(77 days)
The device is intended to be used by medical professionals only for the measurement of systolic and diastolic blood pressure values. The device is intended to be used with blood pressure cuffs supplied for use with the device which are manually attached to a patient and manually inflated, with a manual method for detecting Korotkoff sounds. The device cuffs are available in a range of adult, pediatric and neonate sizes for use in exactly the same way and substantially equivalent to the Accoson greenlight 300 sphygmomanometer under 510(k) number K970111 for adult, pediatric and neonate patient groups.
Accoson Greenlight 300 Sphygmomanometer
This is challenging because the provided text is a 510(k) clearance letter for a sphygmomanometer, which is a very different type of device than what is typically associated with AI/ML and the requested information (e.g., acceptance criteria, study details, ground truth, training sets).
The document is for an Accoson Greenlight 300 Sphygmomanometer, which is a non-invasive blood pressure measurement system. This is a purely mechanical/electronic device, not an AI/ML-driven one. Therefore, the concepts of "AI assistance," "ground truth establishment" for training, "MRMC studies," or "standalone algorithm performance" are not applicable to this device.
The 510(k) clearance process for such a device primarily focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, often through performance testing that adheres to recognized standards (e.g., AAMI, ISO for blood pressure monitors). The letter itself does not contain the detailed study results or acceptance criteria, but rather references the submission made by the manufacturer.
Given this, I cannot directly extract the requested information in the format provided because the device and context are inappropriate for those questions. Instead, I can explain what typically would be expected for a device like this based on common regulatory practices for sphygmomanometers, but this would be inferred and not directly from the provided text.
Based on the typical regulatory requirements for a sphygmomanometer (and what would be found in a 510(k) submission, though not in the letter provided):
1. A table of acceptance criteria and the reported device performance
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Acceptance Criteria (Example for a traditional sphygmomanometer, often based on AAMI/ISO standards):
- Accuracy (Mean Difference): ≤ ±5 mmHg
- Accuracy (Standard Deviation): ≤ 8 mmHg
- Device Measurement Range: Typically 0-300 mmHg (systolic and diastolic)
- Cuff Sizing: Adherence to adult, pediatric, and neonate ranges (as stated in the Indications for Use).
- Inflation/Deflation Rates: Within specified tolerances.
- Durability/Environmental Testing: Device maintains accuracy and function after specified tests (e.g., shock, vibration, temperature, humidity).
- Safety Standards: Compliance with electrical safety (e.g., IEC 60601-1) and biocompatibility for materials in contact with skin.
- Reproducibility: Within specified limits across multiple measurements.
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Reported Device Performance: This information would be in the detailed testing reports submitted by A. C. Cossor & Son (Surgical) Ltd. to the FDA, not in the clearance letter. The letter only states that the FDA "reviewed your Section 510(k) premarket notification... (and) found the device is substantially equivalent." This implies the performance met the specified criteria.
2. Sample size used for the test set and the data provenance
- Sample Size (Clinical Accuracy Testing): For clinical validation of blood pressure devices (e.g., according to ISO 81060-2 or similar standards), typically 85 subjects are required for validation against a reference method (e.g., auscultation by trained observers). This would include a diverse range of blood pressures.
- Data Provenance: Not specified in the letter. Likely collected prospectively during a clinical study conducted by the manufacturer, possibly in the UK or another country.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: For clinical validation using auscultation (the "gold standard" for manual BP), typically two or three trained observers (a.k.a. "experts") are used simultaneously to listen to Korotkoff sounds.
- Qualifications: These would be healthcare professionals (e.g., physicians, nurses, trained technicians) with demonstrated proficiency in indirect blood pressure measurement using a mercury sphygmomanometer and stethoscope, adhering to standardized protocols. They would be trained and show inter-rater reliability.
4. Adjudication method for the test set
- Adjudication Method (Clinical BP Validation): When using multiple observers for auscultation, it's common for the average of their readings (if within a specified tolerance, e.g., 2-4 mmHg) to serve as the reference standard (ground truth). If readings differ significantly, either a third observer is used, or the measurement is discarded and repeated. This isn't strictly an "adjudication" in the AI sense, but rather a method for establishing a reliable reference measurement.
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
- Not Applicable. This device is a traditional sphygmomanometer. There is no AI component, and thus no "human readers improving with AI assistance."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This device is a traditional sphygmomanometer. Its "standalone" performance is its fundamental operation. There is no separate algorithm to be evaluated.
7. The type of ground truth used
- Ground Truth: For accuracy validation, the ground truth would be simultaneous direct arterial blood pressure measurements (invasive) or, more commonly for non-invasive devices, auscultatory measurements using a standardized mercury sphygmomanometer by trained observers (consensus).
8. The sample size for the training set
- Not Applicable. This device does not use a "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established
- Not Applicable. No training set for AI/ML.
In summary, the provided document is a 510(k) clearance for a basic medical device (a sphygmomanometer), not an AI/ML product. Therefore, most of the questions related to AI/ML study methodologies are not relevant and cannot be answered from this specific document.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the seal for the Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY - 5 2004
- Beller Bron
A. C. Cossor & Son (Surgical) Ltd. c/o Mr. A. J. Cossor Director Accoson Works Vale Road London N4 1PS UNITED KINGDOM
Re: K040410
Trade Name: Accoson Greenlight 300 Sphygmomanometer Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurcment System Regulatory Class: II (two) Product Code: DXN Dated: February 16, 2004 Received: March 10, 2004
Dear Mr. Cossor:
Wc have reviewed your Section 510(k) premarket notification of intent to market the device wt have reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the enclosed of to stgasy the Medical Device Amendments, or to connineres phor to may 20, 1978, as econdance with the provisions of the Federal Food, Drug, uevices that have been require approval of a premarket approval application (PMA). and Cosmetic Ace (11et) that de novice, subject to the general controls provisions of the Act. The 1 ou may, therefore, thanks the act include requirements for annual registration, listing of general econtrols proving practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can may be subject to back acceral Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Mr. A. J. Cossor
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Flease be advised that I Dri a location or our device complies with other requirements of the Act that IDA has made a determinations administered by other Federal agencies. You must of any it call the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CIN I at 807), adomig (21 OFR Part 820); and if applicable, the electronic forth in the quality bystems (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation only of probegin marketing your device as described in your Section 510(k) This icuer with anow you to begin maxioning of substantial equivalence of your device to a legally prematication: "The PDF intemsgssification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire spoonte aarros 70- 9 1) 594-4648. Also, please note the regulation entifled, Connect the Office of Court to premarket notification" (21CFR Part 807.97). You may obtain of Small other general international and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Arlene B. Boane
Bra
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Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): Ko40410
Device Name:_Accoson_greenlight 300 sphygmomanometer
Indications For Use:
The device is intended to be used by medical professionals only for the measurement of The device is intended to be used by moules. The device is intended to be used with attesped to a systolic and diastolic blood pressure valuer related which are manually attached to a
blood pressure cuffs supplied for use with the device Kerefleff overde biood pressure curis Supplied for ass with a manual method for detecting Koroticoline in exactly patient and inalidally innated, with a range of adult, pediatric and neonate sizes in exactly The device currs are available in a range of a and, or sale in the United States. the Same Way and Substantally oqurvation the Accoson greenlight 300 sphygmomanometer under 370(it) humr adult, pediatric and neonate patient groups.
Prescription Use Yes (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Ashley B. Brown
(Division Sign Off Division of Cardiovascular Devices
510(k) Number_
Page 1 of 1
§ 870.1130 Noninvasive blood pressure measurement system.
(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).