The proposed Surgical Tray is a reusable perforated container that is intended to store and organize the instruments needed before, during and after implant surgery as well as holding instruments during sterilization.

The Surgical Tray is a container composed of three main components: a lid, a base and an overlay, all made of polyphenylsulfone (Radel R5000). The overlay has co-molded silicone tooling supports. The base has silicone rubber grommets to hold instruments. The base and overlay are custom printed to indicate the surgical workflow and the position of the instruments within the tray for the different product lines.

The proposed Surgical Tray is available in one size with outer dimensions of 7.3 x 5.5 x 2.4 inches and offered in 2 inner tray configurations with varied instrument loads, see Table 5.1.

Table 5.1- Surgical Tray configurations
Product name	Model number	Max no of instruments	Max load (g)	Vent to volume ratio (in-1)
OmniTaper Surgical Tray	68015282	51	513.7	0.033
PrimeTaper Surgical Tray	68015321	45	513.7	0.033

AI/ML Overview

This document describes the premarket notification (510(k)) for Dentsply Sirona Inc.'s "Surgical Trays" (K212281). The acceptance criteria and the study proving the device meets these criteria are detailed in section 5.7 "Non-Clinical Performance Data" and related subsections.

Here's a breakdown of the requested information:

1. A table of acceptance criteria and the reported device performance

Test Name	Acceptance Criteria	Reported Device Performance
Sterilization cycle validation	Sterility assurance level (SAL) of < 10^-6	Pass
Drying validation	No visible moisture≤ 3% weight gain of packaging and absorbable materials	Pass
Reprocessing of trays (cleaning and sterilization)	No signs of flush rust, rust corrosion, deformation or damage	Pass
Simulated use of trays	- No significant wear of the holders- The instruments must have safe seating in the holders after the shake test	Pass
Cytotoxicity	Inhibition of cell proliferation must be at or below 30% compared to untreated cultures	Pass

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

The document does not explicitly state the numerical sample sizes for each test in the non-clinical performance data section. It indicates that the "tested Surgical Tray represents the worst-case validated load of 513.7g." This implies at least one tray was tested for each condition, likely with replicates to satisfy validation requirements, though specific numbers are not provided.

Data Provenance: The studies are described as "Non-clinical testing data submitted, referenced, or relied upon." Given this is a 510(k) submission by Dentsply Sirona Inc., the data is internally generated by the manufacturer or by third-party labs on their behalf. The studies were performed to validate the device's performance characteristics. It's prospective in nature, as the testing was conducted specifically to gather data for regulatory submission. The country of origin of the data is not specified, but the manufacturer is based in York, Pennsylvania, USA.

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

The tests described are performance validations based on established standards and internal test methods. They do not involve "experts" establishing a clinical "ground truth" in the way an AI medical device for diagnosis would. Instead, the "ground truth" is determined by the objective and quantifiable outcomes of the physical and chemical tests (e.g., measuring SAL, visible moisture, weight gain, physical damage, cytotoxicity). The qualification of the personnel conducting these tests would be standard for laboratory and engineering testing, but specific details are not provided as they are not relevant for this type of device validation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This concept (adjudication method for test sets) is primarily relevant for studies involving human interpretation of data, such as images for AI diagnostic devices. For the physical and chemical performance tests of a surgical tray, no human adjudication of ambiguous results is necessary. The acceptance criteria are objective. Therefore, the method is None in the context of expert consensus/adjudication.

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

No, an MRMC comparative effectiveness study was not done. This type of study is specifically for evaluating the effectiveness of AI-assisted diagnostic or interpretative devices in a clinical setting with human readers. The "Surgical Trays" device is a reusable surgical instrument container, not an AI or diagnostic device, so an MRMC study is not applicable.

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. Again, this type of study is relevant for AI algorithms. The device in question is a physical medical device. The "performance" here refers to its physical characteristics and ability to be sterilized and reused, not an algorithm's output.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this device's validation is based on objective, quantifiable physical, chemical, and microbiological measurements against predefined acceptance criteria from recognized standards (e.g., ANSI/AAMI/ISO 17665-1, ISO 10993-5, AAMI TIR12) and internal test methods. For example:

Sterilization validation: Ground truth is the achievement of an SAL of < 10^-6, verified by biological indicators.
Drying validation: Ground truth is the absence of visible moisture and a weight gain of ≤ 3%.
Reprocessing/Simulated use: Ground truth is the absence of visual damage, deformation, rust, or compromised instrument seating.
Cytotoxicity: Ground truth is cell proliferation inhibition at or below 30% compared to controls.

8. The sample size for the training set

Not applicable. This device is a physical medical instrument tray, not a machine learning model or AI device. Therefore, there is no "training set" in the context of data used to train an algorithm.

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

Not applicable. As stated above, there is no training set for this type of device.

Summary

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March 4, 2022

Dentsply Sirona Inc. Courtney Clark Sr. Director, Corporate Regulatory Affairs 221 West Philadelphia Street, Suite 60W York. Pennsylvania 17401

Re: K212281

Trade/Device Name: Surgical Trays Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: KCT Dated: February 1, 2022 Received: February 2, 2022

Dear Courtney Clark:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Clarence W. Murray, III, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K212281

Device Name Surgical Trays

Indications for Use (Describe)

The Surgical Trays are intended for organizing, sterilizing and storing of instruments.

The Surgical Trays are not intended to maintain sterility and are to be used in conjunction with a legally marketed, validated sterilization pouch.

Sterilization parameters:

Pre-Vacuum Steam at 132 °C (270 °F) for 4 min with a 20 minutes dry time

The tested Surgical Tray represents the worst-case validated load of 513.7g. Do not exceed the following maximum load:

Product name	ArticleNumber	Max Load (g)	Vent to VolumeRatio (in-1)
OmniTaper Surgical Tray	68015282	513.7	0.033
PrimeTaper Surgical Tray	68015321	513.7	0.033

Type of Use (Select one or both, as applicable)

|--|--|

| X | Prescription Use (Part 21 CFR 801 Subpart D)

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

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Dentsply Sirona Inc. 221 West Philadelphia Street, Suite 60W York, PA 17401

Image /page/3/Picture/1 description: The image shows the logo for Dentsply Sirona. The logo consists of a stylized leaf-like shape on the left, followed by the text "Dentsply" on the top line and "Sirona" on the bottom line. The text is in a simple, sans-serif font and is aligned to the right of the leaf-like shape.

510(k) SUMMARY Surgical Trays K212281

5.1 Submitter Information:

Dentsply Sirona Inc. 221 West Philadelphia Street Suite 60W York, PA 17401

Courtney Clark Contact Person: Telephone Number: 248-895-4379 Fax Number: 717-849-4343 Email: corporate-ra@dentsplysirona.com

Date Prepared: March 4, 2022

5.2 Device Name:

●	Proprietary Name:	Surgical Trays
●	Classification Name:	Sterilization Wrap Containers, Trays, Cassettes & OtherAccessories
●	CFR Number:	21 CFR 880.6850
●	Device Class:	Class II
●	Product Code:	KCT

5.3 Predicate Device:

The predicate device identified is the following:

Predicate Device Name	510(k)	Company Name
Straumann BLX Surgical Cassette	K180791	Institut Straumann AG

5.4 Device Description:

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The proposed Surgical Tray is available in one size with outer dimensions of 7.3 x 5.5 x 2.4 inches and offered in 2 inner tray configurations with varied instrument loads, see Table 5.1.

Table 5.1- Surgical Tray configurations
Product name	Model number	Max no of instruments	Max load (g)	Vent to volume ratio (in-1)
OmniTaper Surgical Tray	68015282	51	513.7	0.033
PrimeTaper Surgical Tray	68015321	45	513.7	0.033

5.5 Indications for Use

The Surgical Trays are intended for organizing, sterilizing and storing of instruments.

The Surgical Trays are not intended to maintain sterility and are to be used in conjunction with a legally marketed, validated sterilization pouch.

Sterilization parameters:

Pre-vacuum Steam at 132°C (270°F) for 4 minutes with a 20 minutes dry time. The tested Surgical Tray represents the worst case validated load of 513.7g.

Product name	Article number	Max load (g)	Vent to volumeratio (in-1)
OmniTaper Surgical Tray	68015282	513.7	0.033
PrimeTaper Surgical Tray	68015321	513.7	0.033

5.6 Comparison of Technological Characteristics

An overview of the similarities and differences between the proposed and predicate device is given in Table 5.2. The proposed Surgical Tray and the predicate device, Straumann BLX Surgical Cassette (K180791), have the same intended use, same sterilization method and parameters, are made of the same materials and have a similar design. The vent to volume ratio for the proposed Surgical Tray is 0.033 in- while the predicate vent to volume ratio is 0.054 in 1. The proposed Surgical Tray has a lower vent to volume ratio.

When compared to the predicate device, the proposed Surgical Tray can hold more instruments and has a larger maximum sterilization load. The maximum sterilization load for the proposed Surgical Tray is 513.7g, while the predicate's maximum sterilization load is 300g. Sterilization was performed to support the sterilization load of the proposed Surgical Tray and has been validated to SAL of 10°.

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Table 5.2: Similarities and Differences between the proposed and predicate devices
Elements	Proposed DeviceSurgical Tray	Predicate DeviceStraumann BLX SurgicalCassette (K180791)	Comparison
Manufacturer	Sirona Dental Systems GmbH	Institut Straumann AG	Different manufacturer
Indications for use	The Surgical Trays are intended for organizing, sterilizing andstoring of instruments.The Surgical Tray is not intended to maintain sterility and are to beused in conjunction with a legally marketed, validated sterilizationpouch.Sterilization parameters:Pre-vacuum Steam at 132°C (270°F) for 4 minutes with a 20minutes dry time.The tested Surgical Tray represents the worst case validated load of513.7g.Do not exceed the following maximum load:Product name Article number Max load(g) Vent to volume ratio (in-1) OmniTaperSurgical Tray 68015282 513.7 0.033 PrimeTaperSurgical Tray 68015321 513.7 0.033			The Straumann BLX Cassetteis used in healthcare facilities toorganize, enclose,cleaning, sterilize, transport,and store medical devicesbetween surgical uses. TheBLX Cassette is not intended tomaintain sterility; it is intendedto be used in conjunction witha legally marketed, validatedsterilization wrap.The BLX Cassette has beenvalidated for a maximum loadof 300 grams, includingcassette and instruments.Sterilization parameters:Pre-vacuum steam: 132°C(270° F) for 4 minutes with 20minutes drying time	Similar indications but theproposed Surgical Tray is notindicated for cleaning device.The proposed device is intendedto be used with a validatedsterilization pouch.
Product code	KCT	KCT	Same

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Table 5.2: Similarities and Differences between the proposed and predicate devices
Elements	Proposed DeviceSurgical Tray	Predicate DeviceStraumann BLX SurgicalCassette (K180791)	Comparison
General Design	Plastic tray with locking lid. Co-molded silicone andsilicone grommet supports	Plastic tray and lid	Similar, both trays are designedto hold instruments for implantsurgery and sterilization andconsist of a plastic box with aninsert adapted for the specificsurgical procedure. The insertshave silicone holders forinstruments.
Dimensions	7.3 in x 5.5 in x 2.4 in	5.6 in x 3.9 in x 2.4 in	Similar
Material	Base – Radel 5000Lid – Radel 5000Overlay – Radel 5000Tooling support - Silicone	Radel 5000Silicone	Same
Air permeance	Yes, allow moist heat (steam) penetration to achieve sterilization	Yes, allow moist heat (steam)penetration to achievesterilization	Same
Mass ofmaximumsterilization load	OmniTaper Surgical TrayPrimeTaper Surgical Tray	300g	Different
	513.7g513.7g
Vent to volumeratio	OmniTaper Surgical TrayPrimeTaper Surgical Tray	$0.054\ in^{-1}$	Different
	$0.033\ in^{-1}$$0.033\ in^{-1}$
Sterility	Non-sterile	Non-sterile	Same
Sterilization Method	Moist heat (steam)	Moist heat (steam)	Same
Sterilization Parameters	Pre vacuum,At 132°C for 4 minutes with a 20 minutes dry time	Pre vacuumAt 132°C for 4 minutes with a20 minutes dry time	Same
Sterile barrier	FDA cleared sterilization pouch	FDA cleared sterilization pouch	Same
Reusable	Yes	Yes	Same

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5.7 Non-Clinical Performance Data

Non-clinical testing data submitted, referenced, or relied upon, including acceptance criteria and set specifications in test methodology and standards, are summarized below:

Test Name	Test Methodology	Purpose	Acceptance Criteria	Results
Sterilizationcycle validation	• ANSI/AAMI/ISO17665-1:2006/(R)2013• ISO 17665-2:2009	To validate that the trayscan be sterilized viamoist-heat sterilization asspecified on labeling(132° C for 4 minutes)	Sterility assurance level(SAL) of < 10-6	Pass
Dryingvalidation	• AAMI TIR12: 2020• ANSI/AAMI/ISO17665-2:2009	To validate that the trayscan be dried as specifiedon labeling (drying timeof 20 minutes)	No visible moisture≤ 3% weight gain ofpackaging andabsorbable materials	Pass
Reprocessing oftrays (cleaningand sterilization)	Internal Test Method	To confirm that the trayscan be reprocessed asspecified on labeling (upto 200 reprocessing cycleswithout any signs ofabrasion)	No signs of flush rust,rust corrosion,deformation or damage	Pass
Simulated use oftrays	Internal Test Method	To confirm that the trayscan withstand simulateduse of up to 1,500repeated reposition cycles	-No significant wear ofthe holders-The instruments musthave safe seating in theholders after the shaketest	Pass
Cytotoxicity	ISO 10993-5:2009	To confirm that nocytotoxic substances arereleased afterreprocessing of the trays	Inhibition of cellproliferation must be ator below 30% comparedto untreated cultures	Pass

Sterilization validation

The subject device is a multiple-use device provided non-sterile which needs to be end user sterilized. The cleaning and sterilization procedures follow the FDA guidance document, "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling Guidance for Industry and Food and Drug Administration Staff, Document issued on: March 17, 2015".

The sterilization parameters were validated to a sterility assurance level (SAL) of 10th using the biological indicator overkill method according to ANSI/AAMI/ISO 17665-1:2006/(R)2013 (Sterilization of health care products -- Moist heat -- Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices) and ISO 17665-2:2009 (Sterilization of health care products - Moist heat - Part 2: Guidance on the application of ANSI/AAMI/ISO 17665-1).

In addition to the SAL validation, dry times were validated to meet the requirements of the guidance outlined in AAMI TIR12:2020 (Designing, testing, and labeling reusable medical devices for reprocessing in health care facilities: A guide for manufacturers), as required, and ANSI/AAMI/ISO 17665-2:2009.

Usability wear study

Non-clinical performance and wear testing of the proposed Surgical Tray was performed through

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simulated use testing. The Surgical Tray was filled with instruments and subjected to 200 cleaning cycles and 200 sterilization rounds.

In addition, simulated use testing was performed to simulate 1,500 repeated repositioning of relevant instruments in the holder, after which the trays were subjected to a shake test.

There were no signs of damage or alter testing and the instruments were safely seated in the holders. The automated cleaning and sterilization method were validated and demonstrated the effectiveness of the recommended process as stated in the Instructions for Use.

Biocompatibility

Biocompatibility evaluation assessment for the Surgical Tray was performed according to ISO 10993-1:2018 (Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process).

The biocompatibility studies conducted were in vitro cytotoxicity according to ISO 10993-5:2009 (Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity). The test results confirm that the Surgical Trays are biocompatible for their intended use.

5.8 Conclusion

The conclusions drawn from the non-clinical test data support that the proposed Surgical Travs are as safe, as effective and perform as well as or better than the legally marketed predicate device Straumann BLX Surgical Cassette (K180791).

Regulation Number and Section

§ 880.6850 Sterilization wrap.

(a)
Identification. A sterilization wrap (pack, sterilization wrapper, bag, or accessories, is a device intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.(b)
Classification. Class II (performance standards).