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Applied Medical's Inzii Ripstop Redeployable Retrieval System is indicated for use as a receptacle for the collection and extraction of tissue, organs, and calculi during general and laparoscopic surgical procedures.

The Inzii Ripstop Redeployable Retrieval System is a single-use device designed for the containment and extraction of multiple tissue specimens. The device consists of a flexible specimen bag and an introducer tube which can be redeployed for multiple uses within a single procedure. The product will be available in two models, a 10 mm model with a 265 ml specimen bag and a 15 mm model with a 1600 ml specimen bag size. The device is provided sterile and is constructed of a Ripstop nylon specimen bag, various polymers and stainless steel. The major differences between the predicate and the subject device include the subject device featuring a stronger Ripstop nylon specimen bag and the ability to be redeployed multiple times within a single surgical procedure.

The Inzii Ripstop Redeployable Retrieval System is a single-use device designed for the containment and extraction of multiple tissue specimens. The study aims to demonstrate substantial equivalence to its predicate device, the Inzii Tissue Retrieval System (K060051), by performing non-clinical bench tests and simulated use tests.

Acceptance Criteria and Reported Device Performance:

Study Information:

1. Sample sizes used for the test set and data provenance:

   • The document does not explicitly state the exact sample sizes for each specific performance test (e.g., number of devices tested for leak, strength, etc.). It refers to "sample size" generally in the context of the performance data summary.
   • The data provenance is from non-clinical bench tests and simulated use tests conducted by Applied Medical Resources Corporation. There is no indication of country of origin for data or whether it's retrospective or prospective, as these are bench tests.

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

   • This information is not applicable as the document describes performance testing of a physical medical device (specimen retrieval system), not an AI/software device that requires expert-established ground truth. The 'ground truth' here is the objective outcome of the physical/mechanical and biological tests.

3. Adjudication method for the test set:

   • This is not applicable for the type of device and testing described. Adjudication methods like 2+1 or 3+1 are typically used for clinical studies involving reader interpretations, not for bench testing of physical device performance.

4. Multi-Reader Multi-Case (MRMC) comparative effectiveness study:

   • No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic/interpretive devices where human readers' performance is augmented by AI. The Inzii Ripstop Redeployable Retrieval System is a physical surgical tool.

5. Standalone (algorithm only without human-in-the-loop performance) study:

   • No, a standalone study was not done. This concept is specific to AI algorithms. The device described functions with human interaction during surgery.

6. Type of ground truth used:

   • For the performance testing, the "ground truth" used was based on objective measurements and observations from the non-clinical bench tests and simulated use tests. This includes parameters like liquid tightness, resistance to tearing/puncture, and mechanical functionality, as well as established ISO standards for biocompatibility.

7. Sample size for the training set:

   • This information is not applicable as the document describes performance testing of a physical medical device, not an AI/machine learning model that requires a training set.

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

   • This information is not applicable as there is no training set for a physical medical device.

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The DeRoyal Laprador Specimen Retrieval System is a sterile device intended to be used for collection of tissue, organs, and calculi during laparoscopic surgical procedures.

The DeRoyal Laprador Specimen Retrieval System consists of a handle, a cylindrical tube, a string, and a ripstop nylon bag. The system deploys and retracts the nylon bag, which encloses tissue specimens for retrieval during laparoscopic surgical procedures. The device is designed for introduction and use through appropriately sized trocars. The device is sterilized by ethylene oxide.

Here's a breakdown of the acceptance criteria and the study information for the DeRoyal Laprador Specimen Retrieval System, based on the provided text:

Acceptance Criteria and Device Performance

A table of acceptance criteria and reported device performance is not explicitly detailed with quantitative outcomes in the provided document. The document states that "All tests were performed on the DeRoyal Laprador Specimen Retrieval system, the predicate device, and an additional competitor, Applied Medical Specimen Retrieval System (K100959). The proposed device passed all design verification tests and performed comparable to at least one competitor device, thus demonstrating it meets performance specifications and functions safe and effectively."

However, we can infer the types of performance criteria that were assessed:

Note: The document does not provide specific numerical thresholds for "passing" or detailed comparative metrics (e.g., "bag burst resistance was X Newtons, which exceeded the predicate's Y Newtons"). It only states that the device "passed all design verification tests" and "performed comparable to at least one competitor device."

Study Information

Due to the nature of this document (a 510(k) summary for a specimen retrieval system), the type of study described is a bench testing study for device performance and comparison. It is not a clinical study involving human subjects or AI algorithms. As such, many of the requested fields are not applicable in this context.

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

   • Sample Size: Not explicitly stated how many units of each device (DeRoyal, Anchor, Applied Medical) were tested for each criterion. The document refers to "bench testing" without detailing the number of units.
   • Data Provenance: The testing was conducted internally or by a contracted lab for DeRoyal Industries, Inc. This is a prospective test in the sense that the new device was built and then tested, but not a prospective clinical trial. The country of origin of the testing itself is not explicitly stated but can be inferred to be associated with DeRoyal's operations (USA or Dominican Republic based on company locations listed).

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

   • Not applicable. This was a bench test of physical device performance, not a diagnostic or interpretive task requiring expert medical opinion to establish ground truth.

3. Adjudication method for the test set:

   • Not applicable. This was a direct measurement/performance test, not a subjective assessment requiring adjudication.

4. 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 is a physical medical device; there is no AI component or human reader interpretation involved in its direct function.

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

   • Not applicable. This is a physical medical device without an algorithm component.

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

   • The "ground truth" for this study was the pre-defined performance specifications for each characteristic (e.g., a specific pressure leak rate limit, a minimum puncture resistance). The device either met these objective physical parameters or it did not.

7. The sample size for the training set:

   • Not applicable. There is no AI model or training set involved.

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

   • Not applicable.

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