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MD-320W Ultrasound Biomicroscope is intended to be used in clinical ophthalmology for ultrasonic diagnosis on the anterior segment of eyes.

The device is intended to be used in hospitalmology clinics. The operators should be trained professionals and have basic capabilities for PC operation.

It is not allowed to use UBM on patients with eye trauma, inflammation or infection.

MD-320W Ultrasound Biomicroscope is an ultrasonic imaging system with high-resolution. It consists of AC-DC power adapter, main unit, 50MHz sector scan probe, footswitch, USB cable and two user-selectable APPs:

MD3XUBM.AP1-C V1.0 APP (included in MD3XUBM-C V1.0) runs on the windows operating system of the PC and allows the user to control probe scanning, image acquisition and display via the PC user interface.

MD3XUBM.AP1-S V1.0 APP (included in MD3XUBM-S V1.0) runs on the operating system of the legally marketed MD-2300S Ultrasonic A/B Scanner for Ophthalmology (K152318) and allows the user to control probe scanning, image acquisition and display via the MD-2300S user interface.

Under the excitation of electric pulse, the 50MHz ultrasound transducer emits ultrasonic pulse into eye and receives reflective echo from the surfaces of different tissue, thus forming real-time two-dimensional image of eye tissue.

This FDA 510(k) summary for the MD-320W Ultrasound Biomicroscope details its substantial equivalence to a predicate device but does not contain the specific information requested about acceptance criteria and a study proving the device meets those criteria. The provided text focuses on comparing the new device's technological characteristics and intended use to a predicate device (VuPad Ophthalmic Ultrasound System), highlighting non-clinical testing for safety, EMC, and acoustic output.

Therefore, the following information cannot be extracted from the provided 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 about a multi-reader multi-case (MRMC) comparative effectiveness study.
• Whether a standalone performance study was done.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.) for any specific performance study.
• The sample size for the training set.
• How the ground truth for the training set was established.

The document only states that "The software and essential performance have passed verification and validation, and the results comply with the related requirements as per the FDA Guidance document 'Marketing Clearance of Diagnostic Ultrasound Systems and Transducers' issued in June 27, 2019." This is a general statement about compliance with guidance and does not provide specific performance metrics or study details.

In summary, the provided text describes regulatory approval based on substantial equivalence to a predicate device, focusing on technical specifications and general safety/EMC testing, rather than detailed performance study data against specific acceptance criteria.

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MD-6000P Bladder Scanner is intended to measure the urine volume in human bladder.

The device is intended to be used in medical and nursing care institutions. It should be operated by trained professionals. The device is not intended for use on pregnant women. It cannot be used on wounded skin.

MD-6000P Bladder Scanner is a hand-held device which utilizes ultrasonic distance measuring principle to calculate urine volume in the bladder.

The device takes mechanical sector scan by 2.5MHz ultrasonic waves and recognizes the reflected waves of the front and back walls of bladder to get the area of bladder section; then it makes 12 scans at an interval of 15° and calculates the urine volume in human bladder with volume integral algorithm.

Here's a breakdown of the acceptance criteria and the study information based on the provided text, structured according to your request:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document describes bench testing for accuracy using a phantom and a water sac. It does not specify a "test set" in the context of human subjects or a clinical study.

• Test Set Sample Size: Not explicitly stated as a number of measurements, but refers to "scan on the phantom" and "scan on the test object of water sac with known volume." This implies a series of measurements were performed.
• Data Provenance: The document does not provide information on data provenance (e.g., country of origin, retrospective/prospective) for these bench tests.

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

• Number of Experts: Not applicable. The ground truth for the bench tests was established by "nominal value" for the phantom and "known volume" for the water sac.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. Ground truth was based on physical properties (nominal value, known volume) rather than expert consensus requiring adjudication.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not done. The document states: "The MD-6000P Bladder Scanner, subject of this submission, did not require clinical studies to support the determination of substantial equivalence."

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

• Standalone Performance: The accuracy reported (±15% or ±15ml) is from bench testing of the device's measurement capabilities. This can be considered a standalone performance assessment in the sense that it evaluates the device's ability to measure a known volume without a human interpreter influencing the measurement outcome. However, it's not "algorithm-only" performance in the context of AI, as this is a physical measurement device.

7. The Type of Ground Truth Used

• Type of Ground Truth: For the bench testing, the ground truth was based on:
  • Nominal value (for the phantom in the 100-999ml range).
  • Known volume (for the water sac in the 20-100ml range).

8. The Sample Size for the Training Set

• Training Set Sample Size: Not applicable. The document describes a medical device (bladder scanner) that utilizes ultrasonic distance measuring principles and a volume integral algorithm. It does not mention any machine learning or AI components that would require a "training set" in the conventional sense. The "algorithm" here refers to a deterministic calculation method, not a learned model.

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

• Ground Truth for Training Set: Not applicable, as there is no mention of a training set or a machine learning 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 MD-1000A/P is used for ophthalmology to measure axial length (AL), anterior chamber depth (ACD), lens thickness (LT), and corneal thickness (CT).

The MD-1000A is used for ophthalmology to measure axial length (AL), anterior chamber depth (ACD) and lens thickness (LT).

The MD-1000P is used for ophthalmology to measure corneal thickness (CT).

The device should be operated by trained doctors. It should be used cautiously to patients without independent behavior abilities. Cornea trauma or inflammation patients are prohibited to use the device.

The MD-1000 Series of Ultrasonic Biometer/Pachymeter for Ophthalmology consists of three models of products: the MD-1000A/P Ultrasonic Biometer for Ophthalmology, the MD-1000A Ultrasonic Biometer for Ophthalmology and the MD -1000P Ultrasonic Pachymeter.

The MD-1000A/P Ultrasonic Biometer for Ophthalmology is an ultrasonic measuring instrument based on pulse reflection. The MD-1000A/P contains two function units: A Mode Eye Axis Biometric Parameter Measuring Unit (A Biometer) and Corneal Thickness Measuring Unit (Pachymeter).

The A Biometer consists of a 10MHz A-Probe (probe model: Prb1000A/10-C) and an axis biometric parameter measuring unit. The axis is usually divided into three segments: anterior chamber, lens and vitreous body. Since the tissue within the eye varies in different areas, the acoustic velocity through these areas is also different. The summation of these three segments (ACD + LENS + VITR) provides the axial length (AL). Based on the interface reflections of the three different tissues, the ultrasonic A-biometry measures the transmitting time of ultrasound through each tissue and calculates the length of each segment to finally get the axial length.

The Pachymeter consists of a 20MHz P-Probe (probe model: Prb1000P) and the measuring unit. It is on the basis of the measurement of the time interval between the anterior and posterior interface reflection waves of cornea to get the corneal thickness (CT).

The MD-1000 Series has a built-in Thermal Printer, used to print out patient information, A-Scan measuring waveform, IOL calculating parameter and result as corneal thickness measuring result and corneal thickness distribution map.

The built-in memory of the MD-1000 Series can store up to180 patients' records. After examination, it can be connected with a computer to upload the stored measuring data and information, thus realizing mass storage.

Here's a breakdown of the acceptance criteria and the study information derived from the provided text for the MD-1000 Series Ultrasonic Biometer/Pachymeter:

1. Acceptance Criteria and Reported Device Performance

Note: The acceptance criteria for the MD-1000 series are compared directly to the specified performance of its predicate device, the ODM-1000 series, as the document states that the MD-1000 Series has "similar performance characteristics...as its predicate device" and highlights improvements (like AL accuracy and range). For corneal thickness, the predicate's specific criteria aren't detailed, so the MD-1000's reported performance is listed.

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

• Sample Size:
  • Corneal thickness measurement: 60 eyes
  • Axial length measurement: 47 eyes
  • Total subjects: 107
• Data Provenance: The study was conducted by "a hospital" in China (implied by the submitter's location and the mention of 93/42/EEC MEDDEV. 2.7.1 Rev.3, which is a European medical device directive, but the specific country of the hospital is not explicitly stated). The study appears to be prospective as it involved selecting subjects to "implement axial length measurement or corneal thickness measurement" with the device and a comparator.

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

The document does not explicitly state the number of experts or their qualifications used to establish ground truth. The study compares the MD-1000A/P to a "similar product (NIDEX-US-500)" which serves as a reference or "ground truth" for comparison. The assumption is that measurements from the NIDEX-US-500 are considered reliable.

4. Adjudication Method for the Test Set

The document does not mention an adjudication method for the test set. It states that both devices were used to measure the same eye, and the Bland-Altman statistical method was used to assess agreement between the two devices. This implies a direct comparison rather than an adjudication of discrepancies.

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

This section is not applicable to this device. The MD-1000 Series is an ultrasonic biometer/pachymeter, not an AI-assisted diagnostic imaging interpretation device. The study compared the device's measurements directly to another similar device, not human readers with or without AI assistance.

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

This section is not applicable in the AI sense. The device itself performs the measurements (axial length and corneal thickness) as a standalone instrument. The "algorithm" here refers to the device's internal measurement and calculation processes, which are inherently "standalone" in their function. There is no human interpretation of an algorithm's output to assess standalone performance in the context of AI. The clinical validation was a comparison of the device's measurements against another device, which is a form of standalone performance evaluation for a measurement device.

7. The Type of Ground Truth Used

The ground truth for the clinical validation was established by comparison to a legally marketed similar product (NIDEX-US-500). The measurements from the NIDEX-US-500 served as the reference for evaluating the MD-1000A/P's performance.

8. The Sample Size for the Training Set

The document does not provide information regarding a separate training set. As this device is a physical medical instrument (ultrasonic biometer/pachymeter) and not a machine learning algorithm that requires explicit "training" in the typical sense, a training set as understood in AI/ML is not applicable or detailed in this submission. Its improvement in accuracy is attributed to hardware changes like increased sampling frequency (24MHz vs 12MHz).

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

As no training set is mentioned in the context of an AI/ML system, this question is not applicable. The device's operational principles are based on established ultrasound physics and algorithms, rather than being "trained" on a dataset in the way a modern AI would be.

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MD-6000 Bladder Scanner is a portable battery-operated ultrasonic equipment of pulse reflection. It is intended to measure the volume of bladder filled with urine.

The MD-6000 is intended to be used only by qualified medical professionals. Contraindications for the MD-6000 are fetal use and use on pregnant patients.

MD-6000 Bladder Scanner is a portable battery-operated ultrasonic equipment of pulse reflection. It utilizes ultrasonic distance measuring principle to calculate the bladder volume.

It makes mechanical sector scan by 2.5MHz ultrasonic wave and recognizes the reflected wave of the front and back wall of bladder to get the area information of bladder section. It calculates the volume of bladder by volume integral algorithm on the basis of the area information of 12 reference planes which are changed automatically with an interval of 15°.

MD-6000 Bladder Scanner has a Pre-Scan function, which shows the real-time B mode image for sectional plane of bladder. The Pre-Scan function helps a user to locate the bladder easily and get more accurate results.

Built-in thermal printer provides convenience of printing data.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Device: MD-6000 Bladder Scanner

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: 10 volunteers.
• Data Provenance: Not explicitly stated whether the data was retrospective or prospective. The study mentions "collected and evaluated" and "validation to the measuring accuracy of bladder volume to 10 volunteers," which suggests a prospective collection for this specific validation. The country of origin is implied to be China, as the submitter, MEDA Co., Ltd., is located in Tianjin, P.R. China.

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

• Number of Experts: "Professional doctors" were entrusted to make clinical effectiveness tests. The exact number of doctors is not specified, nor are their specific qualifications (e.g., years of experience or specialty).

4. Adjudication Method for the Test Set:

• The document does not describe a specific adjudication method like 2+1 or 3+1 for establishing ground truth from multiple experts. It states that "professional doctors" conducted clinical effectiveness tests, and a comparison was made between the device's measurement and the actual volume of excreted urine. This implies a direct comparison rather than an expert consensus adjudication process.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:

• No, an MRMC comparative effectiveness study involving human readers and AI assistance was not done or reported in this summary. The device's primary function described is measuring bladder volume, not assisting human interpretation of complex medical images.

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

• Yes, a standalone performance evaluation was done. The "validation to the measuring accuracy of bladder volume to 10 volunteers" involved comparing the device's measurement directly to the "actual volume of excreted urine." This assesses the device's performance in isolation.

7. The Type of Ground Truth Used:

• The ground truth for the device's accuracy validation was "actual volume of excreted urine." This is a direct, objective measurement rather than an expert consensus or pathology report.

8. The Sample Size for the Training Set:

• The document does not specify a sample size for a training set. The descriptions focus on the validation study. Ultrasonic bladder scanners typically rely on algorithms derived from physical principles (ultrasonic distance measuring principle, volume integral algorithm) rather than learning from a large training dataset in the same way modern AI algorithms do.

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

• As a training set is not explicitly mentioned (or likely not applicable in the modern sense of AI/ML for this type of device based on the description), there is no information on how its ground truth was established. The device utilizes "ultrasonic distance measuring principle to calculate the bladder volume" and a "volume integral algorithm," which are pre-determined mathematical models rather than learned from a training set with ground truth labels.

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