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.

AI/ML Overview

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:

Technological Characteristics: The components used in the thermoform sheet materials and accessories have been previously used in legally marketed devices.
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

Acceptance Criterion (Inferred)	Reported Device Performance (Inferred)
Material Safety/Biocompatibility	"Appropriate biocompatibility testing has been completed." (Details of specific tests, criteria, and results are not provided in this summary.) The conclusion is that the data supports the safety for dental use.
Functional Equivalence/Prior Use of Components	"All of the components found in Thermoform Materials and Accessories have been used in legally marketed devices and/or were found safe for dental use." The submission states that prior use of components in legally marketed devices supports effectiveness. (Specific performance comparison data to predicates is not provided.)
Intended Use (Fabrication of orthodontic and dental appliances)	The device is intended for the fabrication of orthodontic and dental appliances, mirroring the intended use of predicate devices using similar materials. The implied performance is that the material is suitable for its intended purpose, as demonstrated by the prior use of its components and biocompatibility. (Specific performance for appliance fabrication or patient outcomes related to these appliances is not provided for this specific device, but is inferred from the safety and effectiveness of the components and type of material in existing devices.)

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.

Summary

{0}------------------------------------------------

072522

510(k) SUMMARY

DENTSPLY International Susquehanna Commerce Center West 221 West Philadelphia Street, Suite 60 York, PA 17405-0872

K062828

CONTACT:	Helen Lewis	NOV 1 6 2007
DATE PREPARED:	SEP 0 6 2007
TRADE OR PROPRIETARY NAME:	THERMOFORM SHEET MATERIALS AND ACCESSORIES
CLASSIFICATION NAME:	Sequential AlignerMouthguard	NXCMQC	872.5470Unclassified

DEVICE DESCRIPTION: 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.

Mouthguard and Aligner Materials

INTENDED USE: Thermoform Sheet Materials and Accessories are indicated for the fabrication of orthodontic and dental appliances.

TECHNOLOGICAL CHARACTERISTICS: All of the components found in Thermoform Materials and Accessories have been used in legally marketed devices and/or were found safe for dental use. Appropriate biocompatibility testing has been completed.

We believe that the prior use of the components of Thermoform Sheet Materials and Accessories in legally marketed devices and the biocompatibility data provided support the safety and effectiveness of Thermoform Sheet Materials and Accessories for the indicated uses.

000011

PREDICATE DEVICES:

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features the department's name encircling a symbol of three stylized human figures. The figures are connected and represent the health and well-being of individuals and families. The seal is in black and white.

NOV 1 6 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Helen Lewis Director of Corporate Compliance and Regulatory Affairs DENTSPLY International, Incorporated Susquehanna Commerce Center 221 West Philadelphia Street, Suite 60 York, Pennsylvania 17405-0872

Re: K072522

Trade/Device Name: THERMOFORM SHEET MATERIALS AND ACCESSORIES Regulation Number: Unclassified Regulation Name: None Regulatory Class: Unclassified Product Code: MOC Dated: September 6, 2007 Received: September 7, 2007

Dear Ms. Lewis:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

{2}------------------------------------------------

Page 2 - Ms. Lewis

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807,97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Mitfor Ogl
Chiu Lin, Ph.D.

Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

INDICATIONS FOR USE STATEMENT

510(k) Number (if known):

THERMOFORM SHEET MATERIALS AND ACCESSORIES Device Name:

Indications for Use:

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

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Suor Kuarez

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K072522

Regulation Number and Section

N/A