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The B-Scan module is used for imaging the internal structure of the eye, including the opaque media and posterior pathology, for the purpose of diagnosing pathological or traumatic conditions in the eye. The probe is intended to be used on both adult and pediatric patients that require imaging of the eye.

The B-Scan device is designed as an ultrasound B-Scan, which uses pulsed echo ultrasound to image the structure of the eye. It utilizes an eye-contact probe to generate and receive the ultrasound pulse signals and provides a graphic display of returning pulse echoes to indicate the various structures.

All of the critical functions of the B-Scan are calculated in the same manner as in the predicate device, B-Scan Plus. The software algorithms for clinically critical functions remain the same as in the predicate device. However, the user interface and the workflow of B-Scan have enhancement to support cybersecurity implementation.

Both the subject device and predicate device are compatible with the Connect Software (K070943, K123349) and 4Sight (K152573). The software improvements in Connect were focused on enhancing features that optimize integration with the personal computer's processing, data storage, display, and printing capabilities.

The energy source for the B-Scan is USB power as in the predicate device, B-Scan Plus.

The software utilized on both the Connect and 4Sight platforms is fundamentally identical in core clinical functions, including image scanning, rendering, IOL calculations, data storage, and report formatting. Additionally, the key features within the B-Scan module do not differ significantly between the two systems, nor do they make an impact on the established clinical workflow.

Track 1 is being followed for this 510(k) submission.

Here's a breakdown of the acceptance criteria and the study details for the B-Scan Ultrasonic Imaging System, based on the provided FDA 510(k) clearance letter:

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary primarily focuses on demonstrating substantial equivalence to a predicate device rather than explicitly stating pre-defined "acceptance criteria" for a novel device performance. However, we can infer acceptance criteria from the comparison table (Table 2) and the performance data section, where the subject device's performance is either "Same" or "SE" (Substantially Equivalent) to the predicate, or explicitly lists performance metrics.

For quantitative metrics, the "acceptance criteria" for the subject device can be interpreted as performing comparably or within acceptable limits relative to the predicate device, or meeting specific new specifications.

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

The document does not explicitly state a sample size for patients or images used in any clinical or test set. The performance data mostly refers to bench testing and validation against standards.

• The only mention of a "sample" related to performance is "average time recorded across 5 probes" for the image preview time. This refers to hardware units, not patient data.
• Data Provenance: Not applicable, as no external data set or clinical study on patients is described beyond bench tests. The focus is on device specifications and in-house validation.

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

Not applicable. The submission does not describe a study involving expert readers establishing ground truth for a test set of images for diagnostic performance evaluation. The "Performance" section outlines bench tests and compliance with recognized standards.

4. Adjudication Method for the Test Set

Not applicable. Since there's no mention of a clinical test set requiring human expert review to establish ground truth, there is no adjudication method described.

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

No. The document does not describe a Multi-Reader Multi-Case (MRMC) comparative effectiveness study, nor does it quantify improvement in human readers with AI assistance. The device is purely an imaging system, and there is no mention of AI assistance for image interpretation.

6. Standalone (Algorithm Only Without Human-in-the-loop Performance)

The device described is an "B-Scan Ultrasonic Imaging System," which is a diagnostic tool that produces images for human interpretation. It does not contain an AI algorithm for standalone diagnostic performance. Its performance is related to image acquisition parameters, accuracy of measurements, and adherence to safety/design standards.

7. Type of Ground Truth Used

For the quantitative performance claims (e.g., Clinical Accuracy Line/Area), the ground truth was established by physical measurements against known standards or calibrated references during bench testing ("Physical Accuracy and Range Test"). For other aspects, the ground truth is adherence to technical specifications, safety standards, and validated manufacturing/reprocessing procedures.

8. Sample Size for the Training Set

Not applicable. This device is an ultrasound imaging system, not an AI-driven diagnostic algorithm that requires a "training set" of data in the typical machine learning sense. The software aspects mentioned are primarily for device control, image rendering, data storage, and report formatting, enhanced for cybersecurity and usability – not for learning from data to perform a diagnostic task.

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

Not applicable, as there is no training set mentioned for an AI algorithm.

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MD-2300S Ultrasonic A/B Scanner for Ophthalmology is intended for ophthalmological ultrasonic diagnosis and AL biometric measurement.

The 10MHz B-Probe applies to normal ophthalmological ultrasonic diagnosis; and the 20MHz B-Probe is suitable for observing the details of intraocular and retina structure.

The device should be operated by trained medical staff.

Patients with eyelid trauma and severe eye infection are prohibited from using B-Scan; and patients and cornea trauma are prohibited from using A-Biometric scan.

The A-biometric scan should be used cautiously on patients without independent behavior abilities or who are highly sensitive to contacting measurements, whose ineffective cooperation may result in inaccurate measurements,

MD-2300S Ultrasonic A/B Scanner for Ophthalmology is an ultrasonic imaging instrument specialized in ophthalmological diagnosis. It consists of a main unit, a power adaptor, a 10MHz B-Scan probe, a 20MHz B-Probe, a 10MHz A-Probe, a footswitch, a keyboard and a mouse.

MD-2300S includes two most popular operation modes for ophthalmological clinical diagnosis: B-mode ultrasonic section imaging and A-mode axial biometric parameter measurement.

The 10MHz B-Probe applies to normal ophthalmological ultrasonic diagnosis; and the 20MHz B-Probe is suitable for observing the details of intraocular and retina structure.

The part of B-mode uses 10MHz and 20MHz mechanical sector-scan probes for scanning. It acquires echo signal through ultrasonic pulse transmitting and receiving circuits; and converts it into digital information to save in FIFO; the data information of each echo line is transmitted to the embedded board through USB port. The application software running on Windows XPE platform realizes real time display, saving and case report generation for images of eye tissue.

The part of A-mode uses 10MHz A-biometric probe for A-mode scanning. It acquires echo signal through ultrasonic pulse transmitting and receiving circuits; and converts it into digital information to save in FIFO; the data information of each echo line is transmitted to the embedded board through USB port. Based on the interface reflection of ultrasound wave in three different tissues of anterior chamber, lens and vitreous body, the application software running on Windows XPE platform measures the transmitting time of ultrasound wave in different tissues and then calculates distances of each segment according to the acoustic velocity of different tissues to get the axial length and generates case report of A-biometry automatically, thus provides parameters for intraocular lens implantation operation.

This document describes the premarket notification (510(k)) for the MD-2300S Ultrasonic A/B Scanner for Ophthalmology. The information provided primarily focuses on demonstrating substantial equivalence to predicate devices rather than a standalone clinical study with explicit acceptance criteria and statistical performance metrics for novel AI algorithms.

Here's a breakdown of the requested information based on the provided text, recognizing that some of the questions may not be fully applicable to this type of submission which is focused on substantial equivalence for a medical device rather than an AI/ML algorithm:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly state "acceptance criteria" in the typical sense of a target performance threshold for a new AI algorithm. Instead, it demonstrates the device's technical specifications and clinical utility are substantially equivalent to predicate devices. The "performance" is described in terms of technical characteristics and observational clinical findings.

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

• B-Mode Test Set:
  • Sample Size: "randomly outpatients and inpatients that need to make B-mode ultrasonic examination" (no specific number provided). The selection aimed to cover "typical cases of ultrasonic diagnosis for ophthalmology."
  • Data Provenance: Prospective (implied by "make ultrasonic inspection") clinical validation study conducted at Tianjin Eye Hospital, China.
• A-Mode Test Set:
  • Sample Size: "50 eyes randomly from outpatients and inpatients that need to measure axial length (AL)."
  • Data Provenance: Prospective clinical validation study conducted at Tianjin Eye Hospital, China. Patients' sex and age were not restricted.

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

• B-Mode: "Clinical doctors validate the intended use according to the image quality of B-Scan on orbit and intraocular tissues." The number and specific qualifications of these "clinical doctors" are not stated.
• A-Mode: The ground truth for A-mode measurements was established by comparing measurements from the MD-2300S against a predicate device, the ODM-2100 Ultrasonic A/B Scanner for Ophthalmology. This implies the predicate device's measurements served as the reference. The operators for both devices are described as "expected user representatives," implying trained medical staff, but specific qualifications are not detailed.

4. Adjudication Method for the Test Set

• B-Mode: Not explicitly stated as a formal adjudication process. The text indicates "Clinical doctors validate the intended use according to the image quality." This suggests a qualitative assessment by medical professionals.
• A-Mode: "The statistical processing results for AL measuring data with Bland-Altman statistical method should have no obvious difference." This is a statistical method for assessing agreement between two different methods of measurement, rather than a formal expert adjudication of ground truth.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size of how much human readers improve with AI vs without AI assistance

This document describes the premarket notification for a diagnostic ultrasound system, not an AI/ML device assisting human readers. Therefore, an MRMC comparative effectiveness study involving AI assistance for human readers was not conducted or reported in this submission. The "clinical effectiveness validation" was about the device's inherent diagnostic capabilities.

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

This is not an AI/ML algorithm. The device, an ultrasonic scanner, performs measurements (A-mode) and generates images (B-mode) in a standalone capacity. Operators (human-in-the-loop) are required to use the device. The A-mode's automated measurement of AL and IOL calculation is a function of the device, validated against another device's measurements. The B-mode image quality is validated by clinical doctors' assessment.

7. The Type of Ground Truth Used

• B-Mode: Expert consensus/clinical assessment based on qualitative evaluation of image quality by "Clinical doctors."
• A-Mode: Comparison against a legally marketed predicate device (ODM-2100 Ultrasonic A/B Scanner for Ophthalmology) using the Bland-Altman statistical method to assess agreement. This acts as a reference standard for the AL measurement. Pathology or outcomes data are not mentioned as ground truth sources.

8. The Sample Size for the Training Set

This submission does not discuss an AI algorithm or a "training set." The device is a traditional medical imaging device.

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

Not applicable, as there is no mention of a training set or AI algorithm in this submission.

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The instrument is used for imaging the internal structure of the eye including the opaque media and posterior pathology for the purpose of diagnosing pathological or traumatic conditions in the eye.

The B-Scan Plus device is designed as an ultrasound B- Scan which uses pulsed echo ultrasound to image the internal structure of the eye. It utilizes an eye-contact probe to generate and receive the ultrasound pulses, and provides graphic display of returning pulse echoes to image these structures.

Here's a breakdown of the acceptance criteria and study information for the B-Scan Plus device based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state specific acceptance criteria in terms of numerical performance metrics (e.g., sensitivity, specificity, accuracy, resolution). Instead, the 510(k) summary focuses on demonstrating substantial equivalence to a predicate device (Advent A/B System K960765).

The device performance is described functionally rather than parametrically.

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

The provided 510(k) summary does not contain information about a specific test set, its sample size, or data provenance (e.g., country of origin, retrospective/prospective).

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

The provided 510(k) summary does not contain information about experts used to establish ground truth or their qualifications. As there's no mention of a clinical test set in this document, this information would not be present.

4. Adjudication Method for the Test Set

The provided 510(k) summary does not contain information about an adjudication method for a test set.

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

The provided 510(k) summary does not mention or describe a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. This type of study would typically be conducted to evaluate the impact of an AI-assisted device on human reader performance, which doesn't seem to be the focus of this 510(k).

6. Standalone (Algorithm Only) Performance Study

The provided 510(k) summary does not describe a standalone (algorithm only) performance study. The device is a B-Scan ultrasound system, which inherently involves human operation and interpretation of images. The concept of a "standalone algorithm" doesn't directly apply in the same way as it would for, say, an AI-powered image analysis software.

7. Type of Ground Truth Used

Given the lack of a detailed performance study in the document, there's no explicit mention of the type of ground truth used. For a B-scan ultrasound system, ground truth in clinical validation would typically involve:

• Clinical Diagnosis: Based on a combination of patient history, physical examination, and other imaging modalities (e.g., MRI, CT, other specialized ophthalmic tests).
• Surgical Confirmation: If pathology is surgically removed.
• Histopathology: Microscopic examination of tissue samples.
• Expert Consensus: Agreement among multiple, highly qualified clinicians (ophthalmologists) on the diagnosis based on the full clinical picture.

8. Sample Size for the Training Set

The provided 510(k) summary does not mention a training set or its sample size. The B-Scan Plus is a traditional medical imaging device, not an AI/ML-driven device that typically requires a discrete training set in the same manner.

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

Since there is no mention of a training set, the document does not describe how ground truth for a training set was established.

Summary of Study Information Gaps:

It's important to note that the provided document is a 510(k) summary, which often focuses on demonstrating substantial equivalence to a predicate device rather than presenting extensive clinical trial data with detailed performance metrics. For devices like the B-Scan Plus, the primary means of demonstrating safety and effectiveness relied on showing that its technological characteristics and indications for use were similar to a legally marketed predicate device, and that any differences did not raise new questions of safety or effectiveness. Therefore, many of the detailed study parameters typically associated with AI/ML device submissions are not present here.

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The POD B-Scan is intended to be used for visualization by ultrasound of the eye and orbit by A-scan and B-scan.

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

The POD B-Scan is intended to be used for visualization by ultrasound of the eve and orbit by A-scan and B-scan.

The system is PC-based, and can be used with 35 MHz or 50MHz transducers. 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 from the transducer plane. The system can visualize other parts of the eye.

Summary of the reaconventional 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 PC-based, and the display is on the computer screen.

The provided 510(k) summary for the POD B-Scan ophthalmic ultrasound system (K090884) describes a device seeking clearance based on substantial equivalence to a predicate device. However, it does not present specific acceptance criteria or a detailed study proving the device meets such criteria in terms of clinical performance or diagnostic accuracy.

The summary focuses on:

• Device Description and Intended Use: Visualization of the eye and orbit by A-scan and B-scan, with a focus on the anterior segment due to high-frequency transducers (35 MHz or 50 MHz).
• Technical Characteristics: Conventional ophthalmic A and B-scan system with a motor-driven transducer and angle sensor, PC-based display.
• Testing: Only broadly states "Testing included required ultrasound tests, as well as electrical safety and electromagnetic compatibility tests." This refers to performance and safety standards, not clinical diagnostic accuracy.
• Conclusion: Claims equivalence in safety and efficacy to the predicate device (VuMax High Resolution Ultrasound System, K060626), but does not provide details of how this efficacy was specifically demonstrated.

Given the information provided, here's a breakdown of the requested points:

1. Table of Acceptance Criteria and Reported Device Performance

Accurately filling this table is not possible with the provided document. The 510(k) summary for K090884 does not explicitly state acceptance criteria or report specific performance metrics related to diagnostic accuracy (e.g., sensitivity, specificity, agreement with ground truth for specific pathologies). Instead, it relies on substantial equivalence to a predicate device for safety and efficacy. The "Testing" section broadly mentions "required ultrasound tests," which likely refers to engineering performance, safety (electrical, EMC), and acoustic output parameters, rather than clinical diagnostic performance metrics.

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

The document does not specify any clinical test set or data provenance for evaluating diagnostic performance. The testing mentioned is for electrical safety and electromagnetic compatibility, which typically does not involve patient data or test sets for diagnostic accuracy.

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

Not applicable. Since no clinical test set for diagnostic performance is described, there is no mention of experts or ground truth establishment for such a set.

4. Adjudication Method for the Test Set

Not applicable. No clinical test set is described, therefore no adjudication method is mentioned.

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

No. The document does not describe a MRMC comparative effectiveness study, or any study comparing human readers with or without AI assistance. The device is an ultrasound imaging system, not an AI-driven diagnostic interpretation tool in the context of this submission.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)

No. The device is an ultrasound diagnostic system, meaning it generates images for human interpretation. There is no mention of an algorithm performing diagnoses independently.

7. Type of Ground Truth Used

Not applicable for clinical diagnostic performance. The document focuses on showing substantial equivalence based on technical characteristics, safety, and operational performance, not on direct clinical diagnostic accuracy against a defined ground truth like pathology or outcome data.

8. Sample Size for the Training Set

Not applicable. This device is an ultrasound imaging system, and the submission does not describe it as an AI/ML-driven diagnostic algorithm that would typically have a "training set" in the machine learning sense. The "training" for such a device would be its engineering design and calibration, not a data-driven training set for an AI model.

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

Not applicable. As a training set for an AI/ML model is not described, the establishment of ground truth for such a set is also not discussed.

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The UD-1000 A/B Scanner is indicated for:

• Ultrasound imaging of the eye and orbit
• Producing axial measurements of the eye
• Imaging the intraocular anatomy and pathology of the eye
• Imaging the anterior segment of the eye
• Imaging the anterior angle for Glaucoma Management
• Imaging of other structures of the anterior chamber

This instrument is designed as an ophthalmic diagnostic instrument that performs both Amode and B-mode ultrasound. In B-mode, the instrument acquires an ultrasonic crosssectional image of echoes from ocular structures. The brightness of the various dots in the two-dimensional image depends on the intensity of the echo sources. In A-mode, the instrument provides a one-dimensional display of returning echoes. Positive waves indicate the location of ocular structures; the distances between spikes can be measured.

The B-scan probe transmits focused ultrasonic waves into the eyeball. The transducer oscillates back and forth, resulting in a two-dimensional cross-sectional image view of the ocular structures. The image represents a "slice" through the portion of eye that is being examined. The ultrasonic beam focus range is controlled by six annular oscillators that are arranged concentrically. Multiple images can be saved and played back at the most appropriate resolution.

The B-scan probe is used to indirectly measure axial length based on a linear sampling of the image of the eye. Although this measurement is less accurate than axial length measurement by A-scan biometry, it provides a useful approximation in patients unable to maintain a steady primary gaze or in eyes with dense cataract, detached retina or posterior staphyloma.

The A-scan probe emits a non-focused ultrasound beam that results in a one-dimensional representation of echoes returned from ocular structures through which the beam passes. Ocular abnormalitites may be identified and evaluated by assessing the location and amplitude of the spikes produced by various ocular tissues.

The instrument control panel is a touch panel with membrane switch, rotary encoder and foot switch.

The provided text states, "Performance Data: None. The specifications and indications for use of the UD-1000 A/B Scanner are the same or very similar to those of the claimed predicate devices. The UD-1000 has the same indications for use for which the claimed predicates have been cleared and has no additional indications for use. Because of this, performance data were not required."

Therefore, based on the provided input, no acceptance criteria or study demonstrating that the device meets acceptance criteria are described. The manufacturer asserted substantial equivalence to predicate devices, and as such, performance data, including details on acceptance criteria, test sets, ground truth establishment, or multi-reader multi-case studies, were not required.

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