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The Unimed disposable blood pressure cuff (Models U1682S-C51N to U1685S-C51N) is an accessory used in conjunction with noninvasive blood pressure measurement systems. It is non-sterile and for single-patient use. The cuff is available in neonatal sizes (4–15 cm limb circumference). The cuff is not designed, sold, or intended for use except as indicated.

The Unimed Disposable Neonatal NIBP Cuffs (Models U1682S-C51N, U1683S-C51N, U1684S-C51N, U1685S-C51N) are single-patient-use accessories for non-invasive blood pressure (NIBP) measurement. Each cuff is designed for neonatal limb circumferences ranging from 4 cm to 15 cm (Neonate 2 through Neonate 5) as follows.

• U1682S-C51N: 4 cm - 8 cm.
• U1683S-C51N: 6 cm - 11 cm.
• U1684S-C51N: 7 cm - 13 cm.
• U1685S-C51N: 8 cm - 15 cm.
  The cuffs are intended to be used with compatible blood pressure monitors employing oscillometry. They are non-sterile, and are disposed of after single-patient use to reduce cross-contamination risks.

This 510(k) clearance letter is for a Disposable Neonatal NIBP Cuff. It does not describe an AI/ML powered medical device, nor does it detail a study involving AI/ML.

Therefore, many of the requested criteria related to AI/ML device validation (e.g., sample size for test/training sets, data provenance, number of experts for ground truth, MRMC study, standalone performance, etc.) are not applicable to this document.

The document primarily focuses on establishing substantial equivalence to a predicate device through non-clinical testing and material biocompatibility.

Here's the information that can be extracted from the provided text, primarily related to the non-clinical testing performed to meet acceptance criteria for a physical medical device:

Acceptance Criteria and Device Performance for Disposable Neonatal NIBP Cuff

The acceptance criteria for this device are primarily based on established international standards for non-invasive blood pressure cuffs and biocompatibility. The performance is demonstrated through non-clinical testing, confirming adherence to these standards.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified in the provided document. The non-clinical testing likely involved a representative sample of each cuff model (U1682S-C51N, U1683S-C51N, U1684S-C51N, U1685S-C51N).
• Data Provenance: The document states "Non-clinical tests were conducted..." but does not specify the country of origin where the testing was performed. Given the manufacturer's location (Shenzhen, China), it's plausible the testing was conducted there or at a certified lab supporting the manufacturer. The testing is described as non-clinical, implying it was laboratory-based product verification and validation, not retrospective or prospective human clinical data collection.

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

This is not applicable. This document describes the clearance of a physical medical device (NIBP cuff) via substantial equivalence, not an AI/ML algorithm. Therefore, there is no mention of "ground truth" derived from expert consensus on medical images or data. The "ground truth" for this device would be the defined specifications and performance requirements established by the relevant ISO standards.

4. Adjudication Method for the Test Set

This is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical trial settings, especially for AI/ML performance evaluation where multiple human readers might disagree on findings. For non-clinical device testing like this, adherence to predefined test protocols and specifications is the primary method of evaluation.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI assistance on human reader performance, which is not applicable to a non-AI medical device like a blood pressure cuff.

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

No, a standalone performance evaluation of an algorithm was not done. This is not an AI/ML device.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established by compliance with recognized consensus standards (ISO 81060-1, ISO 80601-2-30, and ISO 10993 series for biocompatibility). The device's performance metrics are evaluated against the specific requirements and test methods outlined in these standards.

8. The Sample Size for the Training Set

This is not applicable. There is no training set mentioned as this is not an AI/ML device.

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

This is not applicable. There is no training set mentioned as this is not an AI/ML device.

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The reusable blood pressure cuff is an accessory used in conjunction with noninvasive blood pressure measurement systems. The cuff is non-sterile and may be reused. It is available in neonate, infant, child and adult sizes. The cuff is not designed, sold, or intended for use except as indicated.

The disposable blood pressure cuff is an accessory used in conjunction with noninvasive blood pressure measurement systems. The cuff is non-sterile and for single-patient use. It is available in neonate size. The cuff is not designed, sold, or intended for use except as indicated.

The device comprises tubing attached to an inelastic sleeve with an integrated inflatable bladder that is wrapped around the patient's limb and secured by hook and loop closure. The device tubing is connected to a non-invasive blood pressure measurement system. It is available in neonatal, infant, child and adult sizes. The subject device includes disposable blood pressure cuff and reusable blood pressure cuff and contains Cuff with/without bladder and single/dual tubes Air Hose.

The provided document is a 510(k) summary for a blood pressure cuff and does not contain detailed information about acceptance criteria, reported device performance for specific metrics, or any study proving such performance. The document explicitly states:

"No clinical study is included in this submission"

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets them because such information is not present in the provided text. The document focuses on demonstrating substantial equivalence to a predicate device primarily through non-clinical data and compliance with voluntary standards for design specifications.

However, I can extract the information that is present:

8. Non-clinical data

• Performance testing: Non-clinical tests were conducted to verify that the proposed devices met all design specifications.
• Compliance with standards: The test results demonstrated that the proposed device complies with ISO 81060-1, Non-Invasive Sphygmomanometers - Part 1: Requirements and Test Methods for Non-Automated Measurement Type, First Edition 2007.

Based on this, here's what can be stated about the available information:

1. A table of acceptance criteria and the reported device performance: Not provided. The document mentions compliance with ISO 81060-1, which would contain performance requirements for non-automated sphygmomanometers (blood pressure cuffs). However, the specific acceptance criteria used for the device and the reported device performance against those criteria are not detailed.
2. Sample sized used for the test set and the data provenance: Not provided. The document only mentions "non-clinical tests" and "performance testing" but does not give details about sample sizes or data provenance.
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 expert-based ground truth establishment is mentioned. The testing focused on technical specifications and standards compliance.
4. Adjudication method for the test set: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done: No. The document explicitly states "No clinical study is included in this submission."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a blood pressure cuff, which is a physical accessory, not an algorithm.
7. The type of ground truth used: Not applicable for performance evaluation as no clinical data or comparative performance study is provided. For demonstrating substantial equivalence, the ground truth indirectly relies on the established performance and safety of the predicate device and the standards.
8. The sample size for the training set: Not applicable. This is a non-AI/ML device.
9. How the ground truth for the training set was established: Not applicable. This is a non-AI/ML 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 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 Reusable Blood Pressure Cuff is an accessory used in conjunction with non-invasive blood pressure measurement systems. The cuff is non-sterile and reusable. It is available in adult size.

The proposed device is an accessory used in conjunction with non-invasive blood pressure measurement systems, and wrap around the patient's limb. The cuff is non-sterile and reusable. The model difference of the proposed device includes bladder type, tube, color, joint model and size.

The provided text is a 510(k) summary for a Reusable Blood Pressure Cuff. It focuses on demonstrating substantial equivalence to predicate devices rather than proving a device's performance against specific acceptance criteria for an AI/ML medical device.

Therefore, the document does not contain the information required to describe the acceptance criteria and the study that proves an AI/ML device meets those criteria.

Specifically, the document does not provide:

• A table of acceptance criteria and reported device performance: The document lists standards the device complies with (IEC 80601-2-30, ISO 81060-1, ISO 10993-5, ISO 10993-10), but these are general safety and performance standards for a mechanical device, not AI/ML acceptance criteria like sensitivity, specificity, or AUC. No specific performance metrics are reported against quantitative acceptance criteria.
• Sample size and data provenance for a test set: No mention of a test set, data provenance, or sample size for evaluating AI/ML algorithm performance.
• Number and qualification of experts for ground truth: Not applicable, as this is not an AI/ML device requiring expert-established ground truth.
• Adjudication method: Not applicable.
• MRMC comparative effectiveness study: Not applicable.
• Standalone (algorithm only) performance: Not applicable.
• Type of ground truth used: Not applicable.
• Sample size for the training set: Not applicable.
• How ground truth for the training set was established: Not applicable.

The document states:

• "6. Non-Clinical Test Conclusion" and "6.1 Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards: IEC 80601-2-30: 2018..., ISO 81060-1:2007..., ISO 10993-5: 2009..., ISO 10993-10: 2010..."
• "6.2 Human Factors / Usability Testing Usability testing is not required per the risk profile of this product."
• "7. Clinical Test Conclusion No clinical study is included in this submission."

This unambiguously indicates that the submission is for a physical medical device (a blood pressure cuff), assessed through non-clinical bench testing for compliance with manufacturing and biocompatibility standards, and not an AI/ML driven diagnostic or assistive device that would require the specified performance evaluations.

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The disposable blood pressure cuff is an accessory used in conjunction with noninvasive blood pressure measurement systems. The cuff is non-sterile and for single-patient use. It is available in neonatal, pediatric and adult sizes. The cuff is not designed, sold, or intended for use except as indicated.

The reusable blood pressure cuff is an accessory used in conjunction with noninvasive blood pressure measurement systems. The cuff is non-sterile and may be reused. It is available in neonatal, pediatric and adult sizes. The cuff is not designed, sold, or intended for use except as indicated.

The device comprises tubing attached to an inelastic sleeve with an integrated inflatable bladder that is wrapped around the patient's limb and secured by hook and loop closure. The device tubing is connected to a non-invasive blood pressure measurement system.

The subject device is categorized into two types of models according to its usage.

Reusable Blood Pressure Cuff models:

1201B1,12L2B1,1202B1,12L3B1,1204B1,1205B1,1206B1,1207B1-1#,1207B1-2#,1207B1-

3#,1207B1-4#,1207B15#,1201W2,12L2W2,1202W2,12L3W2,1203W2,

1204W2,1205W2,1206W2 and 1207W2

Disposable Blood Pressure Cuff models:

1201D1,12L2D1,1202D1,12L3D1,1204D1,1205D1,1204D1,1207D1-1#,1207D1-2#,1207D1-

3#,1207D1-4#,1207D1-5#

Connector models: PLINMA-03-127-003, PLINMA-03-T, PLINMA-03-Z3

The provided text is a 510(k) summary for a Blood Pressure Cuff. It focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a clinical study with detailed performance metrics. The information about a study proving device performance is limited.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily refers to meeting ISO standards and does not present a table of specific acceptance criteria (e.g., specific accuracy ranges for blood pressure measurements) versus reported device performance in a clinical setting. It states that the device was "tested according to ISO 81060-1 Non-invasive sphygmomanometers - Part 1: Requirements and test methods for non-automated measurement type". However, it does not provide the results of this testing in a quantifiable form or against specific, pre-defined acceptance criteria.

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

The document states, "The subject and predicate devices are exactly the same. Since the blood pressure cuffs are identical, no further clinical testing is necessary." This implies that no separate test set with human subjects was used for this 510(k) submission to evaluate the performance of the device in terms of blood pressure measurement accuracy. The data provenance is assumed to be from the predicate device's testing, but details are not provided here.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

Since no separate clinical performance testing was conducted for this submission, no experts were used to establish ground truth from newly collected data for this specific device.

4. Adjudication Method for the Test Set:

Not applicable, as no dedicated clinical performance test set was used for this submission.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

Not applicable, as this is a blood pressure cuff and not an AI-powered diagnostic imaging device. The document does not describe any human reader involvement or AI assistance.

6. Standalone Performance Study:

A standalone performance study focused on technical compliance with ISO 81060-1 was mentioned ("The subject device has been tested according to ISO 81060-1 Non-invasive sphygmomanometers - Part 1: Requirements and test methods for non-automated measurement type"). However, the results of this testing, which would quantify its performance against the ISO standard's requirements, are not provided in this summary. The summary only attests that the device "met the requirements."

7. Type of Ground Truth Used:

For the "performance data" mentioned, the ground truth would be the reference measurements and methods defined within the ISO 81060-1 standard for non-invasive sphygmomanometers. For the biocompatibility testing, the ground truth would be the established scientific methods and criteria for evaluating cytotoxicity, sensitization, and irritation.

8. Sample Size for the Training Set:

Not applicable, as this is a medical device (blood pressure cuff) and not an AI/ML algorithm that requires a training set.

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

Not applicable.

Summary of Acceptance Criteria and Study (based on available information):

Study Details:

• Test Set Sample Size: Not applicable for clinical performance testing, as it was deemed unnecessary due to the device being "exactly the same" as predicates. For technical testing to ISO 81060-1, the sample size is implicitly defined by the standard's requirements for testing a physical device.
• Data Provenance: Not specified for the ISO 81060-1 technical testing, but typically conducted in a laboratory setting.
• Experts for Ground Truth: Not applicable for clinical performance as no new human data was collected. Ground truth for technical testing is established by standard operating procedures and reference equipment.
• Adjudication Method: Not applicable for clinical performance.
• MRMC Study: No.
• Standalone Study: Yes, a technical standalone study was performed to ISO 81060-1 and biocompatibility standards, with results indicating compliance, although specific performance metrics are not listed in this summary.
• Type of Ground Truth: ISO standard requirements and established biocompatibility testing protocols.
• Training Set Sample Size: Not applicable (not an AI/ML device).
• Training Set Ground Truth Establishment: Not applicable.

The document primarily relies on demonstrating substantial equivalence to predicate devices and adherence to relevant ISO standards, rather than presenting a detailed clinical performance study specific to this submission.

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The reusable blood pressure cuff is an accessory used in conjunction with noninvasive blood pressure measurement systems. The cuff is non-sterile and may be reused. It is available in neonate, infant, child and adult sizes. The cuff is not designed, sold, or intended for use except as indicated.

The disposable blood pressure cuff is an accessory used in conjunction with noninvasive blood pressure measurement systems. The cuff is non-sterile and for single-patient use. It is available in neonate, infant, child and adult sizes. The cuff is not designed, sold, or intended for use except as indicated.

The proposed device is an accessory used in conjunction with noninvasive blood pressure measurement systems. It is available in neonatal, infant, child and adult sizes.

The proposed device includes disposable blood pressure cuff and reusable blood pressure cuff. Both disposable and reusable blood pressure cuff have the same structure, which contains Cuff with bladder and single-tube Air Hose.

This document is a 510(k) Premarket Notification from the FDA regarding a non-invasive blood pressure (NIBP) cuff. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study report of the device's accuracy or efficacy as one might find for a more complex AI-driven medical device.

Therefore, the requested information, particularly concerning "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of an AI/algorithm-driven device (like an effect size of human readers improving with AI, or standalone algorithm performance), is largely not applicable to this document. This document primarily describes the physical characteristics, intended use, and manufacturing standards of a blood pressure cuff.

However, I can extract the relevant information where available, focusing on performance data related to blood pressure cuffs.

Here's an analysis based on the provided text:

Key Takeaway: This 510(k) submission primarily relies on physical and material testing and comparison to a predicate device to demonstrate substantial equivalence, not a clinical study proving its performance against specific physiological accuracy criteria in humans, nor an AI-driven system's performance.

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

The document doesn't present a table of acceptance criteria and corresponding reported device performance in the same way one would for an AI model's diagnostic accuracy. Instead, it refers to compliance with established standards for blood pressure cuffs.

• Acceptance Criteria (as implied by standards compliance):
  • Max. Leakage:

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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 blood pressure cuff is an accessory used in con-invasive blood pressure measurement systems. It is non-sterile, single-patient use. It is available in pediatric and adult sizes. The cuff is not designed, sold or intended for use except as indicated.

ONE-CUF blood pressure cuffs are accessories used in conjunction with noninvasive blood pressure (NIBP) measurement systems to obtain a blood pressure measurement. Blood pressure cuffs are non-sterile and single-patient use and may not be reprocessed for use on additional patients. They are available in pediatric and adult sizes. The devices are not designed, sold or intended for use except as indicated. Blood pressure cuffs do not include serviceable parts or components. Non-Invasive Blood Pressure Cuffs incorporate an inflatable non-distensible bladder, sized to encircle a patient's limb. The cuff includes one or two flanges for attaching flexible tubing. This allows air to flow in and out of the cuff bladder for inflation and deflation. Inflation allows for occlusion of an artery to facilitate the measurement of automated noninvasive blood pressure (NIBP). The cuff tubes are terminated with connectors that allow for attachment to a blood pressure hose. This cuff will be offered with two different connection systems, bayonet and DINACLICK.

The information provided describes the ONE-CUF blood pressure cuff and its path to substantial equivalence, primarily based on non-clinical testing and comparison to a predicate device. It explicitly states that no clinical or animal studies were required to support substantial equivalence. Therefore, there is no study described that proves the device meets specific acceptance criteria related to a model's performance in a diagnostic or predictive context (e.g., accuracy, sensitivity, specificity for an AI algorithm).

The "acceptance criteria" referred to in this document are primarily related to product performance specifications and compliance with voluntary standards for a mechanical medical device, rather than the performance metrics of an AI model.

Here's an attempt to structure the answer based on the provided text, recognizing the limitations regarding AI-specific criteria and studies:

1. Table of Acceptance Criteria and Reported Device Performance

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

Not applicable. The reported studies are non-clinical, focusing on device performance and safety specifications rather than a diagnostic model's performance on a test set of patient data. There is no mention of a "test set" in the context of an AI algorithm or diagnostic performance.

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

Not applicable. This device is a blood pressure cuff and does not involve AI or diagnostic interpretation requiring expert ground truth for a test set.

4. Adjudication method for the test set

Not applicable. There is no test set for diagnostic performance or AI algorithm output.

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 non-AI blood pressure cuff. No MRMC study was performed.

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

Not applicable. This device is a non-AI blood pressure cuff. No standalone algorithm performance was evaluated.

7. The type of ground truth used

For the non-clinical tests, the "ground truth" is established by adherence to documented test procedures, engineering specifications, and established international standards (e.g., ISO, IEC) for medical device performance and biocompatibility.

8. The sample size for the training set

Not applicable. This device is a non-AI blood pressure cuff. There is no training set for an algorithm.

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

Not applicable. This device is a non-AI blood pressure cuff. There is no training set for an algorithm.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The “study” proving the ONE-CUF meets its acceptance criteria is a compilation of non-clinical performance testing and biocompatibility testing, along with compliance with relevant voluntary standards. The documentation states:

• Non-Clinical Testing: This included evaluations for Environmental Conditioning, Leak, Pressure Capacity, Mechanical Strength, Tensile Testing, and other performance aspects. While specific results are not detailed in the summary, these tests were submitted to support substantial equivalence.
• Biocompatibility Testing: This was performed in accordance with ISO 10993-1:2018 ("Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process") and included Chemical Characterization, Cytotoxicity, Sensitization, and Irritation/Intracutaneous Reactivity.
• Compliance with Voluntary Standards: The device was designed and tested for compliance with IEC 80601-2-30:2018 (for automated noninvasive sphygmomanometers) and ISO 81060-1:2007 (for non-automated sphygmomanometer test methods).
• Human Factors Validation: Summative usability testing was performed.

The conclusion is that based on these non-clinical performance data, biocompatibility results, and compliance with standards, the device is considered substantially equivalent to a legally marketed predicate device (SOFT-CUF K120125). No clinical or animal studies were required or performed to support this determination.

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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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