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The Medtronic Cardioblate® MAPS Surgical Mapping, Ablation, Pacing, and Sensing Device is a sterile, single use electrosurgery device intended to ablate cardiac tissue using radiofrequency energy when connected to the Cardioblate® 68000 Generator or for temporary cardiac pacing, sensing, recording, and stimulation during the evaluation of cardiac arrhythmias during surgery when connected to an external temporary cardiac pacemaker.

The Medtronic Cardioblate® MAPS Surgical Mapping, Ablation, Pacing, and Sensing Device is a hand held, monopolar, radiofrequency ablation device powered by the Cardioblate® 68000 Generator (cleared via K060400, K080509). It has a saline irrigation system that delivers fluid at the contact point between tissue and electrode tip to cool tissue during radiofrequency energy delivery. The device can also be used with the Medtronic Model 2090/2290 Programmer/Analyzer and the Medtronic Model 5388/5348 External Temporary Pacemaker for two pole sensing of the ventricle or the atrium and two pole stimulation (pacing) of the atrium. The device is intended for intermittent operation. The device is provided sterile (via ethylene oxide sterilization), nonpyrogenic, disposable and for single use only.

The provided text is a 510(k) summary for the Cardioblate® MAPS Surgical Mapping, Ablation, Pacing, and Sensing Device. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a de novo study with explicit acceptance criteria and performance data in the format requested.

Therefore, the document does not contain the detailed information required to fill out the table and answer all questions in the requested format. Specifically, it lacks:

• Explicit acceptance criteria for device performance.
• Quantified reported device performance against those criteria.
• Details about sample sizes for test sets, training sets, or data provenance.
• Information on expert qualifications, adjudication methods, or multi-reader multi-case studies.
• A clear distinction between "standalone" performance and human-in-the-loop performance.
• Detailed descriptions of how ground truth was established for training and testing data.

Instead, the submission relies on demonstrating equivalence through:

• Comparison of Indications for Use: Stating that the MAPS device has the same indications for use as a predicate device (Cardioblate® Monopolar Pen).
• Functional Equivalence Claims: Asserting that the MAPS device produces irrigated, monopolar radiofrequency ablations functionally equivalent to the Cardioblate® Monopolar Pens and performs bipolar sensing, mapping, and pacing functionally equivalent to the Detect device.
• Non-Clinical Performance Data: Mentioning "Verification and validation testing, including bench testing and animal studies," which demonstrated equivalence to predicate devices. However, no specific performance metrics or results from these tests are provided in this summary.

In summary, based solely on the provided text, it is not possible to complete the requested table and answer the questions. The document is a regulatory submission for substantial equivalence, which typically does not include the granular detail of a clinical study report with explicit acceptance criteria and corresponding performance data.

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The U-CLIP™ Uni-Fire is intended for endoscopic and non-endoscopic general soft tissue and prosthetic material approximation/attachment and/or ligation and the creation of anastomosis in blood vessels, grafts and other tubular structures; including use in cardiovascular and coronary artery bypass grafting procedures.

The U-CLIP™ is a self-closing clip for anastomosis and tissue and prosthetic material approximation or attachment applications. The Model M65 U-CLIP" Uni-Fire device consists of a self-closing Nitinol clip that is constrained in an open position in a stainless steel hypotube until released by the surgeon after placement. The clip is released from a slot in the side of the hypotube. After release, the arms of the clip attempt to regain their preferred, closed configuration, thereby holding the tissue layers together. This design allows precise placement of clips prior to closure, and facilitates an interrupted "suture" technique by eliminating knot tying. The device is manufactured with a standard implantable grade of Nitinol.

The provided text describes a 510(k) premarket notification for the U-CLIP™ Uni-Fire, Model M65, not a study involving AI or complex performance metrics. The information is solely about demonstrating substantial equivalence to a predicate device based on design, materials, intended use, and general function. Therefore, most of the requested fields are not applicable or cannot be extracted from this document, as they pertain to clinical studies, AI performance, and expert evaluations.

Here's an attempt to answer the questions based only on the provided text, explicitly stating when information is not available:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states: "Verification and validation testing confirms that functional characteristics are substantially equivalent to the predicate device cited. This included clip strength and clip deployment. All test data obtained satisfied the documented product and performance specifications."
However, specific quantitative acceptance criteria or reported performance values (e.g., exact clip strength in Newtons, deployment success rate) are not provided in this summary.

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

• Sample Size: Not specified in the provided text.
• Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). The text mentions "in vitro, in vivo, and clinical performance information provided in previous pre-market notifications," but no details for this submission's testing.

3. Number of Experts Used to Establish Ground Truth and Their Qualifications:

Not applicable. This is a medical device submission, not an AI or diagnostic tool study requiring expert-established ground truth. The "ground truth" for the device's function would be its physical performance against engineering specifications.

4. Adjudication Method for the Test Set:

Not applicable. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in clinical or image-based diagnostic studies. For this device, performance is likely assessed against engineering specifications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC study was not done. This device is an implantable clip, not a diagnostic or AI-assisted tool that would involve human readers.

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

Not applicable. This is a physical medical device, not an algorithm or software. The "standalone" performance here refers to the device's functional characteristics (clip strength, deployment), which were tested.

7. The Type of Ground Truth Used:

For a medical device like the U-CLIP, the "ground truth" refers to its compliance with fundamental engineering and design specifications (e.g., material properties, dimensions, mechanical strength, deployment mechanism). The text implies its performance was verified against "documented product and performance specifications," which serve as the ground truth for its functional characteristics. No pathology, outcomes data, or expert consensus as a ground truth for performance is mentioned for this particular submission.

8. The Sample Size for the Training Set:

Not applicable. This is not an AI or machine learning device; therefore, there is no "training set."

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

Not applicable, as there is no training set.

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