumulate, the user downloads the images from the hard drive onto the computer's Jaz drive, a removable media drive, by using the computer keyboard and mouse to operate the icons.

The provided 510(k) summary for the Tomey Corporation's ImageScape Digital Retinal Image System (K971685) does not contain information related to specific acceptance criteria or a study proving the device meets such criteria in terms of clinical performance.

Instead, the submission focuses on demonstrating substantial equivalence to existing predicate devices based on:

• Intended Use: All devices (ImageScape, DFC, Imagenet, ORIMS) are intended to capture, store, and manipulate digital images of the retina taken by a fundus camera.
• Technological Characteristics: Similar components (e.g., Kodak MegaPlus digital camera), storage capabilities (Jaz drive, TIFF format), operating systems (Pentium chip, Windows/Macintosh), and input methods (keyboard, mouse).
• Software Functions: Similar functions for image acquisition, analysis, storage, and retrieval, including manipulation (zoom, invert, flip, rotate, brightness/contrast, sharpen) and enhancement (shadow, edge trace, blur).
• Operational Manner: Used by an ophthalmologist with a slit lamp and fundus camera, preparing the patient using standard ophthalmic procedures, and operating icon-driven interfaces.
• Software Verification and Validation: A statement that "Tomey has performed the software verification and validation. The verification and validation results demonstrate that the device meets the system and software specifications and requirements."

Therefore, many sections of your requested outline will be marked as "Not provided" or "Not applicable" based on the content of the K971685 submission. This is typical for 510(k) submissions demonstrating substantial equivalence for devices like this, where clinical performance studies are often not required if technological characteristics and intended use are similar to legally marketed predicate devices.

Here's the breakdown based on the provided document:

1. Table of acceptance criteria and the reported device performance

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size (Test Set): Not provided. This type of information is typically part of a clinical performance study, which was not the primary basis for this 510(k) submission.
• Data Provenance: Not provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable/Not provided. Ground truth establishment for a clinical test set is not part of this substantial equivalence submission.

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

• Not applicable/Not provided.

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/Not provided. This device is a digital imaging system, not an AI-powered diagnostic aid that assists human readers.

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

• Not applicable/Not provided. The device is described as being operated by an ophthalmologist.

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

• Not applicable/Not provided. The submission relies on demonstrating functional and technical equivalence to predicate devices, rather than a direct clinical performance study requiring a gold standard ground truth.

8. The sample size for the training set

• Not provided. Given that this is an imaging system and not a machine learning algorithm in the modern sense, a "training set" as concept might not directly apply. The device's software was developed and validated against specifications.

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

• Not applicable/Not provided. The software verification and validation would have been against predetermined system and software specifications and requirements, as stated in the document. This is distinct from establishing a clinical "ground truth" for a diagnostic algorithm.

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The Tomey DTL Electrode is intended for use in the measurement and recording of ERG signals from the ocular surfaces of the eye. These measurements are only to be performed by licensed practitioners and trained technicians within a medical environment.

There are no differences with respect to the predicate devices for indications for use, or target population.

Tomey DTL Electrode consists of soft silver impregnated nylon fiber threads that are normally placed under the lower eye lid. The electrodes are constructed with 3 to 10 individual fibers between 5 and 20 microns in diameter. The fibers are stabilized at both ends with adhesive attachments. A thin wire is connected to an adaptor cable that permits the electrodes to be used with various ERG Recording systems including the Tomey PE-400/PS-400.

The provided text is a 510(k) summary for the Tomey DTL Electrode. It describes the device, its intended use, and substantial equivalence to predicate devices, along with non-clinical testing performed.

Here's an analysis of the provided information regarding acceptance criteria and studies:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Elution Testing: Sample size for this specific test is not mentioned. The test was "performed according to the requirements of the Ministry of Health and Welfare in Japan," suggesting the data provenance is Japan. This would be considered retrospective in the context of the device's clearance application, as the testing was conducted prior to the submission.
• Rabbit Eye Irritation Testing: Sample size for this test is not mentioned. The test was performed by the "Juridical Foundation, Japan Food Research Laboratory," indicating data provenance is Japan. This is also retrospective.
• Biocompatibility (General): The text refers to "extensive use by many investigators." No specific sample size or formal prospective study is described. This relies on existing literature and collective experience, making it retrospective.
• Safety and Compatibility: This appears to be based on design verification and internal testing, not a formal test set with a specific sample size.

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

This document does not describe the use of experts to establish "ground truth" for a test set in the way this question typically implies (e.g., for diagnostic accuracy). The tests conducted are non-clinical, focusing on material properties and basic safety.

• For the eye irritation test, the "Juridical Foundation, Japan Food Research Laboratory" conducted the test, implying qualified personnel, but specific expert qualifications are not detailed.
• For biocompatibility, it refers to "many investigators, including Dawson, Prager and Lachapelle," but not in the context of establishing a ground truth for a specific test set for the Tomey device.

4. Adjudication Method for the Test Set

Not applicable. The tests described are not clinical diagnostic studies requiring an adjudication method (like 2+1 or 3+1). They are laboratory and material-based tests.

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

No. An MRMC comparative effectiveness study is not mentioned. The device is an electrode for measuring ERG signals, and the testing focuses on its safety and compatibility, not its impact on human reader performance in interpreting ERG results.

6. Standalone (Algorithm Only) Performance Study

No. This device is a physical electrode, not an algorithm, so a standalone algorithm performance study is not applicable. The document focuses on the electrode's physical properties and biological reactions.

7. Type of Ground Truth Used

• Elution Testing: The "ground truth" is defined by the requirements and standards of the Ministry of Health and Welfare in Japan for elution.
• Rabbit Eye Irritation: The "ground truth" is typically defined by the observation of irritation in the rabbit eyes according to established toxicological protocols.
• Biocompatibility: The "ground truth" is derived from a lack of adverse biological reactions (irritation, toxicity) in established animal models and from extensive clinical experience with similar devices.
• Safety and Compatibility: The "ground truth" is based on engineering specifications and direct observation/testing of the device's physical connections and electrical isolation.

8. Sample Size for the Training Set

Not applicable. This document describes non-clinical testing for a medical device (electrode), not the development or training of an AI algorithm based on a "training set."

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

Not applicable, as no training set for an AI algorithm is mentioned or relevant to the device described.

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