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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 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 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 Blood Pressure Cuff is an accessory used in conjunction with non-invasive blood pressure measurement systems. The cuff is non-sterile. 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 reusability.

This document describes the FDA's 510(k) clearance for a "Blood Pressure Cuff" by JKH USA, LLC. The key aspect of this clearance is the assertion that the subject device and the predicate devices are exactly the same. Therefore, the "study that proves the device meets the acceptance criteria" is primarily a claim of identity to previously cleared devices, rather than a new performance study.

Given this, I will tailor the response to reflect that the "study" is a comparison and assertion of sameness, rather than a novel clinical trial.

Here's the breakdown of the acceptance criteria and the "study" that supports it:

Acceptance Criteria and Reported Device Performance

• ISO 81060-1 Non-invasive sphygmomanometers - Part 1: Requirements and test methods for non-automated measurement type
• ISO 10993-1 Biological evaluation of medical devices-Part 1: Evaluation and testing within a risk management process
• ISO 10993-5, Biological evaluation of medical devices-Part 5: Tests for In Vitro cytotoxicity
• ISO 10993-10, Biological evaluation of medical devices-Part 10: Tests for irritation and delayed-type hypersensitivity
  (These standards were also presumably met by the predicate devices, and the claim of identicality implies continued adherence.) |
  | Biocompatibility Established | Biocompatibility tests (cytotoxicity, sensitization, skin irritation) were conducted. Test results show no issue of cytotoxicity, sensitization, or skin irritation, given the skin contact duration of less than 30 days. |
  | No Material or Design Modifications from Predicate | "The subject and predicate devices are exactly the same, and there is no any difference between them." "The blood pressure cuffs are identical to the cleared version and are not modified." |
  | No Further Clinical Testing Necessary Due to Identity | "Since the blood pressure cuffs are identical, no further clinical testing is necessary." |

Details of the "Study" (Comparison and Assertion of Equivalence):

1. Sample sizes used for the test set and data provenance:
   This 510(k) submission relies on a claim of identicality to previously cleared predicate devices (K112544 and K120364, both "Unimed Blood Pressure Cuff" from UNIMED MEDICAL SUPPLIES INC). Therefore, there is no new clinical test set or patient data presented for this specific submission for the purpose of demonstrating performance. The "sample" is effectively the previously validated predicate device itself. No country of origin for a new test set is provided, and the data provenance is historical, based on the previous clearance of the predicate. This is a retrospective comparison based on design specifications.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   Not applicable (N/A) to this submission, as no new test set requiring expert ground truth establishment for a novel device performance study was conducted. The ground truth for the predicate devices would have been established at the time of their clearance through their respective validation studies.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
   N/A. No new test set requiring adjudication was performed.

4. 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 device is a passive blood pressure cuff, not an AI-powered diagnostic imaging tool. Therefore, an MRMC study or AI assistance is not relevant to its function.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
   N/A. This device is a physical medical accessory, not an algorithm.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
   For the non-clinical tests (biocompatibility and standard compliance), the ground truth is established by laboratory test results conforming to the specified ISO standards (e.g., in vitro cytotoxicity, irritation, sensitization tests). For the device's overall performance, the "ground truth" for this submission is the established performance and safety of the predicate devices, which presumably met their own ground truth requirements through standard validations (e.g., accuracy against a reference standard for a blood pressure monitoring system, which the cuff is an accessory to, although the cuff itself simply maintains pressure).

7. The sample size for the training set:
   N/A. This is a passive medical device, not a machine learning model. No training set for an algorithm was used.

8. How the ground truth for the training set was established:
   N/A. No training set for an algorithm was used.

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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 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).

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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.

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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 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.

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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 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.

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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.

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