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Osstell Beacon is indicated for use in measuring the stability of implants in the oral cavity and maxillofacial region.

The Osstell Beacon is a modification of the Osstell ISQ (K082523). The system is designed to measure implant stability in the oral cavity and maxillofacial region. Similar to K082523, the Osstell Beacon is a portable, handheld instrument that involves the use of the noninvasive technique, Resonance Frequency Analysis. The system involves the use of a Smartpeg (aluminum rod) attached to the implant by means of a screw. The Smartpeg is excited by a magnetic pulse from the measurement tip on the handheld instrument. The resonance frequency, which is the measure of implant stability, is calculated from the response signal. Results are displayed as the Implant Stability Quotient (ISQ). The ISQ is a measurement of the implant and is derived from the resonance frequency value obtained from the Smartpeg.

The provided document, a 510(k) summary for the Osstell Beacon device, does not contain detailed information about specific acceptance criteria or a dedicated study proving performance against such criteria. The document focuses on demonstrating substantial equivalence to a predicate device (Osstell ISQ K082523) by detailing technological characteristics rather than presenting a performance study with acceptance criteria.

However, based on the nonclinical testing section, it can be inferred that performance testing was conducted to confirm compliance to design specifications. Since the document claims the "Beacon performs as intended" and lists "Accuracy: ±2 ISQ units" under its specifications, we can reasonably extrapolate this accuracy as an implicit acceptance criterion.

Here's a breakdown of the requested information, with disclaimers about missing details:

1. Table of Acceptance Criteria and Reported Device Performance

Given the information, an explicit table of acceptance criteria and a detailed performance study are not provided in this 510(k) summary. However, an inferred acceptance criterion for accuracy exists:

Note: This is an inferred acceptance criterion based on the device's stated accuracy in its specifications and the claim that performance testing confirmed compliance to design specifications. The document does not explicitly state this as an acceptance criterion from a study protocol.

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

The document states: "Performance testing was conducted to confirm compliance to the design specifications." However, it does not provide any specific sample size for a test set or details about the data provenance (e.g., country of origin, retrospective or prospective nature).

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

The document does not mention the use of experts to establish ground truth for any test set. The device likely provides direct measurements rather than relying on expert interpretation for its core function.

4. Adjudication Method for the Test Set

Since no involvement of experts in establishing ground truth or a test set is explicitly described, there is no mention of an adjudication method.

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

The document states: "Clinical studies were not required to validate the modifications in the Osstell Beacon." This implies that no MRMC comparative effectiveness study was conducted. The device is a measurement tool, and the submission focuses on its equivalence to a predicate device rather than human reader performance with or without AI assistance.

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

The document indicates that "Performance testing was conducted to confirm compliance to the design specifications." The device operates as an "Implant Stability Analyzer" that provides an "Implant Stability Quotient (ISQ)" value directly. This implies a standalone performance evaluation of the algorithm's ability to accurately measure the resonance frequency and calculate the ISQ value. The "Accuracy: ±2 ISQ units" is a standalone performance metric.

7. Type of Ground Truth Used

The type of ground truth used for the performance testing is not explicitly stated but can be inferred as a reference measurement of resonance frequency or implant stability against which the device's calculated ISQ value would be compared. For a measurement device, this typically involves using a highly accurate, calibrated system or a known physical property (e.g., a standard with a known resonance frequency).

8. Sample Size for the Training Set

The document focuses on substantial equivalence and nonclinical testing. It does not mention any training set size because the device's underlying technology (Resonance Frequency Analysis and ISQ software algorithm) is based on established physical principles and is inherited from its predicate device (Osstell ISQ K082523), rather than requiring a machine learning model that needs a training set.

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

As there is no mention of a training set being used in the context of machine learning, there is no information on how its ground truth might have been established. The device relies on a physical measurement and algorithm, not a trainable model.

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The AnyCheck IMT-100 is indicated for use in measuring the stability of implants in the oral cavity and maxillofacial region.

The AnyCheck IMT-100 Dental Implant Mobility Measuring Instrument is a system designed to measure dental implant mobility (stability) in the oral cavity and maxillofacial region. The AnyCheck IMT-100 is a portable, handheld instrument to observe non-invasively the fixation stability of an implant at alveolar bone. The implant stability test (iST) is performed using vibration generated by mechanical contacting of a tapping rod. The AnyCheck IMT-100 numerically indicates a scale result of iST. The higher number means better stability of the target implant.

The provided text describes the 510(k) submission for the AnyCheck IMT-100 Dental Implant Mobility Measuring Instrument. However, it explicitly states that "This submission does not include clinical performance data, similar to the predicate devices." Therefore, information regarding acceptance criteria and a study proving the device meets these criteria in the context of clinical performance (e.g., impact on human readers, expert ground truth, multi-reader studies) is not available within this document.

The document focuses on non-clinical tests to demonstrate substantial equivalence to predicate devices. Here's a breakdown of the relevant information provided:

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

Since no clinical performance data is presented, a table of acceptance criteria for clinical performance and reported device performance in a clinical setting cannot be created from this text.

However, the text mentions non-clinical tests were performed against the company's specified design requirements. The generalized "acceptance criteria" for these non-clinical tests would be:

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

• Test set sample size: Not applicable for clinical performance study as none was conducted. For non-clinical tests, specific sample sizes are not detailed, but it's implied that sufficient samples were used for the various engineering and biocompatibility tests.
• Data provenance: Not applicable for clinical data. For non-clinical tests, the tests were conducted by a certified laboratory (in compliance with ISO standards), implying laboratory-based testing rather than patient data.

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

Not applicable, as no clinical study with human expert review was conducted.

4. Adjudication method for the test set:

Not applicable, as no clinical study with human expert review was conducted.

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 MRMC study was conducted. The device is a "Dental Implant Mobility Measuring Instrument" and not an AI-assisted diagnostic tool that would typically involve human readers.

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

The device itself is a measurement instrument, not an algorithm in the sense of AI software. Its "standalone performance" refers to its ability to accurately measure implant stability. The non-clinical tests (measurement accuracy, output scale, reproducibility) would constitute a form of standalone performance evaluation for its intended function.

7. The type of ground truth used:

• Clinical: Not applicable.
• Non-clinical: The ground truth for the non-clinical tests would have been established by calibrated laboratory standards and established engineering and biocompatibility test protocols (e.g., known electrical safety limits, recognized cytotoxicity assays, precisely manufactured test objects for accuracy/reproducibility).

8. The sample size for the training set:

Not applicable. This device is a physical measuring instrument, not a machine learning model that requires a training set.

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

Not applicable, as there is no training set for a machine learning model.

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