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The Lollipop BiteBlock from RadTec Medical Devices, Inc. is intended to be used for repeat positioning and immobilization of patients undergoing or receiving a course of external beam radiation therapy for the treatment of cancer and other diseases.

It is intended to be used by or under the direction of a licensed physician.

The Lollipop BiteBlock is a multi-configuration, single patient reusable device intended to be used for the planning, positioning, and re-positioning of a patient's oral cavity while they undergo or receive a course of external beam radiation therapy for the treatment of cancer and other diseases. The Lollipop BiteBlock is designed for use in radiation therapy departments in hospitals and/or free-standing treatment centers.

The Lollipop BiteBlock is available in four configurations: lateral tongue localization (LTL), mouth open tongue forward (MOTF), mouth open tongue depressed (MOTD), and mouth open tongue (forward) closed (MOTC). The choice of which configuration is appropriate to the patient is left to the physician's discretion.

The Lollipop BiteBlock is manufactured using 3D printing technology. At least one sample, per lot, from each of the four configurations is measured to ensure that it meets device specifications. The Lollipop BiteBlock is provided to the physician as the final finished device. The 3D electronic files are not sent to the physician at any time.

The provided text describes the Lollipop BiteBlock device and its equivalence to a predicate device. The information below is extracted based on your request.

Acceptance Criteria and Device Performance Study for Lollipop BiteBlock

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size (Test Set): For the Vertical Tongue Force and "Bite" Crush Force tests, at least one sample per lot from each of the four configurations was measured. The exact total number of samples is not specified.
• Data Provenance: The data appears to be prospective, generated from testing specifically for the 510(k) submission. The country of origin for the data is not explicitly stated but implies testing was conducted by RadTec Medical Devices, Inc.

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

• The ground truth for the test set was established through physical testing and measurement against defined engineering criteria. No human experts were used to establish ground truth for these performance tests; the criteria were objective measurements.

4. Adjudication Method

• Adjudication methods like 2+1 or 3+1 are not applicable as the tests performed were physical and objective, based on material failure points and radiation attenuation measurements, not subjective expert interpretations.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No MRMC comparative effectiveness study was done. The device's purpose is related to patient positioning and immobilization, not diagnostic image interpretation.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Not applicable. The Lollipop BiteBlock is a physical medical device, not an algorithm.

7. Type of Ground Truth Used

• The ground truth used for these performance tests was objective, pre-defined engineering and material science criteria (e.g., force thresholds, visual inspection for fractures, radiation shielding efficacy).

8. Sample Size for the Training Set

• Not applicable. This device is a physical product and does not involve AI or machine learning models that require training sets.

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

• Not applicable, as no training set was used.

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