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510(k) Data Aggregation
(267 days)
Meditech Ltd.
The Meditech ABPM-06 (BP6) Ambulatory Blood Pressure Monitor automatically measures the systolic and diastolic arterial blood pressure and the pulse rate of adult patients under ambulatory circumstances using the standard oscillometric method with a standard upper arm cuff, sequentially as preprogrammed by the adjoining software. The device is intended for use with the standard indications for ambulatory blood pressure monitoring.
Ambulatory Blood Pressure Monitor
This FDA 510(k) clearance letter for the Meditech ABPM-06 (BP6) does not provide the detailed information required to fill out the table regarding acceptance criteria and study results. This document is a clearance letter, which confirms that the device has been found substantially equivalent to a predicate device, but it does not typically contain the raw study data or a detailed breakdown of the performance validation study.
The letter only states:
- Device Name: Meditech ABPM-06 (BP6)
- Intended Use: "automatically measures the systolic and diastolic arterial blood pressure and the pulse rate of adult patients under ambulatory circumstances using the standard oscillometric method with a standard upper arm cuff, sequentially as preprogrammed by the adjoining software. The device is intended for use with the standard indications for ambulatory blood pressure monitoring."
- Regulation Name: Noninvasive Blood Pressure Measurement System
- Regulatory Class: Class II
- Product Code: DXN
To answer your request, one would typically need access to the full 510(k) submission, which would include the performance study reports.
However, based on the information provided and general knowledge of blood pressure device validation, I can make some inferences about typical acceptance criteria for non-invasive blood pressure monitors, but these are not explicitly stated in the provided document.
Here is what would typically be expected, but not found in the provided text:
Inferred Acceptance Criteria and Reported Device Performance (Typical for BP Monitors)
| Acceptance Criteria (Inferred/Typical) | Reported Device Performance (Not found in document) |
|---|---|
| Accuracy (Mean Difference to Reference Standard) | This information is not provided in the FDA clearance letter. A typical standard like ISO 81060-2 requires a mean difference (device vs. reference) of ≤ ±5 mmHg for both systolic and diastolic, with a standard deviation of ≤ 8 mmHg. |
| Accuracy (Standard Deviation of Differences) | This information is not provided in the FDA clearance letter. A typical standard like ISO 81060-2 requires a standard deviation of differences (device vs. reference) of ≤ 8 mmHg for both systolic and diastolic. |
| Bias (e.g., AAMI/ISO Standard requirements for absolute differences within certain ranges) | This information is not provided in the FDA clearance letter. For example, AAMI/ISO standards often require that specific percentages of differences fall within certain mmHg ranges (e.g., 60% within ±5 mmHg, 85% within ±10 mmHg, 95% within ±15 mmHg). |
| Clinical Performance (e.g., successful measurements, cuff fit, patient comfort in ambulatory setting) | This information is not provided in the FDA clearance letter. The intended use mentions "ambulatory circumstances," implying that the device was likely tested for usability and performance in a real-world, mobile setting. However, specific metrics are not given. |
| Safety (e.g., absence of adverse events, pneumatic system pressure limits) | This information is not provided in the FDA clearance letter, beyond the general statement of clearance. Safety testing is inherent in device approval, but specific criteria and results are not detailed here. |
| Technical Performance (e.g., battery life, data storage, communication with software) | This information is not provided in the FDA clearance letter. While implied by "preprogrammed by the adjoining software," specific performance metrics are absent. |
| Software Validation (e.g., correct data acquisition, storage, and transfer consistent clinical decision support, user interface functionality) | This information is not provided in the FDA clearance letter. As the device uses "adjoining software," software validation would have been a part of the submission, but its specific acceptance criteria and results are not detailed here. The letter only broadly mentions "preprogrammed by the adjoining software." |
Based on the provided document, the following details are not available:
- Sample size used for the test set and the data provenance: Not mentioned. Such studies typically involve a clinical trial with a specified number of subjects (e.g., 85 subjects as per ISO 81060-2).
- Number of experts used to establish the ground truth for the test set and their qualifications: Not mentioned. For blood pressure monitors, ground truth is typically established by trained human observers using a mercury or auscultatory sphygmomanometer according to standardized protocols.
- Adjudication method for the test set: Not mentioned. The ground truth for BP devices is usually a consensus or average of multiple simultaneous auscultatory measurements by trained observers.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, and the effect size: Not applicable to a standalone blood pressure monitor (it's not an AI-assisted diagnostic imaging device).
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device itself is a standalone measurement device. Its performance is evaluated against an independent reference standard, typically human auscultation.
- The type of ground truth used: Not explicitly stated, but for blood pressure monitors, it's typically auscultatory measurement by trained observers or a validated reference device.
- The sample size for the training set: Not applicable as this is a non-AI hardware device that uses an "oscillometric method." There isn't a "training set" in the machine learning sense.
- How the ground truth for the training set was established: Not applicable.
In summary, the provided FDA clearance letter is a regulatory document confirming substantial equivalence and does not contain the detailed technical and clinical study results that would provide answers to most of your specific questions. That information would be found in the original 510(k) submission.
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(605 days)
AJEX MEDITECH., LTD
This equipment is used for generating X-ray to get the X-ray image for the purpose of diagnosis of patient.
This equipment is possible to move the place for patient because it is designed for portable type.
This equipment is possible to combine with the mobile stand unit for convenience for patient positioning according to user's needs.
The AJEX 1200H/ AJEX 240H Mobile X-ray Generator is designed for the following applications :
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Physician with general practice
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Bedside exposures in hospital ward
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Surgery and Orthopedics
The AJEX 1200H and AJEX 240H are portable x-ray units which operate at 110V or 220V, 50/60 HZ. The units have an LED display with up and down soft keys to control KvP. In addition the unit has preset memory keys to store and select KvP. The units can be installed on a mobile stand, a support arm or can be hand held. The unit should be used only by qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of body parts. The usual safety precautions regarding the use of x-ray units must be observed by the operator.
The provided text describes a 510(k) premarket notification for two portable X-ray units, the AJEX 1200H and AJEX 240H. This submission focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific performance acceptance criteria through clinical studies or standalone algorithm performance.
Therefore, much of the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment is not present in the provided document, as it falls outside the scope of a typical 510(k) submission for this type of device.
Below is a breakdown of what can be extracted and what information is not available:
Acceptance Criteria and Reported Device Performance
The acceptance criteria for this 510(k) submission are based on demonstrating "substantial equivalence" to legally marketed predicate devices. This means that the new devices are considered safe and effective if they have the same intended use and similar technological characteristics to the predicate devices, or if any differences do not raise new questions of safety or effectiveness.
The "device performance" in this context is primarily a comparison of technical specifications and performance parameters against the predicate devices.
| Characteristic | Acceptance Criterion (Substantially Equivalent to Predicate) | Reported Device Performance (AJEX-1200H) | Reported Device Performance (AJEX-240H) |
|---|---|---|---|
| Intended Use | SAME as Predicate | SAME | SAME |
| mA | Comparable to Predicate (14-60 mA or 20,25,30 mA) | 15-80 | 15-40 |
| kVp | Comparable to Predicate (40-100 kVp or 40-120 kVp) | 40-120 | 40-120 |
| mAs | Comparable to Predicate (0.6-100 mAs or 0.6-212 mAs) | 0.6-168 | 0.4-140 |
| Focal Spot | Comparable to Predicate (1.2mm) | 1.8mm | 1.2mm |
| Power Requirement | Comparable to Predicate | 110 or 220V, 50/60Hz | 110 or 220V, 50/60Hz |
| User Interface | SAME as Predicate | Exposure Switch and Console | Exposure Switch and Console |
| Collimator | SAME (manual) | manual | manual |
| Size | Comparable to Predicate | 13.4" x 9.9" x 9.8" | 13.4" x 7.6" x 6.4" |
| Weight | Comparable to Predicate | 44lbs | 32lbs |
The conclusion states: "After analyzing all the data it is the conclusion of JPI that the AJEX-1200H and 240H are as safe and effective as the predicate devise. The systems have few technological differences, and have no new indication for use. thus rendering them substantially equivalent to the predicate devices."
Study Information Not Applicable/Available:
The provided document is a 510(k) summary for X-ray units, not an AI/algorithm-driven device. Therefore, a "study" in the sense of a clinical trial proving diagnostic performance against specific metrics with human readers or standalone AI performance is not detailed. The "study" here is primarily a technical comparison to predicate devices, supported by the engineering and design choices.
- Sample size used for the test set and the data provenance: Not applicable. This is a submission for a hardware device (X-ray unit), not an algorithm or diagnostic imaging study.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for diagnostic image interpretation is not relevant for the substantial equivalence of an X-ray generator.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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. The device is an X-ray generator, not an AI diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
- The sample size for the training set: Not applicable. There is no "training set" in the context of an X-ray generator's substantial equivalence demonstration.
- How the ground truth for the training set was established: Not applicable.
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