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SafeSept® is indicated for use in procedures where access to the left atrium via the transseptal technique is desired. The SafeSept® Transseptal Guidewire is intended for single use only.

The SafeSept® .018" Transseptal Guidewire is made of nitinol, a flexible memory wire material, device that is 140cm in length. The proximal end of the wire has 4 sets of laser-etched markings, which increase in quantity toward the proximal end of the wire. An echogenic marker was added along the shaft proximal to the radiopaque coil. A radiopaque coil located along the shaft, made of a platinum/tungsten alloy, aids in visual quidance during transseptal procedures. The sharp distal tip is able to perforate through the fossa ovalis, a thin wall separating the right and left interatrial septum, when it is supported by a transseptal needle and dilator. When the wire is no longer supported, it is atraumatic and operates as typical quidewire.

The components of the SafeSept® include the .018" transseptal guidewire, dispenser and straightener, and sterile packaging and labeling. The model number of the subject device is SS-140. The SafeSept® .018" Transseptal Guidewire is sterilized by 100% ethylene oxide cycle and is for single use-only.

The subject device is used in transseptal procedures to gain access to the left atrium through the right side of the heart. The device is used by a surgeon by inserting the device through the femoral vein. The subject device is then advanced to the fossa ovalis with the support of the transseptal needle and dilator. The guidewire is used in conjunction with a transseptal needle and dilator. Its duration in the body is less than 24 hours. The SafeSept® .018" Transseptal Guidewire is used in a healthcare facility/hospital.

This document is a 510(k) premarket notification for a medical device called the SafeSept® Transseptal Guidewire (SS-140). It focuses on establishing substantial equivalence to a legally marketed predicate device, rather than providing a study proving performance against acceptance criteria in the context of an AI/ML device.

Therefore, the specific information requested in the prompt related to acceptance criteria, device performance, sample sizes, ground truth establishment, expert adjudication, and MRMC studies, which are typically associated with AI/ML device evaluations, cannot be found in this document.

The document describes the device, its intended use, and compares its technological characteristics to a predicate device. It also mentions performance testing conducted to support substantial equivalence.

Here's an analysis of what is available in the document, framed as closely as possible to your request, but with the understanding that it's for a traditional medical device, not an AI/ML system:

1. Table of Acceptance Criteria and Reported Device Performance & 6. Standalone Performance:

The document doesn't present a formal table of "acceptance criteria" with quantitative targets and reported performance outcomes in the way an AI/ML device would. Instead, it states that various performance tests were conducted to demonstrate comparability to the predicate device. The implied acceptance criterion for these tests is that the subject device's performance should be "comparable" or "similar" to the predicate.

• Tip thickness
• Outer diameter
• Overall length
• Proximal marking locations
• Tensile and compressive forces during insertion and withdrawal
• Peak tensile forces
• Torsion withstand
• Puncture force | "These results were comparable to the predicate device."
  "The subject device data was comparable to the predicate device."
  "subject device was able to withstand torsional forces expected during a transseptal procedure."
  "the subject device puncture force... was similar to the predicate device." |
  | Integrity/Coating | - Proximal Marking Integrity
• Lubrication Coating
• 2x Sterile | "Proximal marking integrity was tested according to ISO 11070 and comparable to the predicate device."
  (Details on lubrication and sterile testing comparability are not explicitly stated, but implied by the overall conclusion of substantial equivalence based on performance data.) |
  | Simulated Use | In Vitro Simulated Use Testing | (Details on specific outcomes not provided, but implies satisfactory performance for substantial equivalence.) |
  | Packaging/Transit | - Package integrity (ASTM F88, ASTM 2096, ASTM F1929)
• Transit robustness (ASTM D4169) | "packaging testing per ASTM F88, ASTM 2096, and ASTM F1929."
  "Transit testing was performed per ASTM D4169... and transit testing was similar to the predicate device." |
  | Biocompatibility | Same material and coating as predicate, allowing adoption of predicate's biocompatibility data. | "Biocompatibility testing was performed on the predicate device... the biocompatibility testing was adopted for the SafeSept® .018" transseptal guidewire." |

This device is not an AI/ML device, so the concept of "standalone performance" in the context of an algorithm's output (without human intervention) is not applicable here. The performance described is the standalone performance of the physical guidewire itself.

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

The document does not specify exact sample sizes for bench testing (e.g., number of guidewires tested for dimensions, tensile strength, etc.). It refers to "the subject device data" and "the predicate device."

• Data Provenance: The tests are described as "Bench Testing" and "In Vitro Simulated Use Testing," suggesting they were conducted in a lab environment. There is no mention of country of origin for the data or whether it was retrospective or prospective.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

Not applicable. This is a physical medical device, not an AI/ML system that requires expert-established ground truth for image interpretation or diagnosis. The "ground truth" for its performance is determined by physical and material testing against established standards and comparison to a predicate device.

4. Adjudication Method for the Test Set:

Not applicable. There is no expert adjudication process described, as it's not relevant for the type of testing performed on this physical device.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

Not applicable. The device is a guidewire, not an AI system. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant or mentioned.

7. Type of Ground Truth Used:

For the performance testing, the "ground truth" is based on:

• Physical and Dimensional Measurements: Conformance to specified engineering dimensions and properties.
• Mechanical Test Standards: Performance against established ISO and ASTM standards for medical devices (e.g., ISO 11070, ASTM D4169, ASTM F88, ASTM 2096, ASTM F1929).
• Comparison to Predicate Device: The primary "ground truth" for substantial equivalence is that the new device's performance is comparable to that of the legally marketed predicate device.

8. Sample Size for the Training Set:

Not applicable. This is a physical medical device, not an AI/ML system, so there is no "training set."

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

Not applicable. As there's no training set for an AI/ML algorithm, this question is not relevant.

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