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

The Osstell IDx 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 IDx is a portable, handheld/tabletop 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 probe 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 stability of the implant and is derived from the resonance frequency value obtained from the Smartpeg. The Osstell IDx can add important information to the evaluation of implant stability and can be used as part of an overall treatment evaluation program. The final implant treatment decisions are the responsibility of the surgeon.

Here's a breakdown of the acceptance criteria and study information for the Osstell IDx, as provided in the document:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for the Test Set and Data Provenance

The document does not explicitly state the sample size used for the test set for the ISQ correlation and torque correlation evaluations. It refers to two different evaluations being performed, but details on the number of individual tests or cases are not provided.

Data provenance (e.g., country of origin, retrospective or prospective) is also not specified.

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

The document does not mention the use of experts to establish ground truth for the non-clinical evaluations. These tests appear to be technical performance comparisons against defined metrics rather than assessments requiring expert interpretation.

4. Adjudication Method for the Test Set

Not applicable as expert adjudication was not mentioned for these non-clinical evaluations.

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

No MRMC comparative effectiveness study was mentioned. The device, Osstell IDx, is a measurement instrument for implant stability, not an AI diagnostic tool requiring human reader comparison.

6. Standalone (Algorithm Only) Performance Study

The studies described are standalone performance tests of the device itself (ISQ and torque correlation, and biocompatibility), comparing it to its predicate device (Osstell ISQ) or established standards. There is no mention of an "algorithm only" study, as the device's function is centered on physical measurement and conversion to an ISQ value.

7. Type of Ground Truth Used

For the ISQ correlation evaluation and Torque correlation evaluation, the "ground truth" implicitly refers to the performance of the predicate device (Osstell ISQ) and the established acceptance criteria (tolerance ranges for ISQ differences and torque variances). Essentially, the new device's measurements are compared to those of a known, previously cleared device or expected physical behavior.

For the Biocompatibility evaluation, the ground truth is established by adherence to recognized international standards: ISO 10993-5 (cytotoxicity) and USP Class VI (biocompatibility).

8. Sample Size for the Training Set

Not applicable. This is a medical device for measuring implant stability, not a machine learning or AI-based device that typically requires a training set. The descriptions of the tests are for verification and validation of the device's physical and functional performance.

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

Not applicable, as no training set is mentioned or implied for this type of device and evaluation.

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The MEGA ISQ is indicated for use in measuring the stability of implants in the oral cavity and maxillofacial region.

The MEGA ISQ is an new generation of the Osstell ISQ, (K082523) the system is designed to measure dental implant stability in the oral cavity and maxillofacial region. Similar to K082523, the MEGA ISQ 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 dental implant by means of a screw. The Smartpeg is excited by a magnetic pulse from the measurement probe 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 stability of the implant and is derived from the resonance frequency value obtained from the Smartpeg.

The provided text describes a 510(k) premarket notification for the "MEGA ISQ" device, which is an updated version of the "Osstell ISQ" predicate device (K082523). The submission focuses on demonstrating substantial equivalence to the predicate, rather than proving novel performance.

Here's an analysis of the acceptance criteria and study information provided:

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

The submission does not present a formal table of acceptance criteria with corresponding performance metrics in the typical sense of a clinical study. Instead, the acceptance criteria are based on demonstrating equivalence to the predicate device through several nonclinical tests.

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

The document does not describe a clinical test set with human subjects. The testing described is primarily non-clinical, focused on demonstrating engineering and material equivalence. Therefore, there is no sample size for a "test set" in a clinical sense, nor a provenance (country of origin or retrospective/prospective) for such data. The comparative performance testing was likely conducted in a lab setting.

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

This information is not applicable as there was no clinical test set requiring expert ground truth establishment. The "ground truth" for the non-clinical tests would be defined by engineering standards and predicate device specifications.

4. Adjudication method for the test set

Not applicable, as there was no clinical test set requiring adjudication.

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

An MRMC study was not done. The device is a direct measurement instrument (dental implant stability analyzer), not an AI-assisted diagnostic tool that would involve human readers.

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

This concept is not directly applicable to the MEGA ISQ as it's a measurement device, not an algorithm-based diagnostic tool. However, the core functionality of the device (Resonance Frequency Analysis) operates autonomously to generate an ISQ value. The "standalone" performance is implicitly covered by the "Comparative performance testing to predicate" and conformance to EMC standards. The device's mechanism for calculating ISQ is independent of human interpretation during the measurement process.

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

For the non-clinical and comparative performance testing, the ground truth was based on:

• Engineering Standards: For EMC testing (EN IEC 60601-1-2).
• Predicate Device Specifications/Performance: For comparative performance of the display, USB interface, and material characteristics. The performance of the predicate device (Osstell ISQ, K082523) served as the benchmark.
• Industry Standards: For sterilization parameters (ANSI/AAMI/ST79:2010/A2:2011).

8. The sample size for the training set

This is not applicable. The MEGA ISQ is a hardware device for physical measurement and does not involve machine learning or a "training set" in the context of AI.

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

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

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Osstell® ISQ Implant Stability Meter is indicated for use in measuring the stability of implants in the oral cavity and craniofacial region.

The Osstell® ISQ Implant Stability Meter is an updated version of the Osstell Mentor (K033689). The system is designed to measure dental implant stability in the oral cavity and craniofacial region. Similar to K033689, the Osstell ISQ 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 dental implant by means of a screw. The SmartPeg is excited by a magnetic pulse from the measurement probe 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 stability of the implant and is derived from the resonance frequency value obtained from the SmartPeg.

The provided text unfortunately does not contain detailed information about acceptance criteria or a specific study proving the device meets these criteria in the way typically expected for a detailed scientific or regulatory report.

The document is a 510(k) Premarket Application for the Osstell® ISQ Implant Stability Meter, indicating it's an updated version of a previously cleared device (Osstell Mentor). The primary focus of this document is to demonstrate "Substantial Equivalence" to the predicate device, not to present a comprehensive de novo study validating new performance criteria or clinical efficacy.

However, I can extract the available information and structure it as requested, acknowledging the limitations of the provided text.

Here's an analysis based on the given text:

Description of the Device and its Purpose:

The Osstell® ISQ Implant Stability Meter is a portable, handheld instrument designed to measure dental implant stability using Resonance Frequency Analysis (RFA). It uses a SmartPeg attached to the dental implant which is excited by a magnetic pulse. The resonance frequency, an indicator of implant stability, is calculated and displayed as an Implant Stability Quotient (ISQ). The device is indicated for use in measuring the stability of implants in the oral cavity and craniofacial region, adding information to implant stability evaluation.

Reason for 510(k) Application:

The modifications from the predicate device (Osstell Mentor) include changes to circuit boards, integration of a docking station, and software. The application states these do "not affect the safety or performance of the device and do not change the intended use."

Acceptance Criteria and Study Details (Based on available information):

Due to the nature of a 510(k) for a modified device seeking substantial equivalence, specific "acceptance criteria" and detailed "device performance" in terms of clinical outcomes or comparative efficacy found in a de novo study are not explicitly stated in the provided text. Instead, the focus is on demonstrating that the modifications do not negatively impact safety or performance compared to the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated. The document refers to "verification and validation tests" and "Performance testing" but does not provide numbers for test sets used.
• Data Provenance: Not explicitly stated. Given that this is a 510(k) for a device from a Swedish company (Osstell AB, Goteborg, Sweden) and the "Summary of Nonclinical Testing" mentions testing for compliance to design specifications, it's highly likely that this testing was internal, conducted by the manufacturer, and likely occurred at their facilities or approved contract labs. The document does not indicate prospective clinical trials or retrospective studies from specific countries for this specific submission's performance validation.

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

• This information is not provided in the text. Since this is a submission focused on technical modifications and substantial equivalence validation (primarily non-clinical performance testing), there is no mention of expert-established ground truth for a clinical test set in the provided summary.

4. Adjudication Method for the Test Set

• This information is not provided in the text. Adjudication methods are typically relevant for clinical studies involving multiple reviewers, which is not described here.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

• No, an MRMC comparative effectiveness study is not mentioned or described in the provided text. The document focuses on the device itself and its technical modifications, not on comparing human reader performance with and without AI assistance (as the device is a measurement tool, not an AI diagnostic aid).

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

• The device itself, the Osstell ISQ, is a standalone measurement instrument. Its "performance testing" described in the summary would be standalone, verifying its ability to accurately measure resonance frequency and calculate ISQ values as designed. However, the text does not detail the methodology or specific results of such standalone testing beyond stating that "Performance testing was conducted to confirm compliance to design specifications; all functions were verified to operate as designed."

7. The type of Ground Truth Used

• For the non-clinical performance testing mentioned, the "ground truth" would generally be the engineering specifications and expected outputs of the device's components and software. This would involve calibrated test equipment and established reference standards to verify that the device accurately measures resonance frequency and computes the ISQ within acceptable tolerances.
• For the broader claim of "safety and effectiveness" remaining equivalent to the predicate, the "ground truth" is established by the prior clearance of the Osstell Mentor (K033689), implying its established clinical utility and safety for measuring implant stability. This submission leverages that established utility rather than generating new clinical ground truth.

8. The Sample Size for the Training Set

• This information is not provided. As the device is a measurement instrument based on physical principles (Resonance Frequency Analysis) and signal processing, it is not described as utilizing a "training set" in the context of machine learning algorithms. The software changes are mentioned, but not in a way that suggests a trainable algorithm requiring a data-based training set.

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

• As a "training set" is not indicated to be part of the device's development or validation, this question is not applicable based on the provided text.

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