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IS3 is indicated for use in measuring the stability of dental implants in the oral cavity and the maxillofacial region.

IS3 measurement system consists of: IS3 Instrument Hand-held instrument, Multi Peg Driver Driver to attach the ISQ peg to the implant, IS3 Charger 100-240 VAC to 5VDC charger for the instrument batteries, Multi Peg Measurement pin to attach to the implant. Different pins are available to fit different implant types.

The IS3 instrument is a hand-held, battery-driven device for measuring the relative stability of a dental implant. A small pin "Multi peg" is attached to the dental implant by a screw-connection, with the Multi Peg Driver. The pin has a small magnet incorporated into its top. The instrument is held towards the Multi Peg, and sends short magnetic pulses that bring the pin into vibration. After a pulse has been sent, the instrument measures the vibration by sampling the signal from the alternating magnetic field that follows from the vibrating pin. The frequency of the signal is determined by the instrument and is presented as an "ISQvalue", 1 to 100, where a higher number means higher stability. The measurement takes about 1 second.

The instrument consists of a microcontroller and circuits to send the magnetic pulses, to receive the measurement signal, and to present the measurement value. A circuit for battery-charging is also included. Two 2-digit LED displays, one on each side of the instrument, show the measurement value and also communicate possible error codes and software id number at start-up. One operating key is used to turn the instrument on and off. The electronics are contained in a plastic body, which is sealed except for the back of the instrument which has a charging connector. The plastic body is made from PC/ABS plastic except for the tip, which is made from PEEK. No part of the instrument is intended to contact the patient; however, there can be unintentional contact with the tip of the instrument. The instrument is battery-driven and contains re-chargeable NiMh-batteries. The batteries can be charged during use, but it should not be attached while measuring due to the risk of power line interference making it impossible to measure. For safety, a charger complying with IEC 60601-1 is used.The charger connector is of a type that does not allow other chargers to be connected, thereby eliminating the risk of the wrong charger being used.

The provided document for the HIOSSEN IS3 device (K180527) does not contain detailed acceptance criteria and a study that proves the device meets these criteria in the typical format of a clinical or performance study for AI/ML-enabled devices.

This FDA 510(k) submission primarily focuses on establishing substantial equivalence to a predicate device (Tellos ISQ Buddy, K143445), not on providing performance metrics against specific, quantitative acceptance criteria for diagnostically or prognostically critical AI/ML-driven tasks. The IS3 device is described as measuring the resonance frequency of an implant pin to determine an "ISQ-value" for implant stability, which is a direct measurement based on a physical principle. It does not appear to involve AI/ML for image analysis, diagnosis, or prediction, which typically require detailed performance studies.

Therefore, many of the requested categories for acceptance criteria and study details cannot be directly extracted from this document, as they are not applicable to the type of device and submission presented.

However, I can provide information based on the document's content regarding the device's technical performance and comparison to predicate devices, which serves as its "proof" of meeting requirements for substantial equivalence.

Here's a breakdown of the available information:

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

The document does not explicitly state quantitative "acceptance criteria" in the format of specific thresholds for metrics like sensitivity, specificity, AUC, or accuracy, as would be common for AI/ML-powered diagnostic devices. Instead, the "performance" is demonstrated by its functional equivalence and compliance with relevant standards, and it measures an ISQ value from 1-100.

2. Sample sized used for the test set and the data provenance
The document does not describe a "test set" in the context of a dataset for validating AI/ML performance. The "testing" mentioned refers to compliance with engineering standards (EMC, software validation, sterilization, biocompatibility, electrical safety) for the device itself, rather than testing its diagnostic accuracy on a clinical dataset. Thus, there is no sample size for a test set of clinical data from this document.

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 test set requiring expert-established ground truth for AI/ML performance is described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.

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 applicable. The IS3 is a direct measurement device, not an AI assistance tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device functions as a standalone instrument for measuring ISQ value. Its performance is inherent in its design and compliance with technical standards, as outlined above. It's not an "algorithm only" in the sense of AI/ML, but a physical measurement system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the fundamental measurement principle, the "ground truth" is the physical resonance frequency of the attached pin, which the instrument is designed to accurately measure and convert to an ISQ value. Beyond this, the device's "performance" is assessed by its ability to meet engineering and safety standards, rather than by comparison to clinical ground truth for a diagnostic task.

8. The sample size for the training set
Not applicable, as this is not an AI/ML device requiring a training set.

9. How the ground truth for the training set was established
Not applicable.

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Mechanical drive unit with coolant supply for transmission instruments with ISO 3964 (DIN13940) compatible coupling system, for use in dental surgery, implantology and maxillofacial surgery (CMF) for treatment of dental hard tissue.

The Implantmed SI-1015 is intended for use in dental surgery, implantology and maxillofacial surgery (CMF) for treatment of dental hard tissue.
The new Implantmed SI-1015 is a redesigned version of the old one.
The submission consists of :

• the control unit,
• a motor with cable with or without light (EM-19 LC/EM-19),
• a wireless or wired foot control (S-NW or S-N2),
• the Osstell Module (SI-SQ)
• and as an attachment the surgical handpieces
• (WS-56 L, WS-75 L, WS-91 L, WS-92 L and S-11 L).
  The user can select five different programs. Switching between these programs is performed by foot control or via touch display.
  Programs 1-3 are used for adjusting the speed and programs 4-5 are for adjusting the torque.
  The control unit is intended to be used with the EM-19 or EM-19 L motor.
  The Implantmed SI-1015 will be delivered with software on the control unit.
  To run the Implantmed SI-1015 according to its intended use, W&H provides five different surgical handpieces.

This document concerns the 510(k) premarket notification for the "Implantmed SI-1015 incl. Accessories," a dental handpiece and accessories, and not an AI/ML powered device. As such, the concept of "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of AI/ML performance metrics (such as accuracy, sensitivity, specificity, and the involvement of ground truth, expert opinions, sample sizes for training/testing, MRMC studies, or standalone algorithm performance) is not applicable here.

Instead, the document focuses on demonstrating substantial equivalence to a previously legally marketed predicate device (Implantmed SI-915/923, cleared under K052741) based on non-clinical performance testing and functional comparison.

Here's a breakdown of the provided information, reinterpreted to align with device performance and comparison for a traditional medical device:

1. Table of Acceptance Criteria and Reported Device Performance (Reinterpreted as comparison to predicate and safety standards)

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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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