Stryker's Precision Thin Reciprocating Blade, 0.010 inch (REF 5100-437-010) is a sterile, single use cutting accessory intended to cut bone in the posterior canal wall during an Otology procedure.

Device Description

Stryker's Precision Thin Reciprocating Blade, 0.010in is a sterile, single use cutting accessory which is operated by a surgical drill (handpiece). This handpiece moves the Precision Thin Reciprocating Blade, 0.010in. in a reciprocating manner so that the blade removes bone material on the back stroke of its cut. The Precision Thin Reciprocating Blade, 0.010in. has a thickness of 0.010 inches and therefore can be used in surgical procedures where a narrow kerf width is required when cutting bone.

AI/ML Overview

The document describes a 510(k) premarket notification for a medical device called "Precision Thin Reciprocating Blade, 0.010in." This device is a sterile, single-use cutting accessory intended to cut bone in the posterior canal wall during an Otology procedure. The submission argues for its substantial equivalence to legally marketed predicate devices.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

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

The document does not explicitly present a table of "acceptance criteria" in the typical sense (e.g., a specific numerical threshold for performance metrics). Instead, it describes performance tests designed to demonstrate functionality, integrity, safety, and effectiveness. The "acceptance criteria" are implied to be satisfactory performance in these tests.

Acceptance Criteria (Implied)	Reported Device Performance
Kerf Width Requirements	Met via "Kerf Width Testing"
Durability and Longevity (Simulated Use)	Met via "Life, Simulated Use Testing"
Thermal Performance (Safety during operation)	Met via "Temperature Testing"
Functionality, Integrity, Safety, and Effectiveness for Indication	Demonstrated via simulated use in cadaveric human temporal bone and PHACON Temporal Bone Model with ENT surgeons.
Biocompatibility (Non-toxic, non-sensitizing, non-irritating)	Met via biocompatibility testing in accordance with ISO 10993-1.

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

Simulated Use (Cadaveric): 3 ENT surgeons used the device in fresh cadaveric Human temporal bone. The provenance is not explicitly stated (e.g., country of origin for the cadaveric specimens), but it is prospective (a new study conducted for this submission).
Simulated Use (Model): 8 ENT surgeons used the device with PHACON's Temporal Bone Model. This is also prospective.
Kerf Width Testing, Life Testing, Temperature Testing: The sample sizes for these specific engineering tests are not provided. The data provenance is implied to be from the manufacturer's internal testing as part of the design validation.

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

For the simulated use studies (both cadaveric and model), 3 ENT surgeons and 8 ENT surgeons, respectively, were involved. Their qualifications are stated as "ENT surgeons," indicating medical specialists in the Ear, Nose, and Throat field. The level of experience is not specified (e.g., "10 years of experience"). For these performance tests, the "ground truth" is not a diagnostic label but rather their expert assessment of the device's functionality and performance during the simulated surgical procedures.

4. Adjudication method for the test set

The document does not describe a formal adjudication method (like 2+1 or 3+1 consensus) for the simulated use studies. The role of the surgeons was to perform the simulated procedures and contribute to the validation, not necessarily to adjudicate findings. Their collective feedback and successful completion of the tasks would be considered the "acceptance."

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

There is no MRMC comparative effectiveness study mentioned in the document. This is a medical device, not an AI software. The study involves surgeons using the device, not interpreting images with or without AI assistance.

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

This question is not applicable. The device is a surgical instrument (a blade), not an algorithm or AI software. Its performance is always in a "human-in-the-loop" context as it is operated by a surgeon.

7. The type of ground truth used

For the performance section ("Section 5.8 Performance Data"):

Functional/Performance Ground Truth: The "ground truth" for the Kerf Width, Life, and Temperature testing is based on engineering specifications and acceptable limits for those parameters.
Clinical Performance Ground Truth: For the simulated use studies, the "ground truth" is the expert assessment and successful completion of the intended surgical task by qualified ENT surgeons in relevant models (cadaveric human temporal bone and PHACON model). This is a form of expert consensus/opinion on functionality and safety in a simulated environment, rather than pathology or outcomes data in a live patient, as no clinical studies were performed.

8. The sample size for the training set

This question is not applicable. The device is a physical surgical instrument, not an AI model requiring a training set.

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

This question is not applicable for the same reason as above.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

January 17, 2017

Stryker Instruments Dr. Joanna McCarthy Senior Regulatory Affairs Specialist Stryker Corporation 4100 E. Milham Ave. Kalamazoo, MI 49009

Re: K161514

Trade/Device Name: Precision Thin Reciprocating Blade, 0.010in Regulation Number: 21 CFR 874.4140 Regulation Name: Ear, Nose, and Throat Bur Regulatory Class: Class I Product Code: EQJ Dated: December 13, 2016 Received: December 15, 2016

Dear Dr. McCarthy:

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. 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.

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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); medical device reporting of medical devicerelated adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely.

Eric A. Mann -S

for Malvina Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose, and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

Indications for Use

Form Approved: OMB No.	0910-0120
Expiration Date:	January 31, 2017
See PRA Statement below.

10(k) Number (if known)	161514
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Indications for Use (Describe)

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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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FORM FDA 3881 (8/14)	Page 1 of 1
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510(k) Number: K161514

Section 5.1 Submitter

510(k) Owner: Stryker Instruments,

4100 E. Milham Avenue,

Kalamazoo,

MI 49001, USA

Phone: 269-323-7700

Fax: 269-389-5412

Contact Person: Joanna McCarthy PhD, Senior Regulatory Affairs Specialist

Date Prepared: 27th May 2016

Section 5.2 Device Information

Trade Name: Precision Thin Reciprocating Blade, 0.010in. Device Common Name: ENT Bur Classification Name: Bur, Ear, Nose and Throat

FDA Product Code	Device	Regulation Number	Class
EQJ	Bur, Ear, Nose and Throat	21 CFR 874.4140	I

Table 5-1. Classification Data for Precision Thin Reciprocating Blade, 0.010in.

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Section 5.3 Comparison against Regulation

Stryker currently markets 31 similar devices within the micro reciprocating saw blade family which are independently listed under the FDA product code EQJ. In this premarket notification all 31 devices covered under the EQJ requlation are compared to the subject device Precision Thin Reciprocating Blade, 0.010in based on their technological characteristics and general ENT indications. It is only the addition of the specific indication for the subject device Precision Thin Reciprocating Blade, 0.010in. that is being compared to the following regulation;

Regulation Description: Ear, Nose and Throat Bur Regulation Number: 21 CFR 874.4140

Section 5.4 Reference Device

Device Name:	Micro Reciprocating Saw Blade (REF MR-0580)
Type:	Reference Device
510(K) Number:	K131053- “ANSPACH XMAX, EMAX2 and EMAX2 PlusSystem with Otologic Attachment System” cleared underFDA Product Codes ERL and EQJ.
Description:	The primary comparator device (ENT Regulation 21CFR874.4140) has successfully addressed decision points 1 to 4in the 510(k) Decision Making Flowchart as per FDA)Guidance for Industry and FDA Staff, The 510(k) Program:Evaluating Substantial Equivalence in PremarketNotifications [510(k)], dated July 28, 2014.However, the technological characteristics (design andmaterial) of the Precision Thin Reciprocating Blade, 0.010inis compared to Anspach Micro Reciprocating Saw Blade,which is cleared through the 510(k) - K131053

The Anspach Effort, Inc .:

Table 5-2. Classification Data for Reference Device.

Section 5.5 Device Description

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Section 5.6 Indications for Use

Stryker's Precision Thin Reciprocating Blade, 0.010 inch (REF 5100-437-010) is a sterile, single use cutting accessory intended to cut bone in the posterior canal wall during an Otology procedure.

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Section 5.7 Comparison of Technological Characteristics against Regulation 21 CFR 874.4140 (ENT Burs) and reference device.

Feature	Comparator ENT Bur (21 CFR 874.4140)	Subject Device: Precision Thin Reciprocating Blade,0.010in.	Justification
Product Class	Class I	Class I	Identical
Regulation	21 CFR 874.4140 - Bur, ear, nose and throat	21 CFR 874.4140 - Bur, ear, nose and throat	Identical
FDA Product Code	EQJ - Bur Ear, Nose and Throat	EQJ - Bur Ear, Nose and Throat	Identical
Intended Function	Intended to cut bone.	Intended to cut bone.	Identical
Patient Population	General	General	Identical
Indications For Use	An ear, nose, and throat bur is a device consistingof an interchangeable drill bit that is intended foruse in an ear, nose, and throat electric orpneumatic surgical drill (874.4250) for incising orremoving bone in the ear, nose, or throat area.The bur consists of a carbide cutting tip on ametal shank or a coating of diamond on a metalshank. The device is used in mastoid surgery,frontal sinus surgery, and surgery of the facialnerves.	Stryker's Precision Thin Reciprocating Blade, 0.010 inch(REF 5100-437-010) is a sterile, single use cutting accessoryintended to cut bone in the posterior canal wall during anOtology procedure.	Similar
Contraindications	None known	None known	Identical

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Feature	Comparator ENT Bur (21 CFR 874.4140)	Subject Device: Precision Thin ReciprocatingBlade, 0.010in.	Justification
Conditions for Use	Single Use	Single Use	Identical
Principle ofoperation/Mechanism ofAction	Legally marketed micro reciprocating blades listedunder FDA product code EQJ (ENT Bur) are used inconjunction with an electric reciprocating handpiece(CORETM Reciprocating Saws), a CORETM Consoleand a footswitch or handswitch. When the system isassembled, the surgeon controls the footswitch; thismodifies the electrical signal to the motor, controllingthe speed of the cutting accessory.	Stryker's Precision Thin Reciprocating Blade, 0.010in.is used in conjunction with an electric motor (CORETMReciprocating Saws), a CORETM Console and afootswitch. When the system is assembled, thesurgeon controls the footswitch or handswitch; thismodifies the electrical signal to the motor, controllingthe speed of the cutting accessory.	Identical
Motor power supply	Powered by Electrical energy.	Electrical energy.	Identical
For use with a surgicaldrill (handpiece) per 21CFR 874.4140	Legally marketed micro reciprocating blades - listedunder FDA product code EQJ (ENT Bur) are used withthe CORETM Reciprocating Saws.	Used with the CORETM Reciprocating Saws asindicated on the product label.	Identical
Source of Activation	Footswitch and Handswitch.	Footswitch and Handswitch.	Identical
Feature	Subject Device: Precision ThinReciprocating Blade, 0.010in.	Device:AnspachReferenceMicro Reciprocating Saw Blade(MR-0580)	Justification
Cutting AccessoryLocking Mechanism	PlugBladelockingTipandmechanism.	Chuck is tightened around shank.	Similar
Shank of the CuttingAccessory	0.125 - 0.124 inches	0.124 inches	Identical
Cutting AccessoryGeometry	Cut Edge: 0.766 in. (19.5mm)Blade Height: 0.137 in.Cut Thickness: 0.010 in.	Cut Edge: 21.35 mm (0.84 in)Cut Thickness: 0.25 mm (0.010 in)	Similar
Cutting AccessoryLength of exposure	1.42 in.	1.37 in.	Similar
Patient ContactingMaterial	Blade Arbor - Stainless Steel	Blade Arbor - Stainless Steel.	Similar
	Blade - Stainless SteelVacuum Brazing Paste - NICROBRAZ51 S ALLOY.	Blade - Stainless Steel.Vacuum Brazing Paste - Unknown.
Sterilization	Supplied sterile, gamma irradiated.	Supplied sterile, gamma irradiated.	Identical
Sterility AssuranceLevel (SAL)	SAL of 10-6	Minimum SAL of 10-6	Identical
Shelf-Life	5 Years	Unknown	Similar
PackagingConfiguration	Individually packaged in foil pouch withPolybag.	Tyvek / Film pouch with the internalpackaging being a PETG clamshellblister.	Similar

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Table 5-3: Comparative Device Justification Table.

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Section 5.8 Performance Data

The following verification tests were performed which demonstrates that the device meets the performance requirements under its indications for use conditions.

Kerf Width Testing ●
Life, Simulated Use Testing ●
Temperature Testing ●

Simulated use of a canal wall reconstruction was completed with 3 ENT surgeons for the specific indication in fresh cadaveric Human temporal bone. To supplement this cadaveric study design validation was also completed for the specific indication using PHACON's Temporal Bone Model with 8 ENT surgeons. This model was selected as a suitable cut media for design validation following a technical evaluation along with expert medical opinion. Collectively, the results of these performance tests demonstrate the functionality, integrity, safety and effectiveness of Stryker's Precision Thin Reciprocating Blade, 0.010in. for its intended use and support a determination of substantial equivalence to the regulation 21 CFR 874.4140 (ENT bur).

5.8.1 Biocompatibility Testing

The subject device Precision Thin Reciprocating Blade, 0.010in. is classified as external communicating device: tissue/bone/dentin with limited patient contact (< 24 hours).

The Biocompatibility evaluation was conducted in accordance with;

AAMI/ANSI/ISO ISO 10993-1:2009/(R)2013, Biological evaluation of medical . devices - Part 1: Evaluation and testing within a risk management process, and Guidance for Industry and FDA Staff.
Draft Guidance for Industry and FDA Staff, Use of International Standard ISO-● 10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing," (Date April 23, 2013).
FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-● 10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing," (Dated May 1, 1995).

Results of testing validate that the subject device is non-sensitizing, non-irritating and non-toxic (cytotoxic and systemic).

5.8.2 Clinical Studies

No clinical studies were performed to support substantial equivalence.

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Section 5.9 Conclusions

The subject device Precision Thin Reciprocating Blade, 0.010in. is substantially equivalent in intended use, operating principle, fundamental technology, overall design and materials to ENT Burs as described in 21 CFR 874.4140.

Risk analysis for the subject device due to the addition of the specific indication reveals no new issues regarding safety or effectiveness.

Regulation Number and Section

§ 874.4140 Ear, nose, and throat bur.

(a)
Identification. An ear, nose, and throat bur is a device consisting of an interchangeable drill bit that is intended for use in an ear, nose, and throat electric or pneumatic surgical drill (§ 874.4250) for incising or removing bone in the ear, nose, or throat area. The bur consists of a carbide cutting tip on a metal shank or a coating of diamond on a metal shank. The device is used in mastoid surgery, frontal sinus surgery, and surgery of the facial nerves.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 874.9.