(106 days)
The IntelliSense Drill is intended to bore a hole into bone for insertion of a screw, wire, cable, plate, pin, bolt, etc. In Bicortical mode, the IntelliSense Drill is indicated to be used in bicortical long bone, such are the fibri, fiber, fibel, f.but, f.but, humerus, ulna, and radius.
The IntelliSense Drill device will contain a drill unit (with attached cable), Control Console, and Sterilization Tray. Proprietary Drill Bits and Drill Bit Bushing will be sold separately as accessories. The drill bits and companion bushings are sold as a pair and are disposable (single-procedure). The IntelliSense Drill's design combines the drilling and depth measurement processes into one procedure, which determines drill bit location. By monitoring the load placed upon the drilling mechanism, the precise location of the drill bit may be determined relative to the bone. Secondary depth monitoring will provide the measurement of the drill bit depth and appropriate screw size.
The provided document is a 510(k) premarket notification decision letter and summary for the McGinley Innovations IntelliSense Drill. It describes the device, its intended use, and claims substantial equivalence to a predicate device (Stryker Total Performance (TPS) System, K943589).
However, the document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria for clinical performance metrics such as accuracy, sensitivity, specificity, etc., typically associated with AI/ML device evaluations. This document focuses on demonstrating substantial equivalence based on technological characteristics and intended use, which is a common pathway for Class I and some Class II medical devices.
Therefore, many of the requested details, particularly those related to clinical performance studies, ground truth establishment, sample sizes for test and training sets, and expert involvement, are not present in this type of regulatory submission.
Here's a breakdown of what can be extracted from the document in relation to your request, and what cannot:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: Not explicitly stated in terms of clinical performance metrics (e.g., accuracy, sensitivity, specificity). The acceptance criterion for this 510(k) submission is "substantial equivalence" to the predicate device.
- Reported Device Performance: The document provides a comparison of technological characteristics with the predicate device, but not performance against clinical outcome metrics. The "performance" discussed is related to features and operational parameters.
Here's a table based on the provided "Table 5-1: Comparison of Proposed Device with Predicate Devices," focusing on features that might be considered performance-related, though not explicitly acceptance criteria in a clinical validation sense:
| Feature | Acceptance Criteria (Implied by Predicate) | Reported Device Performance (IntelliSense Drill) |
|---|---|---|
| Intended Use | Cutting, drilling, reaming, decorticating, smoothing of bone, teeth and other bone-related tissue; placement of screws, wires, pins, and other fixation devices (Stryker TPS System). | Bore a hole into bone for insertion of a screw, wire, cable, plate, pin, bolt, etc. In Bicortical mode, indicated for bicortical long bone (femur, tibia, fibula, humerus, ulna, radius). (This is analogous, though more specific in bicortical mode). |
| Outer Profile: Console | Bench-top style console with touch screen display and optional irrigation pump. | Control Console has a 7 inch diagonal graphical touch screen for the user interface. |
| Operating Parameters Adjustment | User adjusts operating parameters via touch screen. | User adjusts operating parameters via touch screen. |
| System Status Display | Displayed on Touch Screen interface. | Displayed on Touch Screen interface. |
| Software | Microprocessor. | Microprocessor. |
| Non-volatile memory | All current settings are stored when power is down. | System setup parameters (touch screen calibration, cortex breakthrough detection parameters, drill bit offsets) stored; can be viewed, updated, and set to default values via internal USB port. |
| Energy (input)/Power Source | AC. | AC. |
| Console Controller Operation | Bidirectional. | Commercial bidirectional motor controller. |
| Weight | 1.36 Kg (3.0 lbs) [TPS Universal Driver]. | 1.5 Kg (3.3 lbs). (Comparable) |
| Bidirectional Motor | Forward / Reverse Trigger. | Forward / Reverse Trigger. |
| Drill RPM | 1,500 rpm [TPS Universal Driver]. | Speeds up to 1,200 rpm. (Within a comparable range) |
| Torque | 3.3 Nm [Stryker System 2000]. | Peak torque 1.9Nm with 0.3 Nm continuous torque at speeds up to 1,200 RPM. (Within a comparable range, though lower peak torque) |
| Drill Bit Depth Measurement | Manual depth gauge to determine proper screw size. | By monitoring the load placed upon the drilling mechanism, the precise location of the drill bit may be determined relative to the bone. Secondary depth monitoring will provide the measurement of the drill bit depth and appropriate screw size. (This is a new technological characteristic that is superior to the predicate, providing an automated depth measurement). |
2. Sample Size Used for the Test Set and Data Provenance:
- Not Applicable. This document summarizes a 510(k) submission based on substantial equivalence, primarily comparing design and technological characteristics, not clinical performance data from a specific test set. There is no mention of a test set, data provenance, or a study involving such. The unique feature of automated depth measurement is described, but it's not clinically validated with sample sizes in this document.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
- Not Applicable. As there is no clinical test set described, there is no mention of experts or ground truth establishment for such a set.
4. Adjudication Method:
- Not Applicable. No clinical test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No. This document does not mention an MRMC study or any studies comparing human reader performance with or without AI assistance. The device ("IntelliSense Drill") is a physical surgical instrument, not an AI/ML diagnostic or assistive software in the typical sense that would require an MRMC study for assessing human reader improvement. Its "intelligence" is in automating depth measurement during drilling.
6. Standalone (i.e. algorithm only without human-in-the loop performance) Study:
- No. This is a hardware device with an automated feature. While the document describes the mechanism for depth measurement, it does not present a standalone performance study in the context of an "algorithm only" as typically applied to image analysis or diagnostic AI. The intelligence is embedded in the device's function.
7. Type of Ground Truth Used:
- Not Applicable. No clinical ground truth is discussed in this context. The "truth" for substantial equivalence lies in comparing design specifications and intended use with a legally marketed predicate device.
8. Sample Size for the Training Set:
- Not Applicable. The device is a physical instrument, not an AI/ML model that is "trained" on a dataset in the conventional sense. The "intelligence" for depth measurement would likely be based on engineering principles and calibrated during product development.
9. How the Ground Truth for the Training Set Was Established:
- Not Applicable. (See #8) There is no training set for an AI/ML model described. The device's functionality would be based on engineering design and validation against physical principles and benchmarks, not "ground truth" derived from patient data.
In summary: The provided FDA 510(k) document is for a conventional surgical drilling device seeking market clearance based on substantial equivalence to an existing predicate. It highlights technological features rather than presenting clinical trial data typical of AI/ML software devices. Therefore, most of your specific questions related to AI/ML device evaluation criteria are not addressed by this document.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 20, 2015
McGinley Orthopaedic Innovations % Mr. Justin Eggleton MCRA, LLC 1311 H Street North West, 12th Floor Washington, District of Columbia 20005
Re: K143191
Trade/Device Name: McGinley Innovations IntelliSense Drill Regulation Number: 21 CFR 878.4820 Regulation Name: Surgical instrument motors and accessories/attachments Regulatory Class: Class I Product Code: HWE, GEY, GFG, HTW Dated: January 30, 2015 Received: February 3, 2015
Dear Mr. Eggleton:
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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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" (21CFR 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 yours.
Jennifer R. Stevenson -S
For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation 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) K143191
Device Name McGinley Innovations IntelliSense Drill
Indications for Use (Describe)
The IntelliSense Drill is intended to bore a hole into bone for insertion of a screw, wire, cable, plate, pin, bolt, etc. In Bicortical mode, the IntelliSense Drill is indicated to be used in bicortical long bone, such are the fibri, fiber, fibel, f.but, f.but, humerus, ulna, and radius.
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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Image /page/3/Picture/2 description: The image shows the logo for McGinley Innovations. The logo features a gold emblem with the letter "M" in the center, surrounded by a decorative gold border. To the right of the emblem, the words "MCGINLEY INNOVATIONS" are written in gold, with the tagline "REDEFINING MEDICINE" underneath in a smaller font.
| Section 5: 510(k) Summary | |
|---|---|
| DATE OF PREPARATION: | November 5, 2014 |
| COMPANY/OWNER: | Dr. Joseph McGinleyMcGinley Orthopaedic Innovations2435 King Blvd, Ste 230Casper, WY 82604 |
| CONTACT: | Dr. Joseph McGinleyMcGinley Orthopaedic Innovations2435 King Blvd, Ste 230Casper, WY 82604 |
| TELEPHONE | 215-847-1462 |
| FAX: | 435-304-1170 |
| EMAIL: | mcgjoe26@yahoo.com> |
| DEVICE TRADE NAME: | IntelliSense Drill |
| COMMON NAME: | Surgical Drill and accessories |
| CLASSIFICATION NAME: | Surgical instrument motors and accessories/attachments |
| REGULATION NUMBER: | 21 CFR §878.4820 |
| PRODUCT CODE: | HWE |
| SUBSEQUENT PRODUCTCODE: | GEY, GFG, HTW |
| DEVICE CLASS: | Class I |
| PREDICATE DEVICES: | Stryker Total Performance (TPS) System, K943589 |
| DEVICE DESCRIPTION: | The IntelliSense Drill device will contain a drill unit (withattached cable), Control Console, and Sterilization Tray.Proprietary Drill Bits and Drill Bit Bushing will be soldseparately as accessories. The drill bits and companion bushingsare sold as a pair and are disposable (single-procedure). |
| The IntelliSense Drill's design combines the drilling and depthmeasurement processes into one procedure, which determinesdrill bit location. By monitoring the load placed upon the drillingmechanism, the precise location of the drill bit may bedetermined relative to the bone. Secondary depth monitoring willprovide the measurement of the drill bit depth and appropriatescrew size. | |
| INTENDED USE: | The IntelliSense Drill is intended to bore a hole into bone for |
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Image /page/4/Picture/2 description: The image shows the logo for McGinley Innovations. The logo features a gold emblem with the letter "M" in the center, surrounded by a decorative border. To the right of the emblem, the words "MCGINLEY INNOVATIONS" are written in a serif font, with the tagline "REDEFINING MEDICINE" underneath in a smaller font.
insertion of a screw, wire, cable, plate, pin, bolt, etc. In Bicortical mode, the IntelliSense Drill is indicated to be used in bicortical long bone, such as the femur, tibia, fibula, humerus, ulna, and radius.
TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE:
The IntelliSense Drill demonstrates substantial equivalence to the Stryker Total Performance (TPS) System, K943589. Table 5-1 summarizes the key technological characteristics and features of both the predicates and the new device.
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Image /page/5/Picture/2 description: The image shows the logo for McGinley Innovations. The logo features a gold emblem with the letter "M" in the center, followed by the company name "MCGINLEY INNOVATIONS" in gold lettering. Below the company name is the tagline "REDEFINING MEDICINE" in a smaller font.
Table 5-1: Comparison of Proposed Device with Predicate Devices
| Predicate | ||
|---|---|---|
| Feature | IntelliSense Drill | Stryker Total PerformanceSystem |
| 510(k) Number | K943589 | |
| Intended Use | The IntelliSense Drill isintended to bore a hole intobone for insertion of a screw,wire, cable, plate, pin, bolt,etc. In Bicortical mode, theIntelliSense Drill is indicatedto be used in bicortical longbone, such as the femur, tibia,fibula, humerus, ulna, andradius. | The Stryker TotalPerformance (TPS) System isintended for use in the cutting,drilling, reaming,decorticating, and smoothingof bone, teeth and other bonerelated tissue in a variety ofsurgical procedures, includingbut not limited to Dental,ENT, Neuro, and Endoscopic.It is also usable in theplacement of cutting ofscrews, wires, pins, and otherfixation devices. It can also beused to cut metal |
| Outer profile: Console | Control Console has a 7 inchdiagonal graphical touchscreen for the user interface. | Bench-top style console withtouch screen display andoptional irrigation pump. |
| Operating Parameters: | User adjusts operatingparameters via touch screen | User adjusts operatingparameters via touch screen |
| System Status Display | Displayed on Touch Screeninterface | Displayed on Touch Screeninterface |
| Software | Microprocessor | Microprocessor |
| Non-volatile memory | System setup parameters suchas touch screen calibrationdata, cortex breakthroughdetection parameters and drillbit offsets. The setupparameters can be viewed,updated, and set to theirdefault values, using theinternal USB port on the SBC. | All current setting are storedwhen the power is down. |
| Energy (input)/PowerSource | AC | AC |
| Console ControllerOperation: | commercial bidirectionalmotor controller | Bidirectional |
| Weight | 1.5 Kg (3.3 lbs) | 1.36 Kg (3.0 lbs) [TPSUniversal Driver] |
| Dimensions: Drill | Drill to fit in envelope of size | Not stated |
| Feature | IntelliSense Drill | PredicateStryker Total PerformanceSystem |
| Materials: DrillAccessories | Stainless Steel AISI 316 | Stainless Steel |
| Materials:Sterilization Tray | 5052-H32 Aluminum,Silicone, 302 Stainless Steel,304 Stainless Steel Radel, 430Stainless Steel | N/A |
| Materials: Drill Bit | Stainless Steel: AISI 17-4 | N/A |
| Materials: Drill ArmBushing | Polycarbonate | N/A |
| Technological Characteristics | ||
| Design: | The IntelliSense Drill iscomprised of three primarysubsystems: the Drill Unit(with attached cable), theControl Console, and theproprietary Drill Bits. | The device description of theStryker System includesdrills, shavers, shields,guards, motors, attachments,saws, wire drivers, collets,console, irrigation pump,cords, footswitch, handswitch,clips, tubing, cuttingaccessories, and sterilizationcases. |
| Bidirectional Motor | Forward / Reverse Trigger | Forward / Reverse Trigger |
| Drill RPM | speeds up to 1,200 rpm | 1,500 rpm [TPS UniversalDriver] |
| Torque | Peak torque 1.9Nm with 0.3Nm continuous torque atspeeds up to 1,200 RPM | 3.3 Nm [Stryker System2000] |
| Drill Bit DepthMeasurement | By monitoring the load placedupon the drilling mechanism,the precise location of the drillbit may be determined relativeto the bone. Secondary depthmonitoring will provide themeasurement of the drill bitdepth and appropriate screwsize | Manual depth gauge todetermine proper screw size |
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Image /page/6/Picture/2 description: The image shows the logo for McGinley Innovations. The logo features a gold emblem with the letter "M" in the center. To the right of the emblem, the words "MCGINLEY INNOVATIONS" are written in gold, with the tagline "REDEFINING MEDICINE" underneath in a smaller font. The overall design is elegant and professional.
Conclusions:
McGinley Innovations provided sufficient information to demonstrate the IntelliSense Drill is substantially equivalent to predicate Stryker Total Performance System (K943589).
§ 878.4820 Surgical instrument motors and accessories/attachments.
(a)
Identification. Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade.(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 § 878.9.