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Introducer Sheath Kits are intended for use to facilitate the introduction of guide wires, catheters and other accessory medical devices through the skin into a vern or artery and minimize blood loss associated with such introduction.

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I'm sorry, but this document does not contain the information requested regarding acceptance criteria and device performance for an AI/ML-based medical device study.

The provided text is a 510(k) clearance letter from the FDA for an "Introducer Sheath Kit" (product code DYB). This is a physical medical device (a catheter introducer), not an AI/ML-based software device.

Therefore, I cannot extract details about:

1. A table of acceptance criteria and reported device performance for an AI model.
2. Sample size, data provenance, expert qualifications, or adjudication methods for an AI test set.
3. MRMC studies or standalone AI performance.
4. Ground truth types or training set details for an AI model.

The letter focuses on the substantial equivalence of the "Introducer Sheath Kit" to legally marketed predicate devices, and discusses general regulatory requirements for medical devices.

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Introducer Sheath Kits are intended for use to facilitate the introduction of guide wires, catheters and other accessory medical devices through the skin into a vern or artery and minimize blood loss associated with such introduction.

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The provided document is an FDA 510(k) clearance letter for an "Introducer Sheath Kits." This type of document does not contain information about the acceptance criteria and the study that proves the device meets the acceptance criteria for a medical imaging device utilizing AI.

The letter focuses on the regulatory clearance process, establishing substantial equivalence to a predicate device, and outlining general controls and regulations that the manufacturer must adhere to. It concerns a physical medical device (introducer sheath kits) used for facilitating the introduction of guidewires and catheters.

Therefore, I cannot provide the requested information based on the given text.

To answer your questions about acceptance criteria and device performance studies, you would typically need a clinical study report or a data summary from a premarket submission (e.g., PMA or 510(k) summary for an AI/ML medical device), which would detail:

1. Acceptance criteria and reported performance: Specific metrics (e.g., sensitivity, specificity, AUC) and predefined thresholds.
2. Sample size and data provenance: Details of the dataset used for validation.
3. Experts for ground truth: Number and qualifications of readers/experts.
4. Adjudication method: How disagreements were resolved.
5. MRMC study information: If applicable, details on human reader performance with and without AI.
6. Stand-alone performance: Algorithm-only performance metrics.
7. Type of ground truth: How the "truth" was established for the test data.
8. Training set size: Number of cases used for model training.
9. Training set ground truth: How ground truth was established for the training data.

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The Radial Artery Compression Tourniquet is designed for temporary hemostasis of radial artery post percutaneous puncture.

Radial Artery Compression Tourniquets

The provided document is a 510(k) clearance letter for the "Radial Artery Compression Tourniquets" and does not contain the specific information about acceptance criteria, device performance, study details, or AI-related data as requested. This letter confirms that the device is substantially equivalent to a predicate device and can be marketed, but does not include the detailed technical study information you're looking for.

Therefore, I cannot provide the requested information based on the input text.

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The Balloon In-deflation device is used for the inflation of a balloon dilatation catheter, to dilate the vessel or implant a stent.

The Balloon In-deflation Device is a 20ml or 30ml disposable device capable of producing a maximum pressure of 30atm/bars. It is fitted with a threaded plunger, a flexible high pressure extension tube, and a three-way high pressure stopcock. The luminescent pressure gauge with adjustable angle allows physician to read and monitor more easily in clinical environment. The product is designed under ergonomic principle that could be handled comfortably, easily and securely. The balloon in-deflation device mainly composes of four parts, injecting system (syringe), pressure gauge and extension tube, 3way stopcock, respectively. The syringe consists of a screw type plunger and a locking lever, by rotating palm grip to control the plunger; the pressure gauge is to measure pressure and the extension tube is to connect catheters. The angle of the pressure gauge can be re-adjusted during the procedure.

Based on the provided text, here's a description of the acceptance criteria and the study that proves the device meets them:

The document does not detail specific acceptance criteria for each performance characteristic of the Mastro Plus Balloon In-deflation Device. Instead, it asserts substantial equivalence to predicate devices through a comparison of design specifications and non-clinical performance testing. The overarching "acceptance criteria" appear to be that the proposed device must meet all design specifications and perform as safely and effectively as the predicate devices.

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

While explicit acceptance criteria are not presented as numerical targets to be met, the table below infers the performance characteristics evaluated and the proposed device's performance as compared to its predicates. The "Acceptance Criteria" column reflects the general expectation for substantial equivalence (i.e., being comparable to or within acceptable ranges of the predicate's 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 any of the non-clinical tests (biocompatibility or bench testing). It also does not provide details on the data provenance such as country of origin or whether the data was retrospective or prospective. The tests are described as general performance testing and biocompatibility testing.

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 section is not applicable. The device is a "Balloon In-deflation Device," which is a physical medical instrument used for inflation/deflation of balloons and stents. The "ground truth" here is established through engineering and biological testing against specifications and standards, not through expert clinical consensus on interpretations of medical data.

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

This section is not applicable. As above, the "test set" refers to physical device testing, not clinical data requiring adjudication by experts.

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 section is not applicable. The device is a physical medical instrument for catheter inflation/deflation, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study related to AI assistance is irrelevant.

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

This section is not applicable. The device is a physical medical instrument, not an algorithm.

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

The "ground truth" for this device is established through:

• Design specifications: The device is designed to perform according to a set of pre-defined engineering and functional specifications (e.g., pressure range, volume dispensed per rotation, material composition).
• Recognized industry standards: Compliance with standards like ISO 11135-1:2006 for sterilization validation and ISO 11607-1:2006 for sterilization package performance.
• Biocompatibility testing results: Tests like pyrogen, endotoxin, acute systemic toxicity, irritation, cytotoxicity, skin sensitization, haemolysis, complement activity, and thrombosis tests provide "ground truth" regarding the device's biological safety.
• Bench testing results: Tests for appearance, positive/negative pressure sealing, male luer lock, capacity scale, and gauge accuracy provide "ground truth" for the device's physical and functional performance.

8. The sample size for the training set

This section is not applicable. This device is a physical medical instrument, not a machine learning model. Therefore, there is no "training set."

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

This section is not applicable. As stated above, there is no "training set" for this device.

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