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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."

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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 the long term 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.

Based on the provided text, the device in question is Silk Voice®, a vocal fold medialization system. The document is a 510(k) premarket notification of intent to market, and as such, it focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving that the device meets specific performance acceptance criteria in an independent clinical study that would be typical for an AI/ML device.

Therefore, many of the requested items (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance for an algorithm) are not applicable to this type of medical device clearance or the information provided. The "acceptance criteria" here are primarily around demonstrating substantial equivalence through non-clinical testing and comparison to the predicate.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly numerical thresholds like sensitivity/specificity for an AI algorithm. Instead, they are based on demonstrating that the device's characteristics and performance are comparable to the predicate device, and that it meets established safety standards.

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

• Test Set (Non-Clinical/Animal Study):
  • Animal Model: Canine model.
  • Sample Size: n=12 for Silk Voice®; n=12 for the predicate product. (Total 24 animals)
  • Data Provenance: Not specified, but likely proprietary laboratory animal studies (prospective for the study duration). Country of origin is not mentioned.

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

• Not Applicable in the traditional sense for this device. Ground truth for the animal study (histology, gross pathology, imaging) would be established by veterinary pathologists or other trained personnel, but the specific number or their detailed qualifications are not provided in this summary. This is not an AI/ML device relying on human expert annotations for performance validation.

4. Adjudication Method for the Test Set

• Not Applicable. This is not an AI/ML evaluation where human expert adjudication of output is needed. For the animal study, the assessment of gross pathology, histopathology, inflammation, and neovascularization would typically follow established veterinary pathology protocols, which may involve multiple evaluators for quality control, but a formal "adjudication method" as used in AI performance evaluation is not relevant here.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No. An MRMC study is relevant for evaluating the impact of an AI system on human reader performance in image interpretation. This device is an injectable medical implant; therefore, an MRMC study is not applicable.

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

• Not Applicable. This is not an algorithm-based device. "Standalone performance" would refer to an AI's diagnostic accuracy without human intervention. This concept does not apply to an injectable medical device.

7. The Type of Ground Truth Used

• For the non-clinical (pre-clinical) animal study, the "ground truth" for evaluating the tissue response and device retention was established through:
  • Gross Pathology: Macroscopic observations of tissues.
  • Histopathology: Microscopic examination of tissue samples, including scoring of inflammation and neovascularization.
  • Imaging: Incremental imaging performed during the study (specific type not detailed).

8. The Sample Size for the Training Set

• Not Applicable. This device is not an AI/ML algorithm that requires a training set. The "design" of the device is based on materials science and engineering principles, not machine learning model training.

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

• Not Applicable. As there is no training set for an AI/ML algorithm, there is no ground truth establishment for such a set. The development of the Silk Voice® device itself relies on established scientific and engineering principles, and biocompatibility/performance testing data from animal models and bench studies to demonstrate safety and functional equivalency.

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SERI® Contour is indicated for use as a transitory scaffold for soft tissue support and repair to reinforce deficiencies where weakness or voids exist that require the addition of material to obtain the desired surgical outcome. This includes reinforcement of soft tissue in plastic and reconstructive surgery and general soft tissue reconstruction.

SERI® Contour is a knitted, multifilament, bioengineered, long-term bioresorbable scaffold. It is derived from pure silk fibroin. The device is a mechanically strong and biocompatible protein mesh. SERI® Contour is a sterile, single use only product and is supplied in a variety of sizes. ready for use in open or laparoscopic procedures. The scaffold is flexible and well-suited for delivery through a laparoscopic trocar. It is tear resistant, with excellent suture retention, and can be cut in any direction. SERI® Contour provides immediate physical and mechanical stabilization of a tissue defect through its strength and porous (scaffold-like) construction.

The provided text is a 510(k) summary for a medical device (SERI® Contour) seeking substantial equivalence to a predicate device (SERI® Surgical Scaffold). As such, it focuses on demonstrating equivalence rather than establishing acceptance criteria against a defined clinical outcome or proving superiority. The information for a typical AI/software device performance study is not entirely available here because this is for a physical surgical mesh.

However, I will extract and infer the most relevant information based on the typical structure for a medical device efficacy study outlined in your request.

Here's a breakdown of the information that can be extracted or inferred:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: "large animal model" – A specific number is not provided.
• Data Provenance: Prospective (implied by "evaluated in a large animal model" and "in vivo performance testing"). Country of origin is not specified.

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

• Not applicable/Not mentioned. This is a pre-clinical performance study in an animal model, not a human clinical trial where expert clinicians would establish ground truth for diagnosis/outcome.

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

• Not applicable/Not mentioned. This refers to consensus among human readers for clinical ground truth, which is not relevant for this type of animal study.

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

• No, an MRMC comparative effectiveness study was not done. This device is a surgical mesh, not an AI/software diagnostic tool for human readers.

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

• No, this term is not applicable. The device is a physical surgical mesh.

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

• Ground Truth: For the animal study, the ground truth was based on direct measurements of mechanical properties (burst strength) and histological/microscopic evaluation for tissue ingrowth at specified time points (3, 6, and 12 months) in the large animal model. This is a form of direct measurement and pathological assessment.

8. The sample size for the training set

• Not applicable. This is a physical device, not an AI model that requires a training set. The "design change" and "clinical feedback" could be considered analogous to iterative development, but not a formal 'training set' in the AI sense.

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

• Not applicable. (See #8).

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