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The 091 Balloon Guide Catheter is indicated for use in facilitating the insertion and guidance of intravascular catheters into a selected blood vessel in the peripheral and neuro vascular systems. The balloon provides temporary vascular occlusion during these and other angiographic procedures. The Balloon Guide Catheter is also indicated for use as a conduit for Retrieval devices.

The 091 Balloon Guide Catheter is a coaxial-lumen, coil-reinforced, variable stiffness catheter with a compliant balloon at the distal end to provide temporary vascular occlusion during angiographic procedures. A radiopaque marker is included at the distal end of the distal tip of the catheter) for fluoroscopic visualization. A bifurcated luer hub on the proximal end of the catheter allows attachments for flushing, and aspiration. This catheter is designed for use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the peripheral and neuro vascular systems. The dimensions and maximum recommended balloon inflation volume for the 091 Balloon Guide Catheter are indicated on the product label. A Peel-Away Introducer accessory is included within the packaging. It is supplied sterile, non-pyrogenic, and is intended for single use only.

This document describes the validation of the 091 Balloon Guide Catheter. Since the provided text focuses on the device's substantial equivalence to a predicate device for regulatory approval, the "acceptance criteria" and "device performance" primarily refer to engineering performance specifications and bench testing results, rather than clinical efficacy metrics for an AI/ML device. There is no mention of an AI/ML component in this premarket notification.

Therefore, the requested information specifically related to AI/ML device validation (e.g., sample sizes for training/test sets, expert ground truth adjudication, MRMC studies, standalone algorithm performance) is not applicable to this document. The document details the testing performed to ensure the device meets safety and performance standards for a medical device.

Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally implied by the "Pass" result for each test. The reported device performance is that it met all predetermined acceptance criteria for each test.

Details of the Study:

• 1. A table of acceptance criteria and the reported device performance: Provided above. All tests "Passed," indicating the device met all predetermined acceptance criteria.

• 2. Sample size used for the test set and the data provenance: The document states that "Some of the tests were also conducted on the predicate device to help establish substantial equivalence." However, specific sample sizes for each test are not explicitly detailed in this summary. The data provenance is from bench testing and simulated use, conducted to support a regulatory submission in the United States. It is not patient data, so "retrospective or prospective" is not applicable.

• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable in the context of an AI/ML device. For the "In-vitro Simulated Use Study – Benchtop," it states "A simulated interventional procedure was performed by physicians." For "Usability Testing," it mentions "Evaluators representative of the intended user population shall review... then attempt to use the catheters and accessories along with the expected compatible products in a simulated use environment, using worst-case neurovascular models." The specific number or qualifications of these physicians/evaluators are not detailed.

• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable as this is not an AI/ML device with image interpretation or complex diagnostic outputs requiring expert adjudication. Performance was assessed against pre-defined engineering and functional criteria.

• 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 (catheter), not an AI/ML diagnostic or assistive tool.

• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device (catheter), not an AI/ML algorithm.

• 7. The type of ground truth used:

  • Engineering/Performance Specifications: For most tests (e.g., Tensile Strength, Torque Strength, Burst, Leak tests, Dimensional Verification), the "ground truth" is defined by established engineering and materials standards (e.g., ISO 10555-1, USP , ASTM F-1929, ISO 594-1:1986).
  • Simulated Use/Usability: For these tests, the "ground truth" is the successful and safe performance of the device by intended users in a simulated clinical environment, meeting pre-defined operational criteria.
  • Biocompatibility: The "ground truth" is compliance with ISO 10993-1 and specific biological test methodologies (e.g., MEM elution, Magnusson-Kligman Method, ASTM Method for Hemolysis) to ensure the device is not harmful to biological systems.

• 8. The sample size for the training set: Not applicable. This is a physical medical device, not an AI/ML device trained on data.

• 9. How the ground truth for the training set was established: Not applicable.

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The Bleep™ DreamPort nasal adhesive mask is intended to provide an interface from a Continuous Positive Airway Pressure (CPAP) or bi-level system. The mask to be used by adult patients (>66 lbs. / 30 kg, for whom positive airway pressure has been prescribed. The mask is for single-patient reuse in the home, hospital/institutional environment.

The Bleep™ DreamPort nasal adhesive mask is similar to standard nasal pillow CPAP mask for use with patients using CPAP and bi-level equipment for the treat of OSA. The Bleep™ DreamPort nasal adhesive mask is comprised of 2 sub-assemblies: Nasal Port assembly and Airflow management assembly. The device uses single use foam tape to create the seal at the nostrils. This allows the interface to be used without head gear. There is a reusable interface which connects the nasal adhesive to the circuit of the CPAP equipment. It includes integrated exhalation ports.

The provided text describes the Bleep™ DreamPort nasal adhesive mask and its acceptance criteria for FDA clearance, comparing it to a predicate device (Resmed Swift LT). The study primarily focuses on non-clinical performance testing and a limited user study to demonstrate substantial equivalence, rather than a typical multi-reader multi-case (MRMC) or standalone AI performance study. Therefore, some of the requested information, particularly regarding AI-specific criteria, human reader improvement, and extensive expert ground truth establishment, is not applicable to this device's clearance process as described.

Here's an analysis based on the provided document:

Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally framed around demonstrating substantial equivalence to the predicate device (Resmed Swift LT, K073638) and compliance with international standards like ISO 17510-2:2015 and ISO 10993-1.

Study Information:

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

   • User study (Clinical Testing): The document states a "user study was performed," but does not explicitly mention the sample size (number of participants/patients).
   • Non-clinical performance testing (Bench Tests): This refers to the physical device being tested against standards (e.g., CO2 washout, exhaust flow). No "test set" in the sense of patient data is applicable here; tests are performed on the device itself.
   • Data Provenance: Not explicitly stated for the user study (e.g., country of origin, specific clinics). The user study was conducted over "2 nights" for each participant. It's implicitly prospective as it's a "user study" where performance was compared.

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

   • User Study (Clinical Testing): The document does not specify the number or qualifications of experts involved in establishing ground truth (e.g., reading sleep study data). It mentions "mean AHI during use" was compared, implying that existing clinical methods for AHI calculation would be the "ground truth." This is not an AI-specific ground truth establishment (like image annotation by multiple radiologists).
   • Non-clinical performance testing: Ground truth here are the engineering standards and measurements, not expert consensus.

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

   • User Study (Clinical Testing): The document does not specify any adjudication method for the clinical/user study results (e.g., for AHI measurements or leak rates). The comparison was seemingly direct or averaged.
   • Non-clinical performance testing: Not applicable.

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:

   • No, an MRMC comparative effectiveness study was not done. This device is a medical accessory (mask) and not an AI-powered diagnostic tool, so such a study is not relevant to its clearance.

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

   • No, not applicable. This is a physical medical device, not an algorithm. Bench testing is the "standalone" performance for the device itself.

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

   • User Study: The "ground truth" for the user study appears to be clinical measurements such as leak rates and AHI, which are standard metrics in sleep apnea therapy. This would typically be derived from objective CPAP machine data and sleep study results, often interpreted by sleep physicians. It is not described as involving extensive expert consensus or pathology data.
   • Non-clinical performance testing: The ground truth is engineering measurements against established ISO standards.

7. The sample size for the training set:

   • Not applicable. This device is not an AI/machine learning product and therefore does not have a "training set" in that sense. It's a manufactured product whose performance is demonstrated through physical and limited user testing.

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

   • Not applicable. See point 7.

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The Modified HD Guide Catheter is indicated for use in facilitating the insertion and guidance of an occlusion catheter, infusion catheter or other appropriate microcatheter into a selected blood vessel in the peripheral, coronary and neuro vascular systems. It may also be used as a diagnostic angiographic catheter and as a conduit for retrieval devices.

The Modified HD Guide Catheters are single lumen, braided, variable stiffness shaft catheters designed for use in facilitating the insertion and guidance of an occlusion catheter, infusion catheter or other appropriate microcatheter into a selected blood vessel in the peripheral, coronary or neuro vascular system. The catheters include a radiopaque marker on the distal and for angiographic visualization and a luer hub on the proximal end allowing attachments for flushing and aspiration. The catheter shaft has a hydrophilic coating to reduce friction during use. A rotating hemostatic valve with side-arm adapter is provided with each catheter.

Here's an analysis of the acceptance criteria and study details for the Modified HD Guide Catheter, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document categorizes testing into "Testing and Non-Clinical Performance Data" (bench testing) and "Clinical Performance Data" (review of existing clinical studies and post-market data).

• Non-Clinical Performance Data (Bench Testing):

  • The document states "All samples met acceptance criteria." but does not specify the exact number of samples used for each bench test (e.g., Tip Patency during Aspiration, Lumen Compatibility, etc.). It only implies that multiple samples (denoted by "All samples") were tested for each criterion.
  • Data Provenance: The bench testing utilized a "neurovascular model cast from actual human neurovascular arteries." This is a controlled experimental setup, not data from live patients.
  • Specifically for the expanded indications, "Finished sterilized devices were used for the simulated use testing."

• Clinical Performance Data:

  • TREVO 2 Study: 99 patients where the DAC (Modified HD Guide Catheter) was used.
    • Provenance: Retrospective analysis of an IDE trial ("TREVO 2 study... designed to support FDA clearance of the Trevo Retriever in the U.S."). Enrolled at 26 sites in the United States and one site in Spain.
  • TREVO Study: 30 patients where aspiration through DAC was applied (a subset of 34 patients where DAC was used).
    • Provenance: Retrospective analysis of a post-marketing prospective, multi-center, single-arm study performed at seven sites in Europe.
  • Post-Market Surveillance: A review of product complaints and Medical Device Reports (MDRs) from 2008 to July 31, 2013. The exact number of complaints reviewed is not given, but it is stated that 10 MDRs were filed.
    • Provenance: Real-world post-market data.
  • Literature Review: 15 published articles pertaining to DAC use.
    • Provenance: Published scientific literature.

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

• Non-Clinical (Bench) Testing: The document does not specify the number or qualifications of experts involved in observing and confirming the "Pass" results for the bench tests. It likely involved internal engineering or research staff.
• Clinical Performance Data (TREVO and TREVO 2 Studies):
  • The original TREVO 2 and TREVO studies would have had clinical investigators and potentially core labs or adjudication committees, but their specific roles in establishing "ground truth" for catheter performance (as opposed to primary study endpoints for the Retriever device) are not detailed here.
  • The 510(k) summary states that "None of the procedure related or CEC adjudicated events were related to DAC," implying that a Clinical Events Committee (CEC) was used in the TREVO study to adjudicate events. Their specific qualifications are not provided in this 510(k) summary.

4. Adjudication Method for the Test Set

• Non-Clinical (Bench) Testing: No specific adjudication method is mentioned. Results were simply reported as "Pass" based on visual verification or adherence to specified methods.
• Clinical Performance Data: The TREVO study mentioned events being "CEC adjudicated," indicating a Clinical Events Committee (CEC) was involved in reviewing adverse events. The specific method within the CEC (e.g., 2+1, 3+1) is not detailed. The TREVO 2 study also implies similar clinical oversight.

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

There is no MRMC comparative effectiveness study mentioned, nor is there any AI assistance component to this device. This is a physical medical device (catheter), not an AI-powered diagnostic tool. Therefore, this section is not applicable.

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

Not applicable, as this device is a physical catheter and does not involve an algorithm.

7. The Type of Ground Truth Used

• Non-Clinical (Bench) Testing:
  • For most bench tests, the "ground truth" was based on pre-defined acceptance criteria and direct observation of the device's physical performance characteristics (e.g., patency, resistance, integrity, absence of fracture/leakage) in a simulated environment (neurovascular model).
• Clinical Performance Data (TREVO 2 and TREVO Studies):
  • The "ground truth" in these studies relates to the clinical outcomes of the overall thrombectomy procedure, specifically revascularization rates and the absence of device-specific adverse events. While the primary ground truth would be patient outcomes as assessed by clinicians (e.g., angiography for revascularization, neurological exams for NIHSS), the review here focuses on whether the DAC was implicated in any negative outcomes.

8. The Sample Size for the Training Set

Not applicable. This is a physical device and not an AI/machine learning model that requires a training set. The existing clinical data reviewed served as real-world performance evidence, not 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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