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The LOOP™ is a source of illumination for curing photo-activated dental restorative materials and adhesives.

LOOP™ is a high-performance LED (Light Emitting Diode) light source for polymerization of dental materials used by trained dental professionals. It is suitable for use with a broad range of light-cured dental materials including materials for restoratives such as light-cured and dual-cure cements, composites, bonding agents/adhesives, bases, liners, fissure sealants, temporaries, as well as luting materials for brackets and indirect restorations such as ceramic inlays. LOOP™ consists of a wireless handpiece and a charging base with an integrated calibration station. The device is a medical electrical device in accordance with IEC 60601-1-2. LOOP™ features a patented coaxial feedback sensing system that measures the actual irradiance, which is the light power striking the targeted tooth. The feedback data allows LOOPTM to make corrective adjustments to the LED power output hundreds of times per second. This continual corrected "closed loop" operation ensures that the targeted surface of the restorative dental material receives the intended irradiance independent of operator-induced distance variations.

This document is a 510(k) premarket notification for a dental device, the LOOP™ LED Curing Light System. It does not contain the detailed information necessary to fully answer your request regarding acceptance criteria and study proving the device meets those criteria, specifically concerning AI/ML capabilities, human expert adjudication, or large-scale clinical performance studies.

The provided text primarily focuses on demonstrating substantial equivalence to a predicate device based on technical specifications, intended use, and general safety and performance testing. It does not describe an AI/ML-driven device or studies that would typically involve acceptance criteria related to algorithmic performance metrics (e.g., sensitivity, specificity, AUC), human reader studies, or expert ground truth establishment for such a device.

Here's why the document doesn't provide the requested information:

• Device Type: The LOOP™ LED Curing Light System is a physical dental curing light. It is described as having a "patented coaxial feedback sensing system that measures the actual irradiance" and makes "corrective adjustments to the LED power output." This describes a control system, not an AI/ML algorithm that makes diagnoses, predictions, or image interpretations.
• Performance Data: The "Performance Data" section lists various engineering, electrical safety, biocompatibility, and software verification/validation tests. These are standard tests for medical devices, particularly electronic hardware. It explicitly states, "No animal or clinical studies were conducted." This confirms that no clinical performance study, particularly one involving human readers or comparative effectiveness, was performed or submitted.
• Lack of AI/ML Specifics: There is no mention of algorithms, machine learning models, training data, test data, ground truth establishment by experts, or any of the typical components of an AI/ML device submission. The "Software Verification and Validation Testing" section refers to software as a "moderate" level of concern due to potential minor injury from failure, which is standard for embedded software in medical devices, not for AI/ML functionality.

Therefore, I cannot populate the requested table or answer the specific questions about AI/ML study design, expert involvement, and performance metrics because this information is not present in the provided document.

The document describes a different type of device and a different type of substantial equivalence demonstration. If you are looking for information on AI/ML device approvals, this specific document does not provide such details.

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The LOOP is a source of illumination for curing photo-activated dental restorative materials and adhesives.

LOOP™ is a LED (Light Emitting Diode) light source for polymerization of dental materials for use by trained dental professionals. It is suitable for use with a broad range of light-cured dental materials including materials for restoratives such as light-cured and dual-cure cements, composites, bonding agents/adhesives, bases, liners, fissure sealants, temporaries, as well as luting materials for brackets and indirect restorations such as ceramic inlays. LOOP™ consists of a wireless handpiece and a charging base with an integrated calibration station. The device is a medical electrical device in accordance with IEC 60601-1-2.

LOOP™ features a patented coaxial feedback sensing system that measures the actual irradiance, which is the light power striking the targeted tooth. The feedback data allows LOOP™ to make corrective adjustments to the LED power output hundreds of times per second. This continual corrected "closed loop" operation ensures that the targeted surface of the restorative dental material receives the intended irradiance independent of operator-induced distance variations.

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the LOOP LED Curing Light System (K200775).

It's important to note that this document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed acceptance criteria and performance data for every aspect of the device. Consequently, some of the requested information (especially for AI/ML-specific questions like MRMC studies, ground truth establishment, or training set details) will not be present as this is a physical medical device, not an AI/ML-driven one.

Acceptance Criteria and Reported Device Performance

The document doesn't explicitly list "acceptance criteria" in a typical pass/fail numerical sense for the entire device. Instead, it compares specific technical characteristics of the LOOP device to its predicate device, VALO Cordless Dental Curing Light (K110582), to demonstrate "substantial equivalence." The "acceptance" is implied by the similarity and non-inferiority to the predicate.

Here's a table based on the comparisons provided, with the understanding that "performance" here refers to the characteristics that were compared for substantial equivalence.

Study Details

This device is not an AI/ML-driven device; therefore, questions pertaining to AI/ML specific aspects like ground truth, training sets, experts, or MRMC studies are not applicable. The studies performed are standard engineering and safety tests for a medical device.

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

• Irradiance Comparison: The document mentions "Comparative testing was performed by Garrison Dental Solutions for evaluation of the published irradiance outputs." It doesn't specify the sample size of devices or materials tested.
• Biocompatibility: The tests used Hartley Guinea Pigs for hypersensitivity and New Zealand White Rabbits for intracutaneous reactivity. The exact number of animals is not specified in this summary.
• Mechanical & Engineering Testing: No specific sample sizes for units tested are provided for the various mechanical and engineering tests listed.
• Data Provenance: The studies were conducted by Garrison Dental Solutions, LLC. The country of origin of the data is not specified but is implicitly the USA where Garrison Dental Solutions is located. The studies are prospective in nature, as they involve testing the newly developed device.

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. This is not an AI/ML device requiring expert ground truth for image interpretation or diagnosis. The "ground truth" for performance is based on established engineering standards and comparison to a legally marketed predicate device.

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

• Not applicable. This is not an AI/ML device requiring adjudication of expert interpretations.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• No, a MRMC study was not done. This device is a physical curing light, not an AI-assisted diagnostic or interpretive tool.

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

• Not applicable. This device is a physical curing light. Its "performance" is its ability to cure dental materials, not an algorithm's output. The "standalone" performance is assessed through its physical characteristics and direct measurements (e.g., irradiance output).

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

• Not applicable in the AI/ML sense. The "ground truth" for the device's technical specifications and safety is based on:
  • Engineering Standards: Adherence to IEC standards (e.g., IEC 60601-1 for electrical safety).
  • Material Science Principles: Verification of curing capabilities against known properties of dental materials.
  • Biocompatibility Standards: ISO 10993 standards.
  • Predicate Device Performance: The established, legally marketed performance of the VALO Cordless Dental Curing Light (K110582).

8. The sample size for the training set

• Not applicable. This device does not use machine learning algorithms that require a "training set."

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

• Not applicable. As above, there is no training set for a machine learning algorithm.

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The device is used in combination with other dental devices to retain composite or amalgam restorative materials during dental restorations.

Matrix bands are used to retain composite and other restorative materials during dental restorations. In general a matrix band surrounds the tooth and is used to separate the teeth while a composite filling is placed. The type of band is selected based on the tooth height and restoration type. The dentist prepares the tooth and places the band on the tooth. A wedge is inserted for optimal contour, gingival seal, and tooth separation. A ring retainer such as the Composi-Tight 3D Ring or Composi-Tight 3D Thin Tine G Ring is used to hold the band in place. The band is removed after the application of composite resin. The devices are offered in different thicknesses, lengths, and widths to accommodate different sized teeth. Additionally, the device is offered in soft stainless steel and hard stainless steel depending on the preference of the dentist. The devices are offered in sectional matrix style or standard style (Tofflemire style). The Tofflemire style is a longer thinner band with or without lobes. The choice of style is dependent on the preference of the dentist and the specific condition and size of the patient's teeth.

Here's an analysis of the provided 510(k) summary for the "Slicks Matrix Bands & Sectional Matrix Bands," focusing on acceptance criteria and supporting studies:

Acceptance Criteria and Device Performance

Study Details

1. Sample Size and Data Provenance:

   • Test Set: No specific sample sizes for the "test set" are provided for either biocompatibility or shear force testing. The document only states that the device "was subjected to" and "successfully passed" these tests. This likely implies that the tests were performed on representative samples of the Slicks Matrix Bands.
   • Data Provenance: Not specified within the provided text.

2. Number of Experts and Qualifications:

   • Not applicable/Not specified. The biocompatibility and shear force tests are typically laboratory-based tests with objective endpoints, not requiring expert ground truth establishment in this context.

3. Adjudication Method:

   • Not applicable. As these are objective laboratory tests, there would not be an adjudication method in the context of expert review.

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

   • No, an MRMC comparative effectiveness study was not done. The device is a dental instrument, not an AI or imaging diagnostic device where human reader performance is typically assessed and compared with or without AI assistance.

5. Standalone Performance Study:

   • Yes, for the specific performance attributes mentioned (biocompatibility and shear force), the device underwent standalone testing to demonstrate its inherent properties and performance. These tests were conducted on the device itself, independent of human interaction beyond the execution of the test protocol.

6. Type of Ground Truth Used:

   • Biocompatibility: The ground truth for biocompatibility is established by the pass/fail criteria defined within the ISO 10993 standard.
   • Shear Force: The ground truth for shear force is likely a defined minimum force threshold or range that the matrix band must withstand, established by material science standards or internal engineering specifications relevant to dental applications. The text indicates "performance testing to measure shear force," implying a quantitative measure against a predetermined standard.

7. Sample Size for Training Set:

   • Not applicable. This is a medical device (matrix band), not an AI algorithm, so there is no "training set" in the context of machine learning.

8. How Ground Truth for Training Set was Established:

   • Not applicable, as there is no training set.

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