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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 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 subject device is an accessory used in conjunction with noninvasive blood pressure measurement systems. It is available in neonatal, infant, child and adult sizes. The subject device contains Cuff with bladder and Air Hose. Air hose has single tube and double tube. Wrapped the cuff 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 device 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 22 models with different size for different population with different arm size, and the 11 models of 22 are use single tube of air hose and other 11 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 "Disposable Blood Pressure Cuff" by Wenzhou Xikang Medical Instruments Co., Ltd. This document primarily focuses on demonstrating substantial equivalence to a predicate device and does not contain detailed acceptance criteria and study results for performance efficacy in the way a clinical trial or algorithm validation study would.

Instead, the "acceptance criteria" for this device are regulatory and technical standards, and the "study" demonstrating it meets these criteria are non-clinical tests to verify design specifications and compliance with recognized standards.

Here's an breakdown based on the information provided, recognizing that it's a regulatory submission rather than a performance study report:

Description of Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

The "Disposable Blood Pressure Cuff" is seeking 510(k) clearance, which is based on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel effectiveness. Therefore, the "acceptance criteria" are compliance with relevant regulatory standards and the predicate device's characteristics, and the "study" involves non-clinical testing to verify this compliance.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: Not explicitly stated as a number of patients or cuffs in a typical clinical study. The testing appears to consist of laboratory measurements and evaluations against standards. For biocompatibility, standard test methods typically involve specific numbers of samples for in vitro (cytotoxicity, irritation) and in vivo (sensitization) tests, but these numbers are not detailed in this summary.
• Data Provenance: The testing was "non-clinical tests... conducted to verify that the proposed device met all design specifications." This indicates testing was likely performed by the manufacturer or a contract lab. The country of origin of the data is implicitly China, as the manufacturer is Wenzhou Xikang Medical Instruments Co., Ltd. (Wenzhou, Zhejiang, China). The data is retrospective, generated to support the 510(k) submission.

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

• This information is not applicable as this is not a study involving expert-derived ground truth (e.g., medical image interpretation). The "ground truth" here is compliance with established engineering and biocompatibility standards (e.g., ISO 81060-1, ISO 10993).

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

• This is not applicable as there are no expert interpretations or subjective assessments requiring adjudication. The evaluations are based on objective measurements against defined 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:

• No, an MRMC comparative effectiveness study was not done. This device is a blood pressure cuff and does not involve AI or human interpretation in the way a diagnostic imaging device would.

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

• No, a standalone performance study was not done in the context of an algorithm. The device itself is a standalone physical accessory. Its performance is evaluated through compliance with physical and biological standards.

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

• The "ground truth" is defined by international and recognized consensus standards for medical device safety and performance, specifically:
  • ISO 81060-1: For non-invasive sphygmomanometer performance.
  • ISO 10993-1, -5, -10: For biocompatibility.
• The "ground truth" for showing equivalence also includes the technical specifications and materials of the legally marketed predicate device.

8. The sample size for the training set:

• This is not applicable. This device is a physical medical accessory, not an AI/machine learning algorithm that requires a training set.

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

• This is not applicable. As there is no training set for an AI algorithm.

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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 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 disposable 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 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 disposable blood pressure cuff is provided as non-sterile.

The provided document describes the 510(k) premarket notification for a Disposable Blood Pressure Cuff (K152465) by Shenzhen Vistar Medical Supplies Co., Ltd. The submission aims to demonstrate substantial equivalence to a legally marketed predicate device (K151290).

Here's an analysis of the acceptance criteria and the study that proves the device meets these criteria, based on the provided text:

Key Takeaways:

• This submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving novel clinical effectiveness.
• The primary means of demonstrating compliance is through non-clinical testing against recognized industry standards and a comparison of specifications with the predicate device.
• No clinical study was included in this submission. Therefore, there is no information about human reader performance (MRMC studies) or standalone algorithm performance, as these are typically part of clinical trials for AI/software devices.
• The device is a physical medical device (blood pressure cuff), not a software or AI-driven diagnostic tool. Thus, concepts like "ground truth" in the AI sense, expert panels for ground truth establishment, or training sets are not directly applicable in the way they would be for an AI device.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are derived from recognized standards and comparison with the predicate device. The performance is reported as compliance with these standards or equivalence to the predicate.

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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 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.

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This device has the potential to reduce or prevent patient cross contamination which can occur during blood pressure measurement procedures, for single patient use only. It covers a blood pressure cuff to provide a barrier between patient and cuff.

This device is a cover for blood pressure cuffs. It is made of polyethylene coated on Tyvck. Blood pressure cuffs are used throughout the healthcare industry as a means of monitoring patient blood pressure. Because blood pressure cuffs are used on multiple patients there is a concern about cross contamination.

When the blood pressure cuffs become contaminated they should be cleaned. A blood pressure cuff Guard can reduce the need to clean blood pressure cuffs.

In order to address the cross contamination issue for blood pressure cuffs a blood pressure cuff Guard has been designed. The product is a non-sterile, clean, ready to use sleeve that is applied between the patient arm and the blood pressure cuff. The cuff Guard has the potential to reduce transfer of patient contamination to the cuff and from the cuff to the patient.

The blood pressure cuff Guard is a single patient product designed to survive average use during an average hospital stay. If the blood pressure cuff Guard becomes contaminated, soiled or torn during this time it would be replaced with a new blood pressure cuff Guard.

The blood cuff Guard has a two layer structure. The inner layer is made of Tyvck. The outer layer is made of cast film of polyethylene.

The polyethylene is a fluid repellent, and is resistant to microbial penetration, thus provides a barrier between the pressure cuff and patient.

The whole guard is approximately 20 um thick and is available in various different length and width.

The guard is designed as pouchlike with one open, the blood pressure cuff can be packed into it and sealed with adhesive tape, and which can be secured around the patient arm by two velcro. The adhesive tapes are located at the edge of open and the Velcro located at the two ends of outer guard, both of them are not contact with the patient skin.

This document is a 510(k) summary for a Disposable Blood Pressure Cuff Guard (K150227). It describes the device's intention to reduce cross-contamination during blood pressure measurement and claims substantial equivalence to a predicate device.

Here's an analysis of the provided information regarding acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly define "acceptance criteria" in a quantitative performance metric sense (e.g., a specific percentage reduction in microbial count). Instead, the acceptance criteria are implicitly linked to demonstrating substantial equivalence to a predicate device by showing that the proposed device meets design specifications and passes certain non-clinical tests.

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

• Test Set Sample Size: Not explicitly stated. The non-clinical tests (biocompatibility, bench testing) would have involved a certain number of samples or specimens, but the exact count is not provided in this summary.
• Data Provenance: The tests were conducted by Pinghu Sama Medical Packing Co., Ltd. (China). The document does not specify if the data is retrospective or prospective, but as it's for a new device, it would implicitly be prospective testing of the manufactured product.

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

• Number of Experts: Not applicable/not stated. The ground truth for biocompatibility studies is typically established by laboratory testing against ISO standards and interpreted by qualified toxicologists or biologists, not through expert consensus in the way a medical image might be. For bench testing, the "ground truth" would be the design specifications and established engineering principles.
• Qualifications of Experts: Not applicable/not stated in this document.

4. Adjudication method for the test set:

Not applicable. This device's evaluation (biocompatibility and bench testing) does not involve a human reader or an adjudication process in the typical sense for diagnostic devices.

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 physical medical device (a cuff guard), not an AI-powered diagnostic tool, so MRMC studies are not relevant.

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

Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used:

• Biocompatibility: The ground truth for biocompatibility was established by ISO standards (ISO 10993-5 for cytotoxicity and ISO 10993-10 for irritation and sensitization). The test results were compared against the requirements of these standards.
• Bench Testing: The ground truth for bench testing (Dimensions, Adhesive Tape, Compatibility with BP Cuff, Velcro) would be the device's own design specifications and functional requirements.

8. The sample size for the training set:

Not applicable. This device is not an algorithm that requires a training set.

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

Not applicable. This device is not an algorithm that requires a training set.

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Disposable blood Pressure Cuff is intended to be wrapped on the upper arm and used with a non-invasive blood pressure device to determine blood parameters on neonate, pediatric and adult patients.

The proposed devices, Disposable blood Pressure Cuff, are claimed to be Substantially Equivalent (SE) to the predicate devices, Disposable Blood Pressure Cuff.

The provided text describes the acceptance criteria and the study for a Disposable Blood Pressure Cuff.

Here's the information extracted and organized:

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 a specific sample size for a "test set" in the context of an algorithm or AI. Instead, it refers to standards for evaluating biocompatibility and performance of a physical device.

• Test Set Sample Size: Not explicitly stated for specific human subjects or data points, but implies adherence to the sample size requirements of ISO 10993 and AAMI SP10 for device testing.
• Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The manufacturer is Wuxi Medical Instruments Factory in China.

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

Not applicable. This is not an AI or algorithm-based device that would require expert-established ground truth for a test set. The "ground truth" for this device relates to its physical performance and biocompatibility according to established medical device standards.

4. Adjudication Method for the Test Set

Not applicable. This is not an AI or algorithm-based device that would require an adjudication method for a test set.

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

No. This is a physical medical device (blood pressure cuff), not an AI system. Therefore, an MRMC comparative effectiveness study involving human readers with and without AI assistance is not relevant.

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

No. This is a physical medical device (blood pressure cuff). The concept of "standalone performance" for an algorithm is not applicable. The device's performance is tested according to AAMI SP10, which evaluates the physical function of the cuff.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established by adherence to recognized international standards:

• Biocompatibility: ISO 10993 series standards.
• Performance: AAMI SP10:2002+A1:2003+A2:2006.
• Substantial Equivalence: Comparison to legally marketed predicate devices.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI or machine learning algorithm that requires a training set.

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

Not applicable. As this is not an AI/ML device, there is no training set or associated ground truth establishment.

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The Disposable Blood Pressure cuff is intended to be used with a non-invasive blood pressure measurement system to determine blood pressure parameters on neonate, pediatric and adult patients.

The device comprises tubing attached to a soft inelastic sleeve with an integrated inflatable bladder that is wrapped around the patient's limb and secured by hook and loop closure. The device is connected to a non- invasive blood pressure measurement system. The device is available in the following configurations:
· 15 sizes (five neonate, ten pediatric/adult)
· Single and dual cuff tubing with connectors available for use with a wide variety of manual and automated sphygmomanometers

This submission describes a disposable blood pressure cuff. The relevant information related to acceptance criteria and performance studies is as follows:

1. Table of Acceptance Criteria and Reported Device Performance

The device was tested against two recognized standards and an internal marketing specification. The submission states, "These tests have indicated passing results." However, specific numerical acceptance criteria and the detailed performance results for each criterion are not provided in this document.

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

The document does not specify the sample size used for the test set or the data provenance (e.g., country of origin of the data, retrospective or prospective). It simply states that "The Disposable Blood Pressure Cuff has been tested to... standards and requirements."

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

This information is not applicable to the type of device and testing described. The device is a physical medical device (blood pressure cuff), and its performance is assessed against technical standards for accuracy and safety, rather than requiring expert interpretation for ground truth.

4. Adjudication method for the test set

This information is not applicable. Adjudication methods are typically used in studies where human interpretation of data (e.g., medical images) is involved and discrepancies need to be resolved. For a physical device like a blood pressure cuff, performance is measured objectively against technical 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

An MRMC comparative effectiveness study is not applicable as this device is a disposable blood pressure cuff, not an AI-powered diagnostic tool that assists human readers.

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

The "ground truth" for this device's performance is established by the specified industry standards (AAMI SP10: 2002 and IEC 60601-2-30:1999) and an internal marketing specification. These standards define the acceptable range of accuracy for blood pressure measurements and other physical and safety features of the cuff. The device's performance is measured against these objective criteria.

8. The sample size for the training set

This information is not applicable. The development and testing of a physical blood pressure cuff do not involve a "training set" in the context of machine learning or AI. The design and manufacturing process would involve engineering specifications, prototyping, and validation testing.

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

This information is not applicable, as there is no "training set" in the context of this device. The "ground truth" for general design and safety parameters would be established by relevant engineering principles, material science, and regulatory requirements that predate the specific device being developed.

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