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

The product is 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 of MODEL Ks-1222,Ks-1621,Ks-3201,Ks-2203 also includes one selected cuff, one inflation bulb, instruction manual and a vinyl bag. It is conjunction with Stethoscope when use.

The provided document is a 510(k) summary for an Aneroid Sphygmomanometer. It details the device's characteristics and its comparison to a predicate device to establish substantial equivalence. However, this document does not describe a study involving an AI-powered device or a multi-reader multi-case (MRMC) comparative effectiveness study.

The device in question, an "Aneroid Sphygmomanometer," is a manual, non-automated blood pressure meter. The performance testing cited is against ISO 81060-1:2007 "Non-invasive sphygmomanometersPart 1: Requirements and test methods for non-automated measurement type." This standard governs the accuracy of manual blood pressure devices, not AI performance.

Therefore, many of the requested details, such as acceptance criteria for AI performance, sample sizes for test/training sets for AI, ground truth establishment for AI, expert involvement for AI, MRMC studies, and standalone AI performance, are not applicable to this submission.

The document focuses on demonstrating that the new manual device performs similarly to a legally marketed predicate manual device and meets relevant performance and biocompatibility standards for non-automated devices.

However, I can extract the general "acceptance criteria" for the accuracy of the blood pressure measurement as stated in the comparison table and the performance test standard:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for performance testing: The document states "full performance testing representing the current devices currently marketed" and mentions compliance with ISO 81060-1. While the specific number of subjects/measurements is not detailed in this summary, ISO 81060-1 typically requires clinical validation with a certain number of subjects (e.g., at least 85 subjects for blood pressure accuracy evaluation). The document does not specify data provenance (country, retrospective/prospective).
• Data Provenance: Not explicitly stated.

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

• Not applicable for AI-driven performance. For a manual blood pressure device assessed against ISO 81060-1, the "ground truth" for blood pressure typically comes from a reference measurement method (e.g., intra-arterial measurement or a highly accurate clinical standard measurement performed by trained personnel). The document does not specify the number or qualifications of these individuals involved in the ground truth establishment for clinical validation, as it's a standard process dictated by the ISO standard.

4. Adjudication method for the test set:

• Not applicable for AI-driven performance. For a manual blood pressure device, adjudication would not be in the typical sense of expert review of AI outputs.

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 is a manual, non-AI device.

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. The performance testing is for the physical device itself.

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

• For blood pressure measurement accuracy (referenced by ISO 81060-1), the ground truth is typically established by simultaneous measurements using a highly accurate reference method (e.g., intra-arterial pressure or a validated mercury sphygmomanometer measurement by trained observers). This is a technical ground truth related to physical measurement.

8. The sample size for the training set:

• Not applicable. This is a non-AI device; there is no "training set."

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

• Not applicable. This is a non-AI device.

In summary, the provided FDA 510(k) summary is for a traditional, non-automated medical device (Aneroid Sphygmomanometer). Therefore, it does not contain information related to AI-specific study designs, acceptance criteria, or performance metrics. The "study" proving the device meets acceptance criteria refers to non-clinical performance testing against established international standards for manual blood pressure devices and biocompatibility.

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The Aneroid Sphygmomanometer is intended to be used in a healthcare facility by medical professionals or in the home to measure systolic and diastolic pressure on children and 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 Single Patient Use Aneroid Sphygmomanometer is intended to be used in a healthcare facility by medical professionals or in the home to measure systolic and diastolic pressure on children and 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 is a non-invasive blood pressure measurement system for monitoring blood pressure levels. This Non-automated Sphygmomanometer uses an occluding cuff and an aneroid sphygmomanometer to measure pressure. The proposed device is OTC, non-invasive, non-automated, and non-sterile. The proposed device consists of an aneroid qauge, cuff, bladder, and inflation bulb. There are four models, including AS-ND-001, AS-ND-001LG, AS-ND-001CH, and AS-D-001. The differences between models are in the size, color, and material of the cuff.

The Single Patient Use Aneroid Sphygmomanometer 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 OTC, non-invasive, non-automated, and non-sterile. The proposed device consists of a manometer, cuff, and inflation bulb. There are four models: AS-SPU-W, AS-SPU-Y, AS-SPU-LG, and AS-SPU-CH. The differences between models are in the size and color of the cuff.

Both types of aneroid sphygmomanometers use the same measurement method of the Korotkoff sounds method; they are all reusable same measurement range and accuracy. The single-patient use type is for single-patient multiple uses only to avoid cross infection. Both types of aneroid sphygmomanometer can be sold with/without optioned stethoscopes which have been listed with the FDA. The proposed device is Over-The-Counter use, non-sterile, reusable device.

This device is an Aneroid Sphygmomanometer. The provided text describes the performance testing conducted to demonstrate its substantial equivalence to predicate devices, focusing on non-clinical testing.

Here's an analysis of the acceptance criteria and study based on the provided text:

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

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The text does not explicitly state the sample size used for the performance testing.
The data provenance (country of origin, retrospective/prospective) is also not explicitly stated. The manufacturer is Cardicare Company, Ltd. in China, so it's reasonable to infer the testing likely occurred there unless otherwise specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This information is not provided in the document. For aneroid sphygmomanometers, the "ground truth" for accuracy is typically a reference standard manometer, not expert human assessment in the same way it would be for image interpretation. The performance testing references ISO 81060-1, which outlines specific test methods for non-automated sphygmomanometers.

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

This information is not provided in the document and is generally not applicable to the performance testing of an aneroid sphygmomanometer against a technical standard like ISO 81060-1.

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

An MRMC study was not done. This type of study is relevant for AI-powered diagnostic devices involving human interpretation, which is not the case for an aneroid sphygmomanometer.

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

This device is a manual, non-automated aneroid sphygmomanometer. It does not involve an algorithm or AI. Its performance is inherent to its mechanical design and is evaluated in a "standalone" mechanical sense by conforming to relevant standards (ISO 81060-1).

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

The ground truth for the performance testing (accuracy) would be a calibrated reference standard for pressure measurement, as guided by the ISO 81060-1 standard.

8. The sample size for the training set

This information is not applicable. Aneroid sphygmomanometers are mechanical devices and do not involve "training sets" in the context of machine learning.

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

This information is not applicable, as there is no training set for this type of device.

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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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Aneroid Sphygmomanometer is intended to be used by medical professionals or in the home for the measurement of systolic and diastolic pressure on children or 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 proposed device is composed of manometer, cuff bladder, inflation bulb and optioned stethoscopes. It is available in four models, MC-20A, MC-30 and MC-50, which are different in cuff material, cuff bladder material and stethoscope option. The aneroid sphygmomanometer should be used in conjunction with a stethoscope. For model MC-50, there are three types of stethoscope for option: Single Head, Dual Head and Sprague Rappaport stethoscope, while the other models of the proposed device do not have stethoscope in configuration. There are also six sizes of cuff for each model device in order to fit varies arm circumference of user. The proposed device is Over-The-Counter use, non-sterile, reusable device.

This document is a 510(k) Summary for an Aneroid Sphygmomanometer (blood pressure cuff). It primarily demonstrates substantial equivalence to a predicate device rather than presenting a standalone study with acceptance criteria and performance data in the typical sense for an AI/CADe device.

However, I can extract and structure the information related to performance criteria that would be relevant for a medical device like this, based on the non-clinical tests conducted.

Here's the breakdown of the acceptance criteria and the "study" that proves the device meets them:

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

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

The document explicitly states: "No clinical study is included in this submission."

Therefore, there is no information provided regarding a sample size for a test set based on human subjects or its provenance. The testing appears to be primarily laboratory-based to ensure compliance with specific ISO standards.

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

Given that no clinical study was conducted, there were no human subjects or experts required to establish a clinical ground truth for the device's performance in measuring blood pressure on patients. The ground truth for the technical specifications (e.g., pressure accuracy) would be established by the calibration standards and measurement techniques outlined in the ISO standards.

4. Adjudication method for the test set

Not applicable, as no clinical study involving human judgment on a test set (like image interpretation) was performed.

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 and does not involve AI or human "readers" in the context of comparative effectiveness studies against AI.

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

Not applicable. This device is a mechanical medical instrument, not an algorithm. Its standalone performance is assessed against technical standards like ISO 81060-1.

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

The "ground truth" for this device's performance relies on:

• Standardized Calibration: For pressure accuracy (+/- 3 mmHg), the device's readings are compared against a precisely calibrated reference pressure source as per ISO 81060-1.
• Laboratory Testing: For biocompatibility, in-vitro (cytotoxicity) and in-vivo (irritation and sensitization) tests are conducted according to ISO 10993 series to assess the material's interaction with biological systems.
• Technical Specifications: The operating environment, monitor scale range, and physical design aspects are verified against design specifications and relevant parts of ISO 81060-1.

8. The sample size for the training set

Not applicable. This is a mechanical device, not an AI/machine learning model, so there is no "training set."

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

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

Aneroid Sphgmomanometer, Models BK2002, BK2002-3001, BK2002a, BK2002a-3001, BK2015, BK2015-3001, 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 of MODEL BK2002-3001, BK2015, BK2015-3001 also includes one selected cuff, one inflation bulb, instruction manual and a vinyl bag. Model BK2002-3001 and BK2015-3001 include additional stethoscope. It is conjunction with Stethoscope when use.

This document is a 510(k) premarket notification for an Aneroid Sphygmomanometer. It declares the device's substantial equivalence to a predicate device. For devices like this, the acceptance criteria and proof of meeting them are primarily based on established regulatory standards and bench testing, rather than studies involving AI algorithms or human reader performance.

Here's a breakdown of the requested information based on the provided text, focusing on how this type of medical device demonstrates compliance:

1. Table of Acceptance Criteria and Reported Device Performance

For an aneroid sphygmomanometer, the primary performance criterion is accuracy.

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

The document explicitly states: "No clinical study is included in this submission." This indicates that the performance validation was primarily through bench testing and adherence to recognized standards. Therefore, an explicit "test set" in the sense of patient data is not applicable here. The provenance of any internal testing data would be from the manufacturer's own facilities in Wenzhou, Zhejiang, China, and would be prospective testing against the defined standards.

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

Not applicable as this is not a study involving interpretation of complex data (like medical images) requiring expert consensus for ground truth. Ground truth for a sphygmomanometer's accuracy is established by highly accurate reference pressure devices.

4. Adjudication Method for the Test Set

Not applicable for this type of device and testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. This type of study (MRMC) is relevant for AI-powered diagnostic tools where human interpretation is assisted by AI. This device is a manual measurement tool.

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

Not applicable. This device does not contain an AI algorithm. Its performance is inherent to its mechanical and material properties. The accuracy testing ("standalone" in a very literal sense for a mechanical device) would have been performed on the device itself against calibrated reference equipment.

7. The Type of Ground Truth Used

For device accuracy: Comparison against a highly accurate and calibrated reference pressure measurement system.
For biocompatibility: Adherence to ISO standards and material testing.

8. The Sample Size for the Training Set

Not applicable. This device does not involve machine learning or AI, and thus has no "training set."

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

Not applicable for the same reason as above.

Summary of Acceptance Criteria and Study for This Device (Aneroid Sphygmomanometer):

The acceptance criteria for this device are primarily based on established international and national standards for blood pressure measuring devices and medical device safety.

• Acceptance Criteria:

  • Accuracy: Maintain a pressure accuracy of +/- 3 mmHg of reading. This is a critical performance characteristic.
  • Environmental Compatibility: Function correctly within specified temperature and humidity ranges.
  • Biocompatibility: Materials in contact with the patient's skin must meet ISO 10993 series standards for biological evaluation of medical devices.
  • Mechanical and Functional Integrity: The device must inflate, deflate, and hold pressure reliably.
  • Design and Materials: Any changes in design or materials (e.g., PVC bulb, Nylon cuff) must be shown not to negatively impact safety or effectiveness.

• Study Proving Device Meets Acceptance Criteria:

  • Type of Study: The document explicitly states "No clinical study is included in this submission." The "study" here refers to Non-Clinical Testing, specifically bench testing and compliance with recognized standards.
  • Methods:
    • Performance Testing (Bench Testing): The device (and its modified components) underwent testing to verify its pressure accuracy against calibrated standards (consistent with ISO 81060-1). This includes tests for pressure measurement accuracy, repeatability, and potentially rapid deflation and overpressure protection.
    • Biocompatibility Testing: Materials used for the device that contact the patient's skin were tested and demonstrated compliance with ISO 10993 standards (ISO 10993-1, ISO 10993-5, ISO 10993-10).
    • Comparison to Predicate Device: The submission relies heavily on demonstrating substantial equivalence to a previously cleared predicate device (K043286). Performance specifications, materials, and intended use were compared. Any differences (e.g., optional PVC bulb, various cuff sizes/materials, wider target population including children) were evaluated to ensure they did not introduce new safety or effectiveness concerns, and were supported by the non-clinical testing results.
  • Ground Truth: For accuracy, the ground truth is derived from highly accurate and calibrated reference pressure measurement equipment. For material safety, the ground truth is defined by the toxicological and biocompatibility profiles established in the ISO 10993 standards.
  • Sample Size: Not explicitly stated for bench testing, but typically involves a statistically relevant sample of manufactured devices tested against the defined criteria.
  • Data Provenance: Testing was conducted by the manufacturer (Wenzhou Bokang Instruments Co., Ltd.) in China, likely at their in-house or contracted testing facilities, and would be considered prospective testing.

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The Aneroid Sphygmomanometer 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 to monitor both systolic and diastolic pressure.

The Aneroid Sphygmomanometer with stethoscope is a non-invasive blood pressure measurement system for monitoring blood pressure levels. This non-automated sphygmomanometer uses an occluding cuff, an sphygmomanometer to measure pressure and a stethoscope for detecting Korotkoff sounds.

The Aneroid Syphygmomanometer contains:
a. Blood Pressure Cuff
b. Stethoscope, which is use to detect the Korotkoff sounds;
c. Rotary Pin, 300 mmHg gauge, which is use to indicate the measurement result;
d. Air pump bulb, which is use to inflate the blood pressure cuff;
e. User Manual, which is use to instruct the user;

The Aneroid Sphygmomanometer with Stethoscope enables the user to monitor the pressure of flowing blood that is exerted against the arteries at highest (systolic or contraction) and lowest (diastolic or relaxation) pressure.

The proposed device has three models, ZF-113/ZF-114/ZF-115, in this submission, the three models has same intended use, same design and measuring principle, same accessories and same measuring range. The only difference between the models is appearance of gauge.

The provided text describes 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 that the device meets specific acceptance criteria through a clinical or algorithmic performance study in the way one would for an AI/ML medical device.

Therefore, many of the requested points regarding acceptance criteria, study design, ground truth establishment, and expert involvement are not applicable to this type of submission, which relies primarily on bench testing and comparison to an existing predicate device's specifications and performance.

However, I can extract the relevant information regarding acceptance criteria as defined by the device's specifications and compliance with standards.

Here's a breakdown based on the provided document:

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

The document states compliance with EN ISO 81060-1:2012 Non-Invasive Sphygmomanometers – Part 1: Requirements and Test Methods for Non-Automated Measurement Type and includes specific accuracy figures.

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

• The document states: "No clinical study is included in this submission."
• The "tests" referred to are "Non-Clinical Tests" which include bench testing for performance and biological evaluation (cytotoxicity, irritation, sensitization).
• The sample size for these non-clinical tests is not specified in the provided text.
• Data provenance (country of origin, retrospective/prospective) is not applicable or specified as there's no clinical data.

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

• Not applicable. There was no clinical study involving experts establishing ground truth for performance comparison. Performance was assessed via bench testing against established standards (e.g., ISO for accuracy and biocompatibility).

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

• Not applicable. No clinical data requiring expert adjudication was submitted.

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 an Aneroid Sphygmomanometer, a mechanical blood pressure monitor, not an AI/ML-driven diagnostic or assistive device for human readers.

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

• Not applicable. This is a mechanical device, not an algorithm. Its performance is inherent to its physical design and manufacturing.

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

• For accuracy: The ground truth is the reference standard measurement obtained during bench testing, often against a calibrated master device or a known pressure standard, as outlined in EN ISO 81060-1.
• For biocompatibility: The ground truth is determined by the results of in vitro and in vivo tests conducted according to ISO 10993-5 (cytotoxicity) and ISO 10993-10 (irritation and sensitization), which define acceptance criteria for these biological responses.

8. The sample size for the training set:

• Not applicable. This is a mechanical device, not an AI/ML device 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 was involved.

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