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The Breezeway II products are intended for the introduction of diagnostic and therapeutic devices into the human vasculature, including but not limited to intracardiac, renal or other peripheral placements.

Do not use this device for neural placements.

The Breezeway II-Delivery Sheath consists of a braided sheath with a side port with a three-way stopcock, hemostatic valve, and dilator. The Breezeway II Plus models include these same components plus a loader accessory. The distal tip of the sheath is radiopaque and contains side flush portholes. The dilator can be locked on to the hub of the sheath.

This is a 510(k) premarket notification for a medical device called "Breezeway II," a catheter introducer. The document details the device's characteristics and how it compares to a predicate device ("Adelante Breezeway Delivery Sheath," K122958) to demonstrate substantial equivalence, rather than a study proving the device meets an acceptance criteria for an AI/ML powered device. Therefore, it is impossible to provide the requested information.

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The steerable guiding sheath, Destino Reach is intended for the introduction of diagnostic and therapeutic devices into the human vasculature, including but not limited to intracardiac, renal or other peripheral placements. Do not use this device for neural placements.

The Destino Reach Steerable Guiding Sheath is a percutaneous steerable sheath designed to facilitate the intracardiac, renal and peripheral placement of diagnostic and therapeutic devices. The device features an adjustable tip through use of a rotating collar that allows the physician to perform a bi-deflection at the distal tip section of the sheath. The sheath has a hemostatic valve, sideport with stopcock, radiopaque distal tip, contains side flush portholes and is deflectable by rotating the collar incorporated into the handle. The dilator has depth markings and locks onto the sheath. The dilator has a tapered distal tip and an inner lumen recommended for use with 0.035" to 0.038" guidewire and/or transseptal needle.

This document describes the Destino Reach, Steerable Guiding Sheath and does not contain information about an AI/ML powered device. Therefore, it does not provide the specific details requested regarding acceptance criteria and a study proving device performance in the context of AI/ML.

The provided document is a 510(k) summary for a medical device (a steerable guiding sheath) that demonstrates substantial equivalence to predicate devices based on design, manufacturing materials, intended use, principles of operation, and technical characteristics. It details traditional medical device testing and regulatory information.

Based on the provided text, I cannot answer the following questions as they pertain to AI/ML device evaluation:

1. A table of acceptance criteria and the reported device performance: The document lists standards followed for traditional medical devices (e.g., risk management, sterilization, biocompatibility), but not acceptance criteria for an AI/ML specific performance.
2. Sample size used for the test set and the data provenance: Not applicable to a non-AI/ML device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used: Not applicable in the context of AI/ML.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

What the document does provide regarding device performance and testing:

The "DEVICE PERFORMANCE" section on page 5 and "TESTING" section on page 6 outline the types of evaluations performed for this traditional medical device:

• Standards followed:

  • BS EN ISO 14971:2012, Medical devices - Application of risk management to medical devices
  • AAMI/ANSI/ISO 11135: 2014, Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices.
  • AAMI/ANSI/ISO 10993-7:2008, Cor. 2009, Biological evaluation of medical devices, Part 7, Ethylene oxide sterilization residuals.
  • ISO 10555-1 2013, Intravascular catheters- Sterile and single use catheters, Part 1, General requirements. (Note: Requirements for flow rate and power injections not followed as this does not apply to an introducer.)
  • ISO 11070: 1998, Sterile single-use intravascular catheter introducers. (Note: Requirements for needles do not apply since the product is not packaged with a needle).

• Testing Conducted:

  • Functional system testing
  • Risk analysis
  • Biocompatibility
  • Packaging/transportation qualification

The claim is that "Based on this testing, we have determined that the device performs as well as the legally marketed predicate devices identified in this summary." This implies that the device met the performance characteristics expected for its class and intended use, as demonstrated by adherence to recognized standards and specific internal verification and validation tests. However, the exact acceptance criteria thresholds for each test and the specific results are not detailed in this summary.

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The IS4/DF4 plug can be indicated for a patient with an implantable pacemaker/defibrillator that has an unused IS4/DF4 receptacle. The plug prevents the ingression of bodily fluids/blood inside the IS4/DF4 receptacle.

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The provided text describes a 510(k) premarket notification for a medical device called the "IS4/DF4 Port Plug." This document is a letter from the FDA to Oscor Inc. stating that the device is substantially equivalent to legally marketed predicate devices.

However, the document does not contain any information regarding acceptance criteria, device performance results, sample sizes for testing or training, expert qualifications, ground truth establishment methods, or details about any studies (standalone or MRMC comparative effectiveness) that would typically be included in a technical report or clinical trial summary.

The content is purely administrative, focusing on the FDA's regulatory decision of substantial equivalence based on the provided indications for use and the device's classification. It states that the device "prevents the ingression of bodily fluids/blood inside the IS4/DF4 receptacle." This is a functional description, but not a quantifiable performance criterion with an associated study result.

Therefore, based on the provided text, it is not possible to answer the detailed questions about acceptance criteria, study design, sample sizes, expert involvement, or ground truth. The document is a regulatory approval letter, not a technical performance report.

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The Adelante® Magnum is intended to facilitate the introduction of diagnostic and therapeutic devices into the human vasculature, including but not limited to intracardiac, renal or other peripheral placements, while minimizing blood loss associated with such insertions. Do not use this device for neural placements.

Introducer, Model Adelante® Magnum

This document is a 510(k) clearance letter from the FDA for a medical device called "Introducer, model Adelante Magnum." It declares the device substantially equivalent to a predicate device. However, this document does not contain any information about acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, or ground truth establishment.

Therefore, I cannot fulfill your request for that specific information based solely on the provided text. The document primarily focuses on regulatory approval and substantial equivalence, not detailed performance studies.

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The steerable guiding sheath, model Destino Twist is intended for the introduction of diagnostic and therapeutic devices into the human vasculature, including but not limited to intracardiac, renal or other peripheral placements. Do not use this device for neural placements

Steerable Guiding Sheath, model Destino Twist

The provided document is a 510(k) clearance letter from the FDA for a medical device called "Destino twist, steerable guiding sheath." This type of document is a regulatory approval, not a scientific study report describing acceptance criteria and device performance data from a specific study. Therefore, the requested information about acceptance criteria, performance data, sample sizes, ground truth establishment, expert qualifications, adjudication methods, and MRMC studies cannot be extracted from the provided text.

The document only states that the FDA has determined the device is "substantially equivalent" to legally marketed predicate devices for its intended use, which is for the introduction of diagnostic and therapeutic devices into the human vasculature. It does not contain any specific performance data or a study description to support these claims.

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The Adelante® Radial Introducer Set is indicated for the introduction of diagnostic and therapeutic catheters into the human vasculature. Do not use this device for neural placements.

Not Found

This document is a 510(k) clearance letter from the FDA for a medical device called the "Adelante® Radial Introducer Set." It does not contain information about acceptance criteria or a study that proves the device meets those criteria.

The letter approves the device based on its substantial equivalence to predicate devices already on the market but does not detail the specific performance metrics or studies that established this equivalence. It's a regulatory approval, not a technical performance report.

Therefore, I cannot provide the requested information based on the provided text. The document is solely a regulatory communication.

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Indicated for use in procedures where access to the left atrium via the transseptal technique is desired. The SafeSept® Transseptal Guidewire is intended for single use only.

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The provided text is a 510(k) premarket notification letter from the FDA to Oscor Inc. regarding their SafeSept® NF Transseptal Trocar Guidewire. This document primarily focuses on regulatory approval and equivalence to a predicate device. It does not contain any information regarding acceptance criteria, study details, device performance, sample sizes, expert qualifications, or ground truth establishment.

Therefore, I cannot provide the requested information based on the input text. The document confirms the device's regulatory classification, its intended use, and that a substantial equivalence determination has been made, but it does not detail the technical performance studies that would typically include acceptance criteria and study results.

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The guidewire is intended to facilitate the introduction of intravascular devices for use in the coronary and/or peripheral vasculature during diagnostic and interventional procedures.

Not Found

The provided text does not contain information about acceptance criteria, device performance, sample sizes for test or training sets, data provenance, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance.

The document is a 510(k) clearance letter from the FDA to Oscor Inc. for a Guidewire, Pursuer Series. It states that the FDA has reviewed the premarket notification and determined the device is substantially equivalent to legally marketed predicate devices. The enclosure is an "Indications for Use Statement" which describes the intended use of the guidewire but does not include any performance metrics or study details.

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

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The Adelante® Breezeway Delivery Sheath is intended for the introduction of diagnostic and therapeutic devices into the human vasculature, including but not limited to intracardiac, renal or other peripheral placements. Do not use this device for neural placements.

This is a modification to Indications for Use statement only. There was no change in the text of IFU and method of use. Modification and Comparison to Predicate devices. There is no modification to the device itself. The Adelante® Breezeway Delivery Sheath has been cleared in K101497 and will remain intact, and no modifications to product labels.

The provided text is a 510(k) summary for a medical device called the Adelante® Breezeway Delivery Sheath. It describes the device, its intended use, and its substantial equivalence to predicate devices for expanded indications. However, it does not contain any information about acceptance criteria or a study proving the device meets those criteria, nor does it discuss AI performance, sample sizes, expert ground truth establishment, or multi-reader multi-case studies.

The document explicitly states: "This is a modification to Indications for Use statement only. There was no change in the text of IFU and method of use. Modification and Comparison to Predicate devices. There is no modification to the device itself. The Adelante® Breezeway Delivery Sheath has been cleared in K101497 and will remain intact, and no modifications to product labels."

This means the submission focuses solely on expanding the stated uses for a device that was previously cleared (K101497) and has not undergone any changes itself. Therefore, it relies on the previous clearance and the substantial equivalence to existing predicate devices for the expanded indications, rather than new performance studies with specific acceptance criteria.

Therefore, I cannot extract the requested information from the provided text. The document does not describe a study involving performance metrics, sample sizes, expert adjudication, or AI.

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The steerable guiding sheath, model Adelante Destino is intended for the introduction of diagnostic and therapeutic devices into the human vasculature, including but not limited to intracardiac, renal or other peripheral placements.

Do not use this device for neural placements.

This is a modification to Indications for Use statement only. There was no change in the text of IFU and method of use.

There is no modification to the device itself. The Adelante Destino Steerable Guiding Sheath has been cleared in K120459 and will remain intact and no modification to product labels.

This 510(k) summary describes a modification to the Indications for Use (IFU) statement for the Adelante Destino Steerable Guiding Sheath (K122960). The submission explicitly states that there was no change in the device itself or its method of use. Therefore, the information typically associated with acceptance criteria and a study proving a device meets these criteria (such as performance metrics, sample sizes, ground truth establishment, or clinical study designs) is not applicable in this context.

The summary focuses on demonstrating substantial equivalence to predicate devices for the expanded indications, rather than proving performance against specific acceptance criteria through a study.

Here's a breakdown of why many of your requested points are not present in this document:

• No change in device design or performance: The core of this 510(k) is an administrative change to the IFU, not a hardware or software modification that would necessitate new performance testing.
• Focus on substantial equivalence to predicates: The justification for the expanded indications relies on the similarity of the proposed uses to existing cleared predicate devices, implying that the device's inherent performance characteristics, established in its original clearance (K120459), are sufficient for the broader indications.

Therefore, I cannot provide a table of acceptance criteria and reported device performance or information about a study proving the device meets acceptance criteria, as this information is not part of this specific 510(k) submission.

Summary of available information based on your request:

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

   • Not applicable. This 510(k) is for an expanded Indications for Use statement for an existing, unmodified device. There are no specific new acceptance criteria or reported performance data presented for this submission, as the device's performance was presumably established during its original clearance (K120459). The rationale for the expanded IFU is based on comparison to predicate devices for similar indications.

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

   • Not applicable. No new test set data or clinical studies were conducted for this IFU modification.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

   • Not applicable. No new ground truth establishment was performed, as no new clinical data was generated for this submission.

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

   • Not applicable. No test set or clinical study was conducted.

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 device is a steerable guiding sheath, not an AI-powered diagnostic tool. MRMC studies are not relevant to this type of medical device or this type of submission.

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

   • Not applicable. This is a hardware device, not an algorithm.

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

   • Not applicable. No new ground truth was established for this submission.

8. The sample size for the training set:

   • Not applicable. This is a hardware device, not a machine learning model, so there is no "training set."

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

   • Not applicable. As above, no training set for a machine learning model is relevant here.

In summary, this 510(k) submission is solely focused on expanding the labeled indications for use of an already cleared and unmodified device, based on substantial equivalence to predicate devices with similar, broader indications. It does not contain information about new performance studies or acceptance criteria.

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