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The device is intended to be used by medical professionals or in the home for the measurement of systolic and diastolic pressure on new borns, infants, children, young adults. The device is intended to be manually attached to a patient and manually inflated along with a manual method for detecting Korotkoff sounds.

The ANEROID SPHYGMOMANOMETER and ANEROID SPHYGMOMANOMETER WITH STETHOSCOPE are manual blood pressure monitor used to measure blood presure.It consists of a cuff,a inflation bulb,a pressure gauge, an air valve and a stethoscope(optional).

Cuff: The cuff is made of a durable fabric and is wrapped around the upper arm of the patient. It inflates and deflates during the measurement process. The material of outside layer is nylon cloth.

Inflation Bulb: The inflation bulb is a rubber bulb that connects to the cuff and is used to manually inflate the cuff with air. The material is Neoprene or Silicon rubber or Nature latex or PVC.

Pressure Gauge: The pressure gauge is a circular dial with a needle that indicates the pressure within the cuff. It is calibrated in millimeters of mercury (mmHg) and shows the systolic and diastolic blood pressure readings. The material is Aluminum or ABS.

Air Valve: The valve is a control mechanism that allows for the release of air from the cuff once the measurement is complete.

Stethoscope: Although not a part of the device itself, a stethoscope is typically used in conjunction with an Aneroid Sphygmomanometer to listen for the blood flow sounds, known as Korotkoff sounds, in the brachial artery during the measurement. Three model are single head Stethoscope(Model: TY-S01),Dual Head Stethoscope(Model: TY-S05) and Spraque Rappaport Stethoscope(Model: TY-S04) individually.These stethoscopes are listed in FDA database.

The provided submission describes an Aneroid Sphygmomanometer. Here's an analysis of the acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The document explicitly states that the "Accuracy" of the device is ± 3 mmHg, which is also the performance reported. For "Biocompatibility" and "Safety & Performance", compliance with the specified ISO standards is the stated performance.

Note: The submission describes an aneroid sphygmomanometer, which is a mechanical device. The concept of an "AI device" with human-in-the-loop performance or standalone performance, sample sizes for test/training sets, adjudication methods, and expert qualifications for ground truth establishment, are not applicable to this type of device. The provided text is a 510(k) summary for a traditional medical device, not an AI/ML-powered device.

Therefore, the following points are answered with "Not Applicable" (N/A) due to the nature of the device.

2. Sample size used for the test set and the data provenance
N/A - This device is a mechanical blood pressure monitor, not an AI/ML-powered device that uses a "test set" in the context of data. The performance testing refers to compliance with a standard (ISO 81060-1), which involves testing the device itself, not an algorithm's performance on a dataset.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
N/A - See explanation above.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
N/A - See explanation above.

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
N/A - This is a mechanical device, not an AI-assisted one.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
N/A - This is a mechanical device, not an AI algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
N/A - The ground truth for this device's accuracy would be established by direct comparison to a reference standard, as defined by ISO 81060-1, which likely involves a calibrated pressure standard.

8. The sample size for the training set
N/A - This is a mechanical device, not an AI/ML-powered device that requires a "training set."

9. How the ground truth for the training set was established
N/A - See explanation above.

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The device is intended to be used by medical professionals or in the home for the measurement of systolic and diastolic pressure. The device is intended to be manually attached to a patient and manually inflated along with a manual method for detecting Korotkoff sounds. This product can measure the blood pressure of people aged 3 years and above.

Aneroid sphygmomanometer Model QL-20, QL-201/ Aneroid sphygmomanometer with stethoscope, Model QL-50 are a manual non-invasive aneroid sphygmomanometer which respectively uses an inflation cuff wrapped around the upper arm. The cuff is inflated and deflated by a manual inflation bulb. Besides a manometer (Aneroid gauge), the accessories include cuff, inflation bulb, instruction manual and carrying case. Model OL-50 also includes a stethoscope. It is conjunction with stethoscope when use.

The provided text describes a 510(k) premarket notification for an aneroid sphygmomanometer. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel clinical effectiveness or algorithm performance.

Therefore, the requested information (acceptance criteria for an AI/device algorithm, MRMC study, standalone performance, training/test set details, expert ground truth establishment, etc.) is largely not applicable to this specific document as it pertains to a traditional medical device (manual blood pressure cuff) and not an AI/ML-driven diagnostic or assistive device.

However, I can extract and present the performance criteria that are relevant to this device type based on the provided document:

Acceptance Criteria and Device Performance (for an Aneroid Sphygmomanometer)

Since this is a traditional medical device (aneroid sphygmomanometer) and not an AI/ML-driven device, the acceptance criteria and performance evaluation focus on its physical and functional accuracy for blood pressure measurement, as well as biocompatibility, rather than AI performance metrics like sensitivity, specificity, or AUC.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance:

• The document does not specify a patient sample size for testing the aneroid sphygmomanometer itself. The testing performed was "Non-clinical testing" conducted to verify compliance with standards like ISO 81060-1. This standard typically involves technical accuracy testing, often on a test bench or with simulated pressures, and potentially with a limited number of human subjects for specific validation aspects depending on the exact test protocol followed.
• The data provenance is not explicitly stated as it would be for a clinical study. The device is manufactured by Zhejiang LuDe Technology Development Co., Ltd. in China. The testing would have been conducted by the manufacturer or a designated testing facility to meet regulatory requirements.
• The testing was described as "Non-clinical testing," implying it was not a large-scale prospective clinical trial with a defined patient population.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• This is not applicable as the device is a manual blood pressure monitor. "Ground truth" for blood pressure measurement (the actual pressure) is established through standardized calibration and reference measurement methods, not through expert consensus on images or interpretations.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not applicable. Adjudication methods are typically used in studies where human readers interpret data (e.g., medical images) and their interpretations need to be reconciled to form a ground truth. For a physical measurement device like a sphygmomanometer, accuracy is determined by comparison to a calibrated reference standard.

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:

• No, an MRMC study was not done. This type of study is specifically designed for AI-assisted diagnostic tools and involves human readers interpreting cases with and without AI assistance. This document is for a traditional, manual blood pressure monitor without AI capabilities.

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

• Not applicable. This device does not have a standalone algorithm in the sense of an AI interpreting medical data. Its "performance" refers to its physical accuracy in measuring blood pressure.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• The ground truth for the "Accuracy" criterion would be calibrated reference pressures, produced by a precisely controlled pressure source. This is standard for testing blood pressure measuring devices against the ISO 81060-1 standard.

8. The sample size for the training set:

• Not applicable. This device is a hardware product, not an AI/ML model that requires a training set.

9. How the ground truth for the training set was established:

• Not applicable. As above, no training set for an AI/ML model is involved.

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The device is intended to be used by medical professionals or in the home for the measurement of systolic and diastolic pressure on new borns, infants, children, young adults. The device is intended to be manually attached to a patient and manually inflated along with a manual method for detecting Korotkoff sounds.

The device is intended to be manually attached to a patient and manually inflated along with a manual method for detecting Korotkoff sounds. The proposed device is non-invasive, non-automated, non-sterile, reusable device. The proposed device is consisting of manometer, cuff, cuff bladder, inflation bulb and with/without stethoscope. There are eight models including CM-BPM, CM-BPM-S, CM-BPM-D, CM-BPM-R, CM-PBPM-1, CM-PBPM-2, CM-PBPM-3 and CM-PBPM-C. The differences of eight models are on the size and material of manometer, material of cuff bladder, material of inflation bulb and stethoscope type if the device has stethoscope.

This document is a 510(k) Premarket Notification for an Aneroid Sphygmomanometer. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving a device meets specific performance acceptance criteria for an AI/CADe device.

Therefore, the information required to answer the prompt (acceptance criteria and study details for an AI/CADe device) is not present in the provided document. The document details a traditional medical device (a manual blood pressure cuff) and its compliance with standards like ISO 81060-1 for non-automated sphygmomanometers, and biocompatibility standards. It explicitly states: "No clinical study is included in this submission."

The prompt asks for details typical of an AI/CADe device submission, such as:

1. Acceptance criteria table and reported performance: This document lists "Accuracy: +/- 3 mmHg of reading" as a specification, derived from ISO 81060-1, but this is a design specification, not an AI model's performance on a test set. There is no reported performance against this.
2. Sample size and data provenance for a test set: No test set is specified for evaluating AI performance.
3. Number of experts and qualifications for ground truth: Not applicable as there is no AI model or ground truth establishment based on expert consensus.
4. Adjudication method: Not applicable.
5. MRMC comparative effectiveness study: Not applicable.
6. Standalone (algorithm only) performance: Not applicable.
7. Type of ground truth: Not applicable.
8. Training set sample size: Not applicable.
9. Ground truth for training set: Not applicable.

In summary, this document is for a non-AI/non-CADe medical device. It does not contain the type of study information requested for an AI/CADe device.

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The device is intended to be used by medical professionals or in the measurement of systolic and diastolic pressure. The device is intended to be manually attached to a patient and manually inflated along with a manual method for detecting Korotkoff sounds.

Aneroid sphygmomanometer Model NT-20, NT-201/ Aneroid sphygmomanometer stethoscope, Model NT-50 are a manual non-invasive aneroid with sphygmomanometer which respectively uses an inflation cuff wrapped around the upper arm. The cuff is inflated and deflated by a manual inflation bulb. Besides a manometer (Aneroid gauge), the accessories include cuff, inflation bulb, instruction manual and carrying case. Model NT-50 also includes a stethoscope. It is conjunction with stethoscope when use.

The provided text describes a 510(k) premarket notification for an aneroid sphygmomanometer. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving performance against specific acceptance criteria for a new AI/software-as-a-medical-device (SaMD) feature.

Therefore, the document does not contain the detailed information typically found in a study demonstrating how a device meets acceptance criteria, especially for AI or SaMD. Specifically:

1. A table of acceptance criteria and the reported device performance: Not provided. The submission states that performance was "compatible as requirement of ISO 81060-1" and that "All performance specification was verified to comply with the ISO 81060-1 standard" and "Pressure : ±3mmHg of reading," but a detailed table of acceptance criteria and results is absent.

2. Sample size used for the test set and the data provenance: Not provided. The document states "No clinical study is included in this submission," further indicating that a test set against ground truth as would be used for AI/SaMD performance evaluation was not conducted.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no clinical study or test set with expert-established ground truth was conducted.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable, as no clinical study or test set was conducted.

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 manual aneroid sphygmomanometer, not an AI or imaging device that would involve human readers.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a manual device; there is no algorithm in the sense of AI/SaMD.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not explicitly defined in the context of a "test set" for performance evaluation, as the submission focuses on meeting ISO standards. The accuracy is stated as "Pressure : ±3mmHg of reading", implying comparison against a reference standard.

8. The sample size for the training set: Not applicable, as this is not an AI/SaMD device requiring a training set.

9. How the ground truth for the training set was established: Not applicable, as this is not an AI/SaMD device.

Summary of available information related to acceptance criteria and performance:

The acceptance criteria are generally implied to be compliance with relevant standards, primarily ISO 81060-1 for performance and ISO 10993 series for biocompatibility.

Table of Acceptance Criteria and Reported Device Performance (based on implicit statements in the document):

Study Description:

The document states, "No clinical study is included in this submission." Instead, the submission relies on non-clinical testing which included biocompatibility and bench testing. The tests listed in the ISO 10993 series (for biocompatibility) and ISO 81060-1 (for performance) were included. The results of these tests were deemed acceptable, demonstrating that the device meets the performance specifications outlined in the standards. The primary method for proving the device meets the acceptance criteria (which are essentially the requirements of these ISO standards) is through this non-clinical testing and comparison to a predicate device.

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The device is intended to be used by medical professionals or in the measurement of systolic and diastolic pressure. The device is intended to be manually attached to a patient and manually inflated along with a manual method for detecting Korotkoff sounds.

Aneroid sphygmomanometer Model HS-20A,HS-20D,HS-201W, HS-201Y,HS-201C1, HS-201Q3/ Aneroid sphygmomanometer with stethoscope, Model HS-50C,HS-50B, HS-50D are a manual non-invasive aneroid sphygmomanometer which respectively uses an inflation cuff wrapped around the upper arm. The cuff is inflated and deflated by a manual inflation bulb. Besides a manometer (Aneroid gauge), the accessories include cuff, inflation bulb, instruction manual and carrying case. Model HS-50C,HS-50D,HS-50B also include a stethoscope. It is conjunction with stethoscope when use.

The provided document is a 510(k) premarket notification for an Aneroid Sphygmomanometer. This type of regulatory submission primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed study results of the device meeting specific acceptance criteria in the same way, for example, a novel AI algorithm might. Therefore, some of the requested information, particularly around clinical studies, ground truth establishment, and expert consensus, is not directly applicable or available in this document.

However, I can extract information related to the device's technical specifications and the standards it aims to meet for substantial equivalence.

Here's an analysis based on the provided text, addressing the points where information is available:

1. Table of Acceptance Criteria and Reported Device Performance

For this medical device, the "acceptance criteria" are primarily defined by the performance requirements of the ISO 81060-1 standard for non-invasive sphygmomanometers, and the "reported device performance" indicates compliance with these standards.

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

The document does not explicitly state a "sample size" for a test set in the context of a clinical study or a dataset for an algorithm. This submission references "Non-clinical testing included biocompatibility and bench testing." It does not provide details on the number of units tested or the specific methodology for these bench tests, beyond stating that they were included in the ISO 10993 and ISO 81060-1 standards.

The data provenance is from non-clinical testing conducted to demonstrate compliance with standards like ISO 10993 and ISO 81060-1. The document does not specify country of origin for this testing data, but the manufacturer is HONSUN (NANTONG) Co., Ltd in China. The testing would be considered bench testing rather than retrospective or prospective clinical data.

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

Not applicable. For this type of device (a mechanical aneroid sphygmomanometer), ground truth for performance claims is established through a calibrated reference standard (e.g., a manometer calibrated to a known pressure standard) during bench testing, as specified by standards like ISO 81060-1. There would be no "experts" establishing a ground truth in the context of subjective interpretation like with medical imaging.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (like 2+1, 3+1) are typically used for establishing ground truth in studies involving human interpretation of data, often in clinical trials or studies for AI algorithms. For a mechanical device's performance testing (like pressure accuracy), the measurement is objective against a standard, not subject to adjudication.

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

No. This device is an aneroid sphygmomanometer, which is a manual non-invasive blood pressure measurement device. It does not incorporate artificial intelligence, nor does it involve "readers" in the context of image interpretation or diagnostic decision-making. Therefore, an MRMC study or an assessment of human reader improvement with AI assistance is not relevant or applicable.

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

No. This device is a mechanical instrument and does not contain an algorithm. "Standalone performance" in this context would refer to the device's accuracy and performance specifications as outlined in the table above, which are assessed through bench testing against established standards.

7. The Type of Ground Truth Used

For this device, the "ground truth" for pressure accuracy is a calibrated pressure standard as mandated by the ISO 81060-1 standard for non-invasive sphygmomanometers. This standard defines the methods for verifying the accuracy of the device against a known, precise pressure.

8. The Sample Size for the Training Set

Not applicable. This device is a mechanical medical instrument. It does not utilize an algorithm, machine learning, or artificial intelligence; therefore, there is no "training set" of data.

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

Not applicable, as there is no training set for this mechanical device.

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The Aneroid Sphygmomanometer with Stethoscope is a non-automated, mechanical blood pressure monitor that is used for the indirect measurement (non-invasive) and display of arterial blood pressure. It can be used by professionals as well as trained individual users over age 18 at hospitals or at home. The device is for use in OTC.

The Aneroid Sphygmomanometer with Stethoscope is a non-invasive blood pressure monitor that uses an occluding cuff, an aneroid Sphygmomanometer to measure pressure and a stethoscope for detecting Korotkoff sounds. The Aneroid Sphygmomanometer with Stethoscope contains: 1. Adjustable D-ring Cuff (Adult Size) 2. Stethoscope (Attaches to the cuff) 3. Non-stop rotary pin, 300 mmHg gauge 4. Instruction booklet and record 5. Carrying case.

The provided text describes a 510(k) summary for an Aneroid Sphygmomanometer with Stethoscope, Model LD-100. This document primarily focuses on demonstrating substantial equivalence to a predicate device and adherence to recognized standards for non-automated sphygmomanometers.

Based on the provided text, the following information can be extracted:

1. A table of acceptance criteria and the reported device performance:

   Acceptance Criteria	Reported Device Performance
   Conformance to AAMI/ANSI SP10:2002/A2:2006 Standard for Non-automated Sphygmomanometers	AAMI/ANSI SP10:2002/A2:2006 "Standard for Manual, Automated, and Semi-automated Sphygmomanometers" was used. The conclusion states "conformance to AAMI/ANSI SP10:2002/A2:2006".
   Non-clinical mechanical testing	Non-clinical mechanical testing was performed.

2. Sample size used for the test set and the data provenance:

   • The document does not specify sample sizes for any test sets.
   • The document does not specify data provenance (e.g., country of origin, retrospective or prospective) for clinical data. The studies mentioned are referred to simply as "studies" and "non-clinical mechanical testing." It's possible the AAMI/ANSI standard itself outlines testing methodologies that were followed, but the specific details of participants/data provenance are not in this summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • This information is not provided in the document. The studies mentioned are non-clinical and based on a standard for manual/automated sphygmomanometers, which typically involves technical performance metrics rather than expert interpretation of results.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • This information is not provided in the document. Given the nature of a non-automated sphygmomanometer and the focus on technical standards, an adjudication method for a test set is unlikely to be relevant in the same way it would be for an AI diagnostic device.

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:

   • No, an MRMC comparative effectiveness study was not conducted. This device is a mechanical blood pressure monitor, not an AI diagnostic device that assists human readers.

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

   • This device is a "non-automated, mechanical blood pressure monitor." It is not an algorithm. Therefore, a standalone algorithm performance study is not applicable and was not done. The device's performance is inherently "standalone" in the sense that its measurements are direct, although it requires a human operator for proper use and interpretation of Korotkoff sounds via the stethoscope.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • The document implies the ground truth for performance is established by the AAMI/ANSI SP10:2002/A2:2006 standard. This standard outlines performance requirements and test methods for accuracy and other characteristics of sphygmomanometers. The ground truth would therefore be derived from reference devices or established measurement protocols defined in the standard.

8. The sample size for the training set:

   • The device is a mechanical blood pressure monitor, not an AI/machine learning algorithm. Therefore, there is no training set in the context of machine learning.

9. How the ground truth for the training set was established:

   • As there is no training set (the device is mechanical), this question is not applicable.

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