Search Results

Provox® Vega™ Puncture Set is a device for performing a primary or secondary tracheoesophageal (TE) puncture in laryngectomized patients, with integrated placement of a Provox Vega voice prosthesis.

The Provox Vega voice prosthesis is a sterile single use indwelling voice prosthesis 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.

Environments of use include;

• Provox® VegaTM Puncture Set hospitals and sub-acute care institutions.
• Provox® Vega Voice Prosthesis hospitals, sub-acute care institutions and home.

The Provox Vega Puncture Set is a device for creating a primary or secondary TE puncture, with subsequent dilatation of that puncture to a width that facilitates placement of the included Provox Vega voice prosthesis. The Provox Vega voice prosthesis is preloaded on the Puncture Dilator, which is part of the device.

The Provox Vega Puncture Set is intended for single use only and the package contains the following sterile items in a blister package:

• · 1 Pharynx Protector (Fig. 1:1) made of transparent thermoplastic,
• · 1 Puncture Needle (Fig. 1.2) made of surgical stainless steel.
• · 1 Guidewire (Fig. 1.3) made of pre-colored fluoroplastic.
• · I Puncture Dilator with I preloaded Provox Vega voice prosthesis (Fig. 1.4). The Puncture Dilator is made of thermoplastic elastomer and polypropylene; and the Vega voice prosthesis is made of medical grade silicone rubber and fluoroplastic.

The set also includes the following non-sterile items:

• · 1 Instructions for use Provox Vega Puncture Set,
• · 1 Provox Vega Patient's Manual,
• · 1 Provox Brush of a size corresponding to the voice prosthesis,
• · 1 Provox Brush Instructions for Use.
• · I Provox Plug of a size corresponding to the voice prosthesis,
• · 1 Provox Plug Instructions for Use.
• · 1 Emergency Card

The provided text describes the Provox® Vega™ Puncture Set and compares it to predicate devices to establish substantial equivalence. However, it does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria through empirical testing.

The submission focuses on demonstrating that the proposed device is as safe and effective, and performs as well or better than the predicate devices based on:

• Identical indications for use (for the voice prosthesis component)
• Similar materials
• Similar design
• Similar operating principles

Essentially, the argument for equivalence is based on the lack of significant differences in these aspects between the new device and previously cleared devices, rather than a standalone performance study with predefined acceptance criteria.

Therefore, many of the requested sections about acceptance criteria, reported performance, sample sizes, ground truth, expert adjudication, or MRMC studies cannot be extracted from this document because such a study is not detailed.

Here's a breakdown of what can and cannot be answered based on the provided text:

1. A table of acceptance criteria and the reported device performance

• Cannot be provided. The document does not specify quantitative acceptance criteria or report performance metrics from a formal study. The conclusion is based on substantial equivalence to predicate devices, implying that if the predicate devices meet their acceptance criteria, the new device will too due to its similarity.

2. Sample size used for the test set and the data provenance

• Cannot be provided. No specific test set or study involving human subjects or data is described. The comparison is primarily regulatory and technical, based on device specifications and intended use.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Cannot be provided. No ground truth establishment activity is mentioned for a test set.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

• Cannot be provided. No test set or adjudication process is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Cannot be provided. This device is a medical instrument (voice prosthesis and puncture set), not an AI/imaging device. Therefore, MRMC studies or AI improvement metrics are not relevant or discussed.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

• Cannot be provided. Not applicable as this is not an algorithm/AI device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Cannot be provided. No ground truth is established for a performance study. "Ground truth" here is effectively the accepted safety and effectiveness of the predicate devices.

8. The sample size for the training set

• Cannot be provided. Not applicable as this is not an algorithm/AI device that requires a training set.

9. How the ground truth for the training set was established

• Cannot be provided. Not applicable.

Summary of Substantial Equivalence Information (relevant to the document's purpose):

The document aims to demonstrate substantial equivalence to predicate devices rather than report on a new performance study with explicit acceptance criteria.

• Predicate Devices:

  • Atos Medical - Provox® Vega™ Voice Prosthesis with SmartInserter - (K090455)
  • Atos Medical - Provox Voice Prosthesis - (K940638)

• Basis for Equivalence:

  • Indications for Use: The Provox Vega Puncture Set's voice prosthesis component has identical indications to the predicate Provox® Vega™ Voice Prosthesis (K090455). The puncture set's overall function is for performing TE puncture with integrated placement of the voice prosthesis.
  • Materials: Stated as "Identical" for the Voice Prosthesis (medical grade silicone rubber and fluoroplastic) compared to the predicate Vega voice prosthesis. Components like the Guidewire, Puncture Needle, and Pharynx Protector are described as "modifications" of previously cleared or exempted accessories from predicate devices, with materials like pre-colored fluoroplastic, thermoplastic elastomer, surgical stainless steel, and transparent thermoplastic.
  • Design: The Provox Vega™ Voice Prosthesis included in the Puncture Set is stated to be "identical in every aspect" to the voice prosthesis in the predicate K090455. Other components are modifications of existing accessories.
  • Operating Principles: Not explicitly elaborated in detail beyond component function but implied to be similar due to comparable design and intended use.

The conclusion by Atos Medical AB is that "There are no significant differences between the Provox Vega Puncture Set compared to the predicate devices in terms of indications, materials, design and operating principles. Information presented in this submission supports that Provox Vega Puncture Set is as safe and effective, and performs as well or better than the predicate devices." This is the core "proof" presented for regulatory acceptance.

Ask a specific question about this device