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BIJOU Orthodontic Ceramic bracket is indicated for orthodontic movement of natural teeth.

Orthodontic Ceramic bracket, BIJOU is composed of single crystal alumina and consists of three parts: the first part is the slot for the orthodontic wire; the second part is a round groove that is to hold a wire with an elastic "O" ring; the third part is the base that adheres to the tooth surface. A colored marking on wing part of bracket indicates orientation for placement.

The provided document describes the FDA 510(k) summary for the BIJOU Orthodontic Ceramic Bracket, indicating that no clinical performance testing was performed. Therefore, a study proving the device meets specific acceptance criteria as detailed in the request cannot be extracted from this document.

However, the document does list non-clinical performance data and states that the device is substantially equivalent to a predicate device based on these non-clinical tests and other characteristics.

Here's a breakdown of the available information based on your request, with "N/A" where the information is not provided because no clinical study was conducted:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) submission based on substantial equivalence to a predicate device and no clinical data was performed, specific acceptance criteria for "device performance" in a clinical setting are not detailed. The non-clinical performance was evaluated against ISO standards.

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

• Sample Size (Test Set): N/A (No clinical test set was described)
• Data Provenance: N/A (No clinical data)

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

• N/A (No clinical test set or ground truth described)

4. Adjudication method for the test set

• N/A (No clinical test set described)

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

• N/A (No clinical study, and this device is a physical orthodontic bracket, not an AI-assisted diagnostic tool.)

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

• N/A (This is a physical medical device, not an algorithm.)

7. The type of ground truth used

• N/A (No clinical ground truth described. For non-clinical tests, "ground truth" would be defined by the specifications and measurement standards of the relevant ISO standards.)

8. The sample size for the training set

• N/A (No training set described for a clinical study or AI model.)

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

• N/A (No training set or ground truth described for a clinical study or AI model.)

Conclusion from document:

The BIJOU Orthodontic Ceramic Bracket received FDA 510(k) clearance based on its substantial equivalence to the PURE Sapphire bracket (K073045). This determination was made using a comparison of chemical composition, design, indications for use, and non-clinical performance testing (biocompatibility, design characteristics, adhesive strength, and in-house comparative tests). No clinical performance testing was performed or required for this 510(k) submission.

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The device is intended for orthodontic movement of teeth. It is used temporarily and is removed affer orthodontic treatment has been completed. The devices are intended to be single used only.

The MACH BRACKETS are bonded to teeth to apply pressure to the tooth, transmitted through a flexible orthodontic wire, to alter the tooth position. The modified orthodontic ceramic bracket has both aesthetic and self-ligating qualities. The modifications were aimed at facilitating easier orthodontic wire placement and removal through self-ligation and enhancing the bonding and debonding characteristics of the bracket. The MACH BRACKETS is produced using Al2O3, translucent polycrystalline aluminum oxide (99.99%). This MACH BRACKETS are bonded to the teeth with commercially available materials and linked together by "arch wire" that applies steady, gentle produce desired tooth movement.

The document provided is a 510(k) premarket notification for an Orthodontic Ceramic Bracket (Mach Brackets, Bright Brackets). It details the device's description, intended use, technological characteristics, and performance testing for biocompatibility.

Here's an analysis of the acceptance criteria and study information based solely on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document mentions "Bench tests were performed" for biocompatibility. However, it does not provide any details regarding:

• The specific sample size used for any of the biocompatibility tests.
• The data provenance (e.g., country of origin, retrospective or prospective) for these tests. Biocompatibility tests are typically laboratory-based and not derived from clinical patient data in the same way clinical trials are.

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

Biocompatibility tests, as described, do not typically involve human expert establishment of ground truth in the same way clinical diagnostic studies do. The "ground truth" for these tests is defined by the standards (ISO10993-5, ISO10993-10) themselves and the methodologies executed by the testing laboratory.

The tests were performed by the "Dental Devices Testing & Evaluation Center, Yeonsei University, College of Dentistry." While this indicates a reputable institution, no information is provided on:

• The specific number of experts involved in analyzing the test results.
• The qualifications of those experts (e.g., toxicologists, material scientists, with specific years of experience).

4. Adjudication Method for the Test Set

As these are laboratory-based biocompatibility tests and not clinical studies requiring human interpretation of outcomes, no adjudication method (like 2+1 or 3+1 consensus) is mentioned or typically applicable. The results are objective measurements against defined standard criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The document describes biocompatibility bench tests, not a clinical study involving human readers or cases.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This question is applicable to AI/ML devices. The Mach Brackets are physical orthodontic ceramic brackets, not an algorithm or software device. Therefore, a standalone performance study is not relevant or applicable in this context.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

For the biocompatibility tests:

• The "ground truth" is established by the international standards (ISO10993-5 and ISO10993-10) that define acceptable biological responses for medical devices.
• The test results (e.g., "Passed") indicate compliance with these predefined criteria.

8. The Sample Size for the Training Set

This question refers to the training data for AI/ML algorithms. Since the Mach Brackets are a physical medical device and not an AI/ML product, there is no training set in the context of machine learning. The device itself is manufactured; it does not "learn" from data in the AI sense.

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

As explained above, there is no training set for this type of device. Therefore, the establishment of ground truth for a training set is not applicable.

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