(373 days)
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
| Parameter | Acceptance Criteria (Predicate Device) | Reported Device Performance (MD-1000 Series) |
|---|---|---|
| AL Measuring Range | 15~39mm | 15~40mm |
| AL Measuring Accuracy | ≤±0.06mm | ≤±0.05mm |
| Corneal Thickness Resolution | N/A (implied by predicate, not explicitly stated as criteria) | 1um |
| Corneal Thickness Measuring Range | N/A (implied by predicate, not explicitly stated as criteria) | 0.23mm~1.2mm |
| Corneal Thickness Accuracy | N/A (implied by predicate, not explicitly stated as criteria) | Error≤±5µm |
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.
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.