Search Results

Point implant system is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple units restorations including; cemented retained, or overdenture restorations, and final or temporary abutment support for fixed bridgework. It is intended for delayed loading.

Point implant system is a dental implant system consisting of fixtures, mount & mount screws, abutments (cemented, solid, angled, temporary, healing), abutment screws, and cover screws. The applied part is oral and the contact duration is C (>30 days). The patient population is dental prosthetic patients. The materials used include Unalloyed Titanium (ASTM F67), Alloyed Titanium (ASTM F136), and Polyoxymethylene (CAS No.: 30846-29-8).

The provided document is a 510(k) Summary for the Point implant system. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than presenting a study proving a device meets specific acceptance criteria for performance metrics like accuracy, sensitivity, or specificity. Therefore, many of the requested categories about acceptance criteria, efficacy studies, and ground truth are not directly addressed in this type of submission.

However, I can extract information related to non-clinical testing and general acceptance of performance based on standards.

Here's a breakdown of the available information:

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

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 non-clinical tests.
• Data Provenance: Not specified. The manufacturer is PointNix Co., Ltd. from REPUBLIC OF 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 information is not applicable and not provided in a 510(k) summary for a dental implant system. The document focuses on physical, chemical, and biological performance testing against established standards, not on diagnostic accuracy requiring expert consensus as ground truth.

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

• Not applicable. The tests mentioned are non-clinical, objective tests against engineering and biological standards, not requiring human adjudication of results in the way a clinical imaging study might.

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. This is a dental implant system, not an AI-powered diagnostic device. No MRMC studies were mentioned.

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

• Not applicable. This is a dental implant system, not an algorithm.

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

• For the non-clinical tests, the "ground truth" or reference for acceptance is primarily the criteria defined by international and national standards (e.g., ISO 10993, ISO 14801, ISO 11137, ANSI/AAMI, USP), as well as FDA guidance documents. These standards define methodologies and acceptable limits for properties like biocompatibility, fatigue strength, sterility, and packaging integrity.

8. The sample size for the training set

• Not applicable. This is a medical device (dental implant), not a machine learning model that requires a training set.

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

• Not applicable. (See answer to #8).

Summary of Study Type:

The "studies" described are a series of non-clinical performance tests conducted to demonstrate that the physical, chemical, and biological properties of the Point implant system meet established international standards and FDA guidance for dental implants. These are largely laboratory-based tests comparing the device's performance against predefined thresholds and methodologies specified in the standards. No clinical studies (human trials) were included in this 510(k) submission.

Ask a specific question about this device

Point 500 HD/500C HD which is the dental panoramic/panoramic and cephalometric device is intended to produce diagnostic quality radiographic images by acquiring digital 2D X-ray images. The cephalometric system produces cephalomertric radiographic images that maybe used in orthodontic diagnosis procedures.

The Point 500 HD/500C HD is a dental panoramic and cephalometric device which is digital X-ray imaging device. It is intended for dental radiographic examinations of teeth, jaw and TMJ areas by exposing X-ray and then converts this information to the digital signals to acquire images. High-defined images are provided by controlling acquired image with computer and this is used to obtain panoramic and cephalometric images for dental purpose. This equipment is equipped with an X-ray generator and Sensor for panoramic and cephalometric at Rotation unit which are supported by Main frame and Column. When rotation unit is rotating around the patient's teeth and jaw for acquiring panoramic image, X-ray exposes and sensor detects the data from X-ray generator. Detected data from each frame is transferred to PC, and combined together to display panoramic image on PC screen by installed software on PC.

The provided documentation describes the PointNix Dental Digital X-ray Imaging Device models Point 500HD and Point 500C HD. However, it does not contain details about specific acceptance criteria or a study that evaluates the device against such criteria beyond general non-clinical safety and performance testing.

Here's an analysis of the provided text in relation to your request:

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

This information is not present in the provided document. The document focuses on establishing substantial equivalence to a predicate device (Panoura 18S - K111231) through comparison of intended use, operating characteristics, and radiation properties, as well as reporting on non-clinical safety standards. It does not define specific acceptance criteria for image quality or diagnostic performance, nor does it present a study to demonstrate performance against such criteria.

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

This information is not available as no clinical test involving a test set is discussed. The document explicitly states: "Discussion of Clinical Tests Performed: Not Required".

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 information is not available as no clinical test involving a ground truth is discussed.

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

This information is not available as no clinical test involving adjudication is discussed.

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 information is not available. The device described is a dental X-ray imaging system, not an AI-powered diagnostic tool. No MRMC study is mentioned.

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

This information is not available. The device is an imaging hardware system, not a standalone algorithm.

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

This information is not available as no clinical test utilizing a ground truth is discussed.

8. The sample size for the training set

This information is not available. The document describes a medical device (an X-ray imaging system), not a machine learning or AI algorithm that would typically involve a training set.

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

This information is not available, as no training set or ground truth for such a set is discussed.

Summary of what the document does provide regarding device evaluation:

The document outlines the following evaluations:

• Substantial Equivalence: The primary method of demonstrating safety and effectiveness is by showing substantial equivalence to a legally marketed predicate device (Panoura 18S - K111231). Key comparisons include intended use, operating characteristics (tube voltage, tube current, focal spot size, scan time), and radiation.
• Non-Clinical Tests:
  • Electrical, mechanical, and environmental safety and performance testing: Performed according to international standards (EN/IEC 60601-1, EN/IEC 60601-1-3, EN/IEC 60601-2-7, EN/IEC 60601-2-28, and EN/IEC 60601-2-32).
  • EMC testing: Conducted in accordance with EN/IEC 60601-1-2.
  • Results: All test results were reported as "satisfactory."
• Clinical Tests: Explicitly stated as "Not Required."

This type of submission (510(k)) often relies on demonstrating equivalence to an existing device rather than on extensive clinical performance data against specific, pre-defined acceptance criteria, especially for established device types like X-ray systems.

Ask a specific question about this device