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The L1P-1F intraoral scanner (IOS) system is intended for aid in diagnosis of caries.

The L1P-1F intraoral scanner (IOS) system is intended for aid in diagnosis of caries.

The L1P-1F system consists of a scanner and a detachable scanner tip which enables scanning using white and blue (fluorescence) Light Emitting Diodes (LEDs). A single-use scanner body sleeve is mounted on the scanner before being introduced into the mouth of a patient for scanning of the teeth.

The interface to the computer is handled by ScanSuite TRIOS which functions as a Hardware Abstraction Layer (HAL). The scan control of, and data transmission from the scanner is handled by the TRIOS module software, which holds the interface to the user.

The L1P-1F system also consists of the TRIOS Patient Monitoring software which aids in diagnosis of occlusal and surface caries.

The functional principle of L1P-1F (TRIOS 5) is to collect images of the object scanned by means of focus scanning, where light from the LEDs travels through the optical system to the object being scanned and back to an image sensor. 3D data collected by combining blue and white light in turn.

3Shape TRIOS A/S modifies L1P-1F (TRIOS 5) to include a single-use tip, TRIOS Ready Tip (TST-15), as an alternative to the already cleared reusable tip (TST-11).

This FDA 510(k) clearance letter for the TRIOS 5 (L1P-1F) device indicates that the clearance is primarily for a modification to an already cleared device, specifically the introduction of a new single-use tip (TRIOS Ready Tip, TST-15) as an alternative to an existing reusable tip (TST-11). The core functional and intended use of the device remain the same as the predicate.

Therefore, the information provided in this document focuses on the biological safety and design validation of the new tip, rather than a clinical study proving the device meets performance acceptance criteria for caries detection.

Based on the provided text, a direct table of acceptance criteria and reported device performance for caries detection cannot be generated as the document does not contain this information. The performance studies cited are related to the safety and functionality of the new tip, not the diagnostic accuracy of the caries detection functionality.

Here's a breakdown of what can and cannot be extracted from the document:

What is present in the document:

• Device Description: The L1P-1F intraoral scanner (IOS) system is intended for aid in diagnosis of caries, using white and blue (fluorescence) LEDs to collect images.
• Modification: The submission is for a modification to include a single-use scanner tip (TRIOS Ready Tip, TST-15).
• Predicate Device: TRIOS 5 (L1P-1F), K221249. The indications for use are identical to the predicate.
• Non-Clinical Tests: A risk analysis according to ISO 14971 was conducted. Non-clinical tests were performed to verify and/or validate risk control measures for the new tip, following FDA-recognized standards related to biological evaluation, cleanrooms, packaging integrity, electrical safety, usability, and photobiological safety.

What is NOT present in the document (and therefore cannot be answered based on the provided text):

• Specific acceptance criteria for caries detection performance (e.g., sensitivity, specificity, accuracy).
• Reported device performance data for caries detection.
• Sample sizes for clinical test sets used to assess caries detection accuracy.
• Data provenance (country of origin, retrospective/prospective) for clinical studies related to caries detection.
• Number of experts, qualifications, or adjudication methods for establishing ground truth for clinical caries detection data.
• Details of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study for caries detection, including effect sizes.
• Standalone (algorithm-only) performance data for caries detection.
• Type of ground truth used for clinical caries detection (e.g., pathology, outcomes data).
• Sample size for training sets for the caries detection algorithm.
• How ground truth for the training set was established for the caries detection algorithm.

Addressing the points based on available information and limitations:

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

   • Cannot be provided for caries detection performance. The document states that the subject device's indications for use are the same as the predicate device (K221249) and that the technological difference is only the new single-use tip. The focus of this 510(k) is on the safety and functionality of the new tip, not a new clinical performance claim for caries detection. The non-clinical tests relate to the tip's characteristics.

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

   • Not specified for caries detection performance. The document only mentions non-clinical tests for the new tip, not clinical studies for caries detection accuracy.

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 specified for caries detection performance. (See point 2)

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

   • Not specified for caries detection performance. (See point 2)

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 specified for caries detection performance. (See point 2) This 510(k) is for a physical device modification, not typically the type of submission where MRMC studies for AI assistance would be detailed, especially if the underlying diagnostic algorithm is already cleared.

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

   • Not specified for caries detection performance. (See point 2 & 5)

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

   • Not specified for caries detection performance. (See point 2)

8. The sample size for the training set

   • Not specified for caries detection performance. (See point 2)

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

   • Not specified for caries detection performance. (See point 2)

Conclusion based on the provided document:

The provided FDA 510(k) clearance letter details a submission for a modification to an existing device (TRIOS 5 L1P-1F) to include a new single-use tip. The clearance process for this submission primarily involved demonstrating that the new tip, and the modified device as a whole, maintain safety and effectiveness with respect to the predicate, and that the changes do not raise new questions of safety and effectiveness. This was achieved through a risk analysis and non-clinical testing of the new tip's properties (biocompatibility, sterility/packaging integrity, electrical safety, usability, photobiological safety).

The document does not contain any information about clinical performance studies related to the device's ability to aid in the diagnosis of caries, nor does it describe the specific acceptance criteria or reported performance metrics (like sensitivity, specificity, or accuracy) for this diagnostic function. It should be assumed that these performance characteristics were established and cleared as part of the predicate device's original 510(k) submission (K221249), and are not being re-evaluated or re-demonstrated in this specific submission for a tip modification.

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The L1P-1F intraoral scanner (IOS) system is intended for aid in diagnosis of caries.

The L1P-1F intraoral scanner (IOS) system is intended for aid in diagnosis of caries. The L1P-1F system consists of a scanner and a detachable scanner tip which enables scanning using white and blue (fluorescence) Light Emitting Diodes (LEDs). A single-use scanner body sleeve is mounted on the scanner before being introduced into the mouth of a patient for scanning of the teeth.

The interface to the computer is handled by ScanSuite TRIOS which functions as a Hardware Abstraction Layer (HAL). The scan control of, and information from the scanner is handled by the TRIOS module software, which holds the interface to the user.

The L1P-1F system also consists of the TRIOS Patient Monitoring software which aids in diagnosis of occlusal and surface caries.

The functional principle of L1P-1F (TRIOS 5) is to collect images of the object scanned by means of focus scanning, where light from the LEDs travels through the optical system to the object being scanned and back to an image sensor. 3D true colored images of the teeth combined with 2D green and red image as an additional texture are generated by emitting blue and white light in turn.

The provided text describes the 3Shape TRIOS 5 (L1P-1F) intraoral scanner system, which is intended to aid in the diagnosis of caries. The documentation focuses on demonstrating substantial equivalence to a predicate device (DÜRR DENTAL AG – VistaCam iX "Proof" – K150672). However, it does not explicitly provide a table of acceptance criteria and reported device performance in the format requested, nor does it detail a specific study proving the device meets acceptance criteria with all the requested information.

The document discusses key performance attributes tested and compared, which serve as implicit acceptance criteria for establishing substantial equivalence. These include:

1. Fluorescence scanning
2. Color Separation
3. In vitro caries detection study
4. Spatial resolution

Based on the available information, here's an attempt to structure the response, acknowledging where specific details for the requested categories are not explicitly provided in the document:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document mentions an "In vitro caries detection study" and performance testing, but does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective nature).

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

The document does not provide information regarding the number or qualifications of experts used to establish ground truth for any test sets.

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

The document does not specify any adjudication method used for establishing ground truth in a test set.

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

The document does not indicate that an MRMC comparative effectiveness study was done involving human readers with and without AI assistance for the L1P-1F device. The focus is on the device's standalone performance compared to a predicate device.

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

The document describes "Performance Testing" including fluorescence scanning, color separation, in vitro caries detection, and spatial resolution. These tests would inherently involve the device's standalone performance to characterize its technical capabilities, which is then concluded to be "as safe and effective as a legally marketed device." While not explicitly termed "standalone performance study," the non-clinical data and performance testing sections describe the device's intrinsic capabilities.

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

The document mentions an "in vitro caries detection study," which suggests that the ground truth would likely be established by a recognized method for in vitro caries assessment, such as histology, micro-CT, or a standardized artificial caries model assessed by experts, but this is not explicitly stated.

8. The sample size for the training set

The document does not specify the sample size for any training set. Given the nature of the device (an intraoral scanner with integrated fluorescence technology), it's possible that machine learning or AI components might be involved in the "TRIOS Patient Monitoring software," but details on specific training sets are absent.

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

Since no training set details are provided, how its ground truth was established is not mentioned.

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