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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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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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The ULTRATINE Forehead™ is intended for use in subperiosteal browplasty surgery. The ULTRATINE Forehead is specifically indicated for use to fixate the subdermis to the cranial bone in browplasty.

The ULTRATINE Forehead™ consists of a bioabsorbable implant. This device is supplied sterile for single use only.

The provided document is a 510(k) Premarket Notification for the ULTRATINE Forehead™ device. It describes the device's intended use and claims substantial equivalence to predicate devices. However, this type of regulatory document does not typically include detailed acceptance criteria or the results of a formal study with statistical performance values.

510(k) submissions primarily focus on demonstrating substantial equivalence to a legally marketed predicate device rather than proving clinical effectiveness through comprehensive studies with specific performance metrics. The document states that "The ULTRATINE Forehead™ performance data meet the applicable standards and fulfill the device requirements as defined in the user specifications," but it does not provide those specific acceptance criteria or the study data itself.

Therefore, I cannot provide the requested information regarding detailed acceptance criteria, device performance, sample sizes, ground truth establishment, or specific study results for the ULTRATINE Forehead™ device from the given text.

Based on the provided information, I can offer the following:

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

• Acceptance Criteria: Not explicitly stated in the document. The document refers to "applicable standards and fulfill the device requirements as defined in the user specifications," but these specifications are not included.
• Reported Device Performance: Not numerically reported in the document. The document generally states that "The ULTRATINE Forehead™ performance data meet the applicable standards and fulfill the device requirements as defined in the user specifications." This is a general claim rather than specific performance data.

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

• Sample Size (Test Set): Not provided.
• Data Provenance: Not provided. The document mentions "performance evaluations and comparison testing to the predicate devices" but does not detail the nature or source of this data.

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

• Not applicable. The document does not describe a study involving expert-established ground truth.

4. Adjudication method for the test set:

• Not applicable. The document does not describe a study involving adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and 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 bioabsorbable implant for surgical fixation, not an AI-assisted diagnostic or imaging device. Therefore, an MRMC study related to AI assistance is not relevant to this product.

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

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

7. The type of ground truth used:

• Not applicable. The document does not describe a study that would require a ground truth as typically defined for diagnostic or AI-based devices. The "performance data" likely refers to biomechanical testing, material properties, and biocompatibility, which are assessed against engineering standards rather than a clinical "ground truth."

8. The sample size for the training set:

• Not applicable. This is not an AI/algorithm-based device and would not have a training set in that context.

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

• Not applicable. (See #8)

In summary, the provided 510(k) document is for a medical device that demonstrates substantial equivalence based on design, materials, function, and intended use, rather than presenting detailed clinical performance data against specific acceptance criteria in the manner one would expect for an AI or diagnostic device.

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The ULTRATINE TransBleph™ is intended for use in subperiosteal browplasty fixation. The ULTRATINE TransBleph is specifically indicated for use to fixate the subdermis to the frontal bone.

The ULTRATINE TransBleph™ consists of a bioabsorbable implant. This device is supplied sterile for single use only.

The provided text describes a 510(k) premarket notification for the ULTRATINE TransBleph™ Device, which is intended for subperiosteal browplasty fixation. However, the document does not contain a study that proves the device meets specific acceptance criteria through performance metrics. Instead, it relies on demonstrating substantial equivalence to predicate devices.

Therefore, many of the requested elements for a study proving device performance against acceptance criteria cannot be extracted from this document.

Here's what can be gathered based on the provided text, and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: Not specified.
• Data Provenance: Not specified (e.g., country of origin, retrospective/prospective).

3. Number of Experts Used to Establish Ground Truth and Qualifications:

• Not applicable. No ground truth establishment by experts for a test set is described.

4. Adjudication Method for the Test Set:

• Not applicable. No adjudication method is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No MRMC comparative effectiveness study is mentioned. The document focuses on demonstrating substantial equivalence rather than comparative effectiveness with or without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

• Not applicable. This device is a bioabsorbable implant, not an AI algorithm, so an "algorithm only" performance study is irrelevant.

7. Type of Ground Truth Used:

• Not applicable. No ground truth is described as the basis for performance evaluation in the context of a study. The evaluation appears to be based on adherence to "applicable standards" and "user specifications" in direct comparison to predicate devices.

8. Sample Size for the Training Set:

• Not applicable. This device is a physical implant, not an AI model, so there is no "training set."

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

• Not applicable for the same reason as above.

Summary of what the document does state regarding performance, without providing specific data:

• Substantial Equivalence: The primary method of demonstrating safety and effectiveness is by claiming substantial equivalence to legally marketed predicate devices (ENDOTINE TransBleph™ and Vicryl suture).
• Performance Claim: "The ULTRATINE TransBleph™ performance data meet the applicable standards and fulfill the device requirements as defined in the user specifications." However, these "applicable standards" and "user specifications" are not detailed, nor are the specific "performance data" presented.
• Differences: "The differences between the ULTRATINE TransBleph™ and the predicate devices do not affect the safety and effectiveness of the ULTRATINE TransBleph™." And, "Any differences between the ULTRATINE TransBleph™ and the predicate devices are minor and do not raise issues regarding safety or effectiveness."

In conclusion, while the document asserts that performance data meets requirements and supports substantial equivalence, it does not provide the details of a specific study with defined acceptance criteria and quantitative performance results that would allow for the complete answer to your detailed request. The focus of this 510(k) summary is on demonstrating equivalence rather than presenting an independent performance study.

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The ENDOTINE Ribbon™ is indicated for use in elevation and fixation of tissues in the temporal region, midface, lower face/jowl to the deep temporal fascia and the neck to the mastoid fascia during cosmetic procedures.

The ENDOTINE Ribbon™ consists of a bioabsorbable implant pre-loaded on an insertion tool. The device implant is a soft tissue fixation platform. The insertion tool and implant are sterilized together.

Here's an analysis of the provided text regarding the ENDOTINE Ribbon™ device, specifically focusing on the requested information.

It's important to note that this document is a 510(k) summary for a Special 510(k) Premarket Notification. Special 510(k)s are typically used for modifications to a manufacturer's own legally marketed device where the modifications do not affect the intended use or alter the fundamental scientific technology of the device. This usually means that extensive new clinical studies or detailed performance data comparing the new device to the predicate are not provided in the 510(k) summary itself, as the substantial equivalence is often based on the previous clearance and controlled design changes.

Therefore, much of the requested information regarding detailed study design, sample sizes for test/training sets, expert qualifications, and specific acceptance criteria with device performance results are not present in this type of summary. The primary claim here is substantial equivalence to a predicate device already on the market (K051415), which is also an ENDOTINE Ribbon™ from the same company.

Acceptance Criteria and Study to Prove the Device Meets Acceptance Criteria

1. Table of acceptance criteria and the reported device performance:

This 510(k) summary does not include a table of specific acceptance criteria or detailed reported device performance. The document states:

• "The Subject Device meets all internal functional performance requirements."
• "Based on the design, materials, fundamental technology, intended use, and performance specifications, Coapt Systems believes the proposed ENDOTINE Ribbon™ is substantially equivalent to the predicate device, the ENDOTINE Ribbon™ Device, currently marketed under the Federal Food, Drug and Cosmetic Act."

For a Special 510(k) like this, specific acceptance criteria and performance data are usually not provided in the summary. The "acceptance criteria" are generally that the modified device performs comparably to the predicate device and meets established internal design controls and functional requirements, which are often not explicitly detailed in the public 510(k) summary. The comparison is primarily focused on demonstrating that the modifications do not raise new questions of safety or effectiveness.

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

• Sample Size for Test Set: Not specified in the provided document.
• Data Provenance: Not specified. Given the nature of a Special 510(k) for a modification, any testing would likely be internal (e.g., benchtop, mechanical, or limited animal/cadaver studies) rather than a full clinical trial. The document doesn't mention clinical data used specifically for "testing" this modified device, relying instead on substantial equivalence to the previously cleared predicate.

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

• Not applicable/Not specified. This document does not describe a clinical study where experts established ground truth for a test set.

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

• Not applicable/Not specified. This document does not describe a clinical study with an adjudication method.

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 absorbable surgical suture/fixation platform, not an AI-assisted diagnostic or imaging device. Therefore, MRMC studies and AI-related metrics are irrelevant here.

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

• Not applicable. This is not an algorithmic device.

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

• Not applicable/Not specified. The assessment of this device for substantial equivalence relies on design, materials, manufacturing processes, fundamental technology, intended use, and performance specifications compared to its predicate. There isn't a "ground truth" in the diagnostic sense.

8. The sample size for the training set:

• Not applicable/Not specified. There is no mention of a "training set" as this is not an AI/machine learning device.

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

• Not applicable/Not specified.

Summary of Device and Approval Process based on the provided text:

• Device Name: ENDOTINE Ribbon™
• Manufacturer: Coapt Systems, Inc.
• Submission Type: Special 510(k) Premarket Notification (K060828)
• Submission Date: March 22, 2006
• Clearance Date: April 19, 2006
• Classification Name: Absorbable Surgical Suture
• Regulation Number: 21 CFR 878.4493
• Intended Use: Elevation and fixation of tissues in the temporal region, midface, lower face/jowl to the deep temporal fascia and the neck to the mastoid fascia during cosmetic procedures.
• Predicate Device: ENDOTINE Ribbon™ (K051415) by Coapt Systems, Inc.
• Basis for Clearance: Substantial equivalence to the predicate device, stating "no significant new issues of safety or effectiveness have been raised" and that the "Subject Device meets all internal functional performance requirements." This implies that while specific details aren't provided, internal company testing and analysis demonstrated that the modifications did not negatively impact the safety and effectiveness relative to the cleared predicate.

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The ENDOTINE Ribbon™ is indicated for use in elevation and fixation of tissues in the temporal region, midface, lower face/jowl to the deep temporal fascia and the neck to the mastoid fascia during cosmetic procedures.

The ENDOTINE Ribbon™ consists of an insertion tool/cover and a bioabsorbable implant. The device implant consists of fixation tines attached to an anchoring leash. This device along with its insertion tools are supplied sterile for single use only.

Here's an analysis of the provided text regarding the ENDOTINE Ribbon™ device, structured to address your specific questions.

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly state specific, quantifiable acceptance criteria in terms of numerical thresholds for device performance. Instead, it relies on a qualitative assessment of "substantial equivalence" to predicate devices and adherence to general standards.

However, based on the text, we can infer the broad performance and safety "criteria" that were considered met.

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

The document does not specify a numerical sample size for a formal "test set" in the context of controlled clinical trials or efficacy studies. The performance evaluations mentioned are described as:

• "Extensive cadaver modeling and evaluations."
• "Comparison testing to the predicate devices."

The provenance of this data (e.g., country of origin, retrospective/prospective) is not detailed. The phrase "cadaver modeling and evaluations" suggests laboratory-based testing rather than live human studies, and it appears to be a preclinical evaluation.

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

The document mentions:

• "Feedback and user observation from several leading surgeons."

It does not specify the exact number of surgeons or their detailed qualifications (e.g., specific years of experience, subspecialty). These "experts" appear to have provided qualitative feedback rather than establishing a formal "ground truth" for a statistical test set.

4. Adjudication Method for the Test Set

No formal adjudication method (e.g., 2+1, 3+1) is described for a test set. The expert involvement appears to be in the form of "feedback and user observation," suggesting a more informal process rather than a structured adjudication panel for establishing ground truth on a specific dataset.

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

No MCRM comparative effectiveness study was done or reported in this document. The submission is a 510(k) for substantial equivalence, which primarily relies on comparing the new device to existing predicate devices based on design, materials, and intended use, along with some performance testing. It does not involve assessing the improvement of human readers with AI assistance, as AI is not a component of this device.

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

The ENDOTINE Ribbon™ is a medical device (bioabsorbable implant with insertion tool) and does not contain any AI algorithms. Therefore, a standalone algorithm performance study is not applicable and was not performed.

7. The Type of Ground Truth Used

The concept of "ground truth" in the context of a diagnostic or AI algorithm study is not directly applicable here. For this device, "truth" is established by:

• Demonstrating substantial equivalence to legally marketed predicate devices.
• Meeting "user specifications" and "USP Standards for absorbable surgical sutures" (likely referring to material properties, strength, absorption rate, etc.).
• "Extensive cadaver modeling and evaluations" for mechanical performance and design validation.
• "Feedback and user observation from several leading surgeons" confirming usability and perceived performance.

Essentially, the "ground truth" is inferred from these various forms of evidence aligning with established standards and predicate device characteristics, rather than a single, defined "ground truth" dataset.

8. The Sample Size for the Training Set

The document does not mention a training set as this device is not an AI or algorithmic device that requires training. The design process included "extensive cadaver modeling and evaluations," which could be considered a form of developmental "training" for the device's design, but not in the machine learning sense of a "training set."

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

As there is no mention of a training set for an algorithm, the concept of establishing ground truth for it is not applicable. The design verification process involved cadaver studies and comparison to predicate devices, where the "truth" would be successful performance against engineering and biological requirements.

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The ENDOTINE Ribbon™ is indicated for use in subperiosteal midface suspension surgery to fixate the cheek subdermis in an elevated position.

The ENDOTINE Ribbon™ consists of a bioabsorbable implant pre-loaded on an insertion tool. The device implant is a soft tissue fixation platform. The insertion tool and implant are sterilized together.

The provided text is a 510(k) summary for the ENDOTINE Ribbon™, a medical device. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study with specific acceptance criteria and performance metrics for the device itself. Therefore, many of the requested details about a study proving acceptance criteria are not available in this particular document.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not provide a table of acceptance criteria or specific reported device performance metrics in the way that would be found in a clinical study report. The 510(k) process for this device relies on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving performance against specific quantitative criteria. The statement, "The Modified Device meets all internal functional performance requirements," is the closest the document comes to mentioning performance.

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

This information is not available in the provided 510(k) summary. The submission is a regulatory filing for market clearance based on substantial equivalence, not a report of a new clinical study with a test set of data.

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

This information is not available in the provided 510(k) summary. Given the absence of a distinct test set and associated ground truth establishment process, this detail is not relevant to this submission.

4. Adjudication Method for the Test Set

This information is not available in the provided 510(k) summary.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

This information is not available and is not applicable to this device. The ENDOTINE Ribbon™ is a bioabsorbable surgical implant for soft tissue fixation, not an AI-powered diagnostic or assistive tool. Therefore, a study comparing human reader performance with and without AI assistance would not be relevant.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This information is not available and is not applicable to this device. As mentioned, this is a physical implant, not an algorithm or AI system.

7. The Type of Ground Truth Used

This information is not available in the provided 510(k) summary.

8. The Sample Size for the Training Set

This information is not available in the provided 510(k) summary. This device is not an AI/ML product that would require a training set in the conventional sense.

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

This information is not available in the provided 510(k) summary. This is not an AI/ML product.

Summary of Device and Regulatory Context based on the provided text:

The ENDOTINE Ribbon™ is a bioabsorbable implant pre-loaded on an insertion tool, intended for subperiosteal midface suspension surgery to fixate the cheek subdermis in an elevated position.

The manufacturer, Coapt Systems, Inc., sought 510(k) clearance by demonstrating substantial equivalence to their previously marketed device, the ENDOTINE Midface™ ST 4.5 Device (K032698).

The core of the submission states: "Based on the design, materials, fundamental technology, intended use, and performance specifications, Coapt Systems believes the proposed ENDOTINE Ribbon™ is substantially equivalent to the unmodified predicate device... Therefore, safety and effectiveness are reasonably assured, justifying 510(k) clearance for commercial sale."

The FDA's letter confirms that they "have determined the device is substantially equivalent... to legally marketed predicate devices." This means the regulatory body accepted the manufacturer's claim of equivalence, implying that the safety and effectiveness of the ENDOTINE Ribbon™ are considered comparable to a device already on the market, rather than requiring a new, independent study to establish specific acceptance criteria and performance against those criteria.

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The ENDOTINE TransBleph™ is intended for use in subperiosteal browplasty. The ENDOTINE TransBleph™ is specifically indicated for use to fixate the subdermis to the frontal bone.

The ENDOTINE TransBleph™ 3.0/3.5 Device consists of a bioabsorbable implant, an insertion tool, and stainless steel drill bit. The device implant is a soft tissue fixation platform that is anchored in the cranial bone. The insertion tool and the drill bit are sterilized together with the implant device in a plastic tray.

This document is a 510(k) summary for the ENDOTINE TransBleph™ 3.0/3.5 Device. It focuses on establishing substantial equivalence to a predicate device rather than presenting a study with acceptance criteria for device performance. Therefore, most of the requested information regarding acceptance criteria and performance studies cannot be extracted from the provided text.

Here is a breakdown of what can and cannot be answered:

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

• Cannot be provided. The document does not specify quantitative acceptance criteria or a reported device performance study for the ENDOTINE TransBleph™ 3.0/3.5 Device. The submission is based on substantial equivalence to a predicate device and states, "The Modified Device meets all internal functional performance requirements," but no specific criteria or results are listed.

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

• Cannot be provided. There is no mention of a test set or clinical study data in this 510(k) summary.

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)

• Cannot be provided. No test set or ground truth establishment is described.

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 surgical implant, not an AI-assisted diagnostic tool. Therefore, an MRMC study related to AI assistance is not applicable and not mentioned.

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

• Cannot be provided. This is a physical surgical device, not an algorithm.

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

• Cannot be provided. No ground truth establishment related to a performance study is described.

8. The sample size for the training set

• Cannot be provided. This document does not describe the development or training of an algorithm or model.

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

• Cannot be provided. No training set or ground truth establishment for a training set is described.

Summary of what the document does provide:

• Device: ENDOTINE TransBleph™ 3.0/3.5 Device (bioabsorbable implant, insertion tool, drill bit).
• Intended Use: Subperiosteal browplasty surgery, specifically to fixate the subdermis to the cranial bone.
• Regulatory Pathway: 510(k) Premarket Notification.
• Substantial Equivalence: Claimed against the unmodified ENDOTINE TransBleph™ Device (K040740) and other ENDOTINE devices. The basis is similarity in design, materials, fundamental technology, intended use, and performance evaluations (though details of these evaluations are not provided beyond the statement that "The Modified Device meets all internal functional performance requirements").

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The ENDOTINE Midface™ B 4.5 is intended for use in subperiosteal midface suspension surgery. Specifically, the ENDOTINE Midface™ B 4.5 is indicated for use in suspending the subcutaneous tissues of the midface from the infra-orbital rim or zygoma via an anchoring leash.

The ENDOTINE Midface™-ST 4.5 consists of two components: (1) a fixation platform with anchoring leash, and (2) a screw anchor. This device is supplied sterile for single use only.

The ENDOTINE Midface™ B Instrument Kit is packaged separately from the implant device and is provided to the user non-sterile. The kit is comprised of the following tools that aid in the deployment and anchoring of the implant device:

• Sterilization tray (lid, base and mat) to house the instruments for transport and . sterilization
• Drill bit for creating a hole in the infra-orbital rim .
• Tapping tool to create the threads in the drilled hole to conform to the anchor . screw
• . Insertion tool to grasp and deploy the anchor screw
• Clipper tool to remove the screw flange and excess leash length .

The provided text does not contain information about acceptance criteria or a study proving device performance in the context of an AI/ML device.

This document is a 510(k) Premarket Notification for a medical device called "ENDOTINE Midface™ B 4.5 Device", which is a surgical implant for midface suspension.

The 510(k) summary focuses on demonstrating substantial equivalence to predicate devices (other surgical implants) based on:

• Indications for Use: Stating they are "nearly identical" and substantiated by "bench and performance testing."
• Technological Characteristics: Highlighting similar "design, materials and fundamental scientific technology."
• Performance Summary: Stating that a comparative performance study "raised no different questions of safety or effectiveness" and "the results suggest the ENDOTINE Midface™ B 4.5 performs as well as the selected predicate for its intended use."

However, it does not provide details about specific acceptance criteria or the results of any performance study in a quantifiable manner, nor does it involve any AI/ML components.

Therefore, I cannot populate the requested table or answer the specific questions related to AI/ML device performance, sample sizes, ground truth establishment, or human reader effectiveness studies.

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