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Pre-Cemented Orthodontic Bracket System Extension II is indicated for use in bonding orthodontic appliances for orthodontic treatment.

The Pre-Cemented Orthodontic Bracket System Extension II is comprised of precemented ceramic and metal orthodontic brackets, transfer tray and adhesives.

The provided text is a 510(k) summary for the "Pre-Cemented Orthodontic Bracket System Extension II". It describes the device, its intended use, and its substantial equivalence to previously cleared devices.

Based on the information provided, here's an analysis of the acceptance criteria and study information:

Acceptance Criteria and Reported Device Performance

• Prior use of components in legally marketed devices.
• Performance data provided (though specific metrics are not detailed in this summary).
• Previous biocompatibility data.
• The claim that shear bond strength testing, Failure Mode Effect Analysis (FMEA), and biocompatibility testing were not necessary due to no change in the super mesh base from predicate devices. |
  | Substantial Equivalence | The device is deemed substantially equivalent to the predicate devices:
• DENTSPLY International, Inc., Pre-Cemented Orthodontic Bracket System (K061252)
• DENTSPLY International, Inc., Pre-Cemented Orthodontic Bracket System Extension (K081291) |
  | Technological Characteristics | The device represents an addition to K081291, and all its components have been used in legally marketed devices or found safe for dental use. No change in the super mesh base for metal and ceramic brackets. |

Study Information

1. Sample size used for the test set and the data provenance:
   The provided 510(k) summary does not detail any specific clinical or performance study with a test set. It relies on the substantial equivalence to predicate devices and the prior use of components. It states that "performance data provided" but does not specify what this data entails or for which tests it was collected. Therefore, information regarding sample size, country of origin, or whether it was retrospective/prospective is not available.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   Not applicable. No specific "test set" requiring ground truth established by experts is described in this summary. The submission is based on substantial equivalence and component history rather than a new performance study requiring expert adjudication of a test set.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
   Not applicable. As no specific "test set" is detailed, no adjudication method is mentioned.

4. 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 device is a physical orthodontic bracket system, not an AI-assisted diagnostic or imaging tool. Therefore, an MRMC study related to human readers and AI assistance is not relevant or mentioned.

5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
   Not applicable. This is a physical medical device, not an algorithm.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
   Not explicitly detailed. The "ground truth" for the device's safety and effectiveness appears to be derived from the established safety and performance of its predicate devices and the historical use of its components. There is no mention of specific new ground truth generation through e.g., pathology or new outcomes data specific to this device extension. The statement "performance data provided" is vague.

7. The sample size for the training set:
   Not applicable. As this is a physical device and not an AI/machine learning algorithm, there is no concept of a "training set."

8. How the ground truth for the training set was established:
   Not applicable. As there is no training set mentioned, this question is not relevant.

In summary, this 510(k) submission primarily leverages the concept of substantial equivalence to previously cleared devices. It does not present new, extensive clinical study data or a detailed performance study with a separate test set, training set, or expert adjudication as would be seen for a novel diagnostic device or AI algorithm.

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The Pre-Cemented Orthodontic Bracket System Extension is indicated for use in bonding orthodontic appliances for orthodontic treatment.

The Pre-Cemented Orthodontic Bracket System Extension is comprised of pre-cemented ceramic and metal orthodontic brackets, transfer tray, and the adhesives described in K061252. Components of this system are used exactly as described in K061252 (Pre-cemented Orthodontic Bracket System) with the same fundamental technology and for the same intended use. This modification adds a second ceramic orthodontic bracket to the Pre-cemented Orthodontic Bracket System (K060837).

This 510(k) submission (K081291) describes a modification to an existing device, adding a second ceramic orthodontic bracket to an already cleared Pre-Cemented Orthodontic Bracket System (K061252), which itself includes components from K060837. This submission does not contain information about a study based on acceptance criteria in the traditional sense of a clinical performance study with defined endpoints like sensitivity, specificity, or inter-reader agreement.

The device, a Pre-Cemented Orthodontic Bracket System Extension, is a dental device intended for use in bonding orthodontic appliances. The core of this submission focuses on demonstrating that the new component maintains the same safety and effectiveness characteristics as the predicate devices.

Here's an breakdown of the information available in relation to your questions:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not applicable. There is no explicit "test set" in the context of a clinical performance study to evaluate diagnostic performance or similar metrics. The evaluation relies on established safety and performance data from predicate devices and component materials rather than a new clinical trial.
• Data Provenance: Not applicable. The submission refers to "previous biocompatibility data" and "performance date (data)" from the predicate devices (K060837 and K061252) and the prior use of components in legally marketed devices. This would be considered retrospective in the sense of leveraging existing data, but it's not a prospective study.

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

• Not applicable. There is no "test set" in the context of a clinical performance study requiring expert ground truth establishment.

4. Adjudication Method for the Test Set

• Not applicable. There is no "test set" requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No, an MRMC comparative effectiveness study was not done. This device is not an AI-based diagnostic tool, but rather a physical orthodontic bracket system. Therefore, the concept of human readers improving with or without AI assistance is not relevant.

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. This is not an AI algorithm.

7. The Type of Ground Truth Used

• The ground truth, in an indirect sense, is established by regulatory clearance and historical safety/effectiveness of the predicate devices and the individual components used. The biocompatibility data also serves as a ground truth for a specific safety aspect. It's not based on expert consensus for diagnostic accuracy, pathology, or outcomes data from a new study.

8. The Sample Size for the Training Set

• Not applicable. This is not an AI-based device that requires a training set.

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

• Not applicable. No training set for an AI algorithm is involved.

Summary of the Study (or Lack Thereof) to Prove Acceptance Criteria:

The "study" in this context is a benchmarking and equivalency assessment against predicate devices and known material safety. The manufacturer did not conduct a new clinical study to establish acceptance criteria for performance; instead, they demonstrated that:

• The device components are already used in legally marketed devices.
• The device's materials have established biocompatibility, and since the formulation hasn't changed, no new biocompatibility testing was deemed necessary.
• The device maintains the same fundamental technology and intended use as its predicate.

The FDA's review concluded that the device is "substantially equivalent" to the predicate devices, thereby meeting the necessary regulatory acceptance for marketing. This type of submission relies heavily on a comparison to existing, cleared devices rather than new performance data generation for defined acceptance criteria.

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The Pre-Cemented Orthodontic Bracket System is indicated for use in bonding orthodontic appliances for orthodontic treatment.

The Pre-Cemented Orthodontic Bracket System consists of precemented orthodontic brackets and an optional bonding tray. The orthodontic brackets and component used in the application are currently marketed medical devices.

The provided text describes a 510(k) premarket notification for a "Pre-Cemented Orthodontic Bracket System." However, it is not a study that proves the device meets acceptance criteria.

The document is a notification from the FDA confirming that the agency has reviewed the submission and determined the device to be "substantially equivalent" to legally marketed predicate devices. This means that based on the provided information, the FDA believes the new device has the same intended use and technological characteristics as a device already on the market, and therefore does not require a premarket approval application (PMA).

The document does NOT contain:

• Acceptance criteria for performance.
• Results from any studies (clinical or bench) comparing the device's performance against specific metrics.
• Information about sample sizes, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set details.

The 510(k) summary explicitly states: "All of the components found in the Pre-Cemented Orthodontic Bracket System are legally marketed devices or are found in legally marketed devices. As there are no changes in formulation from the predicate devices, we believe that additional biocompatibility testing is not required." This suggests that the substantial equivalence argument relies on the existing safety and effectiveness of the predicate devices and their components, rather than new, independent performance testing of the combined system against defined acceptance criteria.

Therefore, I cannot populate the requested table and information as the provided text does not contain the necessary details about acceptance criteria or a study proving the device meets them.

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