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For use in a variety of open procedures, such as abdominal, pediatric, thoracic, gynecologic, etc. and for use in endoscopic and laparoscopic the assol gynocelling hemostatic transection of vessels and other tissue structures.

Richard-Allan's Reflex AEC 35, with shorter shaft length is substantially equivalent to our currently marketed Reflex AEC 35. These instruments have the same component materials, method of manufacturing, and method of sterilization. These instruments have similar instructions for use.

The provided document is a 510(k) premarket notification for a medical device (Reflex AEC Linear Stapler/Cutter). It states that the device is "substantially equivalent" to an already marketed device and does not involve a study with acceptance criteria and a reported device performance as typically seen for AI/ML-based medical devices or novel technologies requiring extensive clinical trials.

The document does not contain any information regarding:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test or training sets, or data provenance.
• Number of experts or their qualifications, or adjudication methods for ground truth.
• MRMC comparative effectiveness studies or standalone algorithm performance.
• Ground truth types for test or training sets.

This is because the submission is for a modification (shorter shaft length and expanded indications) of an existing device, and the primary focus is on establishing "substantial equivalence" to predicate devices, rather than proving performance against specific acceptance criteria through a formal study as would be done for a new device requiring performance validation.

The key points from the provided text related to safety and effectiveness are:

• Substantial Equivalence: The Reflex AEC 35 with a shorter shaft length is substantially equivalent to the currently marketed Reflex AEC 35. This determination is based on having the "same component materials, method of manufacturing, and method of sterilization" and "similar instructions for use."
• Safety and Effectiveness: The document explicitly states that the difference in shaft lengths "will not affect safety or effectiveness of our device, overall function or application intended for the use of this type of device."
• Intended Use: The modified device has the same intended use as the current Reflex AEC 35, Multifire GIA, and Endo GIA 30: "hemostatic transection of vessels and other tissue structures."
• Expanded Indications: The expanded indication for use (general open procedures like abdominal, thoracic, pediatric, gynecologic) is also stated "will not affect safety or effectiveness of our device, or overall function of this type of device."

Therefore, based on the provided text, a table of acceptance criteria and a study with detailed performance metrics, sample sizes, and ground truth information cannot be extracted because this type of information is not part of a 510(k) submission focused on substantial equivalence for a mechanical device modification.

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The Intubation Endoscope and Introducer Sheath are used in the direct visualization in the trachea and lungs during fiberoptically assisted intubation and airway management.

UROHEALTH Intubation Endoscope Introducer Sheath is a device that consists a malleable or nonmalleable introducer sheath that houses a channel for insufflation of oxygen or fluid delivery, a deflecting mechanism for the distal tip, a channel for scope insertion, and a distal window. The reusable fiber optic imaging and illumination system consists of a focusing ocular lens, a distal objective lens, and a connection for a fiber optic light cable.

The provided 510(k) summary for K970107, the UROHEALTH Intubation Endoscope and Introducer Sheath, describes performance testing but does not present specific acceptance criteria or detailed study results in a quantitative manner as typically expected for device performance. It outlines the types of tests to be conducted rather than reporting the outcomes against defined metrics.

Here's a breakdown based on the provided text, addressing your points:

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

Based on the provided text, specific quantitative acceptance criteria and reported device performance are not available. The summary states:

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The Pivotal devices are sterile, disposable, general surgical instruments for use in endoscopic or open surgical procedures to dissect, transect, manipulate, coagulate, and/or grasp tissue.

The Pivotal instrument and similar currently marketed devices are intended to cut, grasp, manipulate, and coagulate tissue during surgical procedures. The similar marketed endoscopic devices are designed to be used with monopolar electrosurgery and are disposable devices supplied sterile to the user. These devices are available in a variety of blade and jaw configurations. These devices have similar thermoplastic ringed handles that open and close the jaws. The grasper devices are all equipped with a ratchet mechanism that allows the tissue to be held in the jaws without the need for applying constant pressure on the ringed handles.

The provided text is a 510(k) summary for the Pivotal Grasper, Pivotal Dissector, and Pivotal Scissors. This document is focused on demonstrating substantial equivalence to already marketed devices, rather than establishing specific performance acceptance criteria through a clinical study. Therefore, most of the requested information about acceptance criteria and a study proving the device meets them (especially in the context of AI development or human-in-the-loop performance) is not applicable to this type of regulatory submission.

The document states:

• "The Pivotal instrument is substantially equivalent to like devices in commercial distribution."
• "The Pivotal instruments perform the same function and have the same intended use as instruments distributed by Ethicon, United States Surgical Corporation (USSC), and Richard-Allan Medical."
• "The Pivotal instrument complies with the applicable safety, performance, and labeling requirements of the American National Standard Institute and the Association for the Advancement of Medical Instrumentation ANSI/AAMI HF18-1993 Standard for Electrosurgical Devices and ANSI/AAMI ESI-1993 Safe Current Limits for Electromedical Apparatus."
• "The method of sterilization and the method used to validate our sterilization process are in compliance with the ANSI/AAMI/ISO 1135-1994 Medical Devices-Validation and routine control of ethylene oxide sterilization."

Based on this, here's what can be extracted and what cannot:

1. Table of acceptance criteria and reported device performance:

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

• Not applicable / Not specified. This document describes a substantial equivalence submission, which typically relies on comparisons to already proven predicate device designs and performance, not a new clinical test set with human readers, AI, or specific clinical outcomes. The "test set" here refers to the engineering evaluation against standards and predicate devices rather than a patient dataset.

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

• Not applicable / Not specified. Ground truth in the context of this submission refers to technical standards compliance and functional equivalence, established through engineering analysis and comparison, not expert consensus on medical images or patient data.

4. Adjudication method for the test set:

• Not applicable / Not specified. Adjudication methods like 2+1 or 3+1 are used for expert consensus on ambiguous medical cases; this is not relevant to a substantial equivalence submission for surgical instruments.

5. If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done, and its effect size:

• No. An MRMC study is not relevant to this type of device and submission. This is a 510(k) for basic surgical instruments, not an AI or imaging device that would involve human readers.

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

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

7. The type of ground truth used:

• The "ground truth" for this submission is compliance with established industry standards (ANSI/AAMI) for electrosurgical safety and sterilization, and demonstrated functional and material equivalence to legally marketed predicate devices. There is no clinical outcomes data or pathology results mentioned.

8. The sample size for the training set:

• Not applicable. There is no "training set" in the context of this 510(k) submission. This is not an AI/machine learning device.

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

• Not applicable. As above, no training set for this type of device.

In summary, the provided document is a regulatory submission demonstrating substantial equivalence for surgical instruments using engineering and material comparisons to predicate devices and compliance with existing standards. It does not involve the types of studies (e.g., AI performance, multi-reader studies) described in the prompt.

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