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SPINAUT-E is used for delivery of drugs that have been indicated for the epidural space.

SPINAUT-I is intended for the percutaneous introduction and placement of an epidural catheter.

SPINAUT-E consists of a flexible catheter, steering handle and a port for access to the lumen. The catheter has built in steering mechanism that allows for guiding the soft tip through the epidural space and soft tissues for optimal access to the source of distress. The port facilitates the connection of syringes to deliver therapeutic agents by physicians as appropriate to their diagnosis. It is supplied sterile and it is for single use.

There are 9 models in SPINAUT-E: E1000, E2000, E1100, E2100, E3100, S1000, S2000, and S3000. The catheter tip of the model E1000, and E3000 can be bent 50° to the left or to the right (the user can rotate the tip to adjust the direction), but the tip of the model E1100, E2100, and E 3100 can be bent either direction up to 100°. The S1000, S2000, and S3000 have an extra infusion port for drug so that the other main port can be used for other devices. Each model is characterized by the additional port, the lever, and the dimensions.

The SPINAUT-I is intended to be used to prepare or preserve a path for an epidural catheter. When placing SPINAUT-E into the patient, SPINAUT-I can be used as a replacement of the SPINUT-E Catheter Introducer Set. It is supplied sterile and it is for single use.

There are 3 models in SPINAUT-I: ID1000, ID2000, and ID3000 and each model is characterized by the length.

This is a 510(k) premarket notification for a medical device (SPINAUT-E and SPINAUT-I anesthesia conduction catheters), not a study demonstrating AI performance. Therefore, most of the requested information regarding AI acceptance criteria, sample sizes for test/training sets, expert ground truth, MRMC studies, or standalone performance is not applicable to this document.

However, I can extract information related to the non-clinical testing performed to demonstrate substantial equivalence to predicate devices, which serves a similar purpose of validating device performance against pre-set criteria.

Here's a summary based on the provided text, focusing on the available non-clinical testing details:

1. Table of Acceptance Criteria and Reported Device Performance:

The document broadly states that "the test results met the pre-set criteria" for all tests. It does not provide specific numerical acceptance criteria or detailed numerical device performance outcomes for each test. Instead, it lists the types of tests conducted and concludes that the predefined criteria were met.

Specific Tests listed under "Performance Bench Tests" (SPINAUT-E and SPINAUT-I):

• Visual Inspection (Appearance)
• Size Measurement (SPINAUT-E only for shelf life, SPINAUT-I for shelf life and performance)
• Leakage Test (Catheter)
• Tensile strength (Catheter)
• Curved strength (Catheter)
• Fatigue test (Catheter)
• X-ray impermeable test
• Corrosion resistance test
• Flexural Rigidity (Catheter introducer and the needle)
• Pulling (Drawing) Test (Catheter introducer and the needle)
• Package Tensile Test
• Package Peeling Test
• Package Burst Test
• Package Dye Penetration Test
• Package Bubble Test
• Sterility Test
• Connecting Part (Conical) Fitting (SPINAUT-I only)

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

• The document does not specify the exact sample sizes used for each individual non-clinical test. It only states that tests were performed.
• Data Provenance: The tests are "non-clinical testing" and "bench tests" performed by the manufacturer, IMEDICOM Co., Ltd., which is based in the Republic of Korea. The data provenance is industrial laboratory testing, not patient-derived data.

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

• Not applicable. This is not a study involving expert assessment or ground truth establishment in the traditional sense of medical image analysis or clinical trials. The "ground truth" for these non-clinical tests is based on objective measurements against established engineering and medical device standards (e.g., ISO, ASTM, USP).

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

• Not applicable. This is not a study requiring adjudication of expert opinions.

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 document describes a traditional medical device (catheter) and its non-clinical testing for 510(k) clearance, not an AI-powered device or an MRMC study.

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

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

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

• The "ground truth" for the non-clinical tests is based on objective measurements against established international and national standards (e.g., ISO 11137, ISO 11737, ASTM F1980-07, ISO 10993, USP 37, USP 38) and the manufacturer's pre-set internal criteria for performance specifications (e.g., tensile strength, leakage rates, sterility).

8. The sample size for the training set:

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

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

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

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