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The TSP Crosser Transseptal Access System is intended to both puncture the interatrial septum during a transseptal catheterization procedure and to introduce various cardiovascular catheters into the left side of the heart.

Device Description

The TSP Crosser System is intended to be used both to puncture the interatrial septum during a transseptal catheterization procedure and to introduce various cardiovascular catheters into the left heart chambers. The main components of the TSP Crosser System are:

. Steerable introducer sheath with handle and radiopaque wire loop that is compatible with catheters up to 8F
. Dilator that is compatible with guidewires up to a maximum diameter of 0.035"
Transseptal needle with Stylet ●
The System is provided sterile (EO) and is intended for single use only. The device is designed to provide controlled transseptal access in the cardiac left atrial anatomy. The TSP catheter introducer sheath is an elongated shaft with a central lumen capable of incorporating the needle and stylet assembly, the dilator, as well as allow passage and orientation of operational catheters up to 8F. The introducer incorporates a steerable tip that can be deflected bidirectionally up to 180° with a curvature radius of 22mm. The steerable introducer handle includes a rotating knob that maintains the rotational and longitudinal positioning of the sheath and deflects the sheath's tip 180° on each side. There is a nitinol loop wire positioned at the distal end of the introducer that is visible under fluoroscopy and provides a visual aid to the user when positioning the needle on the fossa ovalis. The introducer contains a hemostasis valve to minimize blood loss during catheter introduction and/or exchange. A sideport with a three-way stopcock is provided for air or blood aspiration, fluid infusion, blood sampling, and pressure monitoring.
The dilator has an outer diameter of 8F and inner diameter of 0.035" and includes a central lumen that facilitates the transseptal needle/stylet in a similar fashion to conventional dilators. The transseptal needle assembly consists of a luminal stainless-steel needle and solid stainlesssteel stylet. The needle is used to puncture the interatrial septum during the catheterization procedure and houses a central lumen that accommodates the stylet.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the TSP Crosser™ Transseptal Access System. This type of FDA submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness from scratch through extensive clinical trials for new medical devices.

Therefore, the document does not provide the kind of detailed information about acceptance criteria, study design (like sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or specific ground truths for AI models) that would be present for a novel AI/ML-based device. This device is a physical medical instrument, not an AI model.

The "performance data" section (6.7) refers to bench testing, biocompatibility testing, and in vivo animal studies to assure reliable design and performance, and support substantial equivalence. It also mentions "clinical data collected outside the United States" but doesn't elaborate on its specifics or how it supports the claims for the device.

Given the nature of this document (a 510(k) for a physical medical device and not an AI/ML product), I cannot provide the requested information regarding acceptance criteria for an AI model's performance, sample sizes for AI test/training sets, details on expert ground truth establishment, adjudication methods, or MRMC studies.

The document discusses performance testing in the context of a physical device:

1. Acceptance Criteria and Reported Device Performance (Summary based on the provided text)

Performance Characteristic	Acceptance Criteria (Implied by testing for substantial equivalence)	Reported Device Performance (as demonstrated by testing)
Functional Equivalence	Comparable to predicate devices in terms of:	Supported by design, material, and dimensional comparison.
	- Transseptal septal puncture capability	Bench and biocompatibility tests performed.
	- Introduction of cardiovascular catheters into left heart	In vivo animal studies performed.
	- Single-use, sterile (EO)	Clinical data (OUS) supports safety and performance.
Mechanical Performance	Device maintains integrity and function under simulated use.	In vitro bench testing performed: Visual & Dimensional Verification, Steerability, Air Leakage, Liquid Leakage, Pushability, Torqueability, Simulated Use, Tensile Strength, Corrosion.
Biocompatibility	Biocompatible with human tissue.	Biocompatibility testing performed: Cytotoxicity, Sensitization, Intracutaneous Reactivity, Systemic Toxicity, Pyrogenicity, ASTM Hemolysis (Direct and Indirect), SC5b-9 Complement Activation, and In Vivo Thrombogenicity.
Safety in vivo	Safe and performs as intended in a live system.	In vivo animal studies confirmed safety and performance, and ability to introduce commercial percutaneous catheters.

Missing Information (Not applicable or not provided in the context of this 510(k) for a physical device):

The following points are pertinent to AI/ML device evaluations and are not found in this 510(k) submission for a physical medical device. Therefore, I cannot answer them from the provided text.

1. Sample sizes used for the test set and the data provenance.
1. Number of experts used to establish the ground truth for the test set and the qualifications of those experts.
1. Adjudication method for the test set.
1. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or what the effect size of human readers improving with AI vs without AI assistance was.
1. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done.
1. The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
1. The sample size for the training set.
1. How the ground truth for the training set was established.

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