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N1 is a dental portable X-ray imaging system that captures radiographic images for dental diagnosis using intraoral imaging sensors. Only trained and qualified dental practitioner or radiologist shall use N1 to diagnose and treat diseases related to the teeth, jaws, and/or other oral structures in adults and children.

N1 is a portable dental X-ray imaging device powered by a rechargeable lithium polymer battery pack. It generates X-rays optimized for dental examinations (on teeth, etc.). The N1's X-ray generator equipped with an X-ray tube consists of control unit, user interface, X-ray aperture (collimator), a back-scatter shielding glass, and remote irradiation switch. The x-ray detectors (digital detectors or analog film) are not accessories for use with the N1. N1 is a product designed to diagnose the conditions of teeth through X-irradiation using its intraoral imaging sensors. Software is included for operation and configuration of the N1. It is of Moderate level of concern and it's not based on the predicate software.

The provided FDA 510(k) summary for the N1 device (K232012) does not contain information regarding acceptance criteria or a study that proves the device meets specific performance criteria beyond general safety and electrical compliance.

The document states:

• "No clinical studies are submitted." (Page 5, Section 8)
• "We performed the applicable non-clinical tests in the FDA guidance document for solid state x-ray detectors. The digital detectors used for testing are not part of the subject device." (Page 5, Section 7)
• "Software validation and verification test, EMC/Electrical Safety tests, and performance tests were conducted and the test results support that the subject device is substantially equivalent to the predicate device." (Page 5, Section 7)
• The conclusion mentions some differences in specifications but states, "there was no significant difference in the safety / performance of the product, and it was confirmed that the Portable dental X-ray imaging device had better performance than the equivalent device in some specifications." (Page 6, Section 9) This implies a comparison to a predicate device, but no specific performance metrics or acceptance criteria are detailed.

Therefore, I cannot provide the requested information for acceptance criteria and a study proving those criteria are met from this document. The submission focuses on demonstrating substantial equivalence to a predicate device primarily through non-clinical testing (electrical safety, EMC, software verification/validation) and comparing technical specifications, rather than reporting on a clinical or performance study with defined acceptance criteria for diagnostic accuracy or effectiveness.

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N1™ TiUltra™ TCC Implant system is indicated for use in the maxilla or mandible for anchoring or supporting prosthetic teeth, in order to restore patient esthetics and chewing function. N1™ TiUltra™ TCC Implant system is indicated for single or multiple unit restorations in splinted or non-splinted applications using a 2-stage or 1-stage surgical technique in combination with immediate, early or delayed loading protocols, given that sufficient primary stability and appropriate occlusal loading for the selected technique has been achieved.

N1 TiUltra TCC Implant system is composed of implant site preparation tools, abutments, and abutment screws.

The provided text describes the regulatory clearance of a dental implant system (N1™ TiUltra™ TCC Implant system) and outlines the testing conducted to demonstrate its substantial equivalence to predicate devices. However, it does not contain information typically found in a clinical study report that would detail acceptance criteria and a study proving the device meets those criteria in the context of diagnostic or screening performance (e.g., sensitivity, specificity, accuracy).

Instead, the document focuses on demonstrating substantial equivalence to legally marketed predicate devices through a comparison of technological characteristics, intended use, indications for use, and comprehensive non-clinical and clinical testing. The concept of "acceptance criteria" here refers to demonstrating that the new device is as safe and effective as the predicate, rather than meeting specific performance metrics for a diagnostic task.

Therefore, I will interpret "acceptance criteria" as the criteria for establishing substantial equivalence and "reported device performance" as the outcomes of the non-clinical and clinical studies conducted to support that equivalence.

Here's a breakdown of the information based on the provided text, addressing your specific questions, with explanations for what is not present:

1. Table of acceptance criteria and the reported device performance

Since this is a submission for substantial equivalence, the "acceptance criteria" are demonstrating similarity to predicate devices and acceptable performance in various non-clinical and clinical tests.

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

• Non-Clinical Testing: Sample sizes are not explicitly stated for most non-clinical tests (e.g., sterilization, endotoxin, biocompatibility, packaging, mechanical). The animal study involved a "mini-pig model" but the number of animals or implants within that study is not specified, only that it served a comparative purpose. For heat generation and insertion torque, comparative testing was done between the subject device and the Primary Predicate, but specific numbers are not given.
• Clinical Testing (T-193 EVOLUTION Study):
  • Sample Size: 95 consecutive subjects, treated with 165 implants. 145 implants had 12-month follow-up visit data after loading. Marginal bone level change (MBLC) analysis was based on n=124 implants for paired image analysis.
  • Data Provenance: Retrospective, multi-center, company-sponsored real-world study, conducted in Europe.

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

The document does not specify the number or qualifications of experts used to establish ground truth for the clinical study. The "ground truth" in this context would likely refer to the clinical assessments and measurements (e.g., marginal bone level change, implant survival, soft tissue parameters) recorded by the medical professionals involved in the multi-center European study. It does not mention an independent expert panel for ground truth adjudication outside of the routine clinical measurements.

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

The document does not describe any specific adjudication method (like 2+1 or 3+1) for the clinical study data. The data appears to be collected and reported directly from the clinical sites as part of a real-world study.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This type of study (evaluating human reader performance with and without AI assistance) is typically performed for diagnostic imaging AI devices. The N1™ TiUltra™ TCC Implant system is a dental implant system (hardware), not an AI diagnostic tool.

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

No, a standalone algorithm performance study was not done. As mentioned, this is a physical medical device, not an AI algorithm.

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

For the clinical testing (T-193 EVOLUTION Study), the "ground truth" was established through:

• Outcomes Data / Clinical Data: Marginal bone level change (MBLC), implant survival, implant success rates, soft tissue healing parameters (bleeding index, plaque index), and adverse events, collected directly from clinical practice.
• Radiographic Imaging Data: Used for MBLC assessment.
• Comparative Reference: Historical data from published literature for the predicate NobelActive implant system (MacLean et al., 2016, and Aldahlawi, et al., 2018) was used for non-inferiority comparison of MBLC.
• Animal Study: Micro-CT, histology, and histomorphometry were used to assess osseointegration.

8. The sample size for the training set

This information is not applicable as the document describes a physical medical device product and its substantial equivalence testing, not an AI/ML algorithm that would typically require a training set.

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

This information is not applicable for the same reason as above (not an AI/ML algorithm).

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