The proposed Surgical Drills are reusable invasive surgical instruments designed to prepare an osteotomy for a dental implant procedure. The base material of the drill is made of surgical grade stainless steel. The bone cutting portion of the drill may be coated with diamond like coating (DLC) or laser marked to indicate the depth marks. The Surgical Drills consist of straight drills, and cortical drills. Straight drills are available in diameters 3.2 to 5.1 mm. Step drills are available in diameters 2.3/2.0 to 5.4/4.8 mm. Cortical drills are available in diameters 3.2 to 7.0 mm. The straight and step drills have osteotomy depth indicators and are intended to make osteotomies for Implant Direct endosseous dental implants.

AI/ML Overview

The provided document is a 510(k) summary for a medical device called "Surgical Drills." It is a regulatory submission to the FDA for market clearance, demonstrating substantial equivalence to a predicate device, not an AI/ML device. Therefore, the questions related to AI/ML specific criteria, ground truth, experts, and training/test sets are not applicable here.

However, I can extract and present the acceptance criteria and the studies performed to demonstrate the device's conformance, as detailed in the document.

Acceptance Criteria and Device Performance for Surgical Drills (Non-AI/ML Device)

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria/Test	Reported Device Performance
Biocompatibility	Tested in accordance with ISO 10993-1, ISO 10993-5, ISO 10993-10, and ISO 10993-11.	Successfully tested against the specified ISO standards for biocompatibility.
Performance Testing (Drilling)	No significant changes in axial drilling thrust forces after repeated use.	Results indicate no significant changes in axial drilling thrust forces in all three groups (subject device and predicate device) after repeated use and processing.
Visual Assessment (Cutting Surfaces)	Cutting surfaces assessed visually using SEM images.	(Implicitly, the visual assessment supported the performance, as no negative findings were reported, and the device was deemed substantially equivalent.)
Corrosion Testing	No sign of corrosion after processing according to Instructions for Use (ASTM F1089).	All tested Surgical Drills showed no sign of corrosion without magnification after being boiled for 30 minutes and allowed to cool and air dry.
Cleaning Validation	Cleaning efficiency demonstrated in accordance with AAMI TIR30 and AAMI TIR12, meeting acceptable levels for residual soil markers (TOC and protein).	Cleaning efficiency successfully conducted. Extracts analyzed for total organic carbon (TOC) and protein as residual soil markers, implying acceptable levels were achieved.
Sterilization Validation	Sterilization demonstrated with a Sterility Assurance Level (SAL) of 10^-6 in accordance with ISO 17665-1 (overkill approach).	Sterilization validation successfully conducted to demonstrate an SAL of 10^-6 using the overkill approach as per ISO 17665-1.
Distribution Testing	Passed QA inspection before and after simulated shipping (ASTM D4169-16) with no impact on the device.	All drills subjected to the distribution testing passed the QA inspection prior to and after the distribution simulation, indicating no impact from distribution.

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

The document does not explicitly state numerical sample sizes for each test in the way you would typically see for an AI/ML study. Instead, it refers to "worst-case drills" for corrosion and distribution testing, and "all three groups" for performance testing (referring to the subject device and predicate device, likely with multiple samples per group).

Provenance: This is a regulatory submission for a medical device. The data provenance is from the manufacturing company, Implant Direct Sybron Manufacturing, LLC, specifically from their non-clinical testing performed to support the 510(k) submission. These are prospective tests conducted by the manufacturer.

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

Not applicable. This is a physical medical device (surgical drills), not an AI/ML system that requires expert-established ground truth for classification or prediction. The "ground truth" for these tests is based on objective measurements and established industry standards (e.g., ISO, ASTM, AAMI).

4. Adjudication Method for the Test Set

Not applicable, as this is not an AI/ML study requiring expert adjudication of results. The results are based on objective physical and chemical testing.

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

Not applicable. This is not an AI/ML device, and therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed.

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

Not applicable. This is a physical surgical tool, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical tests is based on:

International Standards: e.g., ISO 10993 series for biocompatibility, ISO 17665-1 for sterilization.
Industry Standards: e.g., ASTM F1089 for corrosion testing, AAMI TIR30 and TIR12 for cleaning validation, ASTM D4169-16 for distribution testing.
Objective Measurements: e.g., axial drilling force measurements, visual/SEM assessment for performance, TOC and protein levels for cleaning, absence of visible corrosion.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI/ML model that requires a training set.

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

Not applicable. There is no training set for a physical surgical device.

Summary

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June 30, 2020

Implant Direct Sybron Manufacturing, LLC Reina Choi Regulatory Affairs Manager 3050 East Hillcrest Drive Thousand Oaks, California 91362

Re: K200265

Trade/Device Name: Surgical Drills Regulation Number: 21 CFR 872.4120 Regulation Name: Bone Cutting Instrument and Accessories Regulatory Class: Class II Product Code: DZI Dated: March 31, 2020 Received: April 1, 2020

Dear Reina Choi:

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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 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 (OS) 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,

for Srinivas "Nandu" Nandkumar, Ph.D. Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K200265

Device Name Surgical Drills

Indications for Use (Describe)

The Surgical Drills are intended to cut into maxilla or mandible to create an osteotomy for endosseous dental implant placement.

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

Prescription Use (Part 21 CFR 801 Subpart D)

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

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FOR FDA USE ONLY

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510(k) Summary

I. SUBMITTER

Implant Direct Sybron Manufacturing, LLC 3050 East Hillcrest Drive Thousand Oaks, CA 91362

Contact Person: Reina Choi, Requlatory Affairs Manager E-mail: reina.choi@implantdirect.com Phone: (818) 444-3306

Date Prepared: March 31, 2020

II. DEVICE

Name of Device: Surgical Drills Common or Usual Name: Endosseous Dental Implant Drills Classification Name: Bone cutting instrument and accessories (21 CFR 872.4120) Requlatory Class: II Product Code: DZI

III.PREDICATE DEVICE

Predicate (primary) Straumann Guided Instruments (K082532)

Predicate (reference) Swiss Plant Dental System (Surgical Drills) (K081396)

IV. DEVICE DESCRIPTION

The Surgical Drills consist of straight drills, and cortical drills. Straight drills are available in diameters 3.2 to 5.1 mm. Step drills are available in diameters 2.3/2.0 to 5.4/4.8 mm. Cortical drills are available in diameters 3.2 to 7.0 mm. The straight and step drills have osteotomy depth indicators and are intended to make osteotomies for Implant Direct endosseous dental implants.

V. INDICATIONS FOR USE

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The Surgical Drills are intended to cut into maxilla or mandible to create an osteotomy for endosseous dental implant placement.

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VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS

Technologicalcharacteristics		Subject Device	Predicate (primary)	Predicate (reference)	Comparison
		Surgical Drills	Straumann GuidedInstruments (K082532)	Swiss Plan Dental ImplantSystem Surgical Drills(K081396)
Manufacturer		Implant Direct SybronManufacturing, LLC	Institute Straumann AG	Implant Direct SybronManufacturing, LLC	Same asreferencepredicate
Design Characteristic	General design	Multiple cutting edges andflutes to create an osteotomy.Shank to fit with hand piece	Multiple cutting edges andflutes to create an osteotomy.Shank to fit with hand piece	Multiple cutting edges andflutes to create an osteotomy.Shank to fit with hand piece	Same
	Base material	Stainless steel	Stainless steel	Stainless steel	Same
	Coating	- No coating- DLC (diamond like coating)	No coating	No coating	Addition of DLC
	Cutting flutes	2 and 4 flutes	2 flutes	2 and 4 flutes	Same asreferencepredicate
	Handpiececonnection shanktype	ISO-1797-1	ISO-1797-1	ISO-1797-1	Same
	Irrigation	External only	External only	External only	Same
	Packaging	Plastic vial, supported by aplastic retainer	Loose inside a blister pack	Plastic vial, supported by aplastic retainer	Same asreferencepredicate
	Sterility	Non-sterile	Non-sterile	Non-sterile	Same
	Reusable orsingle use	Reusable	Reusable	Reusable	Same
Intended use		Bone cutting instruments areintended for use during oralsurgery to drill or cut into theupper or lower jaw and may beused to prepare bone to insert	Bone cutting instruments areintended for use during oralsurgery to drill or cut into theupper or lower jaw and may beused to prepare bone to insert	surgical drills used for thepreparation of the surgical siteprior to implantation	Same as primarypredicate
Technologicalcharacteristics	Subject Device	Predicate (primary)	Predicate (reference)	Comparison
	Surgical Drills	Straumann GuidedInstruments (K082532)	Swiss Plan Dental ImplantSystem Surgical Drills(K081396)
	a wire, pin or screw.	a wire, pin or screw.
Indication for Use	The Surgical Drills areintended to cut into maxilla ormandible to create anosteotomy for endosseousdental implant placement.	Bone cutting instruments areintended for use during oralsurgery to drill or cut into theupper or lower jaw and may beused to prepare bone to inserta wire, pin or screw.	The SwissPlant Dental Implantsystem consists of two-pieceimplants for one or two-stagesurgical procedures that areintended for use in partially orfully edentulous mandibles andmaxillae, in support of single -or multiple-unit restorationsincluding: cement retained,screw retained or overdenturerestorations and in terminal orimmediate abutment supportfor fixed bridgework. TheSwissPlant dental implants areintended for immediateplacement and function onsingle tooth and/or multipletooth applications recognizinginitial implant stability andappropriate occlusal loading,to restore normal masticatoryfunction.	Differences do notaffect substantialequivalence.Refer to changeanalysis followingthis table.

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Analysis of Differences Between Subject Device and Predicate

The Surgical Drills are made from the same materials and have the same general design and handpiece connection as both the primary and reference predicates. The Surgical Drills are delivered non-sterile and are intended for multiple use the same as the primary and reference predicates. The Surgical Drills differ from the predicates in the use of a DLC coating. The addition of the DLC coating was validated through the use of biocompatibility, corrosion, and functional wear testing.

The Surgical Drills and primary predicate have the same intended use. Comparison of subject device and predicate device indications for use:

The name of the device is changed from bone cutting instruments to Surgical l Drills.
-Creating an osteotomy for the purpose of dental implant placement is a type of oral surgery.
-The subject Surgical Drills are used in the maxilla or mandible which is the same as the upper or lower jaw.
-The subject Surgical Drills are used to create osteotomy which is a preparation of the bone.
The subject Surgical Drills are used to create an osteotomy for the purpose of placing a dental implant. A dental implant is a type of screw.

The above comparison details how the differences between the subject device indications for use and the predicate (K082532) device indications for use do not affect substantial equivalence.

Summary:

The design differences between the subject and predicate device was evaluated through biocompatibility, corrosion, and comparative wear testing. The documentation submitted in the premarket notification demonstrates that the Surgical Drills are substantially equivalent to the predicate device.

VII. PERFORMANCE DATA

Summary of Non-Clinical Testing:

Biocompatibility

The Surgical Drills were successfully tested for biocompatibility testing in accordance with ISO 10993-1, ISO 10993-5, ISO 10993-10, and ISO 10993-11. The results of the testing were used to address questions related to substantial equivalence based on differences in manufacturing processes (addition of DLC coating) between the subject and predicate device (K082532).

Performance testing

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Simulated osteotomies were created in simulated bone using the subject device and predicate device (K082532). Drilling axial force was recorded and cutting surfaces were assessed visually using SEM images. Results indicate no significant changes in axial drilling thrust forces in all three groups after repeated use and processing. The results of the testing were used to address questions related to substantial equivalence based on differences in device design between the subject and predicate device (K082532).

Corrosion testing

Corrosion testing (ASTM F1089) was successfully undertaken to ensure that Surgical Drills when processed in accordance with the Instructions for Use will not corrode. Worst-case drills were boiled for 30 minutes and allowed to cool and air dry. All tested Surgical Drills showed no sign of corrosion without magnification. The results of the testing were used to address questions related to substantial equivalence based on differences in manufacturing processes between the subject and predicate device (K082532).

Cleaning Validation

Cleaning efficiency was successfully conducted in accordance with AAMI TIR30 and AAMI TIR12. The study used a clinically-relevant, simulated soil, extended drying time between soiling and processing, and minimal processing parameters for the cleaning process. Extracts of proposed devices were analyzed for total organic carbon (TOC) and protein as residual soil markers. The results of the testing were used to address questions related to substantial equivalence based on differences in product use between the subject and predicate device (K082532).

Sterilization

Sterilization validation was successfully conducted in accordance with ISO 17665-1. The overkill approach as per ISO 17665-1 was used to demonstrate an SAL of 10-°. The results of the testing were used to address questions related to substantial equivalence based on differences in product design between the subject and predicate device (K082532).

Distribution

The Surgical Drills were subjected to distribution testing to determine any impact distribution would have on the subject device. Worst-case drills were subjected to simulated shipping following ASTM D4169-16. Tests included handling, stacking, loose load vibration, vehicle vibration, concentrated impact, and an additional handling test. All drills subjected to the distribution testing passed the QA inspection prior to and after the distribution simulation. The results of the testing were used to address questions related to substantial equivalence based on differences in product packaging between the subject and predicate device (K082532)

VIII. CONCLUSIONS

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The Surgical Drills were evaluated for substantial equivalence using standard and/or comparative testing. Based on technological characteristics and non-clinical test data included in this submission, the Surgical Drills have been shown to be substantially equivalent to the Straumann Guided Instruments (K082532).

Regulation Number and Section

§ 872.4120 Bone cutting instrument and accessories.

(a)
Identification. A bone cutting instrument and accessories is a metal device intended for use in reconstructive oral surgery to drill or cut into the upper or lower jaw and may be used to prepare bone to insert a wire, pin, or screw. The device includes the manual bone drill and wire driver, powered bone drill, rotary bone cutting handpiece, and AC-powered bone saw.(b)
Classification. Class II.