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Storage, management, and display of patient data, diagnostic data, videos, and images from computerized ophthalmic diagnostic imaging devices.

AXIS Image Management System is a browser-based ophthalmic image management system designed for storage, retrieval, and review of images, videos, and reports originating from ophthalmic imaging devices.

AXIS Image Management System and the predicate device are software systems that work on standard network infrastructure provided by the user. Such infrastructure may include a server, network, and computing devices.

AXIS Image Management System provides a central database of patient information and exam image history. The AXIS software resides on a server provided by the user and interfaces with networked imaging instruments. Users utilize their existing browser to access the AXIS software to review images, videos, and reports.

Images can be obtained from diagnostic devices in a variety of industry-standard formats including PDF, JPEG, DCM, and AVI.

This document is a 510(k) premarket notification for the AXIS Image Management System. It primarily outlines the substantial equivalence to a predicate device and does not contain detailed acceptance criteria and study results in the typical format for performance studies of AI-powered medical devices.

Here's an analysis based on the provided text, addressing the points where information is available or noting its absence:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a table of acceptance criteria for specific performance metrics (e.g., sensitivity, specificity, accuracy) because the device is an Image Management System, not a diagnostic or AI-powered analytical tool. Its performance is assessed functionally and through its compliance with standards.

The closest equivalent to "acceptance criteria" are the functional characteristics and compliance with industry standards, which are met by the device.

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

Not applicable. This device is an image management system, not one that performs analysis on a dataset of patient images requiring performance metrics like sensitivity/specificity. The "test set" would refer to the testing done during software verification and validation, which is typically a functional and system-level test, not a clinical data test set. The document does not specify details of the samples used in such testing.

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

Not applicable. As this device is not performing a diagnostic task, there is no "ground truth" to be established by experts in the context of clinical performance like disease detection. The "ground truth" for its functionality would be whether it performs its stated functions (storage, retrieval, display, etc.) correctly according to its design specifications.

4. Adjudication method

Not applicable, for the same reasons as points 2 and 3.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical Performance Data: None required or submitted." As this is an image management system, its primary function is to store, manage, and display data, not to interpret or diagnose, and therefore, it does not involve human readers interpreting cases with or without AI assistance in the way a diagnostic AI would.

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

This refers to the performance of a diagnostic or analytical algorithm. The AXIS Image Management System is not such an algorithm; it is an infrastructure system. Its "standalone" performance refers to its ability to perform its specified functions (e.g., DICOM compliance, data storage, retrieval) without human intervention in the data processing flow, but this is a functional test, not a diagnostic performance test. The document states that "Performance testing was conducted on AXIS Image Management System as part of the software verification and validation and was found to perform as intended," which implies standalone functional testing.

7. The type of ground truth used

For an image management system, the "ground truth" is typically its functional correctness and adherence to standards. For example, a successful ground truth for a storage function would be that data stored can be retrieved accurately and completely. For DICOM compliance, the ground truth is successful interoperability as per the standard. The document states it is "DICOM-compliant as stipulated in its DICOM Conformity Statement" and that it "was found to perform as intended" through software verification and validation.

8. The sample size for the training set

Not applicable. The AXIS Image Management System is not an AI/ML device that requires training data.

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

Not applicable, as there is no training set for this type of device.

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The VuPad ultrasound system is a multi-purpose computer-based ultrasonic diagnostic system for ophthalmic application, 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 VuPad is a portable ultrasound biometric ruler intended for use in ophthalmic applications. The system allows for the measurement of several key ocular features including axial length (AXL), anterior chamber depth, and lens thickness while also aiding in the calculation of associated IOL power for implanted lenses. The device is used by coupling the probe / transducer to the eye either through direct contact or immersion methods. Available modes are biometric A-scan, and UBM (high frequency B-scan). The A-scan mode of the system features a live A-scan trace with storage for up to five scans. There are five (auto/ manual) examination modes that use three different tissue velocities to calculate individual intraocular distances within the eye (ACD, Lens, and Vitreous). Other features include: post examination review of scans & measurement; five IOL formulas (six refractive and three post refractive) for lens power calculations; an immersion scanning capability for zero corneal compression of the eye while scanning and storage for up to five different user profiles. The B-Scan mode produces a live, two-dimensional image to facilitate the identification and measurement of ocular pathologies in the posterior-chamber of the eye, particularly when view of the chamber is obscured, such as is the case with cataracts. The VuPad is a stand-alone system that runs on a Windows 8 platform and may be networked (by the user) for interface with electronic medical records systems, printing, and other purposes. The system consists of the VuPad console, ultrasound probe(s) and transducer(s), and foot pedal.

The provided text describes the Sonomed VuPad (K140199) as a multi-purpose computer-based ultrasonic diagnostic system for ophthalmic applications, used for visualizing the interior of the eye and making measurements, including axial length for IOL power determination. The submission compares the device to two predicate devices: the E-Z Scan 5500+ A-Scan / B-Scan System (K040668) and the VuMax System (K060626).

However, the provided documentation primarily focuses on establishing substantial equivalence to predicate devices based on similarities in intended use, technology, method of operation, and various functional parameters. It does not contain a dedicated study section with acceptance criteria and a detailed report of device performance against those criteria in a clinical or analytical study context.

The only direct performance metric mentioned for the device itself is "A-Scan Measurement Accuracy: ±0.1 mm (clinical) ±0.02 mm (theoretical)." This is listed in the comparison tables as a similarity to the EZScan AB5500+. The document states that "Electrical, mechanical, environments safety and performance testing according to standard IEC 60601-1, IEC 60601-2-37, and EN/IEC 60601-1-2(2001) are currently pending," implying that detailed performance studies to explicitly "prove the device meets the acceptance criteria" were not yet fully completed or included in the summary at the time of submission.

Therefore, many of the requested details about a study evaluating the device against acceptance criteria cannot be extracted from this document, as such a study is not explicitly described.

Here's the information that can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

Based on the "Similarities" table, the clinical measurement accuracy from the predicate device is implicitly adopted as an expected performance level for the VuPad's A-Scan.

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The Master-Vu A-Scan provides intraocular measurements of anterior chamber depth, lens thickness, and axial length which can be used with published industryaccepted refractive formulas to calculate associated IOL powers for implanted lenses.

The Master-Vu A-Scan is a portable ultrasonic A-scan system intended for use in ophthalmic applications. The system allows for the measurement of several key ocular features including axial length (AXL), anterior chamber depth, and lens thickness while also aiding in the calculation of associated IOL power for implanted lenses.

The Master-Vu A-Scan system consists of a solid A-probe, a base unit which houses the electronics, a foot pedal switch, and a USB cable which provides a means of interfacing the system with a host computer.

The standard Master-Vu software allows any Microsoft Windows compatible host computer (PC) to function as the control panel of the system. The host computer is not supplied by Sonomed as part of the Master-Vu A-Scan system and must be provided by the end user. Minimum requirements for compatible host computers are supplied in the documentation accompanying the system.

The Master-Vu software is compatible with the Microsoft Windows XP or Microsoft Windows Vista operating systems, and uses the features of the Windows graphical user interface to direct the operation of the system and maintain patient records. Patient data may be analyzed, saved, retrieved, and printed through the computer interface at the operator's discretion. The Microsoft Windows operating system provides an adequate and user-friendly interface for a wide variety of clinical environments.

This looks like a 510(k) premarket notification for the Sonomed Master-Vu A-Scan, where Sonomed is seeking clearance for a new device based on substantial equivalence to a predicate device. This type of document typically does not contain details about specific clinical studies with acceptance criteria and statistical analysis to prove device performance as an AI/ML product.

Instead, 510(k) submissions for devices like this Master-Vu A-Scan (a diagnostic ultrasound system) focus on:

• Substantial Equivalence: Demonstrating that the new device is as safe and effective as a legally marketed predicate device. This is often done by comparing technological characteristics, intended use, and performance data from engineering tests, not typically large-scale clinical trials in the way AI/ML devices require.
• Performance Benchmarking: This usually refers to electrical, mechanical, environmental safety, and performance testing against industry standards (e.g., IEC 60601-1, IEC 60601-2-37, EN/IEC 60601-1-2(2001) as mentioned in the document). It does not involve "acceptance criteria" related to diagnostic accuracy, sensitivity, or specificity in a clinical context.

Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, expert ground truth, adjudication methods, MRMC studies, or standalone performance because these elements are not typically part of a 510(k) submission for this type of medical device at the time this document was generated (2010).

The document states:
"Electrical, mechanical, environments safety and performance testing according to standard IEC 60601-1, IEC 60601-2-37, and EN/IEC 60601-1-2(2001) are currently pending." (Section 8. Safety, EMC and Performance Data). This implies that compliance with those engineering standards is the primary form of "performance data" for this device, not clinical accuracy metrics.

In summary, the provided document does not contain the specific information you are requesting because it is a 510(k) summary for a diagnostic ultrasound system from 2010, not an AI/ML-driven device with associated clinical performance studies as would be required today.

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The PacScan Plus is Sonomed's newest diagnostic ultrasound system which integrates a contact A-scan system, pachymeter, and analog thermal printer into a single unit for the convenient collection and retention of intraocular measurements. The system's principal application is to serve as an aid in the calculation of the associated IOL power for implanted lenses. As such, the PacScan Plus has been designed to capture key measurements such as axial length, anterior chamber depth and corneal thickness with both accuracy and precision.

The PacScan™ Plus is the latest generation ophthalmic biometry instrument introduced by industry leading Sonomed. The series consists of two different models: PacScan™ 300A+. This A-scan system allows for measuring the axial length 0 (AXL), anterior chamber depth, and lens thickness of an eye and for calculating the associated IOL power for an implanted lens. PacScan™ 300AP+. This system seamlessly integrates the A-Scan and 0 Pachymeter capabilities into a single system. All systems utilize a high-resolution, color backlit touch screen liquid crystal display (LCD) by which the user can enter information and view data and calculations. Each system also includes a built-in thermal printer. The system is compact and lightweight thereby making the system extremely portable.

The provided 510(k) summary for the PacScan Plus device does not contain specific acceptance criteria or details of a study proving the device meets acceptance criteria.

Instead, the summary focuses on:

• Substantial Equivalence: It claims that the PacScan Plus is substantially equivalent to two predicate devices (Sonomed Inc.'s 4000P Pachymeter System and E-Z Scan 5500+ A-Scan / B-Scan System). This means the device's safety and effectiveness are based on its similarity to legally marketed devices, rather than on proving specific performance metrics against pre-defined acceptance criteria.
• Safety, EMC, and Performance Data (Pending/General): It states that "Electrical, mechanical, environments safety and performance testing according to standard IEC 60601-1 and IEC 60601-2-37are currently pending and EMC testing was conducted in accordance with standard EN/IEC 60601-1-2(2001). All tests results were satisfactory." This is a general statement about standard compliance for safety and electromagnetic compatibility, not about clinical performance or acceptance criteria for measurements like axial length or corneal thickness.
• Indications for Use: The device is intended to capture measurements like axial length, anterior chamber depth, and corneal thickness with accuracy and precision as an aid in IOL power calculation. However, no specific numerical thresholds or a study demonstrating this accuracy and precision are provided.

Therefore, I cannot populate the requested table and answer many of the questions as the information is not present in the provided document.

Based on the provided text, the following information is NOT available and therefore cannot be reported:

• A table of acceptance criteria and reported device performance.
• Sample size used for the test set.
• Data provenance (country of origin, retrospective/prospective).
• Number of experts used to establish ground truth or their qualifications.
• Adjudication method for the test set.
• Multi-Reader Multi-Case (MRMC) comparative effectiveness study details.
• Standalone (algorithm only) performance study details.
• Type of ground truth used (expert consensus, pathology, outcomes data).
• Sample size for the training set.
• How ground truth for the training set was established.

Conclusions from the document:

• Device Type: Diagnostic ultrasound system for ophthalmic biometry (A-scan and Pachymeter).
• Purpose: Measures axial length, anterior chamber depth, and lens thickness; calculates IOL power; measures corneal thickness.
• Basis for Clearance: Substantial equivalence to predicate devices (Sonomed 4000P Pachymeter System and Sonomed E-Z Scan 5500+ A-Scan / B-Scan System).
• Safety & Performance Testing: General compliance with IEC 60601-1, IEC 60601-2-37 (pending at the time of submission), and EN/IEC 60601-1-2(2001) for EMC. No specific clinical performance study details are given.

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The Master-Vu High Resolution Ultrasound System is intended to be used for visualization by ultrasound of the eye and orbit by B-scan.

The Master-Vu High Resolution Ultrasound System is intended to be used for visualization by ultrasound of the eye and orbit by B-scan. The system is PC-based, and is used with a 12 MHz transducer. The computer is a standard pc, and is user-supplied. Computer requirements are supplied in the instructions. The scanner is motor-driven. The system can also make measurements. The Master-Vu is a conventional ophthalmic B-scan system using a motor-driven transducer and angle sensor for scanning. It uses a motor-driven 12 MHz transducer. The system is PC-based, and the display is on the computer screen.

The provided document is a 510(k) summary for the Sonomed Master-Vu Ophthalmic Ultrasound System. It describes the device, its intended use, and claims substantial equivalence to a predicate device. However, it explicitly states that no clinical tests were required for this submission. Therefore, it does not contain the detailed information necessary to answer most of your questions about acceptance criteria, study design, and performance data from a clinical trial.

Here's a breakdown of what can be answered and what cannot:

1. A table of acceptance criteria and the reported device performance

• Cannot be provided. The document states, "(2) Clinical tests Not required". Therefore, there are no reported clinical performance data or acceptance criteria for such, as they were not evaluated for this 510(k) submission. The submission focuses on non-clinical tests (ultrasonic emissions and accuracy/validation tests) to demonstrate substantial equivalence to the predicate device.

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

• Cannot be provided. No clinical test set was used or described.

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)

• Cannot be provided. No clinical test set requiring expert ground truth was performed.

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

• Cannot be provided. No clinical test set requiring adjudication was performed.

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

• Cannot be provided. No MRMC study was done, nor is there any mention of AI assistance in this document. This is a conventional ultrasonic B-scan system.

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

• Cannot be provided. This device is a conventional ultrasound system and does not appear to involve an "algorithm only" component in the way a diagnostic AI would.

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

• Cannot be provided. No clinical ground truth was established as clinical tests were not required. The "ground truth" for non-clinical tests would involve physical measurements and technical specifications rather than clinical outcomes.

8. The sample size for the training set

• Cannot be provided. The document does not describe any machine learning or AI components that would require a training set.

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

• Cannot be provided. No training set was involved.

Summary of available information related to acceptance criteria and study:

The Sonomed Master-Vu Ophthalmic Ultrasound System received 510(k) clearance based on demonstrating substantial equivalence to a predicate device (Sonomed EZ-Scan AB 5500+).

The "study" referenced in the document involved:

• Non-clinical tests: Both ultrasonic emissions tests and accuracy and validation tests were done. The acceptance criteria for these tests would be compliance with recognized standards for medical ultrasound devices and performance meeting the specifications of the predicate device.
• Clinical tests: Not required for this 510(k) application. This means the device met the regulatory requirements for safety and efficacy without needing to conduct a clinical trial demonstrating its performance on patient data against clinical acceptance criteria.

The conclusion was that the Master-Vu is "equivalent in safety and efficacy to the legally marketed predicate device" based on these non-clinical tests and technological characteristics.

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The VuMax High Resolution Ultrasound System is intended to be used for visualization by ultrasound of the eye and orbit by A-scan and B-scan. It is not intended to be used for determining the nower of timabaned ocular lenses, but it is capable of making intra-ocular measurements.

The VuMax ultrasound system is a multi-purpose computer-based ultrasonic diagnostic system for ophthalmic applications, intended to both visualize the interior of the eye by means of ultraseunded and to make measurements inside the eye.

The VuMax 35 MHz transducer is for use with the VuMax ultrasound system.

The VuMax 50 MHz transducer is for use with the Vumax ultrasound system.

The VuMax High Resolution Ultrasound System is intended to be used for visualization by ultrasound of the eye and orbit by A-scan and B-scan. It is not intended to be used for determining the nower of timabaned ocular lenses, but it is capable of making intra-ocular measurements.

The system is PC-based, and can be used with a 35 MHz transducer (standard) or a 50 MHz transducer (optional). Because of the higher frequency of the transducers, it is expected that its greatest field of application will be in visualizing the anterior segment, because the focus area is about 11 mm form the transducer plane. The system will visualize other parts of the eye, but the resolution is not as high.

The VuMax is a conventional ophthalmic A and B-scan system using a motor-driven transducer and angle sensor for scanning. The A-scan is derived from the B-scan. There is a choice of transducer frequency of 35 MHz or 50 MHz. It uses a motor-driven 10 MHz transducer with an attached angle encoder. The system is PCbased, and the display is on the computer screen.

The provided text is a 510(k) summary for the Sonomed Inc. VuMax Ophthalmic ultrasonic A and B scan system. It outlines the device description, intended use, technological characteristics, and a brief mention of performance data. However, it explicitly states that clinical tests were "Not required" and that the device's substantial equivalence to a predicate device (Sonomed EZ-Scan AB 5500+) was based on non-clinical tests (ultrasonic emissions and accuracy/validation tests).

Therefore, there is no information available in the provided document regarding acceptance criteria for device performance based on a study, nor any study details that would typically be associated with clinical evaluations of diagnostic accuracy.

Here's a breakdown based on your requested information, highlighting what is not available in the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable/Not provided within the scope of clinical performance.
The document states "Both ultrasonic emissions tests and accuracy and validation tests have been done," but does not provide specific acceptance criteria or performance metrics for these non-clinical tests in the summary. It also does not list any clinical performance data as clinical tests were stated as "Not required."

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

Not applicable. No clinical test set data is provided as clinical tests were not required for this 510(k) clearance.

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

Not applicable. No clinical test data or ground truth establishment based on expert review is mentioned, as clinical tests were not required.

4. Adjudication Method for the Test Set

Not applicable. No clinical test set data is provided.

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

No. The document explicitly states that "Clinical tests" were "Not required." Therefore, an MRMC comparative effectiveness study was not performed.

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

Not applicable. This device is an ophthalmic ultrasound system, which inherently involves human operation and interpretation. The performance evaluation was against a predicate device based on non-clinical data, not a standalone algorithm without human involvement.

7. The Type of Ground Truth Used

Not applicable for clinical performance. For the non-clinical "accuracy and validation tests," the ground truth would likely be established through physical measurements, calibration standards, or simulated targets, rather than clinical ground truth (like pathology or outcomes data). However, the specific type of ground truth for these non-clinical tests is not detailed in the summary.

8. The Sample Size for the Training Set

Not applicable. This device's clearance did not involve AI/ML algorithms requiring a training set in the context of diagnostic performance as described in typical AI device submissions. The "PC-based" nature refers to its operating system, not necessarily an AI component requiring training data for diagnostic interpretation.

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

Not applicable. As no training set for AI/ML was reported, there's no information on how its ground truth would have been established.

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The E-Z scan AB 5500+ ultrasound system is a multi-purpose computer-based ultrasonic diagnostic system ophthalmic applications, intended to both visualize the interior of the eye by means of ultrasound and to mak measurements inside the eye, including the measurement of axial length for determination of IOL power.

The Intended Use of the A_Mode probe for the E-Z scan AB 5500+ ultrasound system is to make measurements inside the eye, including the measurement of axial length for determination of IOL power, and to visualize the eye by means of A-scans.

The intended use of the B-Mode for the E-Z scan AB 5500 is to visualize the interior of the eye by means of ultrasound and to make measurements inside the eye by B-scan ultrasound.

The E-Z Scan AB5500* combines a contact B-scanner used for the visualization by ultrasound of the eye and orbit and an A-scan used for intraocular measurements. The intended use of this system includes the localization and visualization of ophthalmic disorders and measurement of the eye and orbit.

The E-Z Scan AB5500+ is a conventional ophthalmic B-scan system using a motordriven transducer and angle sensor for scanning and a conventional contact A-scan system. The transducer frequency is 10 MHz. It uses a motor-driven 10 MHz transducer with an attached angle encoder. The display is on a video touch screen, also used for controlling the system. The entire device is computer-controlled by an internal microprocessor. The A-scan uses a separate 10 MIIz transducer and its own pulserreceiver.

The provided text describes a 510(k) submission for the Sonomed E-Z Scan AB5500+, an ophthalmic A and B scan system. Here's an analysis of the acceptance criteria and the study information based on the given document:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document explicitly states "Clinical tests: Not required" for both safety and efficacy. This indicates that no clinical test set was used for this 510(k) submission. The substantial equivalence was based on non-clinical tests (ultrasonic emissions, accuracy, and validation) and comparison to existing predicate devices.

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

Since no clinical test set was used, there is no information on experts establishing ground truth for a test set. Ground truth was not established via expert review of clinical data for this submission.

4. Adjudication Method for the Test Set

As no clinical test set was used, there was no adjudication method for a test set.

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

No MRMC comparative effectiveness study was mentioned or performed, as clinical tests were "Not required."

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

The device is an ultrasound system directly operated by a human, not an algorithm. Therefore, a standalone algorithm performance study is not applicable and was not done.

7. The Type of Ground Truth Used

For the safety and efficacy assessment, the ground truth was based on the performance and established safety/efficacy of the legally marketed predicate devices (Sonomed Ophthalmic B-scan B-3000 and Sonomed A-scan A-2000), as well as non-clinical test results (ultrasonic emissions, accuracy, and validation).

8. The Sample Size for the Training Set

There is no mention of a training set in the document. This is common for predicate-based 510(k) submissions for conventional medical devices that do not involve AI/ML algorithms.

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

As no training set was used, ground truth for a training set was not established.

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