Search Results

The Redline Aligner is indicated for the treatment of tooth malocclusion in patients with permanent dentition (i.e. all second molars). The Redline Aligner positions teeth by way of continuous gentle force.

The Redline Aligner is a series of clear, light weight thermoformed plastic aligners designed to be worn in sequence to facilitate the movement to the teeth to the final desired position. The sequential aligners introduce incremental movements that move teeth by way of gentle continuous force. The aligners are to be worn 20-22 hours a day for an average of 2 weeks per aligner or as directed by the clinician and are to be removed only for eating and for cleaning.

A digital or traditional mold impression of the patient's dentition is provided by a dental health professional (e.g. orthodontist or dentist). From the digital data of the patient's dentition. 3Shape A/S Ortho System is used to develop treatment plan. Using the software, dental technicians design a series of intermediate models corresponding to each stage of treatment, gradually realigning the patient's teeth according to the dental health profession's prescription.

The prescribing doctor reviews and approves the model scheme and treatment plan before the molds/models are produced.

Once approved, the 3Shape A/S Ortho System, is used to generate standard format 3D files which are used to physically produce each model/mold in the treatment plan for aligner fabrication. Johns dental laboratories produces the aligner trays by thermal forming a plastic sheet over each model in the treatment plan. The trays are provided to the dental health care professional who provides them to the patients in sequential stages, confirming fit and design. The dental health professional monitors treatment from the moment of the first aligner is delivered to when the final aligner is finished and treatment is complete. The aligners are held in place by pressure and can be removed by the patient at any time.

The provided document is a 510(k) Premarket Notification from the FDA for the Redline Aligner. It primarily demonstrates substantial equivalence to a predicate device rather than presenting a standalone study showing device performance against specific acceptance criteria in the manner one might expect for an AI/ML medical device.

Therefore, it is not possible to fully answer all aspects of your request as the document does not contain information about a study that "proves the device meets the acceptance criteria" in the context of an AI/ML device. The document focuses on showing the Redline Aligner's equivalence to existing devices based on design, materials, and manufacturing processes, rather than on its performance in a clinical trial or a specific AI-driven task.

However, I can extract the information that is present and indicate what is missing:

Description of Acceptance Criteria and Device Performance (Based on provided document)

The document describes non-clinical testing for the Redline Aligner, focusing on manufacturing accuracy and material properties, rather than clinical performance data against specific outcomes.

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size for Test Set: Not explicitly stated as a numerical value. The document mentions an "internal manufacturing validation" where "The final aligner fitness was evaluated according to the in-house fitness acceptance criteria," and "all the aligners including in the study passed." A specific number of aligners tested is not provided.
• Data Provenance: The testing was "internal manufacturing validation," implying it was conducted by Johns Dental Laboratories. The country of origin of this internal data is not specified, but the applicant (Johns Dental Laboratories) is based in Terre Haute, Indiana, United States. It is a retrospective evaluation of manufacturing output.

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified. The "in-house fitness acceptance criteria" would likely be based on internal quality control standards established by qualified personnel, but the roles and qualifications are not detailed.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not specified. The document only states that "all the aligners including in the study passed and were deemed an excellent fit," suggesting a straightforward pass/fail assessment against defined criteria rather than a multi-reader adjudication process typically associated with AI/ML ground truth establishment.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the Effect Size of Human Reader Improvement with/without AI Assistance:

• MRMC Study: No, an MRMC comparative effectiveness study was not done. The Redline Aligner is a physical medical device (orthodontic plastic bracket) and not an AI/ML algorithm that assists human readers.
• Effect Size: Not applicable.

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

• Standalone Performance: No, a standalone performance study for an algorithm was not done. The "3Shape A/S Ortho System" software is mentioned as being used "to develop treatment plan" and "to generate standard format 3D files," but this software's performance as a standalone AI/ML device is not evaluated here. The 510(k) is for the physical aligner.

7. The Type of Ground Truth Used:

• Ground Truth: For dimensional accuracy, the "target input value" from the digital treatment plan served as the reference. For aligner fitness, "in-house fitness acceptance criteria" were used as the standard. For biocompatibility, international standards (ISO 10993-1, ISO 10993-5:2009) were the ground truth for material safety.

8. The Sample Size for the Training Set:

• Sample Size for Training Set: Not applicable. The Redline Aligner is a manufactured physical device, not an AI/ML algorithm that requires a training set. The 3Shape A/S Ortho System is external software, and its training set information is not provided nor relevant to the Redline Aligner's 510(k).

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

• Ground Truth for Training Set Establishment: Not applicable, as there is no training set for the physical device.

Ask a specific question about this device

Ask a specific question about this device

The Tetracore RedLine Anthrax Alert™ Test is intended for the rapid, in vitro qualitative detection of Bacillus anthracis from non-hemolytic colonies obtained from sheep blood agar plates. The test is intended for use in clinical, public health, and hospital laboratories in conjunction with other markers and testing for the identification of Bacillus anthracis.

The Tetracore RedLine Alert™Test is an immunochromatographic test intended for the rapid, in vitro qualitative presumptive identification of Bacillus anthracis from nonhemolytic Bacillus colonies cultured on sheep blood agar plates. The test is intended for use in clinical, public health, and hospital laboratories in conjunction with other markers and testing for the presumptive identification of Bacillus anthracis.

The RedLine Anthrax Alert™ Test Cassette includes a reagent strip consisting of a combination of monoclonal and polyclonal antibodies that selectively detect the presence of Bacillus anthracis in aqueous specimens. The RedLine Anthrax Alert™ Test is supplied with single use test cassettes, Colony Isolation Buffer, and Positive Control reagent.

Here's an analysis of the provided text to extract information about the acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

The document implicitly defines the acceptance criteria through the reported performance characteristics.

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

• Test set sample size:
  • Sensitivity: 145 isolates
  • Specificity: 59 isolates
• Data Provenance: Not explicitly stated. Given it's a 510(k) submission, the isolates would likely be from laboratory cultures and potentially clinical samples, but the geographic origin or whether they were retrospective/prospective is not mentioned.

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

• This information is not provided in the document. The document refers to "isolates" and their characteristics, implying that the ground truth for these isolates (i.e., whether they definitively were Bacillus anthracis or another species) was previously established, but the method and expertise involved are not detailed.

4. Adjudication Method for the Test Set:

• The document does not specify an adjudication method. The testing appears to have been directly against the established identification of the isolates.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:

• No, an MRMC comparative effectiveness study was not done. This device is a diagnostic test (an immunochromatographic assay) designed for automated or semi-automated qualitative detection, not for human interpretation that would be improved by AI assistance.

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

• Yes, the performance characteristics reported (sensitivity and specificity) are for the standalone device (RedLine Anthrax Alert™ Test) without human interpretation affecting the result. The device itself produces the qualitative result.

7. The Type of Ground Truth Used:

• The ground truth used was based on the identity of the bacterial isolates from "non-hemolytic colonies obtained from sheep blood agar plates." This implies a microbiological gold standard, likely established through traditional microbiological identification methods (e.g., Gram staining, cultural characteristics, biochemical tests, molecular methods) which are considered definitive for bacterial species identification. The document does not explicitly state "pathology" or "outcomes data" but rather relies on confirmed bacterial identity.

8. The Sample Size for the Training Set:

• The document does not provide information regarding a separate training set size. The reported performance is based on the "testing of 145 isolates" and "59 isolates," which constitute the evaluation/test set. For a lateral flow immunochromatographic assay, the development and optimization (which could be considered a form of "training") might involve a different process than machine learning algorithms, often relying on reagent optimization and preliminary analytical studies.

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

• As a separate training set is not explicitly mentioned, the ground truth for any development or optimization phases would likely have been established using the same (or similar) microbiological gold standard as described for the test set (i.e., definitive identification of Bacillus anthracis and other relevant bacterial species).

Ask a specific question about this device