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The Transseptal Needle is used to puncture the interatrial septum during a transseptal catheterization procedure to gain left heart access. The Transseptal Needle is intended for single use only.

The Transseptal Sharp Needle consists of a stainless-steel needle and nitinol stylet. The needle comes in two lengths equivalent to the lengths of the TSN Transseptal Needle (predicate) - 71cm and 98cm, and two curves, Curve0 (59°) and Curve1 (72°). The size is 18 gauge with an inner diameter of .0325" at the proximal body and necks down to 21 gauge with an inner diameter of 0.0230" at the distal end with a sharp a-bevel offset tip. The transseptal sharp needle includes a 0.018" diameter nitinol stylet wire with an intermediate 0.013" section, a bulbous distal tip, and a proximal clear plastic handle with an internal mechanism configured to both provide feedback on the position of the stylet tip and as well as to maintain the stylet tip in the extended position to reduce the possibility for further penetration of the needle after the initial crossing of the septum. The components of the Transseptal Sharp Needle include the transseptal sharp needle, stylet. sterile packaqing, and labeling.

There are four model numbers for the transseptal sharp needle: CLICK071, CLICK098, CLICK171, and CLICK198. The Transseptal Sharp Needle is sterilized by 100% ethylene oxide cycle and is for single use-only. The Transseptal Sharp Needle is used in a healthcare facility/hospital.

The transseptal sharp needle is used in transseptal procedures to puncture the fossa ovalis and gain access to the left atrium through the right side of the heart. The device is used by inserting the device through a transseptal dilator assembly. The devices are inserted in the femoral vein. The transeptal sharp needle is then advanced to the fossa ovalis. This mimics the procedure with the predicate device, TSN Transseptal Needle. Both the proposed device and the predicate device (K17950) have a needle point, made of stainless steel, have similar hub and handle, and have similar dimensions, design, and functionality. The needle's duration in the body is less than 24 hours.

The provided text is a 510(k) Premarket Notification from the FDA for a medical device called the "SafeSharp Transseptal Needle." It details the device's indications for use, its comparison to a predicate device, and the performance testing conducted to demonstrate substantial equivalence.

However, the request asks for specific information related to acceptance criteria and a study that proves the device meets acceptance criteria, particularly in the context of an AI/Software as a Medical Device (SaMD).

Reading through the entire document, there is no mention of an AI or software component for the "SafeSharp Transseptal Needle." The device is a physical medical instrument (a needle and stylet) used for puncturing the interatrial septum. The performance testing outlined (visual/dimensional inspection, particulate testing, pull tests, leak testing, simulated use) are all standard engineering and material tests for a physical device, not for evaluating an AI algorithm's performance.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets those criteria in the context of an AI/SaMD.

The document does not describe:

1. A table of acceptance criteria and reported device performance for an AI/SaMD.
2. Sample size, data provenance, number of experts, or adjudication methods for an AI/SaMD test set.
3. MRMC comparative effectiveness study or standalone AI performance.
4. Type of ground truth, training set size, or how ground truth was established for an AI/SaMD.

It seems there might be a misunderstanding or a misapplication of the prompt to this specific document, which describes a conventional hardware medical device.

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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.

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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