Search Results

Silk Voice® is indicated for vocal fold medialization and vocal fold insufficiency that may be improved by injection of a soft tissue bulking agent. Silk Voice® injection augments the size of the displaced or deformed vocal fold so that it may meet the opposing fold at the midline for improved phonation. Vocal fold insufficiency associated with serious aspiration difficulties may be an urgent indication.

Silk Voice® is a sterile, non-pyrogenic, cohesive implant provided in a prefilled syringe and is a ready to use product. Silk Voice is comprised of porous bioabsorbable silk particles suspended in an isotonic, aqueous formulation of cross-linked, high molecular weight hyaluronic acid (HA). The crosslinked HA gel acts as a carrier for the silk particles to facilitate delivery. The main component of Silk Voice is silk particles, manufactured exclusively from regenerated silk fibroin protein, isolated from purified silk fibers. When injected, Silk Voice provides immediate volume augmentation to the vocal fold tissue. The porous particles remain at the site of implantation, providing a scaffold for local tissue infiltration. This cellular infiltrated silk scaffold provides longterm restoration and augmentation.

Silk Voice prefilled syringes are provided in a kit with a catheter, that is designed for endoscopic delivery to the vocal fold. The catheter accessory provided in the kit is specifically designed for delivery of injectable materials into tissue during endoscopic procedures.

The provided text does not contain information about acceptance criteria or specific studies that prove the device meets acceptance criteria in the context of a clinical performance study with human readers or an AI algorithm. The document is an FDA 510(k) summary for a medical device (Silk Voice, SMI-04) and primarily focuses on demonstrating substantial equivalence to a predicate device (Silk Voice, K180631) through bench testing and shelf-life data.

Therefore, most of the requested information cannot be extracted from this document, specifically points 1, 2, 3, 4, 5, 6, 7, 8, and 9 relate to clinical or AI performance studies which are not described here.

Here's what can be extracted:

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

The document states: "All bench testing passed the acceptance criteria." However, the specific quantitative acceptance criteria for each test and the corresponding reported performance values are not detailed in the summary. For example, for "Particle size and circularity analysis", it's mentioned that it passed, but the acceptance range and the measured value are not provided.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. The performance testing described is bench testing, not a clinical study on a test set of human data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable, as there is no test set involving human data or expert review described.

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

Not applicable, as there is no test set involving human data or ground truth adjudication 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

Not applicable. No MRMC study or AI assistance is mentioned.

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

Not applicable. No AI algorithm performance is discussed.

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

Not applicable. The "ground truth" in this context would be the design specifications and regulatory requirements for the bench tests.

8. The sample size for the training set

Not applicable. No training set for an AI algorithm is mentioned.

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

Not applicable. No training set for an AI algorithm is mentioned.

Summary of available information related to performance testing:

The device's performance was evaluated through bench testing and shelf-life testing.

• Bench Testing:
  • Tests Performed: Particle size and circularity analysis, Rheometry, Extrusion force, HA fragment test, Particle concentration, Residual Crosslinker Content, pH, Endotoxin, Catheter leak test, Catheter tensile strength.
  • Outcome: "All bench testing passed the acceptance criteria," demonstrating that the delivery system meets pre-established design input requirements.
  • Biocompatibility: Relied on "Biocompatibility test results of the predicate device submitted as part of the original submission (K180631)," which are stated to "continue to support that Silk Voice® meets the requirements of ISO 10993 for its intended use."
• Shelf-Life Testing: Performed to support labeled expiration dating.
• Sterilization Validation: Conducted for steam and EtO sterilization cycles, demonstrating a Sterility Assurance Level (SAL) of 10-6.

The primary purpose of this submission is to demonstrate substantial equivalence to an existing predicate device (Sofregen's Silk Voice K180631), highlighting that a change in silk particle size ($250 \pm 50 \mu m$ in the subject device vs. $380 \pm 46 \mu m$ in the predicate) "does not affect the safety or effectiveness assessment."

Ask a specific question about this device