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The Implant Location Software-T (ILS-T) is indicated for use by medically trained people as a software interface and image segmentation system for the transfer of imaging information from a CT scanner and as pre-operative software for simulating / evaluating dental implant positioning. Surgical templates may also be fabricated based on the output of the pre-operative planning.

The Implant Location Software-T is a computer program (software) intended for use as an aid to the dental practitioners in the location of dental implants. The Implant Location Software-T-T (ILS-T) guides dental practitioners through the process of pre-operative planning their patients' dental implant surgery. Surgical templates may also be fabricated based on the output of the pre-operative planning. The system provides information but does not make any clinical decisions for the user. The software is supplied on disk-on-key. The Implant Location Software-T is designed to use images acquired from Computer Tomography (CT) scanners, present a graphical image of the planned implants as "virtual implants" on the CT images using DICOM interface standards, provide a summary report that gives planning information for the procedure, and allow user to consult on-line views of the plan during operation.

This 510(k) summary (K070713) for the Tactile Technologies Implant Location Software-T (ILS-T) is a very concise document and does not contain details about specific acceptance criteria or a detailed study proving the device meets them.

Instead, it focuses on establishing substantial equivalence to a predicate device (SimPlant System from Materialise N.V., K053592). The primary "study" mentioned is the comparison to the predicate device, asserting that the ILS-T has the "same intended use and the same principle of operation." This type of 510(k) submission generally relies on the fact that if a device is substantially equivalent to a legally marketed predicate, then it is deemed safe and effective without requiring new clinical trials that define and meet specific performance criteria.

Therefore, many of the requested details cannot be extracted from the provided text.

Here is a summary of what can be inferred or directly stated from the document, with explanations for what cannot be found:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation:
The document does not detail specific acceptance criteria (e.g., accuracy metrics, precision targets, success rates) or quantitative performance results for the ILS-T device. The submission relies on demonstrating substantial equivalence to a predicate device rather than presenting a de novo performance study against explicit criteria.

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

• Sample Size: Not specified.
• Data Provenance: Not specified.

Explanation:
No information is provided about a test set in the context of a performance study for the ILS-T. The submission focuses on substantial equivalence, implying that the predicate device's performance is the benchmark.

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.

Explanation:
Since a specific test set and ground truth establishment process for the ILS-T are not described, there is no information on experts involved.

4. Adjudication Method for the Test Set

• Adjudication Method: Not specified.

Explanation:
No test set or adjudication process is mentioned.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not explicitly mentioned or performed as part of this 510(k) submission.
• Effect Size of Human Reader Improvement with AI vs. Without AI: Not applicable, as no MRMC study was described.

Explanation:
The document does not describe any studies involving human readers or their improvement with or without AI assistance. The device is described as an "aid" and a "software interface" for pre-operative planning, providing information but not making clinical decisions.

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

• Standalone Study: No, a standalone performance study with specific metrics was not explicitly mentioned.

Explanation:
The submission emphasizes substantial equivalence and does not provide data from a standalone performance study.

7. The Type of Ground Truth Used

• Type of Ground Truth: Not specified.

Explanation:
As no specific performance study external to the predicate comparison is described, the type of ground truth used to validate the ILS-T's performance is not mentioned.

8. The Sample Size for the Training Set

• Sample Size: Not specified.

Explanation:
The document does not provide details about a training set for the ILS-T, which would typically be relevant for machine learning or AI-based devices. While the software aids in implant location, it's described more as an interface and segmentation system than a system that learns from data in a traditional AI sense requiring a detailed training set description for regulatory purposes at this time.

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

• Ground Truth Establishment: Not specified.

Explanation:
No information is provided regarding a training set or its ground truth.

Conclusion from Document:

The 510(k) submission for the Tactile Technologies Implant Location Software-T (ILS-T) primarily relies on demonstrating substantial equivalence to the SimPlant System (K053592). This means that the FDA's clearance is based on the premise that the ILS-T shares the same intended use and fundamental operating principles as an already legally marketed device, and therefore does not raise new questions of safety or effectiveness. The document itself does not contain detailed performance data from a specific study performed on the ILS-T to establish acceptance criteria or quantitative performance metrics.

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