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The Medtronic Model 10626 Myocardial Implant Tool is used to facilitate myocardial pacing lead placement. It is designed to assist in the placement and manipulation of the Model 5071 myocardial pacing lead.

The implant tool consists of a handle, malleable shaft and lead hub fixation assembly (tongs) which grab and release a Model 5071 lead when the springloaded button actuator is depressed and released. The handle assembly includes a rotable, thumbwheel. Rotation of this thumbwheel in a clockwise direction results in equivalent rotation of a lead hub fixation assembly located at the distal end of the tool. Depression of the actuator allows fixation to the Model 5071 lead and also activates the fixation release upon completion of implant. Release of the actuator activates the fixation of the tool to the Model 5071 lead.

The provided text describes the Medtronic Model 10626 Myocardial Implant Tool, a Class I accessory device intended to facilitate myocardial pacing lead placement. It is a mechanical tool, not an AI/ML powered device, and therefore the majority of the requested information (related to AI/ML specific studies, ground truth, expert consensus, etc.) is not applicable.

However, I can extract the acceptance criteria and the study performed for this device based on the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated. The text mentions "Testing was performed on tools built according to a documented process and subjected to environmental conditioning." This suggests some number of physical devices were manufactured and tested, but the exact number is not provided.
• Data Provenance: Not applicable in the context of typical AI/ML data provenance (e.g., country of origin of patient data). The testing was an in vitro (benchtop/laboratory) evaluation of the physical device's mechanical and functional properties. The tests were performed by Medtronic.

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 mechanical implant tool, not a diagnostic or AI/ML device that requires expert-established ground truth for its performance evaluation. The "ground truth" for this device's performance is its ability to meet documented engineering and functional specifications.

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

• Not Applicable. As a mechanical device, performance testing involves objective measurements against engineering specifications, not subjective interpretation requiring adjudication among 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:

• No. This is not an AI/ML device and therefore no MRMC study or assessment of human reader improvement with AI assistance was performed or is relevant.

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

• Not Applicable. This is a mechanical tool operated by a human, not an algorithm. Its performance is always tied to human use, though the in vitro tests assess its standalone functional integrity.

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

• The "ground truth" for this device's performance is adherence to predefined product specifications and engineering requirements for its mechanical and functional attributes (e.g., grabber insertion, rotation, lead fixation, shaft flexibility).

8. The sample size for the training set:

• Not Applicable. This device is not an AI/ML model, so there is no "training set."

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

• Not Applicable. There is no training set for this mechanical device.

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The indications or intended use for the DLP Octopus™ Tissue Stabilizer and the predicate product, Cardiothoracic Systems, Inc. (CTS) Thoracic Access Platform and Stabilizer are the same. Both are intended for use du ring coronary artery bypass grafting to isolate diseased artery and minimize motion of the beating heart to facilitate the grafting procedure.

The design of the Octopus"" is similar to both predicate products referenced in the Comparison Information Section. It features plastic handle with vacuum tubing connection, malleable stainless steel arm and suction tip similar to the DLP Cardiac Suction Tube product. The "feet" design of the Octopus" is intended to position the anastomosis site between two "feet" for isolation and stabilization control which is the same as the CTS Thoracic Access Platform and Stabilizer.

This document is a 510(k) summary for a medical device (Octopus™ Tissue Stabilizer) and does not contain information about acceptance criteria or a study proving device performance in the way a clinical trial or AI/ML study would. It's a regulatory document demonstrating substantial equivalence to a predicate device.

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

Here's how I can address the parts that are relevant to this type of document:

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

This document does not specify quantitative acceptance criteria or report performance metrics in the way a clinical study would (e.g., sensitivity, specificity, accuracy). Instead, it focuses on demonstrating substantial equivalence to existing predicate devices.

The "acceptance criteria" in this context are implicitly related to the regulatory requirements for showing that the new device is as safe and effective as the predicate device.

Reported Device Performance (Implicit from the document):

The rest of the requested information (sample size, data provenance, number of experts, adjudication method, MRMC study, standalone performance, type of ground truth, training set size, training set ground truth) is not applicable to this 510(k) summary document, as it describes a mechanical device for surgical use and not an AI/ML algorithm or a study involving human readers and a test set. This document relies on comparisons to predicate devices and biocompatibility testing, not on clinical performance metrics in the sense of accuracy, sensitivity, etc., that would require a ground truth or expert evaluation.

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SPECIFIC INDICATION OF USE: PATENT DUCTUS ARTERIOSUS INTERRUPTION
INTENDED USES: intended for use for General Pediatric Surgery where visualization in confined anatomic spaces minimizing tissue trauma are needed. These instruments are designed to be used in Video-Assisted Thoracoscopic Surgery (VATS). Where size constraints are limiting and immature tissues are potentially vulnerable to mechanical injury.
INDICATIONS: Pediatric Thoracoscopic Procedures Patent Ductus Arteriosus Interruption (PDA)
CONTRA INDICATIONS: For PDA patients with a ductal diameter over 1 cm calcification, presence of a transcatheter device within the ductal lumen, patients with dense pleural adhesions.

These instruments are equivalent to Thoracoscopy instruments for adult sizes but have a reduced dimension with a modified geometric configuration to meet reduced size requirements. These are modifications therefore of equivalent surgical instruments that can be used in general pediatric surgery but also have been designed specifically for pediatric thoracoscopic surgery. Instruments that are needed for the surgical procedures are cannula, lung retractor, clip appliers, grasping forceps with ratchets, scissors, hooks, and clamps. These instruments have specific overtures and dimensions suited for this surgical procedure.

The provided document is a summary of safety and efficacy for a medical device (Burke Congenital Thoracoscopy Instruments) from 1996. It describes the device, its intended use, indications, and contraindications. It does not contain any information about acceptance criteria, performance studies, or clinical trial data.

Therefore, I cannot answer your request for the specified information as it is not present in the provided text.

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Ask a specific question about this device

Ask a specific question about this device