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K Number
K242103
Device Name
TRIOS Ready Tip
Manufacturer
3Shape TRIOS A/S
Date Cleared
2025-04-04

(260 days)

Product Code
NBL
Regulation Number
872.1745
Type
Traditional
Panel
DE
Reference & Predicate Devices
K221249
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

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

Device Description

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).

AI/ML Overview

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.

§ 872.1745 Laser fluorescence caries detection device.

(a)
Identification. A laser fluorescence caries detection device is a laser, a fluorescence detector housed in a dental handpiece, and a control console that performs device calibration, as well as variable tone emitting and fluorescence measurement functions. The intended use of the device is to aid in the detection of tooth decay by measuring increased laser induced fluorescence.(b)
Classification. Class II, subject to the following special controls:(1) Sale, distribution, and use of this device are restricted to prescription use in accordance with § 801.109 of this chapter;
(2) Premarket notifications must include clinical studies, or other relevant information, that demonstrates that the device aids in the detection of tooth decay by measuring increased laser induced fluorescence; and
(3) The labeling must include detailed use instructions with precautions that urge users to:
(i) Read and understand all directions before using the device,
(ii) Store probe tips under proper conditions,
(iii) Properly sterilize the emitter-detector handpick before each use, and
(iv) Properly maintain and handle the instrument in the specified manner and condition.