Search Results

The Lesion Probe and Generator system is intended to create radiofrequency (RF) heat lesions in nerve tissue. It is intended for use only by trained clinicians in a hospital or clinical setting.

The GFX Nerve Ablation System provides a minimally invasive technique for creating a neural lesion inhibiting the function of the target nerve. The Generator and probe are used as a system to both stimulate the nerve for the purpose of locating the probe correctly and to create a neural lesion to inhibit nerve function through the application of RF energy. The GFX Nerve Ablation probes are single use devices supplied sterile to the customer.

Here's a breakdown of the acceptance criteria and the study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state specific quantitative acceptance criteria or detailed performance metrics from a clinical study. Instead, it relies on a comparison to predicate devices and bench testing to demonstrate substantial equivalence.

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

The document does not describe a clinical test set in the traditional sense, such as a cohort of patients for an effectiveness or safety study. The "test set" from a regulatory perspective here refers to:

• Bench Testing Samples: Devices produced under routine manufacturing conditions. The exact quantity of samples is not specified.
• Biocompatibility Testing Samples: Not specified, but implied to be sufficient for meeting ISO standards.
• Sterilization Validation Batches: Not specified, but implied to be sufficient for meeting ISO standards.

The data provenance for these tests is internal to ACI Inc. and would be considered retrospective in the sense that they are internal validation tests, not a forward-looking clinical trial. There is no mention of country of origin for any human data, as no human data is presented for performance evaluation.

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

This information is not applicable or provided in the document. No clinical test set with human data requiring expert ground truth establishment for a diagnostic or AI-assisted system is described. The device is a direct treatment tool, and its "performance" is assessed through engineering and bench testing, not expert interpretation of outputs.

4. Adjudication Method for the Test Set

This is not applicable or provided. There is no clinical test set requiring human adjudication of results.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done and is not described in this document. The device is a therapeutic radiofrequency ablation system, not an imaging or diagnostic aid that would typically involve human readers.

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

This is not applicable. The GFX Nerve Ablation System is a physical device (generator and probe) that creates heat lesions. It is not an algorithm, software, or AI system that operates in a "standalone" or "human-in-the-loop" capacity in the way an AI diagnostic tool would. Its performance is evaluated based on its physical and electrical characteristics and ability to produce lesions, as demonstrated through bench testing and comparison to predicate devices.

7. The Type of Ground Truth Used

For the bench testing and validation, the ground truth would be based on:

• Engineering specifications and standards: For RF energy output, temperature control, impedance monitoring, etc. (e.g., meeting specific voltage, current, and temperature targets).
• Biocompatibility standards: (ISO 10993 series for material safety).
• Sterilization efficacy standards: (ISO 11135 for sterility assurance).
• Physical integrity standards: For packaging and device robustness.

There is no mention of expert consensus, pathology, or outcomes data being used as ground truth for this type of device submission's performance evaluation.

8. The Sample Size for the Training Set

This is not applicable. The GFX Nerve Ablation System is not an AI or machine learning device. It does not have a "training set" in the context of algorithm development.

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

This is not applicable as there is no training set for an algorithm.

Ask a specific question about this device

Flexo Dental Resin Material is used for the fabrication of partial or full removable dentures, as well as occlusal splints and night guards.

The Flexo Dental Resin Material is an injection moldable, flexible thermoplastics resin designed for fabricating removable dental appliances.

The provided text describes the Flexo Dental Resin Material, an injection moldable, flexible thermoplastic resin used for fabricating removable dental appliances. The submission focuses on demonstrating substantial equivalence to a predicate device, Lucitone FRS Flexibel Dental Resin, rather than providing a detailed study proving the device meets specific acceptance criteria through clinical or complex performance studies.

Therefore, many of the requested elements for a study design and acceptance criteria related to AI/algorithm performance are not applicable here.

Here's an analysis based on the provided information, addressing the relevant points and noting where information is not available or not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

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

Not applicable. This is not a study involving a test set of data for an AI/algorithm. The "testing" refers to physical property testing and biocompatibility testing of the material itself. The text does not provide specific sample sizes for these material tests, nor does it detail their provenance.

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

Not applicable. This is not a study requiring expert ground truth for a test set.

4. Adjudication Method for the Test Set

Not applicable.

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 material science submission, not an AI/algorithm-based diagnostic or assistive device.

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

Not applicable.

7. The Type of Ground Truth Used

The "ground truth" in this context refers to established standards for material properties and biocompatibility.

• Physical Properties: Likely established through standardized ASTM or ISO testing methods for dental resins. The comparison is against the predicate device's known performance.
• Biocompatibility: Established through standardized in vitro (e.g., cytotoxicity) testing methods.

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning model.

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

Not applicable.

Summary of the Study (Implied):

The "study" presented here is essentially a substantial equivalence demonstration based on in vitro material property testing and biocompatibility testing, compared against a predicate device.

• Acceptance Criteria Focus: The primary acceptance criterion is that the Flexo Dental Resin Material's physical properties and biocompatibility are equal or similar enough to the legally marketed predicate device (Lucitone FRS Flexibel Dental Resin) to demonstrate it is safe and effective for its intended uses. The composition is also a key factor in this comparison.
• Evidence Provided:
  • Physical Property Testing: Stated that "Physical property testing indicates that Flexo Dental Resin Material performs equal to the predicate device." No specific measurements or methodology are detailed in this summary.
  • Biocompatibility Testing: Stated that "The cytotoxic and biocompatible test has been performed (Non-cytotoxic)." Again, details of the test are not provided.
  • Compositional Similarity: The submission highlights the "similarity in composition" to the predicate device.
• Conclusion: Based on these comparisons, the ACI Flexo Dental Resin Material is considered substantially equivalent to the Lucitone FRS Flexible Dental Resin in design, material, and function.

Ask a specific question about this device