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

The ChecQ is a dental implant stability analyzer comprising a main unit and a charging cradle that uses Resonance Frequency Analysis (RFA) to measure implant stability non-invasively. It works with the ChecQPEG, which attaches to the dental implant, and measures stability by analyzing resonant frequencies generated by magnetic field stimulation from the probe tip. The stability result is displayed on the main unit's screen as an Implant Stability Quotient (ISQ), ranging from 1 to 99. The RFA method evaluates by applying transverse force to the implant using magnetism, measuring movement, and analyzing the resulting resonance frequency. The resonance frequency depends on the bone-implant gap and is calculated using a formula, with values expressed as ISQ scores (1-99) for clinical interpretation. The ChecQ mechanism converts voltage pulses generated by the DAC of the MCU into magnetic pulses, which induce vibrations in the ChecQPEG magnets. The device captures the free vibrations as magnetic pulses, processes them through an FFT to extract the natural frequency, and calculates the ISQ value based on this frequency.

The provided text relates to the FDA 510(k) clearance for the ChecQ (AC100) device, a dental implant stability analyzer. However, the document outlines the equivalence to predicate devices based on non-clinical testing rather than providing detailed acceptance criteria and a study demonstrating the device meets those criteria through a multi-reader multi-case (MRMC) study or a standalone algorithm performance study.

The document emphasizes "technological comparison" and "non-clinical testing" for substantial equivalence. It does not describe a clinical study in the format typically used to assess the performance of an AI/ML medical device, which would involve a test set, ground truth experts, adjudication, and performance metrics like sensitivity, specificity, or AUC.

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

Here is what can be inferred or explicitly stated based on the given information:

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

The document does not specify quantitative acceptance criteria in terms of clinical performance metrics (e.g., sensitivity, specificity, accuracy) for the device. Instead, it focuses on demonstrating equivalence to a predicate device through non-clinical testing.

The reported device performance is described qualitatively:

• "The results confirmed that ChecQ exhibited equivalent performance, establishing its functional equivalence with the predicate device."
• "Additional testing was conducted to evaluate the potential effects of the barrier sleeve on ISQ measurements, confirming that the presence of the barrier sleeve did not impact measurement accuracy."

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

The document mentions "multiple measurements using standardized test jigs" for comparative testing against the predicate device (Osstell Beacon). This indicates an in-vitro, non-clinical test using artificial setups rather than a test set derived from patient data. Therefore, there's no information on:

• Sample size: Not applicable in the context of patient data; the "test set" consists of measurements on test jigs.
• Data provenance: Not applicable as it's not human patient data. The testing appears to be conducted by the manufacturer, presumably in South Korea given the applicant's origin.
• Retrospective or Prospective: Not applicable as it's not a clinical study.

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

Not applicable. The "ground truth" for the non-clinical comparison was established by the measurements from the predicate device (Osstell Beacon) and potentially engineering specifications for dimensional tests. There were no human experts involved in establishing ground truth for a clinical test set.

4. Adjudication method for the test set

Not applicable, as there was no clinical test set requiring expert 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

No. The document explicitly states that the "ChecQ dental implant stability analyzer underwent comparative testing against the predicate device, Osstell Beacon, to assess its accuracy. The self-test methodology involved multiple measurements using standardized test jigs..." This is a non-clinical comparison of the device's output to a known standard (the predicate device) or engineering specifications, not an MRMC study with human readers.

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

Yes, in a sense, a "standalone" performance comparison was done, but it was comparing the device's measurement (ISQ score) against the measurement of another device (Osstell Beacon) on artificial test jigs, not against a clinical ground truth for diagnostic accuracy. The device (ChecQ) measures "Implant Stability Quotient (ISQ), ranging from 1 to 99," directly.

7. The type of ground truth used

The "ground truth" for the non-clinical comparison was the output of the predicate device (Osstell Beacon) under the same test conditions, and engineering specifications for mechanical properties and dimensions. It was not expert consensus, pathology, or outcomes data from patients.

8. The sample size for the training set

Not applicable. This device is an electro-mechanical measurement device, not an AI/ML algorithm that requires a "training set" in the context of machine learning. The device determines ISQ values based on resonance frequency analysis and established formulas, not through learned patterns from a training dataset.

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

Not applicable, for the same reason as point 8.

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Luvis Chair is intended to supply power to and serve as a base for dental devices and accessories. This device includes a dental chair and is intended for use in the dental clinic environment and is designed for use by trained dental professionals, dentists and/or dental assistants.

The Luvis Chair (LC700C) includes a chair used by dentists to provide seating for patients during dental procedures. It is designed to position the patient during treatment. The chair consists of a seat, backrest, and armrests that can be adjusted to accommodate the patient's position. Additionally, it may feature a headrest to offer additional support. Dental unit chairs come equipped with various tools and attachments, including dental lights, suction devices, and air- water syringes. The chair's controls are usually located within reach of the dentist, allowing for quick adjustments during the procedure. The Luvis Chair is intended to supply power to and serve as a base for dental devices and accessories.

This document is a 510(k) Premarket Notification for a dental chair (Luvis Chair LC700C). However, it does not contain acceptance criteria or a study proving the device meets acceptance criteria in the manner requested.

Instead, it asserts substantial equivalence to a predicate device based on similar intended use, principles of operation, and technological characteristics. It lists various standards the device complies with for safety, performance, and biocompatibility.

Therefore, I cannot populate the table and answer the questions as requested because the specific information about acceptance criteria and detailed study results (like sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies) are not present in this 510(k) summary.

The document indicates that "the conducted tests, as well as all verification and validation activities, demonstrate that the design specifications and technological characteristics of the Luvis Chair (LC700C) meet applicable requirements and standards." It also states, "The subject device had been subjected to the applicable safety and performance testing before release to ensure the device meets all its specifications." However, it does not provide the specific acceptance criteria (e.g., "device must perform with X% accuracy for Y function") or the detailed results of these tests for comparison or to be presented in a table format.

Summary of what is present:

• Device Name: Luvis Chair (LC700C)
• Intended Use: To supply power to and serve as a base for dental devices and accessories. It includes a dental chair for use in a dental clinic environment by trained dental professionals.
• Predicate Device: Osstem Implant Co., Ltd. K3 (K183347)
• Reference Device: MeqaGen Implant Co., Ltd. N2 (K211556)
• Testing Conducted (Non-Clinical Test Summary):
  • Thermal, electrical, mechanical safety & Electromagnetic Compatibility (compliance with ANSI AAMI ES60601-1, IEC 60601-1-2, IEC 80601-2-60)
  • Software Validations (basic documentation level, moderate level of concern, designed and developed according to a software development process, verified, and validated)
  • Biocompatibility (in vitro cytotoxicity test, oral mucosa irritation test, skin sensitization test; in accordance with ISO 10993-1 and ISO 7405)
  • Performance Test (in accordance with IEC 80601-2-60, ISO 7494-1, ISO 7494-2)
  • Cleaning and Sterilization Validation (in accordance with FDA guidance for reprocessing, ISO 17665-1, ISO TS 17665-2, ISO 16954, ISO 19458)
• Conclusion: The device meets applicable requirements and standards, and the differences from predicate devices do not raise new questions of safety and effectiveness.

Missing Information (and why it's missing from this document):

The request for a detailed table of acceptance criteria vs. reported performance, sample sizes for test/training sets, data provenance, number and qualifications of experts, adjudication methods, MRMC studies, standalone performance, and ground truth types are typical for AI/ML-enabled devices or those requiring specific performance metrics (e.g., diagnostic accuracy). This document is for a dental chair, which is a Class I medical device. For such devices, "acceptance criteria" are usually defined by compliance with recognized electrical safety, mechanical safety, biocompatibility, and performance standards (like the ISO and IEC standards listed). The "study" proving it meets these is often a series of engineering tests and validations against those standards, rather than clinical trials or AI performance evaluations with detailed ground truth analysis as would be done for a diagnostic or image analysis device.

Therefore, the requested information (points 1-9) in the format of specific performance metrics is not applicable or not provided in this regulatory submission for a dental chair.

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Dentis s-Clean SQ-SL Fixture is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple unit restorations including; cemented retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. This system is dedicated for one and two stage surgical procedures. This system is intended for delayed loading.

Dentis s-Clean SQ-SL Fixture is two type as Mini and Regular according to the connection. Dentis s-Clean SQ-SL Fixture is a thread type implant made of Pure titanium according to ASTM F67 which will be placed in the alveolar bone to replace the function of the missing tooth. This device has connection between the upper prosthesis and the internal Hex.

The surface of fixture is treated with SLA (Sandblasted with Large-grit and Acid-etching).

The dimensions of fixtures are as following:

Tolerance of dimension shall be within ± 1% range.

s-Clean SQ-SL Fixture is compatible with devices in K192688 and K210134 as below:

s-Clean SO-SL Fixture Mini is compatible with devices in K210080 as below:

Denis s-Clean SQ-SL Fixture is provided sterilized.

Dentis s-Clean SQ-SL Fixture is packaged with Cover screw that was cleared in FDA as K192688 and K210080.

This document is a 510(k) Summary for the Dentis s-Clean SQ-SL Fixture, a dental implant. It does not contain information about the acceptance criteria or a study proving the device meets those criteria from an AI/algorithm performance perspective. The document focuses on establishing substantial equivalence to predicate devices through non-clinical testing.

Therefore, I cannot provide the requested information regarding AI/algorithm acceptance criteria, test set details, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details because this information is not present in the provided text.

The "Non-Clinical Test Data" section describes engineering and biocompatibility tests conducted on the device, not an AI algorithm.

Non-Clinical Test Data Summary (from the document):

• Tests performed on the subject device: Fatigue Testing (ISO 14801:2016).
• Tests performed on predicate devices and leveraged for the subject device:
  • Sterilization Validation Test on Fixtures (ISO 11137-1,2,3 referenced in K192688).
  • Shelf-Life Test on Fixtures (ASTM F1980 referenced in K153639).
  • Biocompatibility testing on fixtures (ISO 10993-1:2009, ISO 10993-3:2014, ISO 10993-5:2009, ISO 10993-6:2007, ISO 10993-10:2010 and ISO 10993-11:2006 referenced in K153639).
  • Bacterial Endotoxin Test Report on Fixtures (ANSI/AAMI ST72:2011, USP <161>, and USP <85> referenced in K192688).
• Acceptance Criteria for these non-clinical tests: "met the criteria of the standards" (e.g., ISO 14801:2016 for fatigue).
• Study Design/Purpose: To demonstrate substantial equivalence to predicate devices.
• MR Environment Condition: A non-clinical worst-case MRI review was performed using scientific rationale and published literature to evaluate magnetic safety, addressing magnetically induced displacement force and torque.

This document describes a traditional medical device (dental implant) clearance process, not one involving Artificial Intelligence.

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Dentis i-Clean System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple unit restorations including; cemented retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. This system is dedicated for one and two stage surgical procedures. This system is intended for delayed loading.

Dentis i-Clean system is intended for use as an aid in prosthetic restoration. It consists of Abutments and Abutment screws.

The Dentis i-Clean System is a dental implant system consisting of abutments and abutment screws. The device is not an AI/ML device, and therefore the standard acceptance criteria for such devices, along with the study design elements listed, do not apply.

Here's an overview of the non-clinical testing performed to demonstrate substantial equivalence, as described in the provided document:

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

Since this is not an AI/ML device, there are no performance metrics like sensitivity, specificity, or AUC with acceptance criteria described in the document. The substantial equivalence is based on meeting engineering and biological safety standards for medical devices.

The non-clinical tests performed and their respective standards are:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify a "test set" in the context of AI/ML. The tests mentioned are non-clinical (mechanical, sterilization, biocompatibility, MRI review). The sample sizes for these engineering and biological tests are not detailed in this summary but are typically defined by the respective ISO standards. The data provenance is presumed to be from laboratory testing performed by, or on behalf of, Dentis Co., Ltd. (Korea, as per submitter address) or the referenced predicate device manufacturers. These are not human data, so "retrospective or prospective" does not apply.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable, as this is not an AI/ML device involving human experts for ground truth establishment.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as this is not an AI/ML device.

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, as this is not an AI/ML device.

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

Not applicable, as this is not an AI/ML device.

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

Not applicable in the context of AI/ML. For medical devices, "ground truth" is typically defined by adherence to established engineering standards (e.g., ISO 14801 for fatigue) and biological safety standards (e.g., ISO 10993 for biocompatibility, ISO 17665 for sterilization).

8. The sample size for the training set

Not applicable, as this is not an AI/ML device.

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

Not applicable, as this is not an AI/ML device.

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The Dentis s-Clean SQ-SL Narrow Implant System is intended for surgical placement in the upper and lower jaw arches, to provide a root form means for single or multiple units' prosthetic attachment to restore a patient's chewing function. The Dentis s-Clean SQ-SL Narrow Implant System is limited to the replacement of maxillary lateral incisors and mandibular incisors. It is intended for delayed loading.

The Dentis s-Clean SQ-SL Narrow Implant System may be used as an artificial root structure for single tooth replacement of mandibular central and lateral incisors and maxillary lateral incisors.

The implants may be restored immediately

1. with a temporary prosthesis that is not in functional occlusion,
2. when splinted together as an artificial root structure for multiple tooth replacement of mandibular incisors, or
3. for denture stabilization using multiple implants in the anterior mandible and maxilla.

The implants may be placed in immediate function when good primary stability has been achieved and with appropriate occlusal loading.

The Dentis s-Clean SQ-SL Narrow Implant System is used to replace missing teeth in various situations ranging from a single tooth loss to the complete loss of incisors teeth. This system is restricted to substitute the maxillary lateral incisors and mandibular incisors. It is one and two stage endosseous screw type implant with internal connection, intended for single use. Dentis s-Clean SQ-SL Narrow Implant System is a suitable treatment option when the possibility of placing a standard implant is limited due to physical conditions, where the horizontal space is limited by adjacent teeth and roots, or in situations with a narrow alveola ridge.

The provided text is a 510(k) summary for a dental implant system. It focuses on demonstrating "substantial equivalence" to predicate devices, rather than presenting a study to prove a device meets specific performance acceptance criteria for a novel function. As such, the information required for a study proving device performance against acceptance criteria (sections 1-9 of your request) is largely absent from this type of regulatory document.

However, I can extract information related to the acceptance criteria for ensuring safety and performance based on the type of testing performed, which is primarily non-clinical (bench) testing.

Here's an attempt to answer your questions based on the provided text, highlighting where information is absent or not applicable to this type of regulatory submission:

Device: Dentis s-Clean SQ-SL Narrow Implant System

Indications for Use (from K230246): The Dentis s-Clean SQ-SL Narrow Implant System is intended for surgical placement in the upper and lower jaw arches, to provide a root form means for single or multiple units' prosthetic attachment to restore a patient's chewing function. The Dentis s-Clean SQ-SL Narrow Implant System is limited to the replacement of maxillary lateral incisors and mandibular incisors. It is intended for delayed loading.

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

The document does not provide a table of acceptance criteria with specific numerical performance metrics. Instead, it lists the types of tests performed and states that the device was found "substantially equivalent." For specific performance criteria, one would typically refer to the referenced ISO standards (e.g., ISO 14801:2016 for fatigue). The "reported device performance" is implicitly that it met the requirements of these standards.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: Not specified for any of the tests. For fatigue testing per ISO 14801, a minimum number of samples is typically tested, but the exact number isn't provided here.
• Data Provenance: Not specified, but the submission is from Dentis Co., Ltd. in Korea. The studies are described as "non-clinical test data," implying bench testing, not patient data. Therefore, "retrospective or prospective" is not applicable in the clinical trial sense.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This is a 510(k) submission for a dental implant system, demonstrating substantial equivalence through non-clinical (bench) testing, not through expert-reviewed clinical imaging data or diagnostic performance studies. "Ground truth" in this context refers to the defined metrics and standards of the bench tests (e.g., fatigue cycles to failure, material composition analysis).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This concept applies to clinical studies involving human readers and interpretations, not to non-clinical bench testing.

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 device is a dental implant system, not an AI-powered diagnostic tool requiring human reader studies.

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

Not applicable. The device is a physical dental implant, not an algorithm.

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

The "ground truth" for this device's non-clinical testing is defined by international and national standards for material properties, mechanical performance, biocompatibility, and sterilization (e.g., ISO 14801:2016, ISO 10993-1:2009, ANSI/AAMI ST79). For the MR environment assessment, it relies on "scientific rationale and published literature."

8. The sample size for the training set

Not applicable. This is not a machine learning model.

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

Not applicable. This is not a machine learning model.

Summary of the "Study" (Non-Clinical Testing):

The "study" described in this 510(k) summary is a set of non-clinical (bench) tests designed to demonstrate that the Dentis s-Clean SQ-SL Narrow Implant System is as safe and effective as previously cleared predicate devices.

• Purpose: To demonstrate substantial equivalence to predicate devices (K161244, K182194, K210080, K171027, K171694) in terms of materials, design, mechanical performance, biocompatibility, and sterilization, rather than proving performance against novel clinical acceptance criteria.
• Key Tests Performed:
  • Fatigue Testing: Performed on the subject device according to ISO 14801:2016 under worst-case scenarios.
  • Biocompatibility Testing: Leveraged from predicate devices (K171694) and based on ISO 10993-1:2009. The rationale is that the subject device uses the same materials and manufacturing process.
  • End User Sterilization Validation: Leveraged from predicate devices (K171694 and K171027) based on ANSI/AAMI ST79, ISO 17665-1,-2, ISO 11737-1,-2, and ISO 11138-1. The rationale is similar product category, material, manufacturing process, facility, and packaging.
  • Surface Modification (TiN Coating): Data provided to compare chemical composition, SEM, EDS, adhesion, and thickness between subject and predicate (K171694).
  • MR Environment Compatibility: Non-clinical worst-case MRI review performed based on scientific rationale and published literature, referencing FDA guidance.
• Conclusion: The device "constitutes a substantially equivalent medical device, meeting all the declared requirements of its intended use," based on these non-clinical tests and comparisons to predicate devices.

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s-Clean Link Abutment Narrow is intended for use with dental implant as a support for single or multiple tooth prostheses in mandibular central and lateral incisors and maxillary lateral incisors.

s-Clean Link Abutment Narrow is intended for use with the s-Clean OneQ-SL Narrow Fixture according to connector part in the chart. All digitally designed zirconia for use with s-Clean Link Abutment Narrow are intended to be manufactured at a Dentis validated milling center.

The s-Clean Link Abutment Narrow is intended to provide support for customized prosthetic restorations such as crowns and bridges. The s-Clean Link Abutment is composed of a two-piece abutment that is a link abutment at the bottom and a coping (CAD/CAM patient specific superstructure) as the top-half. The submission also includes an abutment fixation screw. The s-Clean Link Abutment are pre-manufactured (stock) abutments, made from a titanium alloy conforming to ASTM F136.

The top half of the s-Clean link abutment composed of zirconia is referenced from our previously cleared K222913 submission.

s-Clean Abutment Screw is made of Ti-6Al-4V ELI (ASTM F136) and cleared in K161244.

The diameters of s-Clean Link Abutment Narrow are 4.0 and 4.5mm.

s-Clean Link Abutment Narrow is provided non-sterile and must be sterilized after the cementation of the patientspecific superstructure on the Link Abutment Narrow.

Accessing the provided text, there is no information about an AI/ML device, its acceptance criteria, or a study proving that it meets those criteria. The document describes a traditional medical device, specifically a dental implant abutment (s-Clean Link Abutment Narrow), and its 510(k) clearance process.

Therefore, I cannot provide the requested information. The text does not contain details regarding:

1. A table of acceptance criteria and reported device performance for an AI/ML device.
2. Sample sizes or data provenance for an AI/ML test set.
3. The number or qualifications of experts for establishing ground truth for an AI/ML device.
4. Adjudication methods for an AI/ML test set.
5. A multi-reader multi-case (MRMC) comparative effectiveness study for AI assistance.
6. Stand-alone performance of an AI algorithm.
7. The type of ground truth used for an AI/ML device.
8. The sample size for an AI/ML training set.
9. How ground truth for an AI/ML training set was established.

The document focuses on non-clinical testing for equivalence to a predicate device, material testing, sterilization validation, biocompatibility, and MRI compatibility for a physical dental implant component.

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Dentis I-FIX Abutment is intended for use as an aid in prosthetic rehabilitation.

Dentis I-FIX Abutment consists of I-FIX Angled Type Fixture Healing Abutment, I-FIX Angled Type Fixture Healing Abutment Screw, and I-FIX Abutment Screw.

I-FIX Angled Type Fixture Healing Abutment and I-FIX Angled Type Fixture Healing Abutment Screw are compatible with following Implant Systems:
Proprietary Name: I-FIX System (Angled Type Fixture)
Compatible Implants (K number): K083586
Implant diameter size: Ø 2.0, 2.5, 3.0 mm
Implant length: 10~16 mm

I-FIX Abutment Screw is only used with I-FIX Cemented Abutment and I-FIX Free Abutment cleared in K083586.

The dimensions of abutments are as following:

1. I-FIX Angled Type Fixture Healing Abutment: (D) 4.03 X (L) 3.2, 4, 5 and 7 mm, Angulation 0°
2. I-FIX Angled Type Fixture Healing Abutment Screw: (D) 2.15 X (L) 4.0, 4.8, 6.1 and 8.0 mm, Angulation 0°
3. I-FIX Abutment Screw: (D) 2.15 X (L) 4.7 mm, Angulation 0°

Tolerance of dimension for Abutments shall be within ± 1% range.

The Abutments have below featured:

• I-FIX Angled Type Fixture Healing Abutment: Uses - The healing Abutment is used for protecting inner hole of fixture and adjusting the appropriate height during the healing period. Surface - Non. Materials - Titanium Grade 4.
• I-FIX Angled Type Fixture Healing Abutment Screw: Uses - The healing Abutment is used for protecting inner hole of fixture and adjusting the appropriate height during the healing period. Surface - Non. Materials - Ti-6Al-4V ELI.
• I-FIX Abutment Screw: Uses - I-FIX Abutment screw is used with the previously cleared devices, K083586 such as I-FIX Cemented and Free Abutment for connecting with fixture. Surface - Non. Materials - Ti-6Al-4V ELI.

I-Fix Angled Type Fixture Healing Abutment and I-FIX Angled Type Fixture Healing Abutment Screw are packaged as a set and provided sterilized. I-FIX Abutment Screw is provided non-sterilized.

Materials:

• I-FIX Angled Type Fixture Healing Abutment is fabricated from pure titanium (Conforming to ASTM Standard F67)
• I-FIX Angled Type Fixture Healing Abutment Screw and I-FIX Abutment Screw are fabricated from Ti-6Al-4V ELI (Conforming to ASTM Standard F136)

This FDA 510(k) submission for the Dentis I-FIX Abutment indicates that the device is substantially equivalent to predicate devices, meaning it does not require a new study to prove its effectiveness or safety. Instead, the submission relies on existing data from predicate devices and non-clinical testing. Therefore, there is no specific de novo study described for this device with acceptance criteria and reported device performance in the traditional sense of a clinical trial.

However, I can extract the acceptance criteria that were met through non-clinical testing by referring to the standards and guidance mentioned.

Here's a breakdown of the requested information based on the provided document:

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

The document does not provide a table with quantitative acceptance criteria and specific numerical reported device performance for the Dentis I-FIX Abutment as one would expect from a de novo clinical study. Instead, it states that various non-clinical tests were performed and that "The results of the above tests have met the criteria of the standards and demonstrated the substantial equivalence with the predicate device."

Here are the types of criteria that were met, based on the standards cited:

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify sample sizes for the non-clinical tests performed. These tests are typically conducted on a limited number of device samples in a laboratory setting. The data provenance is also unspecified beyond the general reference to "Non-Clinical Test Data" and the identification of Dentis Co., Ltd. as the manufacturer in Korea.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This section is not applicable as the submission relies on non-clinical engineering and materials testing, not a study requiring expert clinical assessment for ground truth. The "ground truth" here is objective measurement against established engineering and biocompatibility standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This section is not applicable as there was no clinical study with a test set requiring adjudication of findings.

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

This section is not applicable. The Dentis I-FIX Abutment is a physical dental device, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was conducted.

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

This section is not applicable. The device is a physical medical device, not an algorithm.

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

The "ground truth" used for non-clinical testing was based on:

• Established international and national standards (e.g., ISO, ASTM, ANSI/AAMI).
• Material specifications (e.g., ASTM F67, ASTM F136).
• Engineering specifications (e.g., dimensional tolerances).

8. The sample size for the training set

This section is not applicable. There was no "training set" in the context of machine learning or AI development for this physical device. The device design and manufacturing processes are based on established engineering principles and materials science.

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

This section is not applicable for the reasons stated in point 8.

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The device is intended for use in stabilizing and fixating bone filling material and/or barrier membranes used for guided bone/tissue regeneration in the oral cavity. Single patient use only.

SAVE GBR is manufactured by Ti-6Al-4V ELI. The SAVE GBR is composed of GBR Screw and Bone Tack and these screws and tacks are used to fix barrier membranes in bone regeneration procedures.

The diameter of the GBR screw is 1.4 and length is 3.9, 4.38, 5.9, 6.38, 7.9 and 8.38mm. The diameter of the Bone Tack is 2.5 and length is 2.6 and 4.1mm.

These screws and tacks are implanted for a maximum duration of 6 months. The SAVE GBR is provided sterile.

The subject device is compatible with the OssBuilder membrane cleared in K172354.

The provided document is a 510(k) premarket notification for the "SAVE GBR" device, which is an intraosseous fixation screw or wire used in guided bone/tissue regeneration in the oral cavity. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a standalone clinical study.

Therefore, much of the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in terms of clinical performance metrics (like sensitivity, specificity, accuracy, or human reader improvement with AI) is not applicable to this type of regulatory submission.

The document describes non-clinical testing performed to demonstrate the safety and effectiveness of the device compared to its predicates. The "acceptance criteria" here are typically compliance with relevant international standards and equivalence to predicate devices in terms of material, design, and performance characteristics.

Here’s a breakdown of the information that can be extracted from the provided text, addressing the points where applicable:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The FDA 510(k) process for this device type doesn't establish numerical "performance" criteria in the way a diagnostic AI device might have sensitivity/specificity targets. Instead, "acceptance criteria" are compliance with standards and demonstration of equivalence to legally marketed predicates. The "reported device performance" reflects how the device met these engineering and material standards.

The following questions are not applicable to this 510(k) submission as it concerns a physical medical device (implants) and not a diagnostic or AI-driven system that would typically undergo such evaluations.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not Applicable. This document describes non-clinical (biocompatibility, mechanical, sterilization) testing of a physical implant device, not a diagnostic algorithm tested on a dataset of patient cases.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not Applicable. Ground truth for a diagnostic algorithm is not relevant here. The ground truth for device safety and performance relies on validated laboratory methods and engineering standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not Applicable. This pertains to expert review of diagnostic cases, which is not relevant for this physical device.

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. MRMC studies are for diagnostic interpretation improvement with AI. This document is for a physical implantable device.

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

• Not Applicable. This refers to the performance of an algorithm; it is not relevant for this physical device.

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

• The "ground truth" for this device's regulatory clearance is compliance with recognized international standards (e.g., ISO, ASTM for materials, sterilization, mechanical properties) and demonstration of substantial equivalence to legally marketed predicate devices through comparative testing and analysis. This is based on objective measurements and verified material properties, not clinical expert consensus on diagnostic images or patient outcomes.

8. The sample size for the training set

• Not Applicable. There is no "training set" in the context of an AI algorithm for this device. Testing involves samples of the physical device for non-clinical evaluations.

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

• Not Applicable. No training set; ground truth is established by engineering and materials science standards.

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SAVE GBR is a metal device intended for use with a dental implant to stabilize and support of bone graft in dentoalveolar bony defect sites.

The SAVE GBR consists of Healing Cap, Cover Cap and Spacer. The SAVE GBR are manufactured by Ti-6A1-4V ELI and used with a dental implant to stabilize and support of bone graft in dento-alveolar bony defect sites.

The subject device is compatible with the OssBuilder membrane cleared in K172354.

The dimension of the device is as below:

The healing cap and cover cap have same functions and uses but have different design and name. The SAVE GBR are removed from the patient after such time when sufficient bone regeneration is done.

I am sorry, but the provided text (K222451_Decision_Letter[1].pdf) does NOT contain information about acceptance criteria, device performance results, sample sizes for test and training sets, expert qualifications, ground truth establishment, or any details related to an AI/ML-driven medical device study.

The document is a 510(k) premarket notification letter from the FDA regarding a dental device called "SAVE GBR." This device is a metal component used with dental implants to stabilize and support bone grafts. The core of this FDA submission is to demonstrate substantial equivalence to already legally marketed predicate devices, not to present performance data from an AI/ML model.

Therefore, I cannot fulfill your request for information regarding acceptance criteria and study details for an AI-driven device based on this input. The document focuses on material composition, dimensions, sterilization, shelf life, and intended use as compared to predicate devices, rather than AI performance metrics.

Ask a specific question about this device