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Atlas Implant Systems are designed for use in dental implant surgery. They are intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including, cement retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. They are not intended for use of immediate loading.

The Atlas Implant System includes a variety of precision-machined fixtures manufactured from titanium. These implants are surgically inserted into the upper and/or lower jawbone and serve as a replacement for a patient's tooth root providing a stable foundation for restorations.

The provided document, K071148, is a 510(k) Pre-market Notification for the Atlas Implant System. This type of submission focuses on proving substantial equivalence to a predicate device rather than undergoing a de novo clinical trial with comprehensive acceptance criteria and detailed performance studies typical of AI/software medical devices.

Therefore, the document does not contain the information requested regarding acceptance criteria related to device performance in the context of an AI/software medical device.

Specifically, the document states:

• 14-8. Performance: "Laboratory testing was conducted to determine device functionality and conformance to design input requirements." This refers to mechanical and material testing of a physical implant, not a software algorithm's performance.
• No mention of sample sizes for test sets, data provenance, number or qualifications of experts, adjudication methods, MRMC studies, standalone performance, type of ground truth, or training set details.

The document discusses substantial equivalence for a dental implant, comparing its physical and material characteristics (e.g., material, design, dimensions, surface treatment) to a predicate device (ALLFIM IMPLANT SYSTEM K050635). The "acceptance criteria" for a 510(k) for a physical implant like this are primarily about demonstrating that it is as safe and effective as a legally marketed predicate device, typically through bench testing and comparison of technical specifications, not through clinical performance metrics against a defined ground truth.

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Allfim Implant System is an integrated system of endosseous dental implants which designed to support prosthetic devices for partially or fully edentulous patients.

Allfim Implant Systems (Atlas Fixtures and Atlas Shoulder Abutments) consists of two-stage, root-form dental implants, associated abutment systems, which provide the clinician with cement-retained, screw-retained and overdenture-type restorative options.

The devices covered by this submission are Atlas Fixtures, and Atlas Shoulder Abutments which are placed into dental implant to provide support for prosthetic reconstruction.

The non-hexa-shoulder abutment is designed for single crown use only. The hexa-shoulder abutment is designed for bridge use only

Allfim Implant System is an integrated system of endosseous dental implants which designed to support prosthetic devices for partially or fully edentulous which dostyled in the more and Atlas Fixtures and Atlas Shoulder Abutments) consists of two-stage, root-form dental implants, associated abutment systems, which provide the clinician with cement-retained, screw-retained and overdenture-type restorative options. The devices covered by this submission are Atlas Fixtures, and Atlas Shoulder Abutments which are placed into dental implant to provide support for prosthetic reconstruction.

The provided text is a 510(K) summary for a medical device (Allfim Implant Systems) seeking FDA clearance. It focuses on establishing substantial equivalence to predicate devices rather than providing detailed performance studies with acceptance criteria, sample sizes, expert evaluations, or specific statistical results as would be found in a clinical trial report.

Therefore, most of the requested information cannot be extracted from this document. The submission explicitly states:

"10-8. Performance: Laboratory testing was conducted to determine device functionality and conformance to design input requirements."

This indicates that internal laboratory testing was performed, but no specific data, acceptance criteria, or a detailed study report for these tests are included in this 510(K) summary. The summary's primary purpose is to compare the new device to existing, legally marketed predicate devices to assure safety and effectiveness, rather than to present novel performance data from human or extensive standalone studies.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

• Cannot be provided based on the input. The document states "Laboratory testing was conducted to determine device functionality and conformance to design input requirements" but does not specify what those requirements or acceptance criteria were, nor does it report any specific performance metrics or outcomes from such testing.

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

• Cannot be provided based on the input. No sample sizes for a test set are mentioned, and no specific data provenance (country of origin, retrospective/prospective) is detailed for any performance evaluation. The document refers to "laboratory testing," which typically does not involve patient data or independent test sets in the way clinical studies do.

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

• Cannot be provided based on the input. No mention of experts or ground truth establishment relevant to a test set's performance evaluation is present.

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

• Cannot be provided based on the input. No adjudication method is described as there is no detailed test set analysis.

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:

• Cannot be provided based on the input. This device is an endosseous dental implant system, not an AI-assisted diagnostic tool. Therefore, an MRMC study related to AI assistance for human readers is not applicable and not mentioned.

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

• Cannot be provided based on the input. This device is a physical implant system, not an algorithm, so a standalone performance test in this context is not applicable.

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

• Cannot be provided based on the input. No ground truth is described in the context of performance testing as would be relevant for devices that generate diagnostic outputs. The "performance" mentioned is about device functionality and conformance to design requirements, likely assessed through engineering and mechanical tests.

8. The sample size for the training set:

• Cannot be provided based on the input. There is no mention of a "training set" as this is not an AI/machine learning device.

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

• Cannot be provided based on the input. Not applicable (see point 8).

Summary of available information regarding acceptance criteria and study:

The 510(K) submission for the Allfim Implant Systems primarily relies on substantial equivalence to predicate devices (BIOPLANT Implant Systems (K041655) and Branemark Systems (K925777, K925779, K961728, K971706)).

• Acceptance Criteria & Reported Performance:

  • The document states: "Laboratory testing was conducted to determine device functionality and conformance to design input requirements."
  • It implicitly accepts that if the device performs functionally and conforms to design requirements (likely mechanical and material properties similar to predicate devices), then it is substantially equivalent.
  • No specific quantitative acceptance criteria or performance metrics (e.g., fracture resistance in Newtons, fatigue life cycles) are reported in this summary. The "performance" is demonstrated by its similarity in design and materials ("threaded, root form implants constructed of titanium with roughened surfaces") to devices already on the market.

• The Study (or lack thereof):

  • The "study" cited is "Laboratory testing."
  • No details are provided about this laboratory testing, such as specific protocols, results, or comparison against predefined acceptance criteria.
  • The core of this 510(K) is the Substantial Equivalence Comparison, arguing that because "Allfim Implant Systems (Atlas Fixtures and Atlas Shoulder Abutment Systems) and predicate implants share a substantially equivalent intended use" and are "similar in fundamental scientific technology in that they are all threaded, root form implants constructed of titanium with roughened surfaces," "no new questions of safety or effectiveness have been raised for the Implant system."

In essence, for this type of device and 510(k) submission, the "study" demonstrating that the device meets "acceptance criteria" is largely implied through its similarity to already cleared devices, supported by general statements about internal laboratory testing. Detailed direct human performance data or specific quantitative acceptance criteria and results are not typically required or provided in such a summary unless a significant new technological characteristic is introduced that deviates from known predicates.

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BioPlant Systems refer to sets of root form endosseous dental implants and compatible implant abutment systems. BioPlant Systems are designed for use in dental implant surgery and are intended to be used in a manor in which they (the implants) integrate with the bone (osseointegration). The BioPlant abutment systems include various abutments designed to enable the implant process from healing thru final restoration. Clinical studies have demonstrated that, when surgically implanted under controlled conditions, a successfully osseointegrated implant will achieve a firm and direct connection between the living bone and surface of the titanium implant. BioPlant implants are for single or two-stage surgical procedures. Bio Plant Systems are intended for immediate placement in partially or fully edentulous mandibles and maxillae (type I or II bone), in support of single or multiple-unit restorations including; cemented retained, screw retained, or over-denture restorations, and terminal or intermediate abutment support for fixed bridgework. Multiple tooth applications may be splinted with a bar.

The Bio Plant System includes a variety of types and sizes of precision-machined self-tapping root-form implants, abutments and accessory fixtures manufactured from biocompatible, commercially pure (CP) titanium or biocompatible, wrought titanium or gold alloy. The implants are available with hex-lock features and either smooth (bright) or textured (abrasive blasted) surface finish. Implants range in diameter from 3.3 mm to 6.0 mm and in length from 7 mm to 18 mm. The implants are intended to be surgically inserted into the upper and/or lower jawbone and serve as a substitute or replacement tooth while providing a stable and secure foundation for restorations. Drill sequences, arms and insertion instruments, as specified, are available.

The provided text describes the Cowell Medi BioPlant System, an endosseous dental implant system, and its acceptance criteria as defined for its 510(k) submission to the FDA. The submission relies heavily on demonstrating substantial equivalence to predicate devices and provides non-clinical testing data to support this claim, rather than new clinical trials.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Cowell Medi BioPlant System are primarily based on demonstrating substantial equivalence to existing legally marketed predicate devices (Nobel Biocare's Brånemark System and Implant Innovations, Inc. (3i) Dental Implant Systems). The performance criteria are therefore linked to matching or being functionally equivalent to these predicates across various attributes.

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

• Test Set (Non-clinical): For the mechanical fatigue and static shear testing, the document states: "BioPlant System production unit implant-abutment system samples, considered physically representative of the design most prone to worst-case mechanical loading following implantation, were subjected to testing per part 5 of ISO 14801."

  • The exact sample size (number of units tested) is not explicitly stated in the provided text, beyond "All samples survived" and "All samples exhibited acceptable yield points."
  • Data Provenance: The document does not specify the country of origin for the non-clinical testing data directly. Given that the manufacturer is Cowell Medi Co., Ltd. from Busan, Korea, it's reasonable to infer the testing was likely conducted in Korea or by an accredited lab on behalf of the manufacturer. The testing adheres to ISO 14801, an international standard. The data is prospective in the sense that custom tests were performed on the BioPlant System samples to demonstrate performance against established standards.

• Test Set (Clinical): No new clinical test set was used for the BioPlant System itself. The submission explicitly states: "Cowell Medi perceives the adequacy of such existing documentation substantiates the exclusion of both animal and human clinical studies protocols or data." Instead, they rely on "Abundant, significant, peer reviewed documentation supporting the successful clinical performance of root-form endosseous dental implants and abutment systems exists." This refers to retrospective evidence from the wider body of literature and the predicate devices.

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

• Non-clinical Testing: For the mechanical and static shear testing, ground truth is established by objective engineering standards (ISO 14801) and the physical properties of the materials and design, not by expert consensus. There are no "experts" establishing unique ground truth in this context; rather, the tests measure objective performance metrics.
• Clinical Ground Truth: No new clinical ground truth was established by experts for the BioPlant System specifically. The submission relies on existing "peer-reviewed documentation" and the clinical history of the predicate devices. The "ground truth" for clinical performance, in this case, is derived from the established safety and effectiveness of similar devices in the medical literature.

4. Adjudication Method for the Test Set

• Non-clinical Testing: Not applicable. The mechanical and static shear tests have objective pass/fail criteria (e.g., survival after 5 million cycles, acceptable yield points, no fractures prior to yield). There's no human adjudication of ambiguous results.
• Clinical Testing: Not applicable, as no new clinical studies were performed.

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 document describes a dental implant system, not a diagnostic AI device requiring multi-reader, multi-case studies or assessment of human reader improvement with AI assistance.

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

• Not applicable. The device is a physical medical device (dental implants and abutments), not an algorithm or AI system.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

• Non-clinical: Objective physical and mechanical standards (ISO 14801), laboratory measurements of fatigue resistance and yield strength.
• Clinical: The clinical ground truth for showing "successful osseointegration" and "firm and direct connection between the living bone and surface of the titanium implant" is based on the general body of "Abundant, significant, peer reviewed documentation" for root-form endosseous dental implants. This implies reliance on historical outcomes data and expert consensus within the dental community regarding the performance of similar, established devices.

8. The Sample Size for the Training Set

• Not applicable. This is not an AI or machine learning device requiring a training set. The device design and manufacturing processes are likely informed by years of engineering knowledge and clinical experience with dental implants, rather than a quantifiable training dataset in the AI sense.

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

• Not applicable. As stated above, this is not an AI device.

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