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The Medtronic Octopus TE Stabilizer is used to stabilize the epicardial surface of the non-arrested heart during coronary artery surgery. It is intended to be used by trained medical professionals in operating room environments.
The Stabilizer is intended to stabilize the epicardial surface of the nonarrested heart during coronary artery surgery. It is intended to be used only by medical professionals in operating room environments.

The non-sterile, reusable Medtronic Octopus TE Heart Stabilizing System is a suction-based tissue stabilizer with a collapsible pod assembly, a rigid shaft and 5 articulating links designed to enable transfer into the thoracic cavity via a 12 mm thoracic port or traditional sternotomy access. It is comprised of four distinct elements: (1) the Medtronic Octopus TE Tissue Stabilizer, (2) the Medtronic Octopus TE Suction Lines, (3) the Medtronic Octopus TE Vacuum Lines, and (4) the Medtronic Octopus TE Irrigator (optional).
The Medtronic Octopus TE Heart Stabilizer is secured to a flexible arm and universal mounting rail, which attached to the operating table rail. Vacuum is delivered to the pod assembly by a disposable suction line inserted through the shaft of the stabilizer and a disposable vacuum line that connects the stabilizer to the vacuum source. The accessories are sold separately.

The provided text is a 510(k) summary for the Medtronic Octopus® TE Stabilizer & Accessories, which is a cardiovascular surgical instrument. It outlines the device's description, intended use, and substantial equivalence to predicate devices. However, the document does not contain information about specific acceptance criteria or a study proving the device meets those criteria, as it would apply to a diagnostic or AI-driven medical device.

This 510(k) pertains to a physical surgical instrument, not a device that generates data or requires performance metrics like sensitivity, specificity, or accuracy. The assessment of such a device focuses on "substantial equivalence" to legally marketed predicate devices in terms of design, materials, manufacturing processes, and intended use, rather than a clinical performance study with statistical endpoints.

Therefore, most of the requested information (acceptance criteria, device performance table, sample sizes, data provenance, expert qualifications, adjudication, MRMC study, standalone performance, ground truth types and establishment) is not applicable to this type of regulatory submission and is not present in the provided text.

Here's a breakdown of why the information is not present based on the nature of the device:

• 1. A table of acceptance criteria and the reported device performance: Not applicable. Performance for a surgical instrument is assessed through comparisons of its technological characteristics (e.g., design, materials, principle of operation) to predicate devices, and potentially through bench testing for safety and functional specifications, not a performance table against clinical acceptance criteria as would be seen for a diagnostic or AI device.
• 2. Sample sized used for the test set and the data provenance: Not applicable. There is no "test set" in the context of clinical performance data for this type of surgical instrument in this document.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth or expert review process of clinical data is described in this 510(k) summary for the device's performance.
• 4. Adjudication method for the test set: Not applicable.
• 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 not an AI-assisted diagnostic device.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm-based device.
• 7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable.
• 8. The sample size for the training set: Not applicable. This is not a machine learning device.
• 9. How the ground truth for the training set was established: Not applicable.

Summary of Relevant Information from the Document:

• Device Type: Cardiovascular Surgical Instrument/Heart Stabilizer.
• Regulatory Pathway: 510(k) Premarket Notification, indicating substantial equivalence to predicate devices.
• Predicate Devices: Medtronic Octopus Tissue Stabilizer (K964445) and the CTS (Guidant) Vacuum Assist Stabilizer (K992833).
• Basis of Equivalence: Patient population, intended use, function, basic system components, device design, and principal of operation were found to be substantially equivalent to the predicate devices.
• Study Described: The document refers to "Comparisons between the new and predicate devices shows that technological characteristics (i.e. device design and principal of operation) are substantially equivalent." This implies an engineering and design comparison rather than a clinical study with performance metrics in the typical sense.

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The Heart Stabilizer Pad is used on an appropriate heart stabilizer unit for coronary bypass surgery. It provides a mechanical means for immobilization of the anastomotic site on a beating heart and provides coronary artery isolation and occlusion by compression.

Pilling Weck Surgical Stabilizer Removable Pads

I am sorry, but the provided text does not contain the detailed information necessary to describe the acceptance criteria and the study proving the device meets those criteria in the format requested.

The document is a 510(k) clearance letter from the FDA for a device called "Pilling Weck Surgical Stabilizer Removable Pads." This letter primarily:

• Confirms that the device is substantially equivalent to legally marketed predicate devices.
• States its regulatory class (Class I) and product code.
• Outlines the general regulatory requirements that apply to the device, such as GMP regulations, registration, and prohibitions against misbranding and adulteration.
• Provides the "Indications for Use" for the device.

It does not include:

• Specific acceptance criteria (e.g., performance metrics, thresholds).
• Details of any specific study (clinical or analytical) conducted to demonstrate device performance against such criteria.
• Information regarding sample sizes, data provenance, ground truth establishment, expert qualifications, or comparative effectiveness studies.

Therefore, I cannot populate the table or answer the specific questions about the study details based on the provided text.

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The CTS Vacuum Assist Stabilizer is intended for use during the performance of minimally invasive cardiac surgery. Used in conjunction with the CTS Ultima™ OPCAB™ System, the stabilizer isolates and provides local immobilization of the target vessel on the beating heart.

The CTS Vacuum Assist Stabilizer consists of a curved shaft with an articulating foot at the distal end and a mount that connects to the CTS AccessRail™ Platform. The stabilizer provides local immobilization of an anastomotic site.

The provided text is a 510(k) Summary for the CardioThoracic Systems, Inc. Vacuum Assist Stabilizer. It outlines the device's description, intended use, and claims substantial equivalence to a predicate device. However, it does not contain any information regarding acceptance criteria, specific study designs, or performance metrics that would allow for the completion of the requested table and answers.

The summary states: "Functional bench, animal and histology testing has been conducted and the results of the testing verified that the Vacuum Assist Stabilizer performs as designed and is suitable for its intended use." This is a general statement and does not provide the detailed information needed to address your specific questions about acceptance criteria, study sizes, ground truth establishment, or clinical performance.

Therefore, I cannot provide the requested information based on the input text. The document is a regulatory submission summary rather than a detailed study report.

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The CTS Heart-LIFT Balloon Positioner is a surgical instrument intended to lift and position the heart during cardiac surgery.

The CTS Heart-LIFT Balloon Positioner consists of a manually inflatable, latex-free balloon attached to a malleable shaft. The balloon is inflated using a hand pump, which is attached via a flexible air tube to the proximal end of the malleable shaft. A pressure release valve allows deflation of the balloon. There also is a pressure relief valve to prevent over-inflation.

Here's an analysis of the provided text regarding the 510(k) submission for the CardioThoracic Systems, Inc. Heart-LIFT Balloon Positioner, focusing on acceptance criteria and study details:

This 510(k) summary does not include the type of detailed acceptance criteria and study information typically found for devices that rely on performance metrics like sensitivity, specificity, accuracy, or reader studies. This is because the Heart-LIFT Balloon Positioner is a Class I device and its submission is based on substantial equivalence to a predicate device (Janke-Barron Heart Support manufactured by Baxter), rather than a detailed performance study with statistical endpoints.

Therefore, many of the requested categories (like sample size for test sets, number of experts, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable or not provided in this type of submission.

The "acceptance criteria" here are met by demonstrating that the new device is functionally similar and safe for its intended use compared to an already marketed equivalent.

Summary of Acceptance Criteria and Study Information from the Provided Text:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Not explicitly stated for a statistical "test set." The studies mentioned are "functional bench testing" and "animal testing." These are likely engineering and pre-clinical tests, not necessarily human clinical trials with defined statistical sample sizes for a diagnostic or AI device. Data provenance (country of origin, retrospective/prospective) is also not specified.

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

• Not applicable. The "ground truth" for this type of device, which is a surgical tool, would be its physical properties and its performance in a surgical environment (bench/animal testing), not expert interpretations of data like in an imaging study.

4. Adjudication method for the test set:

• Not applicable. This applies to expert reviews, which were not conducted for this type of device submission.

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, not done. This type of study is relevant for AI/diagnostic devices where human reader performance is a key measure. The Heart-LIFT Balloon Positioner is a surgical instrument.

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

• No, not applicable. This applies to AI algorithms.

7. The type of ground truth used:

• The "ground truth" for this device's performance is established through functional bench testing (evaluating physical properties and operational stability) and animal testing (evaluating its ability to lift and position the heart in a living system). This is more akin to engineering performance standards and pre-clinical safety/efficacy observations rather than expert consensus, pathology, or outcomes data in a clinical trial sense.

8. The sample size for the training set:

• Not applicable. This is for AI algorithms, which this device is not.

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

• Not applicable. This is for AI algorithms, which this device is not.

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