(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.
§ 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.