Search Results

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.

Ask a specific question about this device

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.

Ask a specific question about this device

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 has same structure, which contains Cuff with bladder and Air Hose. Air hose has single tube and double tube.

The disposable blood pressure cuff is single use device, and which is made of non-woven fabrics & PVC (Cuff) and PVC (Air Hose), the non-woven fabrics & PVC (Cuff) is the material used to contacting with the patient.

The disposable blood pressure cuff has 24 models with different population with different arm size, and the 12 models of 24 are use single tube of air hose and other 12 models are use double tube of air hose, which is used for different noninvasive blood pressure measurement system.

The reusable blood pressure cuff is reusable device, and which is made of PU & PVC (Cuff) and PVC (Air Hose), thereinto, the PU & PVC (Cuff) is the material used to contacting with the patient.

The reusable blood pressure cuff has 16 models with different population with different arm size, and the 8 models of 16 are use single tube of air hose and other 8 models are use double tube of air hose, which is used for different noninvasive blood pressure measurement system.

The provided document is a 510(k) summary for the Caremed Reusable Blood Pressure Cuff and Caremed Disposable Blood Pressure Cuff. It focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific acceptance criteria through a clinical study for a new medical AI or advanced diagnostic device. Therefore, much of the requested information (e.g., sample size for test sets and training sets, number of experts, adjudication methods, MRMC studies, ground truth types) is not directly applicable or available in this type of submission for a blood pressure cuff.

However, I can extract information related to the performance data provided within the context of a 510(k) submission for this device.

1. Table of Acceptance Criteria and Reported Device Performance

For a blood pressure cuff, the "acceptance criteria" and "reported device performance" are primarily related to safety, material biocompatibility, and functional performance (e.g., pressure range, leakage, and compliance with recognized standards).

Ask a specific question about this device

Med-link 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 proposed device, Med-link Reusable Blood Pressure Cuffs is rectangle soft inelastic sleeve with bladder, to which a single-tube or twin-tube is connected. It 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 various sizes for different limb range. It is provided non-sterile.

The Med-link Reusable Blood Pressure Cuff underwent non-clinical testing to assess its safety and essential performance. The acceptance criteria and reported device performance are based on compliance with specific ISO and IEC standards.

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not explicitly state the sample sizes used for each specific non-clinical test (ISO 81060-1, IEC 80601-2-30, biocompatibility tests). It indicates that "A series of safety, essential performance and biocompatibility tests were performed."
The provenance of the data is not specified in terms of country of origin or whether the tests were retrospective or prospective. It states the tests were "conducted in accordance with" the listed standards, implying a controlled testing environment.

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

This information is not provided in the document. The non-clinical testing primarily focuses on objective measurements against international standards rather than expert-derived ground truth as might be seen in diagnostic imaging studies.

4. Adjudication Method for the Test Set:

This information is not applicable and is not provided. The testing involves standardized laboratory and performance tests, not a judgmental adjudication process.

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:

This information is not applicable and is not provided. The device is a blood pressure cuff, not an AI-assisted diagnostic tool for which MRMC studies would typically be conducted.

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

This information is not applicable and is not provided. The device is not an algorithm, so standalone algorithm performance is not relevant. The performance of the cuff is evaluated as a physical accessory for blood pressure measurement systems.

7. The Type of Ground Truth Used:

The ground truth for the performance claims relies on:

• International Standards: Compliance with ISO 81060-1, IEC 80601-2-30, ISO 10993-5, and ISO 10993-10. These standards establish the acceptable technical performance and safety criteria for such devices.
• Biocompatibility Testing: Objective laboratory tests (cytotoxicity, skin irritation, skin sensitization) directly measure the device's interaction with biological systems against established thresholds.
• Predicate Device Comparison: The inherent assumption is that if the device performs equivalently to legally marketed predicate devices that have already met regulatory requirements, then it is safe and effective.

8. The Sample Size for the Training Set:

This information is not applicable to this type of medical device. Blood pressure cuffs are mechanical devices, and their performance is established through physical and biological testing, not machine learning models that require training sets.

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

This information is not applicable for the reasons stated in item 8.

Ask a specific question about this device

The Reusable Blood Pressure Cuff is an accessory used in conjunction with noninvasive blood pressure measurement systems. The cuff is non-sterile and reusable in infant, pediatric but not neonatal, and adult sizes.

The proposed device is an accessory used in conjunction with noninvasive 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 given text is a 510(k) Summary for a Reusable Blood Pressure Cuff, which is a submission to the FDA to demonstrate substantial equivalence to previously marketed devices. This document focuses on proving that the new device is as safe and effective as existing products, primarily through non-clinical testing and comparison to predicate devices, rather than an extensive study proving new performance criteria for a novel device or an AI algorithm.

Therefore, many of the requested details, such as "number of experts used to establish ground truth," "adjudication method," "MRMC comparative effectiveness study," "standalone performance," and "sample size for training set," are not applicable to this type of regulatory submission and product. The device is a physical medical accessory, not an AI algorithm.

I will extract the available and relevant information.

Acceptance Criteria and Device Performance for Reusable Blood Pressure Cuff (K171889)

The acceptance criteria for the Reusable Blood Pressure Cuff (K171889) are established by demonstrating compliance with recognized international standards and substantial equivalence to predicate devices. The study conducted was primarily non-clinical testing to verify design specifications and biological compatibility.

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 document does not specify sample sizes for the non-clinical tests (e.g., how many cuffs were tested for biocompatibility or performance). The data provenance is not detailed beyond the manufacturer being Suzhou Minhua Medical Apparatus Supplies Co., LTD in China, implying testing was likely conducted in China. The study refers to "non-clinical tests" and "test results" and "laboratory tests," which are inherently prospective for the specific devices being tested.

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 applicable. The device is a physical medical accessory, and the "ground truth" for its performance is established by compliance with international engineering and biocompatibility standards, not by expert consensus on diagnostic interpretations.

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

This information is not applicable. Adjudication methods are typically used in clinical studies involving interpretation (e.g., imaging reads) where there can be differing opinions among experts. This product's evaluation is based on objective measurements against engineering and biological standards.

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

This information is not applicable. MRMC studies are relevant for diagnostic devices, particularly those involving human interpretation of data/images, often with AI assistance. This device is a blood pressure cuff and does not involve "readers" or "AI assistance" in that context.

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

This information is not applicable. The device is a physical blood pressure cuff, not an algorithm.

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

The "ground truth" for the Reusable Blood Pressure Cuff is compliance with:

• Engineering Standards: IEC 80601-2-30: 2013 (Medical Electrical Equipment - Basic Safety And Essential Performance Of Automated Non-Invasive Sphygmomanometers).
• Biocompatibility Standards: ISO 10993-5: 2009 (Tests For In Vitro Cytotoxicity) and ISO 10993-10: 2010 (Tests For Irritation And Skin Sensitization).
• Substantial Equivalence: Comparison to legally marketed predicate devices (K133117 and K152468) regarding intended use, principles of operation, materials, and performance specifications.

8. The sample size for the training set

This information is not applicable. "Training set" refers to data used to train algorithms, primarily in machine learning or AI. This device is a physical medical accessory.

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

This information is not applicable as there is no "training set" for this physical device.

Ask a specific question about this device

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 infant, pediatric and adult sizes. 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 proposed device is an accessory used in conjunction with noninvasive blood pressure measurement systems. It is available in neonatal, infant, pediatric and adult sizes. The proposed device includes disposable blood pressure cuff and reusable blood pressure, both disposable and reusable blood pressure cuff has same structure, which contains Cuff with bladder and Air Hose. Air hose has single tube and double tube. The disposable blood pressure cuff is single use device, and which is made of non-woven fabrics &PVC (Cuff) and PVC (Air Hose), thereinto, the non-woven fabrics & PVC (Cuff) is the material used to contacting with the patient. The disposable blood pressure cuff has 26 models with different size for different population with different arm size, and the 13 models of 26 are use single tube of air hose and other 13 models are use double tube of air hose, which is used for different noninvasive blood pressure measurement system. The reusable blood pressure cuff is reusable device, and which is made of 210D Nylon TPU (Cuff) and PVC (Air Hose), thereinto, the 210D Nylon TPU (Cuff) is the material used to contacting with the patient. The reusable blood pressure cuff has 16 models with different size for different population with different arm size, and the 8 models of 16 are use single tube of air hose and other 8 models are use double tube of air hose, which is used for different noninvasive blood pressure measurement system.

This is a 510(k) premarket notification for Reusable Blood Pressure Cuffs and Disposable Blood Pressure Cuffs. The submission aims to demonstrate substantial equivalence to previously cleared predicate devices.

Here's an analysis of the provided information concerning acceptance criteria and the study:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by compliance with specific international standards. The performance is reported as meeting these standards.

Ask a specific question about this device

Med-link 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 proposed device, Med-link Disposable Blood Pressure Cuff is rectangle soft inelastic sleeve. There is a single-tube or twin-tube connected to a sealed gas chamber. It is wrapped around the patient's limb/thigh and secured by hook and loop closure. The device tubing is connected to a non-invasive blood pressure measurement system. It is available in various sizes for different limb range. It is provided non-sterile.

This document is a 510(k) premarket notification for the Med-link Disposable Blood Pressure Cuff. It aims to demonstrate substantial equivalence to legally marketed predicate devices.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily based on the FDA recognized consensus standard ISO 81060-1:2007/ AAMI/ANSI/ISO81060-1:2007/(R)2013 Non-Invasive Sphygmomanometers -Part 1: Requirements And Test Methods For Non-Automated Measurement Type, and ISO 10993 (Biological evaluation of medical devices) series for biocompatibility.

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

The document does not explicitly state the sample size used for the performance testing. It mentions "Performance testing was performed on the subject device," but does not specify the number of devices or measurements.

The data provenance is not specified regarding country of origin or specific study design (retrospective or prospective). The tests are described as "non-clinical testing," which suggests laboratory-based evaluations rather than human subject trials for the core performance and biocompatibility aspects.

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

This document describes the testing of a basic medical accessory (blood pressure cuff). The "ground truth" for its performance is established by objective measurements against a recognized standard (ISO 81060-1). There is no mention of experts establishing a "ground truth" in the way one might for diagnostic imaging or a subjective clinical assessment. The ground truth for biocompatibility is established through standardized laboratory tests.

4. Adjudication Method for the Test Set

Not applicable. The performance and biocompatibility tests are objective measurements against established standards, not subjective assessments requiring adjudication by multiple experts.

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

No. This is a 510(k) submission for a blood pressure cuff, which is a physical accessory, not an AI or imaging-based diagnostic device. Therefore, an MRMC comparative effectiveness study, which typically evaluates human readers' performance with and without AI assistance, is not relevant or applicable here.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. This device is a passive accessory and does not involve an algorithm. Its function is to interface with a blood pressure measurement system.

7. Type of Ground Truth Used

The ground truth used for performance testing (accuracy and reliability of pressure transmission, cuff inflation/deflation, etc.) is the adherence to the ISO 81060-1 standard's objective requirements and test methods.

For biocompatibility testing, the ground truth is established by the results of standardized laboratory tests (Cytotoxicity, Skin Irritation, Skin Sensitization) as defined by the ISO 10993 series.

8. Sample Size for the Training Set

Not applicable. This device is not an AI/machine learning algorithm and therefore does not have a "training set."

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

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

Ask a specific question about this device

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 infant, pediatric and adult sizes.

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

The proposed device is Reusable blood pressure cuff, which contains Cuff with bladder and Air Hose. Air hose has single tube and double tube.

During the operation process, the integrated inflatable bladder will wrapped around the patient's limb and secured by hook and loop closure, and the air hose will connected to the noninvasive blood pressure measurement systems.

The reusable blood pressure cuff is reusable device, and which is made of 210D Nylon TPU (Cuff) and PVC (Air Hose), thereinto, the 210D Nylon TPU (Cuff) is the material used to contacting with the patient.

The reusable blood pressure cuff has 16 models with different size for different population with different arm size, and the 8 models of 16 are use single tube of air hose and other 8 models are use double tube of air hose, which is used for different noninvasive blood pressure measurement system.

The Reusable blood pressure cuff is provided as non-sterile.

This document pertains to the 510(k) premarket notification for a Reusable Blood Pressure Cuff (K152468).

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

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present "acceptance criteria" as a separate, quantitative table for the device's main function (blood pressure measurement accuracy). Instead, it focuses on demonstrating substantial equivalence to a predicate device (K151290) through a comparison of various features and compliance with relevant standards for safety and performance.

The "Non-Clinical Test Conclusion" section indicates that the device met design specifications and was substantially equivalent, based on compliance with specific ISO standards.

Ask a specific question about this device

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 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 infant, pediatric and adult sizes.

The proposed device is an accessory used in conjunction with noninvasive blood pressure measurement systems. It is available in neonatal, infant, pediatric and adult sizes. The proposed device includes disposable blood pressure cuff and reusable blood pressure, both disposable and reusable blood pressure cuff has same structure, which contains Cuff with bladder and Air Hose. Air hose has single tube and double tube. The disposable blood pressure cuff is single use device, and which is made of non-woven fabrics & PVC (Cuff) and PVC (Air Hose), thereinto, the non-woven fabrics & PVC (Cuff) is the material used to contacting with the patient. The disposable blood pressure cuff has 18 models with different size for different population with different arm size, and the 9 models of 18 are use single tube of air hose and other 9 models are use double tube of air hose, which is used for different noninvasive blood pressure measurement system. The reusable blood pressure cuff is reusable device, and which is made of 210D Nylon TPU (Cuff) and PVC (Air Hose), thereinto, the 210D Nylon TPU (Cuff) is the material used to contacting with the patient. The reusable blood pressure cuff has 10 models with different size for different population with different arm size, and the 5 models of 10 are use single tube of air hose and other 5 models are use double tube of air hose, which is used for different noninvasive blood pressure measurement system. Both disposable and reusable blood pressure cuff are provided as non-sterile.

Here's a breakdown of the acceptance criteria and the study information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes the device (Disposable/Reusable Blood Pressure Cuff) as "substantially equivalent" to predicate devices, rather than presenting explicit acceptance criteria with numerical performance targets and reported device performance against those targets. The submission relies on demonstrating equivalence through adherence to recognized standards and comparison of features with predicate devices.

However, based on the non-clinical tests conducted, we can infer some "acceptance criteria" through compliance with the listed standards and the qualitative results:

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

The document does not specify a "test set" in the context of clinical data for performance evaluation. Instead, it refers to non-clinical tests conducted to verify design specifications and substantial equivalence.

• Sample Size for Non-Clinical Tests: Not explicitly stated (e.g., number of cuffs tested for biocompatibility or pressure limits). The document only mentions that "Non clinical tests were conducted."
• Data Provenance: The tests were conducted internally by the manufacturer (Xuzhou Maicuff Technology Co.,ltd.) or by a testing laboratory on their behalf, in the context of a 510(k) submission to the FDA. The country of origin for the manufacturing and testing would likely be China, where the company is based. The tests are prospective in the sense that they were conducted for this specific submission to demonstrate compliance.

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

Not applicable. This device is a blood pressure cuff and the testing described is non-clinical (biocompatibility, performance to standards), not a diagnostic or AI-driven device requiring expert adjudication of "ground truth" for patient cases.

4. Adjudication Method for the Test Set:

Not applicable, as there is no clinical test set requiring expert adjudication for ground truth. The evaluation is based on non-clinical testing against established standards.

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

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "No clinical study is included in this submission." The device is a physical accessory (blood pressure cuff), not a diagnostic tool where reader performance would be a primary concern.

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

Not applicable. This device is a physical medical accessory (a blood pressure cuff), not an algorithm or software. Therefore, an "algorithm only" performance study is irrelevant.

7. The Type of Ground Truth Used:

For the biocompatibility tests, the "ground truth" is established by the accepted scientific methodologies and criteria outlined in the ISO 10993 standards (e.g., cell viability for cytotoxicity, skin reaction assessment for irritation and sensitization).

For the functional/performance tests, the "ground truth" or reference values are derived from the requirements and test methods detailed in ISO 81060-1:2012 for non-invasive sphygmomanometers.

8. The Sample Size for the Training Set:

Not applicable. This device is a physical medical accessory, not a machine learning model, so there is no concept of a "training set."

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

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

Ask a specific question about this device

The GH 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 GH 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.

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

This document describes the premarket notification for GH Disposable and GH Reusable Blood Pressure Cuffs. However, it does not contain specific acceptance criteria or an explicit study proving the device meets acceptance criteria in the format requested.

The document states that "Both new devices were designed and manufactured in accordance with the following standards:" and lists several ISO and ANSI/AAMI standards. It concludes that "Based on the comparison of intended use, design, materials and performance, we conclude that the new devices are substantially equivalent to the predicates. The differences between the devices do not raise new questions of safety and effectiveness."

Without the full test report or direct mention of performance metrics in relation to acceptance criteria, I cannot provide the detailed information requested in your table format. The document implies that the device meets the standards cited, which would inherently include performance criteria, but these are not explicitly presented as "acceptance criteria" with "reported device performance."

Therefore, I cannot fulfill all parts of your request. I can, however, extract what information is present regarding testing and standards:

G. Summary of Testing indicates that the devices were designed and manufactured in accordance with the following standards:

• ANSI/AAMI SPIO, Manual, electronic or automated sphygmomanometers, 2002+AI.:2003+A2:2006+(R)2008: This standard sets requirements for the accuracy and performance of blood pressure measuring devices.
• ISO 10993-1, Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process, 2009: This standard outlines a framework for assessing medical device biocompatibility.
• ISO 10993-5, Biological evaluation of medical devices- Part 5: Tests for In Vitro cytotoxicity, 2009: This standard specifies test methods for assessing in vitro cytotoxicity of medical devices.
• ISO 10993-10, Biological evaluation of medical devices -- Part 10: Tests for irritation and delayed-type hypersensitivity, 2002+A1 :2006: This standard describes test methods for assessing skin irritation and sensitization caused by medical devices.

Based on the provided document, the following information is available:

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

• This information is not explicitly provided in the document. The document states that the devices comply with specific standards (ANSI/AAMI SPIO, ISO 10993 series), implying they meet the performance and safety criteria outlined in those standards. However, the specific acceptance criteria and the measured device performance against those criteria are not detailed.

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

• Not provided in the document.

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)

• Not applicable as this document does not describe a clinical study involving ground truth established by experts for a test set. The testing referenced relates to engineering and biocompatibility standards.

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

• Not applicable.

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 is a medical device (blood pressure cuff), not an AI-assisted diagnostic tool.

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

• Not applicable.

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

• Not applicable in the context of diagnostic accuracy. For the device itself, the "ground truth" for compliance testing would be the specifications and requirements defined by the cited standards (e.g., accuracy limits for pressure, chemical composition for biocompatibility tests).

8. The sample size for the training set

• Not applicable. This is not a machine learning or AI device.

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

• Not applicable.

In summary, the provided document is a 510(k) summary indicating substantial equivalence to predicate devices based on design, materials, intended use, and compliance with general medical device standards. It does not provide specific performance data against explicit acceptance criteria in the format requested.

Ask a specific question about this device