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The device is indicated for use as a receptacle for the collection of tissue, organs and calculi during general and laparoscopic procedures.

The proposed device, Specimen Retrieval Bag, is comprised of retracted bag, opening support, outer introducer shaft, outer introducer handle, inner introducer handle, string and pull loop. The device is available in a series of models. The difference between each model is the retracted bag size and volume. The device is provided sterile and single use.

The provided text describes a 510(k) premarket notification for a Specimen Retrieval Bag. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving the device meets specific performance acceptance criteria for a novel medical device.

Therefore, many of the requested categories for a study proving acceptance criteria cannot be extracted because such a study was not presented in this document.

Here's what can be extracted and what cannot:

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

The document provides a comparison of the proposed device against a predicate device, focusing on technological characteristics and compliance with general standards. It does not explicitly state "acceptance criteria" for a study to prove performance but rather lists the tests performed to demonstrate substantial equivalence to the predicate.

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

The document does not provide details on the sample sizes used for the non-clinical tests or the data provenance. It only states that "performance tests were performed on both proposed device and predicate device."

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 information is not applicable and not provided. The study is a non-clinical, bench-testing evaluation designed to demonstrate substantial equivalence, not a clinical study involving human readers or expert ground truth for interpretation.

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

This information is not applicable and not provided, as there was no clinical study or expert adjudication 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

No MRMC or clinical study was done. The document explicitly states: "No clinical study is included in this submission."

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

This concept is not applicable as the device is a physical specimen retrieval bag, not an AI algorithm. The tests performed are non-clinical, bench tests.

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

For the non-clinical performance tests, the "ground truth" would be the established scientific and engineering principles and the performance of the predicate device, as well as compliance with recognized standards (e.g., ISO, ASTM). It's not a clinical "ground truth."

8. The sample size for the training set

This information is not applicable as there is no mention of a "training set." The device is a physical medical device, not an AI or machine learning model that requires training data.

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

Not applicable as there is no training set mentioned.

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The Specimen Retrieval Bag is indicated for use as a receptacle for the collection and extraction of tissue, organs and calculi during general and laparoscopic surgical procedures.

The Applied Medical Specimen Retrieval Bag consists of a stylet, an introducer sheath with a locking pneumoperitoneal seal at the proximal end and a retrieval bag sealed radially on the distal end. The locking seal serves as a mechanism for maintaining positive pressure in the peritoneal cavity during laparoscopic procedures. The sheath contains a dual lumen, where the larger of the two lumens acts as the working channel for the insertion and removal of grasping instruments while the second and smaller lumen contains the bag activation wire for positioning, opening and closing of the bag. The dual lumen design allows the use of a single trocar for placement and retrieval of tissue, organs and calculi.

Here's an analysis of the provided text in the context of device acceptance criteria and studies, as requested:

Device: Applied Medical Specimen Retrieval Bag

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: The document does not specify the sample size for any tests. It only states that "Mechanical and biocompatibility tests were performed."
• Data Provenance: The document does not provide information on data provenance (e.g., country of origin, retrospective/prospective). It describes laboratory-based mechanical and biocompatibility tests, not clinical data involving human subjects.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• This information is not applicable to this submission. The device is a physical medical device (specimen retrieval bag) and its performance is evaluated through engineering and biocompatibility testing, not through expert review of data like imaging or clinical assessments. Ground truth in this context would be defined by engineering specifications and biocompatibility standards.

4. Adjudication Method for the Test Set

• This information is not applicable. Adjudication methods are typically used in studies involving human interpretation or clinical endpoints. This submission describes physical and material property testing.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done

• No, an MRMC comparative effectiveness study was not done. This type of study assesses human reader performance, often with and without AI assistance, which is not relevant to a physical specimen retrieval bag.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done

• No, a standalone study in the context of an algorithm's performance was not done. This device is a physical tool, not an algorithm. Its "standalone" performance would be its inherent functional and structural integrity, which was tested.

7. The Type of Ground Truth Used

• The ground truth for this device's evaluation would be based on:
  • Engineering Specifications: Defined parameters for strength, sealing capability, lumen dimensions, etc.
  • Biocompatibility Standards: Established international standards (e.g., ISO 10993 series) for material safety testing and acceptable biological responses.
  • Predicate Device Performance: The functional and safety characteristics of the legally marketed predicate device (Endopouch™ Specimen Retrieval Bag) served as a benchmark for "comparability."

8. The Sample Size for the Training Set

• This concept is not applicable. A "training set" is relevant for machine learning algorithms. This submission describes testing of a physical medical device.

9. How the Ground Truth for the Training Set Was Established

• This concept is not applicable for the same reason as point 8.

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