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The OriGen Reinforced Dual Lumen cannula is indicated for use as a single cannula for both venous drainage and arterial re-infusion of blood in the internal jugular vein during extracorporeal life support procedures of six hours or less.

The OriGen Reinforced Dual Lumen catheter (RDLC) is the same design as the OriGen Dual Lumen Catheter (the predicate device), but with the addition of a wire reinforcement layer on the tip of the device. Both are dual lumen catheters with unequal lumen areas for drainage and reinfusion. A thin sheath is used to cover and secure the wire layer and is heat shrunk into a permanent position. Other characteristics of the catheter are the same.

This is not an AI/ML medical device. It is a dual-lumen catheter used for extracorporeal life support. Therefore, the questions related to AI/ML device studies are not applicable.

However, I can extract the acceptance criteria and the summary of the study performed for this device:

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

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

• Sample Size: Not explicitly stated. The document mentions "applicable tests were carried out," but does not specify the number of units tested for each in vitro test.
• Data Provenance: The tests were conducted "in accordance with the requirements of ISO 10993-1 and the FDA 1995 memorandum." These are non-clinical, in-vitro tests, not involving human data (retrospective or prospective).

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

• Not applicable. This is a medical device (catheter), not an AI/ML diagnostic or prognostic tool that requires expert-established ground truth from images or other patient data. The "ground truth" for this device's performance is established by objective engineering and material science standards as per ISO 10993-1 and FDA guidelines.

4. Adjudication method for the test set:

• Not applicable. As this is not an AI/ML device assessing patient data, no adjudication method for a test set by human experts is relevant.

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 is not an AI/ML device.

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

• Not applicable. This is not an AI/ML device.

7. The type of ground truth used:

• For this device, the "ground truth" can be considered the established engineering and performance specifications and safety standards defined by ISO 10993-1 and FDA guidance for medical device biocompatibility, structural integrity, and functional performance (e.g., flow rates). These are objective, measurable criteria.

8. The sample size for the training set:

• Not applicable. This is a physical medical device, not an AI/ML model that requires a training set.

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

• Not applicable. This is a physical medical device, not an AI/ML model.

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The OriGen tissue storage bags are indicated for use in protecting, storing and freezing cells and tissues.

Not Found

This looks like a 510(k) submission for a medical device (OriGen Tissue Storage Bags) where the primary change is the sterilization method. The provided documents focus on the regulatory approval process and the substantial equivalence to a predicate device, rather than detailed performance studies and acceptance criteria for an AI/machine learning device.

Therefore, most of the information requested in your prompt (about AI/ML performance, sample sizes for test/training sets, expert ground truth, adjudication methods, MRMC studies, standalone performance, etc.) is not present in these documents.

However, I can extract the following information related to acceptance criteria and the "study" demonstrating the change:

1. Table of Acceptance Criteria and Reported Device Performance

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

Not explicitly stated for the "physical testing," but the submission indicates "Physical testing has demonstrated..." This implies a test dataset was used, but the size, specifics, and provenance are not detailed in these regulatory summary documents. This is a change in manufacturing process for an existing device, not a new device with a performance study.

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

Not applicable. The "study" here is physical testing of the device itself (likely material properties, integrity, functionality), not an assessment requiring expert human interpretation of results in the way an AI/ML diagnostic device would.

4. Adjudication Method for the Test Set

Not applicable. The assessment would likely involve laboratory tests and measurements against predefined specifications, not expert adjudication.

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 is not an AI/ML device.

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

Not applicable. This is not an AI/ML device.

7. The Type of Ground Truth Used

The ground truth for the physical testing would be established by the pre-change device's characteristics and performance, likely through engineering specifications and quality control standards. The "physical testing" aimed to show that the new sterilization method did not alter these established characteristics.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device, and there is no mention of a "training set."

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

Not applicable. There is no training set mentioned.

Summary of what can be inferred from the document:

The core "study" cited is "Physical testing" which aimed to demonstrate that changing the sterilization method from Ethylene Oxide (EtO) to radiation did not change the product characteristics or performance of the OriGen Tissue Storage bags. The acceptance criteria essentially were that the characteristics and performance remain the same as the original EtO-sterilized device (approved under K915471), with the added benefit of eliminating EtO residues. The details of this physical testing (e.g., sample size, specific tests, quantitative results) are not provided in this 510(k) summary letter.

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Ask a specific question about this device

Ask a specific question about this device