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The OTI OCT Ophthalmoscope is intended to offer simultaneous acquisition of highresolution transversal OCT (Optical Coherence Tomography) and confocal images of the eye fundus. It is indicated in situations where these images are required for diagnosis.

The OTI OCT Ophthalmoscope produces simultaneous acquisition of highresolution transversal OCT (Optical Coherence Tomography) and confocal images of the eye fundus. In addition conventional longitudinal OCT images may also be collected. The system uses a high power superluminescient diode operating at 850nm. The software uses a tabbed interface: the user can select any of the primary functional modules at any time by clicking on the tab for that function at the top of the screen. When there are several major components in a function, these are presented as tabs below the principal tab bar.

The provided text is a 510(k) summary for the OTI OCT-Ophthalmoscope. It describes the device, its intended use, and states that no clinical tests were required for its clearance. Therefore, a study demonstrating the device meets acceptance criteria, as well as several other requested details, cannot be found in this document.

The document states:

• (b) Clinical tests: Not required.
• (c) Conclusions: The OCT-Ophthalmoscope is equivalent in safety and efficacy to the legally-marketed predicate device.

This indicates that the device's clearance was based on demonstrating substantial equivalence to pre-existing legally marketed devices (K012727, K943956) through non-clinical tests (accuracy, optical emissions analyses, electrical safety tests, and software validation tests), rather than a clinical study with acceptance criteria for device performance.

Therefore, the following information cannot be provided from the given text:

• A table of acceptance criteria and reported device performance.
• Sample size used for the test set and data provenance.
• Number of experts used to establish ground truth and their qualifications.
• Adjudication method for the test set.
• Information on a multi-reader multi-case (MRMC) comparative effectiveness study or effect size.
• Information on standalone algorithm performance.
• Type of ground truth used (expert consensus, pathology, outcomes data, etc.) for any clinical study.
• Sample size for the training set.
• How the ground truth for the training set was established.

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The OTI-scan HF module is an option for the OTI-scan (K030770), a multi-purpose personal-computer-based ultrasonic B-scan diagnostic system for ophthalmic applications.

Transducer for B-scans with OTI-Scan HF Module

The OTI-scan HF module is an ultrasonic ophthalmic B-scan system that uses the principles of sonar (pulsed ultrasound) to visualize and measure the interior of the eye with high-frequency transducers to obtain better accuracy.

The OTI-Scan HF Module did not report any clinical study to prove the device met acceptance criteria. The submission states "Not required" for clinical tests. The device's equivalency was based on non-clinical tests including accuracy tests, ultrasonic emissions tests, electrical safety tests, and software validation tests, concluding it is equivalent in safety and efficacy to a legally-marketed predicate device.

Table of Acceptance Criteria and Device Performance:

Since no clinical study was conducted or required, no specific acceptance criteria or reported device performance for clinical outcomes were provided in the document. The general acceptance criteria focused on non-clinical aspects:

Details on Clinical Study (or lack thereof):

1. Sample size used for the test set and the data provenance: Not applicable, as no clinical test set was required or reported.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no clinical test set was required or reported.
3. Adjudication method for the test set: Not applicable, as no clinical test set was required or reported.
4. 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, as no clinical study involving human readers or AI assistance was conducted or reported.
5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable, as the device is an ultrasonic B-scan system and not an AI algorithm. Its performance is tied to its physical and software functionality rather than an AI's standalone diagnostic capability.
6. The type of ground truth used: For the non-clinical tests, the ground truth would have been established by engineering specifications, regulatory standards, and established testing protocols for ultrasonic devices and software.
7. The sample size for the training set: Not applicable, as no clinical test or AI model training was reported.
8. How the ground truth for the training set was established: Not applicable, as no clinical test or AI model training was reported.

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The OTI-scan ultrasound system is a multi-purpose personal-computer-based ultrasonic diagnosis system for ophthalmic applications, intended to both visualize the interior of the eye by means of ultrasound and to make measurements inside the eye, including the measurement of axial length for determination of IOL power.

The OTI-scan is a compact Ultrasonic ophthalmic A-scan system and B-scan system that uses the principles of sonar (pulsed ultrasound) to measure the axial length of the eyes and to visualize the interior of the eye.

Here's a breakdown of the acceptance criteria and the study information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document states:

• "Clinical tests: Not required."
• "Non-clinical tests: The A-B scan has had accuracy tests, ultrasonic emissions tests, electrical safety tests, and software validation tests."

Based on this, no clinical test set was used. The device's performance was established through non-clinical (laboratory/engineering) testing and comparison to an existing predicate device. Therefore, there's no information on sample size or data provenance (country of origin, retrospective/prospective) for a clinical test set.

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

Since no clinical test set was required or performed, there's no information on experts used to establish ground truth. The acceptance was based on non-clinical testing and substantial equivalence to a predicate device.

4. Adjudication Method for the Test Set

As no clinical test set was required, there is no adjudication method described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document explicitly states "Clinical tests: Not required."

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

This refers to the device's inherent technical performance. The non-clinical tests (accuracy, ultrasonic emissions, electrical safety, and software validation) would fall under assessing the device's standalone performance. However, there's no detailed quantitative data provided from these tests, only that they were performed.

7. The Type of Ground Truth Used

For the non-clinical tests, the "ground truth" would likely be established by:

• Reference standards/phantoms for accuracy testing (e.g., measuring known distances or properties).
• Physics-based measurements for ultrasonic emissions and electrical safety (conformance to established standards).
• Software specifications and formal verification/validation procedures for software validation.

Since no clinical study was performed, there is no clinical ground truth (like expert consensus, pathology, or outcomes data) established.

8. The Sample Size for the Training Set

The document does not describe any training set because the submission is a Special 510(k) for a device that is functionally equivalent to an already marketed device (OTI i-scan, K960622). Machine learning or AI model training data is not mentioned or relevant to this submission. The device is an ultrasonic hardware and software system, not an AI diagnostic algorithm in the modern sense.

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

As no training set is mentioned or relevant to this type of device submission, this information is not applicable.

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The A-scan 100 is an ophthalmic A-scan system intended to be used for measurement of axial distances in the eye and for the calculation of the power of an implanted intraocular lens (IOL), indicated for patients requiring intraocular lenses.

The A-scan 100 is a compact device Ultrasonic ophthalmic A-scan system that uses the principles of sonar (pulsed ultrasound) to measure the axial length of the eyes. The device includes four popular formulas to calculate the implanted IOL power, using the Ultrasound Axial Length measurement. The results may be printed through a PC computer printers.

The provided text indicates that the device, an Ophthalmic Ultrasonic A-scan System A-scan 100, is substantially equivalent to a predicate device (OTI i-scan, K960622). However, it does not contain a detailed study report with specific acceptance criteria, reported device performance figures, or information on study methodologies for clinical performance.

Here's a breakdown of what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information:

• Specific numerical acceptance criteria for accuracy, precision, or other performance metrics. The document only states that tests were conducted.
• Actual numerical results or metrics for the device's performance against any established criteria.

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

According to the document:

• Sample Size: "Clinical tests: Not required." This indicates that no separate clinical test set was used for this 510(k) submission, as the device's equivalence was established through non-clinical testing and comparison to a predicate.
• Data Provenance: Not applicable for clinical tests, as none were conducted.

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

Missing Information: Not applicable, as no clinical test set was used requiring ground truth established by experts.

4. Adjudication Method for the Test Set

Missing Information: Not applicable, as no clinical test set was used.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

Missing Information/Not Applicable: The document explicitly states "Clinical tests: Not required." Therefore, no MRMC study was performed or reported for this submission.

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

The device is an "Ophthalmic Ultrasonic A-scan System" and likely involves direct measurement rather than an algorithm performing a standalone diagnostic task. While "software validation tests" were performed, there's no indication of a standalone algorithm performance evaluation in the context of interpretation or diagnosis without human involvement. The focus is on the device's ability to measure axial length and calculate IOL power.

7. The Type of Ground Truth Used

Missing Information/Not Applicable: Since clinical tests were not required, the concept of establishing ground truth for a clinical dataset does not apply here. The "accuracy tests" would have likely used a known standard or calibrated phantom as ground truth, but the details are not provided.

8. The Sample Size for the Training Set

Missing Information/Not Applicable: The device is described as an "Ophthalmic Ultrasonic A-scan system that uses the principles of sonar (pulsed ultrasound) to measure the axial length of the eyes." It includes "four popular formulas to calculate the implanted IOL power." This description suggests a deterministic system based on physical principles and established formulas, rather than a machine learning or AI-based system that would require a "training set" in the conventional sense.

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

Missing Information/Not Applicable: As there is no indication of a machine learning component requiring a training set, this information is not relevant to this submission.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The provided 510(k) summary for the A-scan 100 does not describe a clinical study with acceptance criteria and reported performance in the traditional sense of evaluating diagnostic accuracy against a ground truth. Instead, it relies on demonstrating substantial equivalence to a legally marketed predicate device (OTI i-scan, K960622) through non-clinical testing.

The relevant section, "(6) Performance Data," states:

• (a) Non-clinical tests: "The A-scan 100 has had accuracy tests, ultrasonic emissions tests, electrical safety tests, and software validation tests."
• (b) Clinical tests: "Not required."
• (c) Conclusions: "The A-scan 100 is equivalent in safety and efficacy to the legally-marketed predicate device."

This means the "study" that proves the device meets the acceptance criteria is a compilation of engineering and bench testing, not a human clinical trial. The exact acceptance criteria for these non-clinical tests (e.g., accuracy within a certain tolerance for axial length measurement) are not detailed in the provided document, nor are the specific results of those tests. The conclusion of equivalence is based on these non-clinical tests demonstrating that the new device performs comparably to the predicate device in terms of fundamental operational and safety characteristics.

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The OTI Di-thex Ophthalmic Diathermy Unit is intended to be used for producing haemeostasis in the anterior and posterior segment of the eye, for conjunctival welding (coaptation), retinal coagulation using endodiathermy tips, and for cutting in ophthalmic surgery, using a high frequency current applied by a bipolar probe.

The system consists of a central control unit that supplies radio frequency energy to a handpiece. The unit can be used for standard diathermy procedures, and can be also used as a cutting instrument for membrane dissection in the eye with the appropriate handpieces and tips. Power level is microprocessor-controlled, and the power-level setting is shown by a bar-graph display on the front panel. The system has a set of alarms which alert the user and suspend operation for such cases as overtemperature, overvoltage, and computer errors.

Here's an analysis of the provided 510(k) summary regarding the acceptance criteria and study data for the Di-rhex Ophthalmic Diathermy System:

Summary of Device Performance Data and Acceptance Criteria:

This 510(k) submission for the Di-rhex Ophthalmic Diathermy System relies on substantial equivalence to predicate devices rather than establishing specific quantitative acceptance criteria and performing a rigorous statistical study to meet those criteria. The primary "acceptance criterion" appears to be demonstrating that the device is equivalent in safety and efficacy to existing legally marketed devices, as summarized in section (c) of the "Performance Data."

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Non-clinical Tests: No sample size is specified for power output tests or software validation. Data provenance would be from internal testing by Ophthalmic Technologies Inc.
• Clinical Tests: The document states "The Di-rhex has had a clinical evaluation in Canada."
  • Sample Size: Not specified. No number of patients or procedures is mentioned.
  • Data Provenance: Canada (prospective, as it was an "evaluation" of the new device).

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

• Clinical Evaluation: Not specified. The document does not describe how ground truth was established for the clinical evaluation. Given it was a "clinical evaluation," it would inherently involve medical professionals, but their number and specific qualifications (e.g., years of experience, subspecialty) are not provided.
• Non-clinical Tests: Ground truth for these would typically be defined by engineering standards and internal specifications, not expert consensus in the medical sense.

4. Adjudication Method for the Test Set:

• Not specified. There is no mention of an adjudication process for the clinical evaluation.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

• No. The document does not mention an MRMC study. The clinical evaluation appears to be a single-center, uncontrolled assessment, rather than a comparative effectiveness trial involving multiple readers and cases. The claim of equivalence is based on the overall performance compared to predicate devices, not through a direct comparative study with human readers assisted by AI. (Note: Diathermy is a direct energy delivery device, not an imaging AI device, so an MRMC study in the context of interpreting results with AI assistance would not be applicable here.)

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

• N/A. This device is a surgical instrument. "Standalone" performance with "algorithm only without human-in-the-loop performance" doesn't directly apply as it's not an AI diagnostic/interpretive algorithm. Its "standalone" performance lies in its ability to deliver the specified energy (which was assessed via power output tests) and function safely (software validation, safety tests). The intended use inherently involves a human operator.

7. The Type of Ground Truth Used:

• Non-clinical Tests: Ground truth for power output tests would be the device's engineering specifications and calibration standards. For software validation, it would be the software requirements and functional specifications.
• Clinical Evaluation: The type of ground truth used for the clinical evaluation is not explicitly stated. However, for a surgical device evaluation, it would implicitly be the clinical judgment of the operating surgeons and post-operative assessment of patient outcomes (e.g., successful hemostasis, coagulation effect) based on standard medical practice. It's not pathology, or a separate "consensus" in the diagnostic sense, but rather the observed clinical results.

8. The Sample Size for the Training Set:

• N/A. This device is a hardware system, not an AI algorithm that requires a "training set" of data in the machine learning sense. The device is designed, tested against specifications, and evaluated clinically.

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

• N/A. As above, it's not an AI algorithm with a training set. The "ground truth" for its design and testing would be engineering principles, safety standards, and clinical requirements for ophthalmic diathermy.

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The Ophthalmic Technologies Inc. (OTI) 3D i-scan is intended to be used as an accessory with the OTI i-scan Ophthalmic B-scan Ultrasound system (K960622) to provide a three-dimensional visualization of the interior of the globe. The device is indicated when it is desirable to have a three-dimensional depiction (perspective rendering) of the interior of the globe for diagnostic purposes.

The 3D i-scan works in conjunction with the Ophthalmic Technologies Inc. (OTI) i-scan ophthalmic B-scan system. It automatically makes a series of 201 B-scans at different angles, and then combines them to produce a perspective image, called the "3D image." Scanning is done through a closed eye-lid. The 3D i-scan consists of a computer and computer monitor, and a mechanical scan assembly which holds the B-scan ultrasonic scanner and rotates it at a speed synchronized with the lateral scanning rate of the probe. Ultrasonic gel is used as a coupling medium between the transducer and the surface of the eye-lid. The computer system assembles the multiple images of the interior of the eye, all taken at a slightly different angle, and produces a three-dimensional representation of the interior of the eye on the computer monitor screen. Software facilities are included for a number of types of image manipulation, such as slicing, changing perspective or line, and measurement of distances, areas, and volumes.

The provided text describes a 510(k) submission for the Ophthalmic Technologies 3D i-scan, a program designed to convert ultrasound scans into perspective images for ophthalmic diagnosis. However, the document does not contain detailed acceptance criteria or a comprehensive study plan with explicit performance metrics.

Here's an analysis of the information available based on your request, with significant gaps noted:

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: Not specified.
• Data Provenance: Not specified. It's implied that "outside experts" conducted the tests, but no geographical origin or retrospective/prospective nature of the data is mentioned.

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

• Number of Experts: Not specified. The document states "A test of the measurement accuracy of the system, done by outside experts, is included."
• Qualifications of Experts: Not specified.

4. Adjudication Method for the Test Set

• Not specified.

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

• No MRMC study is mentioned or described. The document focuses on the device's standalone capabilities and its equivalence to a predicate device.

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

• Yes, a standalone performance assessment was done. The described tests for "measurement accuracy" and "imaging capabilities" relate to the device's inherent ability to convert B-scans into 3D images and perform measurements, which are standalone functionalities. The 3D i-scan is described as a "Program to convert Ultrasound scans to perspective images," implying an algorithm-only function in generating the 3D view.

7. The Type of Ground Truth Used

• Implied Ground Truth: For the "measurement accuracy" test, the ground truth would likely be physical measurements or known geometric properties of the objects or phantoms being scanned.
• For the "imaging capabilities" validation, the ground truth would likely be established 2D ultrasound images (B-scans) or known anatomical structures, against which the generated 3D images are compared for fidelity and correct representation. The document does not explicitly state the source (e.g., pathology, clinical outcomes, or expert consensus on a different imaging modality).

8. The Sample Size for the Training Set

• Not specified. The document describes the device as almost entirely a software system but does not detail its development process, including training data.

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

• Not specified. Due to the lack of information on a training set or machine learning aspects, this detail is absent. The device acts more as an image processing and visualization tool rather than a diagnostic AI that learns from labeled data in the way modern AI models do.

Summary of Device and Study:

The Ophthalmic Technologies 3D i-scan is a software accessory that works with an existing Ophthalmic B-scan Ultrasound system (OTI i-scan) to create 3D visualizations of the eye's interior. It achieves this by automatically taking a series of 201 B-scans at different angles and combining them. The 510(k) submission highlights its "measurement accuracy" and "imaging capabilities" validation through tests conducted by "outside experts." The core argument for substantial equivalence is based on its similarity to the predicate device (Life Imaging Systems Sirus, K961403) and the fact that it is primarily a software addition.

Key Gaps in Information from the Document:

The provided document is a 510(k) summary, which often provides a high-level overview. It lacks the granular detail of a full study report, specifically:

• Quantifiable acceptance criteria (e.g., "accuracy must be within X mm").
• Specific numerical results of the performance tests (accuracy values, image quality metrics).
• Details about the test cases (number, characteristics).
• Specifics about the "outside experts."
• Any mention of AI/ML, training data, or human-in-the-loop performance studies, which are common in more recent device submissions. This device predates the widespread use of deep learning in medical imaging.

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The Ophthalmic Technologies i-Scope™ is intended to be used for visualization of intra-ocular structures, as a means to introduce micro instruments into the eye, or as a means to introduce laser fibers into the eye for photocoagulation.

The Ophthalmic Technologies i-Scope™ is a rigid ophthalmic fiber-optic microendoscope. The i-Scope has an imaging fiber bundle with 10,000 pixels, an illumination fiber, and a working channel for an optional laser fiber or microinstruments. The laser fiber is disposable and can be replaced between cases. The fiber is not manufactured by Ophthalmic Technologies. The image fiber bundle terminal is connected to an orientation ring, video adapter and video camera. The illuminating bundle fiber can be connected to the OTI "XE-LITE" Xenon Light Source, or other light sources which have been cleared by the FDA. The laser fiber is disposable and can be replaced between cases.

The K971679 510(k) submission for the Ophthalmic Technologies i-scope does not contain a study that establishes acceptance criteria for its device performance in the way a diagnostic AI device would. Instead, this submission focuses on demonstrating substantial equivalence to predicate devices through non-clinical performance and material comparisons, as clinical tests were not required. The device is an ophthalmic endoscope, not an AI-based diagnostic tool.

Therefore, many of the requested categories for AI device studies are not applicable or cannot be extracted from this document.

Here's an attempt to address the request with the available information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Not Applicable. This submission does not describe a clinical test set with human or patient data for evaluating performance against predefined acceptance criteria. The "tests" mentioned are non-clinical, likely involving physical measurements or comparisons.

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

• Not Applicable. Ground truth, in the context of diagnostic performance, is not established or reported in this submission for the evaluation of the device.

4. Adjudication method for the test set

• Not Applicable. No test set requiring adjudication in the context of diagnostic performance is described.

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, a MRMC comparative effectiveness study was not done. This device is an ophthalmic endoscope, not an AI diagnostic tool, so such a study would not be relevant.

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

• Not Applicable. The OTI i-scope is a physical medical device (endoscope), not an algorithm. Standalone algorithm performance is irrelevant.

7. The type of ground truth used

• Not Applicable. For the non-clinical tests (resolution, light output), the "ground truth" would be the known physical properties or established measurement standards, rather than expert consensus, pathology, or outcomes data in a clinical sense.

8. The sample size for the training set

• Not Applicable. This device is not an AI algorithm that requires a training set.

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

• Not Applicable. This device is not an AI algorithm and therefore has no training set or associated ground truth.

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The OTI i+tech "i-scan" ultrasound system is intended to both visualize the interior of the eye by means of ultrasound and to make measurements inside the eye, including the measurement of axial length for determination of IOL power.

The OTI i+tech "i-scan" ultrasound system is a multipurpose personal-computer-based ultrasonic diagnosis system for ophthalmic applications. It includes three separate transducers which provide: 1. A Biometry X-mode for measurement of axial length, using a focused probe which can be hand-held or placed in a tonometer-holder. The operator has a choice of automatic measurement (in which the system automatically finds the critical structures in the eye and makes the measurements) or manual (in which the A-scan is presented on screen and the operator selects the points for a the measurements). 2. An A-scan mode for observation and measurement of the internal structures in the eye, with its own handheld probe. 3. A B-scan mode, usinç a hand-held motor-driven transducer, permitting visualization of internal structures in the eye. In X-mode, the system also performs IOL calculations with a choice of several algorithms.

The provided K960622 document describes the "i-scan" Ophthalmic Ultrasound System. However, it does not contain specific acceptance criteria, detailed study results, or the structured information requested in the prompt's numbered list. The document states that the device was compared to a predicate device on ten eyes and found to have "equivalent accuracy," but provides no quantifiable metrics or details about this comparison.

Therefore, many of the requested fields cannot be filled based on the provided text.

Here's a summary based on the available information, with clear indications where the information is not provided in the document:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size (Test Set): 10 eyes
• Data Provenance: Clinical tests comparing the i-scan with a predicate device. The country of origin is not specified, but the submitter is in Canada. It's a prospective clinical test to compare the new device to an existing one.

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

• Not Provided. The document does not mention the number or qualifications of experts involved in establishing ground truth for the clinical comparison.

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

• Not Provided. The document does not describe any adjudication method for the clinical test set.

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. This device is an ophthalmic ultrasound system for visualization and measurement, not an AI-assisted diagnostic tool for interpretation by human readers in the context of an MRMC study. The "AI" component would be referring to the "automatic measurement" function, but the document does not describe an MRMC study related to its effectiveness in improving human reader performance.

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

• Partially Addressed - "Automatic Mode": The device has an "automatic measurement" option for IOL measurement where the "system automatically finds the critical structures in the eye and makes the measurements." Bench tests were performed on a phantom in this "automatic mode." However, details on the specific performance metrics or a comparison to human performance in standalone mode are not provided.

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

• Not Explicitly Stated for Clinical Tests. For the clinical tests, the ground truth is implied to be the measurements obtained from the predicate device (Sonomed Model A2500), as the new device's accuracy was compared to it.
• Phantom Measurements: For bench tests, a phantom was used, implying the "truth" was the known measurements of the phantom.

8. The sample size for the training set

• Not Applicable / Not Provided. The document does not mention a "training set" in the context of machine learning or AI model development. The automatic measurement function's development process (if it involved machine learning) is not described.

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

• Not Applicable / Not Provided. No training set is mentioned in the document.

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