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The Reusable NIBP 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 adult size.

Reusable NIBP Cuff is a reusable accessory used in conjunction with a non-invasive blood pressure measurement system. It 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.

Reusable NIBP Cuff is made of PU synthetic leather (Cuff), TPU film (bladder) and TPU (Air Hose), and the PU synthetic leather is the material used to contacting with the patient's intact skin.

The provided document is an FDA 510(k) clearance letter for a reusable NIBP (Non-Invasive Blood Pressure) cuff. It details the device's indications for use, safety and performance testing, and a comparison to a predicate device to establish substantial equivalence.

Based on the provided text, there is no information about a study proving the device meets acceptance criteria related to a diagnostic algorithm or AI performance. The document is for a physical medical device (blood pressure cuff) and focuses on its physical characteristics, materials, and mechanical performance (e.g., durability of inflation cycles, biocompatibility) rather than a software or AI-driven diagnostic.

Therefore, I cannot provide answers to the specific points requested (acceptance criteria table, sample size for test/training sets, expert ground truth, MRMC study, standalone performance, etc.) as they pertain to the evaluation of an AI/algorithm-based device, which is not what this document describes.

The acceptance criteria stated for this device primarily revolve around:

• Compliance with recognized standards: ISO 81060-1 (Non-Invasive Sphygmomanometers), ISO 10993-5 (Cytotoxicity), and ISO 10993-10 (Irritation and Skin Sensitization).
• Biocompatibility: Demonstrated through testing for cytotoxicity, sensitization, and irritation.
• Mechanical Durability: 10,000 inflations and 3,000 hook and loop closures.
• Pressure Limits: 0-300mmHg.
• Intended Use and Patient Population Matching: For adult size, non-sterile, reusability.
• Substantial Equivalence: To a legally marketed predicate device (Orantech Inc. Reusable NIBP Cuff, K173197).

The document explicitly states: "Clinical performance is not deemed necessary." and there is no mention of an AI/ML component in this device.

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

The 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 includes reusable blood pressure cuff. All the reusable blood pressure cuff has same structure, which contains Cuff with bladder and Air Hose. Air hose has single tube. The reusable blood pressure cuff is reusable device, Model CK-XT-78211-XXX series are made of PU synthetic leather (Cuff) and TPU (Air Hose), and the PU synthetic leather (Cuff) is the material used to contacting with the patient's intact skin. Model CK-XT-78243-XXX series are made of Nylon (Cuff) and silica gel (Air Hose), and the Nylon (Cuff) is the material used to contacting with the patient's intact skin.

The provided text describes a 510(k) submission for a Reusable NIBP Cuff, demonstrating its substantial equivalence to a predicate device. However, it does not include detailed acceptance criteria and a study proving the device meets those criteria in the format requested.

The document focuses on non-clinical data and biocompatibility testing, primarily to show compliance with international standards and substantial equivalence, rather than a direct comparison against specific performance acceptance criteria for the blood pressure measurement accuracy itself (which is typically addressed by standards like ISO 81060-2).

Therefore, it is not possible to fully answer the request based on the provided text. I will extract the available information and explicitly state what is missing.

Missing Information from the Provided Document:

• A table of specific acceptance criteria for blood pressure measurement accuracy and corresponding device performance data against these criteria. The document mentions compliance with ISO 81060-1 but does not provide the specific performance results or acceptance limits for accuracy from this standard.
• The exact sample size used for any performance testing related to blood pressure measurement accuracy.
• Data provenance (country of origin, retrospective/prospective) for any detailed performance study.
• Number and qualifications of experts for ground truth establishment.
• Adjudication method for a test set.
• Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done.
• Whether a standalone (algorithm only) performance study was done.
• The specific type of ground truth used for performance validation (e.g., direct arterial measurement, oscillometric reference).
• Sample size for the training set (no training set mentioned as this is a physical medical device, not an AI/software device).
• How ground truth for the training set was established (not applicable).

Based on the provided text, here is the information available:

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

The document states that non-clinical tests were conducted to verify that the subject device met all design specifications and complied with specific standards, implying these standards define the acceptance criteria. However, explicit numerical acceptance criteria and the device's reported performance against them are not provided in a detailed table as requested.

The relevant standards mentioned are:

• ISO 81060-1: Non-Invasive Sphygmomanometers - Part 1: Requirements and Test Methods for Non-Automated Measurement Type, First Edition 2007.
• 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 Skin Sensitization.

For biocompatibility testing, the acceptance criteria are generally "no sensitization observed" and "Negligible (no observed primary irritation)" and passing cytotoxicity tests, which the device reportedly met. These are general statements rather than specific numerical criteria.

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

• Sample Size: Not specified for any performance testing related to NIBP accuracy. For biocompatibility, "the battery of testing" was mentioned, but specific sample sizes of biological material or animals are not detailed.
• Data Provenance: Not specified. The submission sponsor and correspondent are based in China (Shenzhen, P.R. China).

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

• This information is not provided as the device is a physical NIBP cuff, not an AI/software device usually requiring expert ground truth in this context. The performance verification likely involved physical laboratory testing and possibly clinical studies, not expert review of images or data.

4. Adjudication method for the test set

• Not applicable/Not provided. This usually pertains to studies involving expert review for AI/image analysis.

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/Not provided. This pertains to AI-assisted diagnostic devices.

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

• Not applicable/Not provided. This pertains to AI/software performance. The device is a physical medical accessory.

7. The type of ground truth used

• For NIBP cuff performance (ISO 81060-1): The standard typically describes methods for validating the accuracy of non-invasive blood pressure measurements, often against a reference method (e.g., intra-arterial pressure measurement) or a validated simulator. The exact ground truth method used in their specific tests is not detailed in this summary.
• For Biocompatibility (ISO 10993-5, -10): The ground truth is established through standardized laboratory assays for cytotoxicity, sensitization, and irritation using accepted biological models (e.g., cell cultures, animal models, or human patch tests).

8. The sample size for the training set

• Not applicable. This device is a physical NIBP cuff, not a software or AI algorithm that requires a training set.

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

• Not applicable. As above, no training set is relevant for this type of device.

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The reusable blood pressure cuff is an accessory used in conjunction with noninvasive blood pressure measurement systems. The cuff is non-sterile and may be reused. It is available in neonate, infant, child and adult sizes.

The 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 reusable NIBP cuff has 9 models with different size for different population with different arm size.

This document is a 510(k) summary for a Reusable NIBP Cuff, not an AI/ML medical device submission. Therefore, it does not contain the information requested in the prompt regarding acceptance criteria and study details for an AI-powered device.

The document discusses the substantial equivalence of the Reusable NIBP Cuff to an existing predicate device based on:

• Intended use and Indications for Use: An accessory for non-invasive blood pressure measurement systems, non-sterile, reusable, available in various sizes.
• Technical specifications: Material, tube number, limb circumference range, repeated inflation limits, pressure limits, sterility, biocompatibility.
• Performance Data: Non-clinical tests according to ISO 81060-1 (Non-Invasive Sphygmomanometers), ISO 10993-5 (In Vitro cytotoxicity), and ISO 10993-10 (irritation and skin sensitization).
• Clinical test: Explicitly stated as "not required" for this device.

None of the requested information regarding AI/ML device performance, acceptance criteria, sample sizes for AI model testing, expert consensus, MRMC studies, or ground truth establishment for AI is present in this regulatory submission for a physical medical device.

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