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The ADMIRAL XTREME™ PTA Balloon Dilatation Catheter is intended to dilate stenoses in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

The ADMIRAL XTREME™ PTA Balloon Dilatation Catheter is an over-the-wire percutaneous transluminal angioplasty (PTA) catheter consisting of a proximal hub, dual lumen shaft, and a distal dilatation balloon. The ADMIRAL XTREME™ PTA Balloon Dilatation Catheter is compatible with guidewires with a maximum diameter of 0.035" and with 5, 6 or 7 FR introducer sheaths, depending on the diameter/length of the dilatation balloon. The catheter is provided with a hydrophilic coating and is available in useable catheter lengths of 40cm, 80cm and 120cm. The ADMIRAL XTREME™ PTA Balloon Dilatation Catheter includes additional balloon lengths of 150 mm, 200 mm, 250 mm and 300 mm. The modified ADMIRAL XTREME™ PTA Balloon Dilatation Catheter is manufactured from the same materials as the predicate ADMIRAL XTREME™ PTA Catheter and has the same Intended Use.

This is a 510(k) summary for a medical device, the ADMIRAL XTREME™ PTA Balloon Dilatation Catheter. It's important to understand that this document describes a submission for regulatory clearance, not a scientific study proving clinical effectiveness or diagnostic accuracy in the way an AI algorithm study would.

Therefore, many of the requested categories related to AI performance, ground truth, expert consensus, and comparative effectiveness studies are not applicable to this type of device submission. This submission focuses on demonstrating substantial equivalence to a previously cleared predicate device, primarily through engineering performance testing.

Here's an breakdown of the available information based on your request, with clarifications on why certain categories are not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

The document states: "Verification testing of the ADMIRAL XTREME™ PTA Balloon Dilatation Catheter demonstrated that the device met the acceptance criteria." While the specific numerical acceptance criteria values are not provided in this summary, the types of tests performed indicate the areas of acceptance.

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

• Sample Size for Test Set: This document does not specify the exact sample sizes used for each of the verification tests. These would typically be determined by engineering and statistical principles relevant to device testing (e.g., number of units tested for burst strength, fatigue, etc.).
• Data Provenance: The testing appears to be internal verification testing performed by the manufacturer (Invatec S.p.A.). The country of origin of the data would therefore be Italy (where Invatec S.p.A. is located). This is prospective testing, as it was conducted specifically for this submission to verify the performance of the modified device.

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

• Not Applicable. This is a physical medical device. "Ground truth" in the context of expert consensus, as typically applied to AI or diagnostic image analysis, is not relevant here. The "ground truth" for these engineering tests are established physical standards, measurements, and specifications.

4. Adjudication Method for the Test Set

• Not Applicable. As explained above, this is physical device testing, not a clinical study requiring expert adjudication of outcomes or diagnostic findings. The results are based on objective measurements against predefined engineering specifications.

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 submission is for a physical medical device (PTA balloon catheter), not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study and AI-related effectiveness metrics are not relevant.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done

• Not Applicable. As above, this is not an AI algorithm.

7. The Type of Ground Truth Used

• Engineering Specifications and Standards: The "ground truth" for this device's performance is based on established engineering specifications, industry standards (e.g., ISO 10993 for biocompatibility), and regulatory requirements. For example, balloon burst strength is measured against a specified pressure value, and dimensions are checked against design blueprints.

8. The Sample Size for the Training Set

• Not Applicable. This is not an AI algorithm that requires a "training set."

9. How the Ground Truth for the Training Set Was Established

• Not Applicable. As above, this is not an AI algorithm.

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The SCUBA™ Biliary Stent System is indicated for use in the palliation of malignant neoplasms in the biliary tree

The SCUBA Biliary Stent System consists of a balloon-expandable MP35N (cobalt, nickel, chromium molybdenum alloy) stent mounted on a 5 F over-the-wire (OTW) balloon catheter. The stent is provided in nominal expanded diameters of 5 mm to 10 mm, and stent lengths of 18 to 75 mm. The SCUBA Biliary Stent System has an 80 cm usable length and is compatible with 6 or 7 F introducer sheaths, and guidewires up to 0.035" diameter.

The provided text does not contain specific acceptance criteria or an explicit study description with detailed performance metrics.

The "Performance Data" section states:
"Preclinical bench and biocompatibility testing was conducted to evaluate the safety and performance of the SCUBA Biliary Stent System. Testing included comparative testing with the predicate devices. Test results indicate that the SCUBA Biliary Stent System is safe and effective for the intended purpose, has comparable performance to the predicate devices, and is biocompatible."

This is a general statement and lacks the quantitative data, sample sizes, and detailed methodology typically found in a study proving device meets acceptance criteria.

Therefore, most of the requested information cannot be extracted from the provided text.

Here's a breakdown of what can and cannot be answered based on the provided document:

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

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

• Sample Size: Not specified.
• Data Provenance: Not specified (the testing was "preclinical bench and biocompatibility testing," implying laboratory tests, not clinical data from specific countries or patients).
• Retrospective/Prospective: Not specified.

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. The testing described is preclinical bench and biocompatibility testing, which typically does not involve human experts establishing ground truth in the way clinical studies do.

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

• Not applicable. (See #3)

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 study was not done (the device is a physical medical device, not an AI-powered diagnostic tool).

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

• Not applicable (the device is a physical medical device, not an algorithm).

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

• Not applicable. For preclinical bench and biocompatibility testing, "ground truth" would be established by validated testing methods and reference standards for material properties, mechanical integrity, and biological response, rather than medical expert consensus or patient outcomes.

8. The sample size for the training set

• Not applicable (the device is a physical medical device, not an AI model that requires a training set).

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

• Not applicable (See #8).

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The REEF HP 0.035" OTW PTA Balloon Dilatation Catheters are intended to dilate stenoses in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

The Reef HP 0.035"OTW PTA Balloon Catheter is an over-the-wire percutaneous transluminal angioplasty (PTA) catheter consisting of a proximal hub, dual lumen shaft, and a distal non-compliant dilatation balloon. The REEF HP 0.035" OTW PTA Balloon Dilatation Catheter is compatible with guidewires with a maximum diameter of 0.035" and with 5, 6 or 7 FR introducer sheaths, depending on the diameter/length of the dilatation balloon. The catheter is provided in useable catheter lengths of 50 cm, 80cm and 120 cm.

The provided documentation is a 510(k) summary for a medical device (REEF HP 0.035" OTW PTA Balloon Dilatation Catheter), not a study evaluating an AI/ML powered device. Therefore, it does not contain the specific information requested in the prompt regarding acceptance criteria, study design parameters (sample size, data provenance, ground truth establishment, expert qualifications, adjudication methods), or comparative effectiveness studies typically associated with AI/ML device evaluations.

The document states:

• Performance Data: "Bench testing of the REEF HP 0.035" OTW PTA Balloon Dilatation Catheter demonstrated that the device met the bench test acceptance criteria."
• Biocompatibility: "Biocompatibility testing was performed in accordance with ISO 10993-Part 1."

However, it does not provide:

1. A table of acceptance criteria or reported device performance metrics and their values.
2. Details about sample sizes for test sets, data provenance, or anything related to "test sets" in the context of an AI/ML algorithm.
3. Information on experts, ground truth establishment (beyond general bench testing), or adjudication methods, as these are not relevant to the traditional medical device being described.
4. Any mention of a multi-reader multi-case (MRMC) comparative effectiveness study.
5. Any mention of a standalone algorithm performance study.
6. The type of ground truth used (e.g., pathology, expert consensus) for algorithm training or testing.
7. Sample size for a training set.
8. How ground truth for a training set was established.

This document is a regulatory submission for a conventional medical device (a balloon catheter), focusing on its substantial equivalence to predicate devices based on design, materials, technological characteristics, and bench performance, rather than an AI/ML diagnostic or assistive device.

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The MO.MA® ULTRA Proximal Cerebral Protection Device is indicated as an embolic protection system to contain and remove embolic material (thrombus/debris) while performing angioplasty and stenting procedures involving lesions of the internal carotid artery and or the carotid bifurcation. The reference diameter of the external carotid artery should be between 3-6 mm and the reference diameter of the common carotid artery should be between 5-13 mm.

The MO.MA® ULTRA Proximal Cerebral Protection Device consists of a multi-lumen shaft integrating two compliant occlusion balloons. The device is packaged with one hollow mandrel, one hemostatic valve with two-way stopcock and extension tubing, three 40 um filter baskets, one 30 cc syringe with male luer, one T-safety connector and two 1-way stopcocks. The MO.MA® ULTRA Proximal Cerebral Protection Device achieves cerebral protection by occluding the common carotid artery (CCA) and the external carotid artery (ECA) with two compliant balloons. Occluding the CCA and ECA produces blockage of antegrade and retrograde blood flow at the carotid bifurcation to prevent distal embolization of particulate debris and allow removal of particulate debris by blood aspiration.

Here's the analysis of the provided text regarding the MO.MA® ULTRA Proximal Cerebral Protection Device:

Acceptance Criteria and Device Performance Study

The provided 510(k) summary for the MO.MA® ULTRA Proximal Cerebral Protection Device focuses on establishing substantial equivalence to a predicate device and relies on clinical data compared against a pre-established performance goal. It does not explicitly define traditional "acceptance criteria" in terms of specific performance metrics (like sensitivity, specificity, accuracy) but rather sets a performance goal for a clinical outcome.

1. Acceptance Criteria and Reported Device Performance

Note: The exact quantitative performance goal for MACCE and the device's actual MACCE rate are not explicitly stated in this 510(k) summary, only that the device met the goal.

2. Sample Size and Data Provenance for the Test Set

• Sample Size for Test Set: 262 patients
• Data Provenance: Prospective, multi-center study conducted in the United States (184 patients at 20 sites) and Europe (78 patients at 5 sites).

3. Number of Experts and Qualifications for Ground Truth

The document does not specify the number of experts used to establish ground truth or their qualifications. The study focused on clinical outcomes (MACCE), which are typically assessed by physicians and clinical staff involved in patient care and follow-up, but no independent expert panel for ground truth assessment is described.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method for the test set. Clinical endpoints like MACCE are usually determined by the treating physicians and confirmed through medical records, but there's no mention of a specific adjudication panel or method (e.g., 2+1, 3+1).

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

There was no MRMC comparative effectiveness study described. This device is a physical medical device (cerebral protection device) used during a procedure, not an AI/software product requiring human reader interpretation or assistance. Therefore, the concept of human readers improving with or without AI assistance does not apply.

6. Standalone (Algorithm Only) Performance

This question is not applicable as the device is a physical medical device, not an algorithm or AI.

7. Type of Ground Truth Used

The ground truth used was outcomes data, specifically the 30-day major adverse cardiac and cerebrovascular events (MACCE) composite rate.

8. Sample Size for the Training Set

This question is not applicable. The device is a physical medical device, not an AI/software requiring a training set.

9. How the Ground Truth for the Training Set was Established

This question is not applicable as there was no training set for an algorithm.

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