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The Blom-Singer® FirstFit™ Surgical Kit (FFSK) is indicated for use during surgical creation of primary or secondary tracheoesophageal puncture, dilation of the tracheoesophageal wall, and to guide the placement of the voice prosthesis for tracheoesophageal voice restoration following total laryngectomy.

The FFSK contains a sterile single use indwelling Blom-Singer® Indwelling Voice Prosthesis device intended for voice rehabilitation after surgical removal of the larynx (laryngectomy). Cleaning of the voice prosthesis is performed by the patient while it remains in situ.

The FirstFit Surgical Kit (FFSK) is a kit for creating a primary or secondary TE puncture, with subsequent dilatation of that puncture to a width that facilitates placement of the included Blom-Singer® Indwelling Voice Prosthesis, cleared in K082206.

The FFSK is for transient use as an aid to a surgical operation to puncture and stent the tracheoesophageal septum. The FFSK is provided sterile (by ethylene oxide) in a sealed tray, ready to be introduced into the surgical field. Additionally, it is used to guide voice prosthesis placement in a total laryngectomized patient as a primary or secondary procedure. Puncture and placement should take place in a sterile field with the patient being under anesthesia.

The FFSK is designed for primary or secondary tracheoesophageal puncture (TEP) with retrograde voice prosthesis insertion. This kit includes: one (1) 13-gauge curved core puncture needle, one (1) 36-inch guidewire with rounded tips, one (1) pharynx protector tool with handle and notched cylinder, one (1) voice prosthesis inserter pre-loaded with a Blom-Singer® Indwelling Voice Prosthesis of the diameter and length specified on the package label.

The Blom-Singer® Indwelling Voice Prosthesis devices (VP) are indwelling devices primarily made of silicone, designed to provide voicing after total laryngectomy. The voice prostheses are placed in a surgically created fistula between the trachea and esophagus in order to divert air through the prosthesis valve to create voicing. The use of an indwelling device means that routine removal for cleaning by the patient is not necessary, thus making it easier for the patient to maintain the device the risk of accidental dislodgment of the device.

The provided FDA 510(k) summary does not contain information on rigorous acceptance criteria and a detailed study proving the device meets those criteria in the context of an AI/software medical device, as the device is a physical surgical kit (FirstFit Surgical Kit). Therefore, the requested information regarding AI model performance (e.g., sample sizes for training/test sets, ground truth establishment, MRMC studies, standalone performance, expert qualifications) is not applicable to this submission.

However, I can extract the relevant performance testing and findings for the physical device as described in the summary:

Device Name: FirstFit Surgical Kit
Regulation Name: Laryngeal Prosthesis (Taub Design)
Regulatory Class: Class II
Product Code: EWL

Here's a breakdown of the performance testing that serves as the "study" for this physical device:

1. Table of Acceptance Criteria and Reported Device Performance (as inferred from the submission)

For a physical surgical kit, the "acceptance criteria" are generally related to its ability to perform its intended surgical functions safely and effectively. The submission describes a cadaver study as the primary performance evaluation.

2. Sample Size and Data Provenance for the Test Set

• Sample Size: 15 users performing 2 punctures & placements each on fresh cadaver tissue. The exact number of cadavers is stated as "37 cadavers" needing additional instrumentation for dilation out of an unstated total number of cadavers used. However, the primary performance data seems to be derived from the "15 users performing 2 punctures & placements each".
• Data Provenance: Fresh cadaver tissue. The country of origin is not specified. This was a prospective "usability validation testing methodology."

3. Number of Experts and Qualifications for Ground Truth

• Ground Truth Establishment: For a physical device, "ground truth" usually refers to the successful and safe execution of the surgical procedure. In this case, the "usability engineering" study was conducted by "users" (presumably surgeons or medical professionals who would use the device). The document does not specify if these users were considered "experts" for establishing ground truth, nor does it explicitly state their qualifications (e.g., number of years of experience). The assessment of "no tissue damage" would likely have been made by the study observers or the users themselves.

4. Adjudication Method for the Test Set

• The document does not describe a formal "adjudication method" in the sense of multiple reviewers arbitrating discrepancies. The study observed the performance of the 15 users.

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

• No. This is a physical surgical kit, not an AI/software device. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable.

6. Standalone Performance (Algorithm Only)

• N/A. This is a physical surgical kit. There is no algorithm to test in standalone mode.

7. Type of Ground Truth Used

• Observed Performance on Cadaveric Tissue: The "ground truth" was the observed successful (or, in 3 cases, difficult) completion of the surgical steps (puncture, dilation, prosthesis placement) and the absence of tissue damage in the simulated-use cadaver study. It's a pragmatic assessment of procedural success and safety.

8. Sample Size for the Training Set

• N/A. This is not an AI/machine learning device that requires a "training set."

9. How Ground Truth for the Training Set Was Established

• N/A. Not applicable for a physical device.

In summary, the "study" for this device was a usability engineering study conducted on cadavers to demonstrate the safe and effective performance of the FirstFit Surgical Kit in creating tracheoesophageal punctures, dilating them, and guiding voice prosthesis placement. The primary finding was that the device met its functional goals, with an important caveat regarding potential tissue stiffness in cadavers leading to a labeling update for real-world use.

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The Steerable Introducer is intended for percutaneous catheter introduction into the vasculature and into the chambers of the heart. The sheath deflection facilitates catheter positioning.

The Steerable Introducer consists of a single use, bi-directional steerable sheath connected to a handle with steering controls, a hemostasis valve with side port and 3-way stopcock, a tapered dilator and compatible guidewire. The device is provided sterile in a sealed Tyvek pouch and carton with IFU.

The sheath distal tip and dilator shaft are radiopaque for visualization under fluoroscopy. The dilator is designed to accommodate a guidewire and includes a proximal hub with a female luer tapered fitting for flushing.

This document is a 510(k) premarket notification for a medical device (Steerable Introducer 12F), seeking a determination of substantial equivalence to a predicate device. It details the device's technical characteristics, intended use, and performance data from various tests. However, it does not describe an AI/ML-based device or its acceptance criteria and study in the context of AI/ML performance.

The information provided in the document refers to a physical medical device (a steerable catheter introducer) and its non-AI related performance testing (e.g., dimensional, material, mechanical, biocompatibility, sterilization).

Therefore, I cannot extract the information required by your prompt, as it specifically asks for details related to an AI/ML device's acceptance criteria and the study proving it meets those criteria.

The provided text does not contain any information about:

1. AI/ML Acceptance Criteria or Device Performance: There is no mention of metrics like sensitivity, specificity, AUC, or any other performance indicators typically used for AI/ML models.
2. Test Set Sample Size or Data Provenance: This document is about a physical medical device, not a software algorithm tested on data.
3. Experts for Ground Truth/Adjudication: This concept is not applicable here.
4. MRMC Comparative Effectiveness Study: Not relevant for a physical device.
5. Standalone AI Algorithm Performance: There is no AI algorithm.
6. Type of Ground Truth: Not applicable.
7. Training Set Sample Size or Ground Truth Establishment: Not applicable.

The document focuses on:

• Device Description: Physical attributes and components.
• Intended Use & Indications for Use: What the device is meant to do (introduce catheters into the heart).
• Technological Characteristics: How it operates (bi-directional steering, radiopacity).
• Performance Data: Bench testing (e.g., deflection, kink resistance, hemostasis), biocompatibility testing (ISO 10993-1), and sterilization methods, all aimed at demonstrating the device's safety and effectiveness as a physical product.
• Substantial Equivalence Claim: Comparing the new device's features and performance to a legally marketed predicate device (FlexCath Advance K123591) to show it's "as safe and effective."

In conclusion, based on the provided text, I cannot answer your request as it pertains to AI/ML device performance and testing. The document describes a traditional physical medical device.

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The 8.5F Steerable Introducer is intended to provide a conduit allowing introduction, removal, and exchange of compatible therapeutic and/or diagnostic tools into the cardiovascular system while maintaining hemostasis. The device facilitates access to the left and right sides of the heart, including left atrium and left ventricle access through the interatrial septum. It features a deflectable distal tip that enables guidance of compatible tools.

The Steerable Introducer is indicated when introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum.

The steerable introducer consists of a steerable sheath connected to a handle with steering controls, a hemostasis valve with sideport featuring a 3-way stopcock, and a tapered dilator. The device is provided sterile in a sealed Tyvek pouch and carton with IFU. The sheath distal tip and dilator shaft are radiopaque for visualization under fluoroscopy. The dilator is designed to accommodate a guidewire, with size compatibility as indicated on the product labels. A dilator hub is provided with a female luer tapered fitting for flushing (see illustration below). The device includes a side port with stopcock to allow fluid injection and sampling, drip infusion, pressure monitoring, flushing and aspiration.

The steerable introducer usable length, lumen length, outer diameter, curl size, and inner diameter/tool compatibility specifications are indicated on the product labels. The distal end of the steerable sheath features 180° bi-directional deflection to provide directional control to the compatible tools interacting with the device.

This document describes the Steerable Introducer 8.5F, a medical device for introducing cardiovascular catheters. The information provided focuses on the device's design, intended use, and the performance data submitted to the FDA for 510(k) clearance.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly defined with numerical targets in the provided text. Instead, the document states that the device was tested to "meet the device intended use and to ensure conformance to the product specifications" and "meets all its physical and performance specifications." The performance data section lists the types of tests conducted and generally states that the device "passed" or "meets" these specifications.

Therefore, the table can be constructed as follows:

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

The document does not specify the sample sizes used for any of the tests listed (e.g., shaft deflection, simulated use, leak testing). It also does not provide information on the data provenance (e.g., country of origin, retrospective or prospective nature). The studies appear to be bench testing and laboratory studies conducted as part of the device development and regulatory submission.

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

This information is not provided in the document. The studies described are primarily performance and safety tests for a physical medical device, not diagnostic or AI-driven systems requiring ground truth established by medical experts in the traditional sense.

4. Adjudication Method for the Test Set

This information is not applicable and not provided. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or studies involving human assessment where disagreements in interpretation need to be resolved. The studies described are engineering and biological performance tests.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for evaluating the performance of diagnostic aids (like AI algorithms) by comparing human readers' performance with and without the aid. The Steerable Introducer 8.5F is a physical medical device, not a diagnostic AI system.

6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done

No, a standalone study in the context of an "algorithm only without human-in-the-loop performance" was not done. This device is a physical tool, not an algorithm. The performance data relates to the physical and mechanical properties of the device itself.

7. The Type of Ground Truth Used

The concept of "ground truth" as typically applied to diagnostic or AI studies (e.g., pathology, expert consensus) is not directly applicable here. The "ground truth" for this device's performance studies would be the objective measurements and engineering standards (e.g., a shaft deflecting to a certain angle, a guidewire fitting, no leaks under specific pressure) that define whether the device meets its specifications and intended function. These are inherent physical properties or design requirements.

8. The Sample Size for the Training Set

This information is not applicable and not provided. There is no "training set" as this is not an AI/machine learning device. The device's design is based on engineering principles and similarities to predicate devices, not data-driven machine learning.

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

This information is not applicable and not provided for the same reasons as point 8.

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