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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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