The Pneumatic Drill System is a pneumatically operated surgical instrument system. The pneumatic motor provides power to operate removable rotating surgical cutting tools and their accessories intended for use in neurosurgery, including craniotomy and spinal surgery; as well as Ear Nose and Throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial and sternotomy surgeries.

Additionally, the Pneumatic Drill System is incision/cutting, removal, drilling, and sawing of soft and hard tissue and bone, and biomaterials during open and minimally invasive spine procedures, which may incorporate application of various surgical techniques during the following lumbar spinal procedures:

Lumbar Microdiscectomy
Lumbar Stenosis Decompression
Posterior Lumbar Interbody Fusion (PLIF)
Transforaminal Lumbar Interbody Fusion (TLIF)
Anterior Lumbar Interbody Fusion (ALIF)
Direct Lateral Interbody Fusion (DLIF)

Device Description

The Pneumatic Drill System is a pneumatically powered high-speed drill system consisting of a choice of various Pneumatic Handpieces (comprising of a High Pressure and Exhaust Hose, and Handpiece) equipped with a foot or finger controller, Pneumatic Foot Control Unit, Surgical Dissecting Tools, System Accessories, and where applicable, Attachments to support various Surgical Dissecting Tools, and System Accessories.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a surgical drill system. This type of submission is for establishing substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific acceptance criteria through a study with quantifiable performance metrics. Therefore, many of the requested categories are not applicable or cannot be extracted directly from this document.

However, I can provide information based on the typical content of a 510(k) summary regarding performance claims and testing.

Here's an analysis of the provided information relative to your request:

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

This document does not provide a table of acceptance criteria with corresponding performance metrics in the way one might expect for an AI/CAD diagnostic device. The "performance" described is largely functional and safety-based, focused on equivalence to predicate devices and suitability for expanded indications.

Acceptance Criteria Category	Reported Device Performance / Assessment
Functional Suitability for Expanded Indications	The cadaver validation study and review of supporting literature supports the use of the Medtronic Drill System in Lumbar Microdiscectomy (LM), Posterior Lumbar Interbody Fusion (PLIF), Transforaminal Lumbar Interbody Fusion (TLIF), Lumbar Stenosis Decompression (LSD), Anterior Lumbar Interbody Fusion (ALIF), and Direct Lateral Interbody Fusion (DLIF) spinal surgical procedures, as well as any variations of these procedures.
Acceptability for Intended Use (Cadaveric)	The Medtronic Pneumatic Drill System is acceptable for its intended use in various surgical procedures.
Safety and Effectiveness for Expanded Indications	Results of cadaveric testing have demonstrated that the addition of the proposed indications do not present any new issues of safety or effectiveness.
Performance during Surgical Use	The systems perform as intended during surgical use, similar to the use during various other surgical procedures on currently cleared indications.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Test Set (Cadaveric Testing): The document mentions "Users evaluated the acceptability of the subject drill system to its intended use on a variety of procedures using cadavers." However, the specific sample size of cadavers used is not provided.
Data Provenance: Not specified, but likely from a laboratory or clinical setting where cadaveric studies are conducted. It would be considered prospective for the purposes of evaluating the device for expanded indications.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

The document states "Users evaluated the acceptability...". The number and specific qualifications of these "users" (likely surgeons or medical professionals) are not provided. Their role was to evaluate the acceptability of the drill system, which serves as the "ground truth" for its functional performance in a surgical simulation.

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

The document does not describe a formal adjudication method (like 2+1 or 3+1) for the cadaveric testing. The phrase "Users evaluated the acceptability" suggests a direct evaluation by the involved parties, but no specific adjudication process is detailed.

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 relevant for AI/CAD systems that assist human readers in tasks like image interpretation. This submission is for a surgical drill system, which does not involve "human readers" in the context of image interpretation.

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

No, a standalone AI algorithm performance study was not done. This device is a physical surgical instrument, not an AI algorithm. Its performance is intrinsically linked to human-in-the-loop operation by a surgeon.

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

For the cadaveric testing: The "ground truth" was established by the evaluation and assessment of the surgical performance and acceptability by the "users" (presumably surgeons) during simulated surgical procedures on cadavers. This would fall under a form of expert assessment/consensus regarding functional performance and safety.
For the clinical literature review: The "ground truth" was based on existing published clinical evidence regarding the safe and effective use of drill systems.

8. The sample size for the training set

Not applicable. This document describes a physical surgical device, not an AI model that requires a training set.

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

Not applicable. As above, no training set for an AI model is involved.

In summary:

This 510(k) submission focuses on demonstrating substantial equivalence for a physical surgical device and its suitability for expanded indications through functional testing and literature review, rather than quantifiable performance metrics typical of AI or diagnostic devices. Therefore, many of the specific questions about AI study design and ground truth establishment for AI models are not relevant to this document.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized depiction of a human figure with outstretched arms, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.

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

March 23, 2017

Medtronic Powered Surgical Solutions Deep Pal Regulatory Affairs Manager 4620 North Beach Street Fox Worth, TX 76177

Re: K163182

Trade/Device Name: Medtronic Legend Pneumatic: MR7 Pneumatic: Triton Pneumatic Drill System incorporating various Pneumatic Handpieces; Attachments; Surgical Dissecting Tools; and System Accessories Regulation Number: 21 CFR 882.4370 Regulation Name: Pneumatic Cranial Drill Motor Regulatory Class: Class II Product Code: HBB, KFK, ERL, EQJ, HSZ, GET, HBE, DWH Dated: December 22, 2016 Received: December 23, 2016

Dear Mr. Pal:

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.

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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) 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.

Michael J. Hoffmann -S

for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K163182

Device Name

Medtronic Legend Pneumatic; Triton Pneumatic Drill System incorporating various Pneumatic Handpieces; Attachments; Surgical Dissecting Tools; and System Accessories

Indications for Use (Describe)

Lumbar Microdiscectomy
Lumbar Stenosis Decompression
Posterior Lumbar Interbody Fusion (PLIF)
Transforaminal Lumbar Interbody Fusion (TLIF)
Anterior Lumbar Interbody Fusion (ALIF)
Direct Lateral Interbody Fusion (DLIF)

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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SECTION 9: 510(k) SUMMARY

This summary is submitted in accordance with the requirements of 21CFR807.92.

9.1 DATE PREPARED

November 10, 2016

9.2 NAME AND ADDRESS OF MANUFACTURER

Table 4: Manufacturer information

Establishment Name	Establishment Registration Number
Medtronic Powered Surgical Solutions4620 North Beach StreetFort Worth, TX 76137 USA	1625507
Medtronic Xomed, Inc.6743 Southpoint Drive NorthJacksonville, FL 33216 USA	1045254

9.3 CONTACT PERSON

Deep Pal Regulatory Affairs Manager Telephone: 817.788.6685 Facsimile: 817.788.6222 E-Mail: deep.pal@medtronic.com

9.4 PROPRIETARY NAME

Medtronic Legend Pneumatic, MR7 Pneumatic, Triton Pneumatic Drill System incorporating various Pneumatic Handpieces, Attachments, Surgical Dissecting Tools and System Accessories

9.5 COMMON/USUAL NAME

Surgical Drill Motors and Accessories

9.6 DEVICE CLASSIFICATION NAME

Table 5: FDA device classification information

Description	FDA Code	Regulation Number
Saw, pneumatically powered	KFK	21CFR878.4820
Motor, drill, pneumatic	HBB	21CFR882.4370
Drill, surgical, ent (electric or pneumatic) including handpiece	ERL	21CFR874.4250
Bur, ear, nose and throat	EQJ	21CFR874.4140
Instrument, surgical, orthopedic, pneumatic powered & accessory/attachment	HSZ	Pre-Amendment
Pneumatic motor for general surgery	GET	21CFR878.4820
Drills, burrs, trephines and accessories (simple, powered)	HBE	21CFR882.4310
Blades, saw, surgical cardiovascular	DWH	21CFR878.4820

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9.7 PREDICATE DEVICE IDENTIFICATION

Table 6: Subject Devices that are in the scope of this Submission

SUBJECT SYSTEM DESCRIPTION	PREDICATE
	SYSTEM DESCRIPTION	510(k) NUMBER
Triton Pneumatic Drill System	Oscillating and Reciprocating Saw Drill-Reamer	K870157
- Pneumatic Handpiece	- Pneumatic Handpiece	K870157
- Pneumatic Foot Control Unit	- Pneumatic Control Unit	K870157
- Surgical Dissecting Tools	- Surgical Dissecting Tools	K870157
- Attachments	- Attachments	K870157
- System Accessories	- System Accessories	K870157
Legend Pneumatic High Speed System	Legend Pneumatic High Speed System	K020069
- Pneumatic Handpiece	- Pneumatic Handpiece	K020069
- Pneumatic Foot Control Unit	- Pneumatic Control Unit	K020069
- Surgical Dissecting Tools	- Surgical Dissecting Tools	K020069, K072315
- Attachments	- Attachments	K020069
- System Accessories	- System Accessories	K020069
Midas Rex MR7 Pneumatic High Speed System	Midas Rex MR7 Pneumatic High Speed System	K090112
- Pneumatic Handpiece	- Pneumatic Handpiece	K090112
- Pneumatic Foot Control Unit	- Pneumatic Control Unit	K090112
- Surgical Dissecting Tools	- Surgical Dissecting Tools	K020069, K072315
- Attachments	- Attachments	K020069
- System Accessories	- System Accessories	K090112

9.8 DEVICE DESCRIPTION

The device design, function, the intended use and the general operating principles, and conditions of use of the overall Medtronic Pneumatic Drill Systems remain similar to those cleared under K870157, K020069, K072315, and K090112.

INDICATIONS FOR USE 9.9

The Pneumatic Drill System is a pneumatically operated surgical instrument system. The pneumaic motor provides power to operate removable rotating surgical cutting tools and their accessories intended for use in neurosurgery, including craniotomy and spinal surgery; as well as Ear Nose and Throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial and sternotomy surgeries.

Additionally, the Pneumatic Drill System is incision / cutting, removal, drilling, and sawing of soft and hard tissue, bone, and biomaterials during open and minimally invasive spine procedures, which may incorporate application of various surgical techniques during the following lumbar spinal procedures:

Lumbar Microdiscectomy o
o Lumbar Stenosis Decompression
Posterior Lumbar Interbody Fusion (PLIF) o
O Transforaminal Lumbar Interbody Fusion (TLIF)
Anterior Lumbar Interbody Fusion (ALIF) O
O Direct Lateral Interbody Fusion (DLIF)

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COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE 9.10

The Pneumatically powered drill system, designed to remove soft and hard tissue, and bone, and biomaterials is the technological principle for both the subject and predicate systems.

The subject and predicate systems are based on the following same technological elements:

A Pneumatic Drill System Application: Designed to remove soft and hard tissue, bone, and biomaterials during various surgical applications.
A Operating Principle: The pneumatic energy is supplied to the Handpiece to provide power to operate interchangeable Surgical Dissecting Tools supported by Attachments and intended for use in various surgical procedures to remove soft and hard tissue, bone, and biomaterials.

In terms of the materials used in manufacturing of the patient contacting components of the subject Pneumatic Drill System, the subject Attachments and Surgical Dissecting Tools are similar to the predicate Medtronic Attachments and Surgical Dissecting Tools.

9.11 DISCUSSION OF THE PERFORMANCE TESTING

Testing was completed to ensure the functionality of the Medtronic Pneumatic Drill System for the expanded indications. The following table summarizes the testing completed:

TEST	DESCRIPTION	RESULTS
ClinicalLiteratureReview	A comprehensive clinical literaturesearch was conducted and reviewedregarding the safe and effective useof the Drill System for the expandedindications for use, which is thesubject of this submission.	The cadaver validation study, andreview of supporting literature,supports the use of the MedtronicDrill System in LM, PLIF, TLIF, LSD,ALIF, and DLIF spinal surgicalprocedures, as well as anyvariations of these procedures.
CadavericTesting	Users evaluated the acceptability ofthe subject drill system to itsintended use on a variety ofprocedures using cadavers.	The Medtronic Pneumatic DrillSystem is acceptable for itsintended use in various surgicalprocedures.

9.12 CONCLUSIONS

The subject Medtronic Penumatic Drill Systems when compared to the predicate Drill Systems have same intended use, where the subject and the predicate drill systems are intended for use in various surgical procedures to remove soft and hard tissue, and biomaterials. Results of cadaveric testing have demonstrated that the addition of the proposed indications do not present any new issues of safety or effectiveness, and the systems perform as intended during surgical use, similar to the use during various other surgical procedures on currently cleared indications.

Regulation Number and Section

§ 882.4370 Pneumatic cranial drill motor.

(a)
Identification. A pneumatic cranial drill motor is a pneumatically operated power source used with removable rotating surgical cutting tools or drill bits on a patient's skull.(b)
Classification. Class II (performance standards).