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MTP Disposable Equipment Covers, KARL STORZ 15" Touch Screen are intended to cover equipment used in medical settings in order to maintain a sterile field and as an aid in the clean up of equipment after surgery. The covers are not intended to be used as patient drapes and have no patient contact.

MTP Disposable Equipment Covers, KARL STORZ 15" Touch Screen

The provided text is a 510(k) premarket notification letter from the FDA regarding "MTP Disposable Equipment Covers, KARL STORZ 15'' Touch Screen." This document is a regulatory approval letter and does not contain any information about acceptance criteria, study designs, sample sizes, expert qualifications, or ground truth establishment for a medical device's performance.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided input. The document is about the regulatory clearance process for a non-active, disposable cover, not the performance evaluation of a diagnostic or therapeutic AI-powered device.

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The MTP Unidrive® II Plus Disposable Tubing Set is intended to be utilized with the Karl Storz Unidrive® II Plus System for the controlled infusion of sterile irrigant solution during ENT endoscopic surgical surgery.

The MTP Unidrive® II Plus Disposable Tubing Set is utilized with the Karl Storz Unidrive® II Plus System. It is sold as sterile and single use device.

This 510(k) submission (K021811) for the MTP Unidrive® II Plus Disposable Tubing Set does not contain information about acceptance criteria or a study proving that the device meets those criteria.

Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (K003994, manufactured by KSEA). Substantial equivalence means the new device is as safe and effective as a legally marketed device that is not subject to premarket approval (PMA).

Here's why the requested information is not available in this document:

• Acceptance Criteria and Device Performance: The document does not specify quantitative acceptance criteria or report specific performance metrics for the MTP Unidrive® II Plus Disposable Tubing Set. The primary demonstration of safety and effectiveness relies on its similarity to the predicate device.
• Study Details (Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone, Ground Truth, Training Set): Because the submission is based on substantial equivalence and not a performance study evaluating novel claims, none of these study-related details are provided. The FDA's decision is based on comparing the new device's characteristics to the predicate device, not on clinical trial data or performance testing that would typically involve such metrics.

Summary of what is provided regarding equivalence:

The "SUBSTANTIAL EQUIVALENCE TABLE FOR MTP Unidrive® II Plus DISPOSABLE TUBING SET" (page 1) details the comparative features:

The FDA's letter (pages 2-3) confirms the "substantial equivalence determination," allowing the device to be marketed. This decision is based on the MTP device having the "same basic features and intended uses" as the predicate device (KSEA K003994). This regulatory pathway (510(k)) does not typically require extensive novel clinical performance studies if substantial equivalence can be demonstrated.

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These instruments are manually operated surgical devices intended for abdominal, thoracic, and gynecologic minimally invasive surgical procedures to establish a path of entry for endoscopic instruments and endoscopes.

The MTP Disposable Trocars body contact material is polycarbonate.

This submission pertains to the MTP Disposable Trocars, which are manually operated surgical devices. The provided documents focus on the 510(k) submission process for these devices, asserting their substantial equivalence to predicate devices already on the market. Crucially, the documents do not contain information about specific acceptance criteria or a study demonstrating that the device meets such criteria.

Therefore, I cannot provide the requested table or detailed study information.

Here's why and what information is available:

• Type of Device: The MTP Disposable Trocars are a surgical instrument. For devices like these, substantial equivalence is often established based on similarities in materials, design, intended use, and performance characteristics to legally marketed predicate devices. This typically involves demonstrating that the new device does not raise new questions of safety or effectiveness.
• Missing Information: The provided text is a 510(k) summary and the FDA's clearance letter. These documents confirm the regulatory pathway and clearance but do not contain detailed performance study data, acceptance criteria, sample sizes, expert qualifications, or ground truth methodologies that would be found in a comprehensive clinical or performance validation study report.

Summary of available information as per your request, indicating where information is lacking:

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

   • Not provided. The document focuses on demonstrating substantial equivalence, not on specific performance metrics or acceptance criteria for a new, unique performance claim.

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

   • Not provided. No performance study is detailed.

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 provided. No test set or related ground truth establishment is described.

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

   • Not provided. No test set or adjudication method is described.

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/Not provided. This device is a manual surgical instrument, not an AI-assisted diagnostic or therapeutic tool with human readers.

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

   • Not applicable/Not provided. This device is a manual surgical instrument, not an algorithm.

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

   • Not provided. No ground truth establishment for performance is described. The "ground truth" for regulatory assessment here is typically the established safety and effectiveness of the predicate devices.

8. The sample size for the training set:

   • Not applicable/Not provided. This is not an AI/algorithm-based device and thus does not have a training set in that context.

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

   • Not applicable/Not provided. As above, no training set is relevant for this type of device in the context of the provided documentation.

In essence, the provided documents represent the regulatory clearance of a medical device based on substantial equivalence, rather than a detailed performance study with specific acceptance criteria and results for an AI or diagnostic tool.

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The MTP Uropump Disposable Tubing Set is intended for use by qualified surgeons in the infusion of sterile irrigant solution into the ureter and urinary tract during ureterorenoscopic examinations.

The MTP Uropump Disposable Tubing Set is intended to be utilized with the Karl Storz Uropump Irrigation/Suction System for the infusion of sterile irrigant solution into the ureter and urinary tract during ureterorenoscopic examinations.

The MTP Uropump Disposable Tubing Set is intended for use by qualified surgeons in the infusion of sterile irrigant solution into the ureter and urinary tract during ureterorenoscopic examinations. The body contact materials are PVC, silicone, polyolefin, and Makrolon.

This document is a 510(k) summary for the MTP Uropump Disposable Tubing Set. It does not contain information about acceptance criteria or a study proving that a device meets acceptance criteria.

The document details the device's identification, indication for use, device description, and claims substantial equivalence to a predicate device. It also includes the FDA's clearance letter.

Therefore, I cannot fulfill your request for information regarding acceptance criteria and a study proving device performance from the provided text.

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The MTP Extraction Bag is intended for use by qualified surgeons in tissue extraction procedures during laparoscopic surgery.

The Extraction Bag for use in Laparoscopy is intended for use by qualified surgeons during laparoscopic procedures, including cholecystectomy, appendectomy, nephrectomy, lymphadenectomy, intestinal resection, oophorocystectomy and myomectomy.

The MTP Extraction Bag is intended for use by qualified surgeons in tissue extraction procedures during laparoscopic surgery. The body contact materials are high density polyethylene and polyurethane film.

The provided document is a 510(k) summary for the MTP Extraction Bag, a medical device used in laparoscopic surgery. It does not contain information about acceptance criteria or a study proving that a device meets such criteria. Medical devices like the MTP Extraction Bag are typically evaluated for substantial equivalence to a predicate device rather than undergoing performance studies that would generate the type of data requested in the prompt. Therefore, I cannot extract the requested information from this document.

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The MTP Arthropump Disposable Tubing Set is intended for use by qualified surgeons for the infusion of sterile irrigant solution into joints during arthroscopic surgical procedures.

The MTP Arthropump Disposable Tubing Set is intended to be utilized with the Karl Storz Arthropump Irrigation System for the infusion of sterile irrigant solution into joints during arthroscopic surgical procedures.

The MTP Arthropump Disposable Tubing Set is intended for use by qualified surgeons for the infusion of sterile irrigant solution into joints during arthroscopic surgical procedures. The body contact materials are PVC, silicone, polyolefin, and Makrolon.

I apologize, but this document does not contain the information requested regarding acceptance criteria and studies proving device performance. The provided text is a 510(k) summary for a medical device (MTP Arthropump Disposable Tubing Set), which focuses on establishing substantial equivalence to a predicate device rather than detailing specific performance studies with acceptance criteria, sample sizes, expert ground truth establishment, or multi-reader multi-case studies.

The document primarily covers:

• Applicant and contact information
• Device identification and indication for use
• Device description
• Claim of substantial equivalence to a predicate device
• FDA's letter acknowledging the 510(k) submission and substantial equivalence determination.

Therefore, I cannot provide a table of acceptance criteria and device performance, nor details about sample sizes, ground truth establishment, or multi-reader studies from this document.

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The MTP Hamou Endomat Disposable Tubing Sets are intended for use by qualified surgeons for the controlled infusion of sterile irrigant solution into body cavities during laparoscopic and hysteroscopic procedures.

The MTP Hamou Endomat Disposable Tubing Set is intended to be utilized with the Karl Storz Hamou Endomat Irrigation System for the controlled infusion of sterile irrigant solution into body cavities during laparoscopic and hysteroscopic procedures.

The MTP Hamou Endomat Disposable Tubing Sets are intended for use by qualified surgeons for the controlled infusion of sterile irrigant solution into body cavities during laparoscopic and hysteroscopic procedures. The body contact materials are PVC, silicone, polyolefin, and Makrolon.

The provided document is a 510(k) Summary of Safety and Effectiveness for the MTP Hamou Endomat Disposable Tubing Sets. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with acceptance criteria and performance data for the device itself.

Therefore, the requested information regarding acceptance criteria, device performance, study details (sample size, data provenance, expert ground truth, adjudication, MRMC, standalone performance, ground truth type for test and training sets, training set sample size, and ground truth establishment for training set) is not available in the provided text.

The document states:
"The MTP Hamou Endomat Disposable Tubing Sets are substantially equivalent to the predicate device since the basic features, design and intended uses are the same."

This means the submission relies on the established safety and effectiveness of a previously cleared device (the predicate device) because the new device shares fundamental characteristics and intended use. There is no new performance study described in this 510(k) summary.

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