Search Results

THERMOFORM SHEET MATERIALS AND ACCESSORIES are indicated for the fabrication of orthodontic and dental appliances.

Thermoform Sheet Materials are flat sheets of thermoplastic. The sheets are heated by the practitioner and then vacuum-formed over a dental impression of the patient's teeth. The sheet is then trimmed to fit. The Accessories are sheet material formulations manufactured by injection molding.

This 510(k) premarket notification describes a medical device, but it does not contain the kind of detailed study information (acceptance criteria, performance data, sample sizes, expert qualifications, etc.) that would allow for a comprehensive description of acceptance criteria and a study proving those criteria are met.

The document K062828, referenced in the header, is the original 510(k) submission summary for the device (THERMOFORM SHEET MATERIALS AND ACCESSORIES). The rest of the provided text (K072522) is the FDA's letter granting clearance for the device, based on the original K062828 submission.

The critical section for your request is within the K062828 summary (pages 000010 and 000011). However, even this summary is very brief.

Here's what can be extracted and what is missing, based on the provided text:

Missing Information:

• A specific table of acceptance criteria with numerical targets.
• Measured device performance against specific criteria.
• Details of any specific "study" beyond general biocompatibility testing and prior use.
• Sample sizes for test sets or training sets.
• Data provenance (country, retrospective/prospective).
• Number and qualifications of experts for ground truth.
• Adjudication methods.
• MRMC comparative effectiveness study or standalone performance.
• Type of ground truth used (beyond "prior use of components" and "biocompatibility data").
• How ground truth was established for the training set (as no explicit training set is mentioned for AI/algorithmic development).

Based on the provided text, the device is of a type (thermoplastic sheets) that typically relies on material biocompatibility and established manufacturing processes, rather than AI/algorithmic performance or complex diagnostic accuracy studies.

Attempted Answer based on available information (with significant blanks):

The provided 510(k) summary for "THERMOFORM SHEET MATERIALS AND ACCESSORIES" (K062828 and the subsequent FDA clearance letter K072522) does not detail a formal study with specific acceptance criteria and performance metrics in the way one would expect for a diagnostic or AI-driven device.

Instead, the submission relies on the concept of substantial equivalence to predicate devices by demonstrating that:

1. Technological Characteristics: The components used in the thermoform sheet materials and accessories have been previously used in legally marketed devices.
2. Biocompatibility: Appropriate biocompatibility testing has been completed.

The "study" in this context is the submission of evidence supporting these two points, rather than a performance study measuring a specific clinical outcome with a defined test set.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance

• Test Set Sample Size: Not applicable/Not specified, as this is not a study measuring diagnostic accuracy or a specific clinical outcome with a "test set" of patients/cases for an AI algorithm. The evaluation is primarily on material properties and prior use.
• Data Provenance: Not specified for the "biocompatibility testing." For the "prior use of components," it refers to legally marketed devices, implying a history of use in various countries where those devices are marketed, but no specific provenance is given. This is a review of existing data/history of components and not a new prospective clinical study described here.

3. Number of Experts and Qualifications for Ground Truth

• Not applicable/Not specified. The "ground truth" here is less about expert consensus on a diagnostic finding and more about the proven safety and effectiveness of the materials and components themselves based on established regulatory pathways for material science. Regulatory experts at the FDA evaluate the submitted evidence.

4. Adjudication Method for Test Set

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

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No. This device is a material for fabricating dental appliances, not an imaging device or an AI diagnostic tool. Therefore, an MRMC study is not relevant or performed for this submission.

6. Standalone (Algorithm Only) Performance Study

• No. This device is a material, not an algorithm.

7. Type of Ground Truth Used

• The "ground truth" for this type of device submission is primarily based on:
  • Material Biocompatibility Data: Scientific evidence from established biocompatibility tests.
  • Prior Regulatory Approval / Market History of Components: Evidence that the individual components of the thermoform sheets have been previously used in legally marketed devices and deemed safe and effective for dental applications. This relies on previous predicate device approvals.

8. Sample Size for the Training Set

• Not applicable/Not specified. There is no AI model or algorithm requiring a training set described in this submission.

9. How Ground Truth for the Training Set was Established

• Not applicable.

Ask a specific question about this device