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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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Calcium Hydroxylapatite Vocal Fold Implant is indicated for vocal fold medialization and vocal fold insufficiency that may be improved by injection of a soft tissue-bulking agent. Calcium Hydroxylapatite Vocal Fold Implant 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.

Calcium Hydroxylapatite Vocal Fold Implant is a ready to use product. Calcium Hydroxylapatite Vocal Fold Implant is comprised of calcium hydroxylapatite particles, blended into an aqueous gel formulated from sodium carboxymethyicellulose, glycerin, and a phosphate buffer. The gel acts as a carrier for the particles to facilitate placement. The main component of Calcium Hydroxylapatite Vocal Fold Implant is synthetic calcium hydroxylapatite, a material with over thirty years of use as an implant material used in orthopedics, neurosurgery, dentistry, otolaryngology, plastic surgery and ophthalmology. Calcium hydroxylapatite is also the main mineral component found in bones and teeth so it is a major component of the body. The calcium hydroxylapatite meets the requirements of ASTM F1185. The carrier consists of glycerin (USP) sodium carboxymethylcellulose (USP) and phosphate buffer (USP). The carrier resorbs in vivo, so that the calcium hydroxylapatite remains at the site of implantation, providing a scaffold for local tissue infiltration. This cellular infiltrated hydroxylapatite scaffold provides the longterm restoration and augmentation.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Calcium Hydroxylapatite Vocal Fold Implant:

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided text, no specific, quantifiable acceptance criteria (e.g., specific performance metrics, thresholds for success) for the device are detailed. The submission primarily focuses on establishing substantial equivalence to a predicate device rather than fulfilling pre-defined performance criteria through a separate clinical trial with specific endpoints.

The reported device performance is largely qualitative and comparative:

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

The document does not describe a clinical "test set" in the context of a performance study with human subjects for the Calcium Hydroxylapatite Vocal Fold Implant. The primary evidence presented is comparison to a predicate device and pre-clinical (in vitro and animal) studies.

• Pre-clinical tests: In vivo and in vitro tests were performed for biocompatibility. No specific sample sizes (e.g., N for animal studies or specific in-vitro replicates) are provided.
• Data Provenance: The biocompatibility studies cited are "preclinical safety studies and animal implant studies" (source not specified further, but assumed to be internal or from contract labs) and "in vivo and in vitro tests" (source not specified). There's no mention of country of origin for this data or if it was retrospective or prospective in the context of a clinical trial.

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

Not applicable. The submission does not describe a test set requiring expert-established ground truth for performance evaluation in the way a diagnostic AI would (e.g., reading images). The "ground truth" for the device's properties (biocompatibility, material composition, mechanism of action) comes from established scientific principles, ASTM standards (F1185 for the material), and laboratory testing.

4. Adjudication Method for the Test Set

Not applicable, as there is no described test set with human assessments requiring adjudication.

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. This device is an implantable material, not an AI-assisted diagnostic or therapeutic tool for human readers. Therefore, an MRMC study is not relevant to its regulatory submission.

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

Not applicable. The device is a physical implant, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" used for this submission is based on:

• Material Science and Chemistry: Adherence to ASTM F1185 for calcium hydroxylapatite.
• Biocompatibility Testing: Results from in vivo and in vitro tests, as well as animal implant studies.
• Sterilization Standards: Conformance to ISO 17665.
• Risk Management Standards: Adherence to ISO 14971.
• Predicate Device Equivalence: The primary ground truth for its intended use, mechanism of action, and safety profile is implicitly the established track record and regulatory approval of the legally marketed predicate device (K070090, Radiesse Laryngeal Implant).

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable. This is not an AI/ML device.

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The VF LiquiGel is indicated for vocal fold medialization in the treatment of vocal fold insufficiency, where insufficiency may be improved by injection of a soft tissue bulking agent. VF LiquiGel injection augments the size of the displaced or deformed vocal fold so that it may meet the opposing fold at the midline for improved glottal closure. Improved glottal closure may allow improved phonation, improvement of cough, and an improved ability to protect the airway during swallowing. VF LiquiGel is a temporary implant that degrades over time. The product is intended to be durable for a minimum of one month.

Sterile, latex free, non-pyrogenic, highly thixotropic, high yield strength clear gel with a neutral pH. The durability of the gel is due to slow degradation of the synthetic gel carrier. The thixotropic character of the gel allows it to be a very thick and cohesive gel but able to be injected through very fine needles with minimal force.

The provided document is a 510(k) Premarket Notification for the VF LiquiGel device by Coapt Systems, Inc. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than providing extensive clinical study data (such as those for novel devices or PMAs) that would typically include detailed information on acceptance criteria and specific study outcomes in the way requested.

The document states that "The VF LiquiGel performance data meet the applicable standards and fulfill the device requirements as defined in the user specifications," but does not provide the specific acceptance criteria or detailed results of a study designed to prove the device meets those criteria. Instead, it relies on demonstrating substantial equivalence in design, materials, function, and intended use to a legally marketed predicate device (VF Gel, K080956).

Therefore, I cannot provide all the requested information because it is not contained within the provided text. The document is primarily a comparison to a predicate device to establish substantial equivalence.

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

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

The document does not explicitly present acceptance criteria for performance in a quantitative way. Instead, it compares characteristics of the VF LiquiGel to its predicate, VF Gel, and states equivalency. The "reported device performance" is essentially that it is "Equivalent" to the predicate in all assessed parameters, implying it meets the same functional and safety profiles.

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

The document does not describe a clinical "test set" in the context of a prospective or retrospective study on patients using the VF LiquiGel. The evaluation is based on performance evaluations and comparison testing to the predicate device (Section 10.1, Substantial Equivalence Comparison, 1. Indications Summary; 3. Performance Summary), likely bench testing and material characterization, rather than a clinical study with a patient sample size. Therefore, there's no information on data provenance from human subjects or study design (retrospective/prospective).

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 described clinical test set for this 510(k) submission, there are no experts establishing ground truth for such a set. The "ground truth" for substantial equivalence is based on regulatory and scientific comparison to the predicate device's established safety and effectiveness.

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

Not applicable. There is no described clinical test set requiring adjudication.

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. This device is a medical implant (a gel), not an AI-assisted diagnostic tool.

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

Not applicable. This device is a medical implant (a gel), not an algorithm.

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

The "ground truth" in this 510(k) context is the established safety and effectiveness profile of the predicate device (VF Gel, K080956) and the scientific understanding of the materials and mechanism of action, validated through material characterization and biocompatibility testing (meeting ISO 10993 and NF/USP requirements). No clinical outcomes data for the subject device are presented to establish ground truth.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device. The "training set" doesn't apply here.

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

Not applicable. This is not an AI/machine learning device.

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Vocalis Gel is indicated for vocal fold medialization and vocal fold insufficiency that may be improved by injection of a soft tissue bulking agent. Vocalis Gel 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. The product is intended to be durable for a minimum of one month.

Sterile, latex free, non-pyrogenic, high yield strength, isotonic, clear gel injectable implant. The gel consists primarily of sterile water for injection (USP), glycerin (USP) and mannitol (USP). The high yield strength is created by small amounts of carbomer (USP). The gel carrier allows tissue infiltration over time. All components are listed as GRAS (Generally Recognized as Safe 21 CFR 182). The character of the gel allows it to be very thick and cohesive but sheer to be easily injected through very fine needles with minimal force.

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the Vocalis Gel device.

Acceptance Criteria and Device Performance for Vocalis Gel

Unfortunately, the provided document does not explicitly state specific acceptance criteria (e.g., numerical targets for performance metrics) for Vocalis Gel.

Instead, the document focuses on demonstrating substantial equivalence to predicate devices and fulfilling general regulatory requirements for medical devices. The primary "performance" is implicitly demonstrated through biocompatibility, sterilization, and pre-clinical safety assessments.

The device's intended effect, "vocal fold medialization and vocal fold insufficiency that may be improved by injection of a soft tissue bulking agent...to meet the opposing fold at the midline for improved phonation" and being "durable for a minimum of one month," are clinical outcomes rather than quantifiable device performance metrics presented in this 510(k) summary.

Based on the available information, the closest approximation to "acceptance criteria" and "reported device performance" are as follows:

Study Details Proving Device Meets Acceptance Criteria:

The provided document describes pre-clinical tests rather than a study with a defined "test set" or "ground truth" as might be seen for diagnostic AI devices.

1. Sample size used for the test set and the data provenance:

   • Test Set Sample Size: Not specified in terms of number of subjects or samples. The document refers to "in vivo and in vitro tests" and "animal implant studies" but does not give specific numbers for these.
   • Data Provenance: Not explicitly stated (e.g., country of origin). The studies appear to be laboratory-based pre-clinical (in vitro and in vivo animal) rather than human clinical data. They are retrospective in the sense that they were conducted before the 510(k) submission.

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

   • This concept is not applicable to the type of pre-clinical studies described. Ground truth, in this context, would be established by scientific methods and validated assays (e.g., cytotoxicity assays, irritation tests, histological analysis for biocompatibility in animal models) performed by trained laboratory personnel or specialists in relevant fields (e.g., toxicology, pathology). There is no mention of "experts" in the sense of clinical reviewers adjudicating results for the pre-clinical tests.

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

   • Not applicable. This concept pertains to human review of data, typically in diagnostic or qualitative assessment studies. The pre-clinical tests described would be evaluated based on objective scientific measurements and established criteria for toxicity, irritation, etc.

4. 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. Vocalis Gel is an injectable medical device, not a diagnostic imaging or AI-assisted system for human readers. Therefore, an MRMC study is not relevant to its evaluation.

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

   • Not applicable. This refers to AI algorithm performance. Vocalis Gel is a physical medical device.

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

   • For biocompatibility: Histological analysis from animal implants, and various laboratory assays (e.g., cytotoxicity, hemocompatibility).
   • For irritation, sensitization, acute and sub-chronic toxicity, genotoxicity, and hemolysis: Standardized in vivo (animal) and in vitro (cell culture, biochemical) assays with pre-defined endpoints and controls.
   • For sterility: Biological indicators and physical parameters measured during the sterilization cycle to confirm a 10⁻⁶ SAL.

7. The sample size for the training set:

   • Not applicable. This device does not involve a "training set" in the context of machine learning or AI.

8. How the ground truth for the training set was established:

   • Not applicable. See point 7.

In summary, the provided document for Vocalis Gel focuses on demonstrating the device's safety, biocompatibility, and manufacturing quality through pre-clinical laboratory and animal studies, rather than clinical performance metrics with specific numerical acceptance criteria typically seen for diagnostic devices or those with direct, quantifiable output. The acceptance is based on demonstrating substantial equivalence to predicate devices and fulfilling these fundamental safety and sterilization requirements.

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Vocalis and Vocalis SM are indicated for vocal fold medialization and vocal fold insufficiency that may be improved by injection of a soft tissue bulking agent. Vocalis 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. The product is intended to be durable for a period of one month.

Sterile, latex free, non-pyrogenic, semi-solid, cohesive subdermal implant. The principle durable component is synthetic calcium hydroxylapatite. The semi-sold nature is created by suspending the calcium hydroxylapatite particles in a durable high yield strength thixotropic gel. The isotonic gel carrier consists primarily of sterile water for injection (USP), glycerin (USP) and mannitol (USP). The thixotropic high yield strength gel is created by the Carbopol 974P NF (USP).

The provided text is a 510(k) summary for the Vocalis and Vocalis SM vocal fold implants. It describes the device, its intended use, and substantial equivalence to predicate devices, but it does not contain information about acceptance criteria or a study proving the device meets those criteria.

The document focuses on:

• Intended Use: Vocal fold medialization and vocal fold insufficiency to improve phonation, with a durability of one month.
• Product Description: Sterile, latex-free, non-pyrogenic, semi-solid, cohesive subdermal implant with synthetic calcium hydroxylapatite suspended in a thixotropic gel.
• Substantial Equivalence: Lists several predicate devices (K013243, K070090, K071663, K080956).
• Pre-Clinical Tests: Biocompatibility, sterilization, and general in vivo/in vitro tests for irritation, sensitization, cytotoxicity, toxicity, genotoxicity, and hemolysis. These tests concluded the device is non-irritant, non-toxic, and has no long-term safety concerns.
• Risk Assessment: Identified primary risks associated with nasopharyngoscopy and injection laryngoplasty.
• Summary: Concludes the device is safe and effective as a space-filling material for soft tissue augmentation in laryngeal procedures.

Therefore, I cannot extract the requested information, as the document does not contain details about acceptance criteria, specific performance studies with sample sizes, expert involvement, or ground truth establishment for clinical effectiveness. The review is a premarket notification centered on demonstrating substantial equivalence through non-clinical testing and comparison to existing devices.

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The VF Gel is indicated for vocal fold medialization in the treatment of vocal fold insufficiency, where insufficiency may be improved by injection of a soft tissue bulking agent. VF Gel injection augments the size of the displaced or deformed vocal fold so that it may meet the opposing fold at the midline for improved glottal closure. Improved glottal closure may allow improved phonation, improvement of cough, and an improved ability to protect the airway during swallowing. VF Gel is a temporary implant that degrades over time. The product is intended to be durable for a minimum of one month.

Sterile, latex free, non-pyrogenic, highly thixotropic, high yield strength clear gel with a neutral pH. The durability of the gel is due to slow degradation of the synthetic gel carrier. The thixotropic character of the gel allows it to be a very thick and cohesive gel but able to be injected through very fine needles with minimal force.

This document describes a 510(k) summary for a medical device called "VF Gel." The summary focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove acceptance criteria with specific performance metrics. Therefore, many of the requested data points (e.g., sample sizes for training/test sets, ground truth establishment, expert qualifications, MRMC studies, standalone performance) are not applicable or available in this type of submission.

Here's a breakdown of the information that can be extracted from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The submission does not present a table of quantitative acceptance criteria or specific device performance metrics in the way one might expect for an AI/algorithm-based device. Instead, the "acceptance criteria" are implied by the demonstration of "substantial equivalence" to a predicate device, meaning the new device (VF Gel) is as safe and effective as the legally marketed predicate. The "reported device performance" is essentially that it meets the requirements of a substantially equivalent device.

The table below summarizes the comparison of "VF Gel Plus" (the subject device) to "VF Gel" (the predicate device) from Table 7: Substantial Equivalence Summary, which outlines the characteristics compared to establish equivalence. The "Impact on Safety and Effectiveness" column effectively serves as the "reported device performance" in this context, indicating that the new device does not raise new safety or effectiveness concerns.

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

• Sample Size for Test Set: This information is not provided in the 510(k) summary. The submission focuses on a comparison of characteristics to a predicate device, not a performance study with a test set of patient data.
• Data Provenance: This information is not provided. As it's a device for vocal fold medialization, any "performance evaluations and comparison testing" mentioned are likely preclinical (e.g., benchtop, material characterization), or may refer to clinical experience with the predicate device, but specific data provenance for a test set is absent.

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

• This information is not applicable/not provided. The submission does not detail a study involving expert-established ground truth for a test set in the context of an AI/algorithm. The "ground truth" for this medical device's approval is based on its physical and functional equivalence to a legally marketed predicate device.

4. Adjudication method for the test set:

• This information is not applicable/not provided. There is no described test set or expert adjudication process for such a test set.

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:

• This information is not applicable/not provided. This is a submission for a physical medical implant (gel), not an AI/algorithm. Therefore, an MRMC study related to AI assistance is irrelevant.

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

• This information is not applicable/not provided. This is a physical medical device, not an algorithm.

7. The type of ground truth used:

• The "ground truth" in this context is the established safety and effectiveness of the predicate device. The VF Gel's "ground truth" is that its design, materials, function, and intended use are similar enough to the predicate device that it can be considered substantially equivalent. This is based on material properties, biocompatibility, and functional evaluations rather than expert consensus on patient outcomes or pathology from a dataset.

8. The sample size for the training set:

• This information is not applicable/not provided. This is a physical medical device, not an AI/algorithm that requires a training set.

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

• This information is not applicable/not provided. As above, there is no training set for a physical device.

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The VF Gel Plus is indicated for vocal fold medialization in the treatment of vocal fold insufficiency, where insufficiency may be improved by injection of a soft tissue bulking agent. VF Gel Plus injection augments the size of the displaced or deformed vocal fold so that it may meet the opposing fold at the midline for improved glottal closure. Improved glottal closure may allow improved phonation, improvement of cough, and an improved ability to protect the airway during swallowing. VF Gel Plus is a temporary implant that degrades over time. The product is intended to be durable for a minimum of one month.

Sterile, latex free, non-pyrogenic, semi-solid, cohesive subdermal implant. The principal durable component is synthetic calcium hydroxylapatite. The semi-solid nature is created by suspending the calcium hydroxylapatite particles in a high yield strength thixotropic gel. The isotonic gel carrier consists primarily of sterile water for injection (USP), glycerin (USP) and mannitol (USP). The thixotropic high yield strength gel is created by the carbomer (NF). The calcium hydroxylapatite particles are 25 to 45 microns in size while being smooth but irregular in shape and are present in the product at 30% by volume.

The provided text describes a 510(k) summary for a medical device called "VF Gel Plus." It focuses on establishing substantial equivalence to a predicate device rather than presenting a study with acceptance criteria and device performance metrics in the way one might find for an AI/ML device or a diagnostic accuracy study.

Therefore, many of the requested elements (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable or not present in the provided document, as it outlines a regulatory submission for a physical implant, not a data-driven model.

However, I can extract information related to the device's intended use and the general claim of performance based on comparison to a predicate device.

Here's a breakdown of the information that is available or derivable from the text:

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

The document does not specify quantitative acceptance criteria with corresponding device performance metrics in the traditional sense of a clinical trial for a diagnostic device. Instead, it claims substantial equivalence to a predicate device based on design, materials, function, intended use, and performance evaluations.

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

• Sample Size: Not specified. The document refers to "performance evaluations and comparison testing" but does not detail a specific test set size or methodology for a clinical study with a control group. This is common for 510(k) submissions for physical implants where equivalence is demonstrated through non-clinical testing (e.g., material compatibility, degradation) and comparison to the predicate's known clinical performance, rather than a new large-scale clinical trial.
• Data Provenance: Not specified.

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

• Not Applicable. This type of information is relevant for studies involving human interpretation or data labeling, such as for AI/ML or diagnostic accuracy studies. The provided document is for a physical implant where ground truth would typically relate to material properties, biocompatibility, and functional outcomes in in vitro or in vivo (animal) models, or clinical observation, rather than expert consensus on a test set.

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

• Not Applicable. See point 3.

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. This is a physical medical implant, not an AI-assisted diagnostic or decision support tool where "human readers" or AI assistance would be relevant.

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

• Not Applicable. This is a physical medical implant, not a standalone algorithm.

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

• Implied Ground Truth: For this type of device, the "ground truth" would pertain to the physical and biological performance of the implant, such as:
  • Biocompatibility (e.g., no adverse tissue reactions)
  • Material properties (e.g., degradation rate, injectability, stability)
  • Functional outcome (e.g., ability to augment vocal fold, leading to improved phonation, cough, airway protection) – these are assessed clinically but the study demonstrating equivalence likely relies on laboratory/pre-clinical data and existing knowledge of the predicate.
• The document states "VF Gel Plus performance data meet the applicable standards and fulfill the device requirements as defined in the user specifications," implying that performance was measured against established benchmarks for similar devices.

8. The sample size for the training set

• Not Applicable. This is not an AI/ML device that requires a training set.

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

• Not Applicable. This is not an AI/ML device that requires a training set.

In summary, the provided document is a 510(k) summary for a physical medical implant asserting substantial equivalence to an existing device. It does not contain the detailed study design, acceptance criteria, and performance metrics typically found in clinical trials for diagnostic devices or AI/ML products.

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BioForm's Radiesse Laryngeal Implant is indicated for vocal fold medialization and vocal fold insufficiency that may be improved by injection of a soft tissue bulking agent. Radiesse Laryngeal Implant 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.

Radiesse Laryngeal Implant is a sterile, non-pyrogenic injectable material consisting of calcium hydroxylapatite (CaHA) suspended in an aqueous formulation of USP grade pharmaceutical excipients consisting of sterile water, glycerin, and sodium carboxymethylcellulose, stabilized with a phosphate buffer. These excipients have prior and extensive use in intramuscular injectable pharmaceutical products including Cortone®, Decadron®, and Dalalone® drugs. Glycerin, sodium carboxymethylcellulose and phosphate buffer are listed in 21 CFR 182 as Generally Recognized as Safe (GRAS), Sections 182.1320, 182.1745, and 182.6285, respectively.

Calcium hydroxylapatite particles (30%-40% by volume) are combined with this aqueous formulation to create the implant media. The calcium hydroxylapatite meets ASTM F1185.

The provided text is a 510(k) summary for the Radiesse Laryngeal Implant. This documentation focuses on demonstrating substantial equivalence to predicate devices and detailing the device's biocompatibility, sterilization, and general safety. It does not contain information about specific clinical studies with acceptance criteria or performance metrics directly related to efficacy in human subjects.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes for test set, data provenance, number of experts, adjudication methods, or ground truth for the test set.
3. Information on multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.
4. Sample size for the training set or how ground truth was established for the training set.

The document primarily states:

Acceptance Criteria/Performance (Implied Safety/Equivalence):

• Biocompatibility: "The battery of prectinical safety studies and animal implant studies show that the Radiesse Laryngeal Implant is biocompatible when injected into soft tissues." (Section 4.6)
• Sterilization: Processed in-house using a computer-controlled autoclave system, validated to an "overkill methodology to 10-6 SAL." (Section 4.7)
• Pre-Clinical Safety: "In vivo and In vitro tests were performed to address cytotoxicity, sensitization, mutagenticity, and hemolysis. Results identified the Radiesse Laryngeal Implant as nontoxic with no concerns for long-term safety." (Section 4.8)
• Substantial Equivalence: The device is deemed substantially equivalent to predicate devices (K060812 Juliesse™ Injectable Laryngeal Augmentation Implant and K013243 Coaptite Laryngeal Augmentation System) for its stated intended use. This is the primary "acceptance criterion" for a 510(k) clearance.

Study that Proves Device Meets Acceptance Criteria:
The studies mentioned are:

• Preclinical Safety Studies: These included "animal implant studies," "in vivo and in vitro tests" for cytotoxicity, sensitization, mutagenicity, and hemolysis. (Sections 4.6, 4.8)
• Sterilization Validation: An "overkill methodology to 10-6 SAL" was used for steam sterilization. (Section 4.7)

Summary of available information based on your request:

• Sterilization: Achieved 10-6 SAL (Sterility Assurance Level) through validated steam sterilization.
• Toxicity: Identified as nontoxic with no long-term safety concerns based on in vivo and in vitro tests (cytotoxicity, sensitization, mutagenicity, hemolysis).
• Substantial Equivalence: Deemed substantially equivalent to predicate devices K060812 (Juliesse™) and K013243 (Coaptite). |
  | Test Set Sample Size & Data Provenance | Not applicable / Not provided. The review is based on preclinical data and equivalence to existing devices, not a clinical test set with human performance data. |
  | Number & Qualifications of Experts for Ground Truth | Not applicable / Not provided. |
  | Adjudication Method for Test Set | Not applicable / Not provided. |
  | MRMC Comparative Effectiveness Study Done? Effect Size? | No MRMC study was done or reported in this document. |
  | Standalone (Algorithm Only) Performance Done? | Not applicable. This is a physical implant, not an algorithm. |
  | Type of Ground Truth Used | For preclinical studies: biological endpoints (cytotoxicity, sensitization, etc.) and observations from animal implants. For substantial equivalence: comparison to predicate device characteristics and performance (as previously established). |
  | Training Set Sample Size | Not applicable / Not provided. This term typically applies to machine learning algorithms, which is not the case here. |
  | How Ground Truth for Training Set Established | Not applicable / Not provided. |

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