Search Results

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.

Ask a specific question about this device