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The Patton Tripol™ is intended for use in open and laparoscopic surgeries where grasping, coagulating, and transecting of tissue is indicated.

The Patton Tripol™ is a forceps that grasps, coagulates, and transects tissue, utilizing electrical current. The device is compatible with available bipolar generators.

This document is a 510(k) summary for the Patton Tripol™ Bipolar Forceps. It does not contain information about the acceptance criteria or a study proving the device meets acceptance criteria in the context of an AI/ML medical device.

The document describes a medical device (bipolar forceps) that grasps, coagulates, and transects tissue using electrical current. The submission is focused on demonstrating substantial equivalence to existing predicate devices (Dexide Bipolar Forceps II+ Device and Bicoag Coagulating Forceps).

Therefore, I cannot provide the requested information from the provided text, as it pertains to a traditional medical device submission and not to an AI/ML device study.

Here's why each point cannot be addressed:

1. A table of acceptance criteria and the reported device performance: Not present. Substantial equivalence claims for traditional devices often rely on material properties, design comparisons, and functional testing, not statistical performance metrics like sensitivity/specificity against a ground truth.
2. Sample size used for the test set and the data provenance: Not applicable. There's no "test set" in the context of an AI/ML model.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI/ML model is not relevant here.
4. Adjudication method: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable. This type of study is for evaluating human performance with and without AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. There is no algorithm.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable. There is no training set for an AI/ML model.
9. How the ground truth for the training set was established: Not applicable.

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The Patton Endo-Bag is a single use retrieval bag designed to temporarily contain organs or tissues and facilitates their removal from the patient without contamination, during laparoscopic surgery.

The Patton Endo-Bag™ is a single-use retrieval bag designed to temporarily contain organs or stones, and facilitate their removal from the patient without contamination during laparascopic surgery.

The provided text describes a 510(k) submission for the "Patton Endo-Bag™," a laparoscopic specimen retrieval system. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than explicit acceptance criteria with specific performance thresholds that a device must meet through a new study.

Therefore, the information requested regarding acceptance criteria, a study proving the device meets them, sample sizes, expert involvement, and ground truth establishment is not applicable to this 510(k) summary. The approval is based on demonstrating that the new device has the same intended use and similar technological characteristics to previously approved devices, without raising new questions of safety or effectiveness.

Here's how to interpret the provided document in the context of your request:

1. Table of acceptance criteria and the reported device performance:

• Not Applicable. The 510(k) summary does not describe specific numerical acceptance criteria (e.g., minimum tensile strength, maximum leakage rate) or report performance data against such criteria. The "performance" demonstrated is substantial equivalence to the predicate devices.

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

• Not Applicable. No test set or data from a study demonstrating performance against acceptance criteria is described in this 510(k) summary. The submission focuses on comparison to predicate devices.

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 Applicable. No experts or ground truth establishment for a test set are mentioned, as there is no performance study described.

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

• Not Applicable. 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. This device is a physical medical device (specimen retrieval bag), not an AI imaging or diagnostic tool. Therefore, an MRMC study or AI-related effectiveness study is not relevant.

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

• Not Applicable. This is a physical device, not an algorithm.

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

• Not Applicable. No performance study with ground truth data is described.

8. The sample size for the training set:

• Not Applicable. This is a physical device, not a machine learning algorithm requiring a training set.

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

• Not Applicable. As above, no training set or ground truth establishment is relevant to this device.

Summary of the 510(k) for Patton Endo-Bag™:

The submission demonstrates substantial equivalence to predicate devices (ENDOPOUCH SPECIMEN RETRIEVAL BAG and PLEATMAN SAC SPECIMEN CONTAINER) by highlighting that the Patton Endo-Bag™ shares the same:

• Intended Use: Temporarily contain organs or stones to facilitate removal during laparoscopic surgery without contamination.
• Technological Characteristics: Implied to be similar by the substantial equivalence claim, although specific technical details for comparison are not provided in this summary.

The FDA's letter confirms that the device is substantially equivalent to legally marketed predicate devices, allowing its marketing subject to general controls. No new clinical or performance studies with acceptance criteria were required for this type of submission.

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The Patton Speculum™ is intended for use to retract the vagina in diagnostic and therapeutic obstetrical and gynecological procedures.

The Patton Speculum™ is a handheld mechanical device with a pistol-grip handle, four retracting blades, and a ratchet lock. When the handle is squeezed, the blades move in such a way as to expand the cylindrical surface enclosing them.

The provided text is a 510(k) summary for the Patton Speculum™. This document describes the device, its intended use, and its substantial equivalence to predicate devices. However, it does not contain any information about acceptance criteria, performance studies, sample sizes, expert involvement, or any form of clinical or technical testing data.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study proving the device meets them, as this information is absent from the provided text. The 510(k) summary focuses on regulatory approval based on substantial equivalence, not on a detailed performance study with acceptance criteria.

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The Funnel Trocar™ is an access device for laparoscopic procedures. The new instrument creates and maintains a passageway for laparoscopic instruments during a variety of general, gynecologic, thoracic, and urological procedures.

The Funnel Trocar™ is a disposable single patient use device fabricated from surgical grade stainless steel, and biocompatible medical grade polymers. The device is available in a variety of diameters (5mm. 7/8mm. 12mm) and lengths (55mm. 70mm, and 100mm). The Funnel Trocar™ is supplied with either a shielded cutting obturator (trocar). The cannula is equipped with a luer fitting to provide access for insufflation of the operative area. The cannula is available with or without stability threads.

The provided text is a 510(k) summary for the Funnel Trocar™ and the FDA's clearance letter. This type of document focuses on establishing substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a study with the elements you've requested for AI/software devices.

Therefore, most of the information regarding detailed study design, sample sizes, ground truth establishment, expert qualifications, and MRMC studies will not be present in this document. The Funnel Trocar™ is a physical surgical device, not an AI or software-based medical device.

Here's a breakdown based on the information available and the nature of the device:

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

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

This information is not provided in the 510(k) summary. For physical devices, testing typically involves mechanical, material, and biocompatibility tests rather than clinical studies with "test sets" in the context of AI/software. If such tests were performed, the details would be in supporting documentation not included in this summary.

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)

This is not applicable and not provided. This concept relates to ground truth establishment for analytical or diagnostic software, which is not relevant to a physical surgical trocar.

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

This is not applicable and not provided. Similarly, this is a concept used for human review in studies, especially for diagnostic accuracy, and is not relevant to the clearance of a physical surgical instrument like a trocar.

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

This is not applicable for this device. An MRMC study is designed for evaluating diagnostic algorithms, typically AI or software, and is not relevant to a physical surgical trocar.

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

This is not applicable for this device. This refers to the performance of an AI algorithm independently, which is not what the Funnel Trocar™ is.

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

This is not applicable and not provided. For physical devices, "ground truth" would relate to engineering specifications, material properties, and functionality testing, not a diagnostic outcome. The "truth" for substantial equivalence is met by demonstrating the device performs as intended and is as safe and effective as its predicates.

8. The sample size for the training set

This is not applicable and not provided. "Training set" refers to data used to train AI/machine learning models, which is not involved in the development or clearance of this physical medical device.

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

This is not applicable and not provided for the same reasons as point 8.

In summary: The provided document is a 510(k) premarket notification for a physical medical device. The focus is on demonstrating substantial equivalence to already legally marketed devices, not on proving performance through clinical studies with the highly specific criteria you've outlined for AI/software devices. Therefore, most of your requested information is not relevant or present in this context.

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