EXACTECH STERILE MODULAR DRILL BIT

• K Number: K960720
• Device Name: EXACTECH STERILE MODULAR DRILL BIT
• Manufacturer: EXACTECH, INC.
• Date Cleared: 1996-04-23 ( 61 days)
• Product Code: HWE
• Regulation Number: 878.4820
• Type: Traditional
• Panel: OR
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

The Sterile Modular Drill Bit is indicated for use in general orthopedic procedures to predrill bone in preparation for bone screw placement

Device Description

The Exactech Sterile Drill Bit is intended for use in orthopedic procedures for drilling bone. The drill bit is designed with a 120° point angle for smooth, effective, bone cutting. The 30° helix angle maintains strength, but provides an efficient channel by which cut bone may escape. The outer diameter (OD) tolerance and associated drill bit guide geometry minimize drill bit damage.

The five (5) modular bits are designed in long and short versions. They have a high tolerance press fit cross pin that provides easy assembly and disassembly with positive bayonet style locking capability in both the flexible and fixed angle drill bit drivers.

All bits are constructed of 455 stainless steel for strength, hardness and resistance to wear.

AI/ML Overview

The provided text describes a medical device, the Exactech Sterile Modular Drill Bit, and its regulatory submission. However, it does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria.

The document is a "Summary of the Safety and Effectiveness Information for the Premarket Notification" for a 510(k) submission, which primarily focuses on demonstrating substantial equivalence to a predicate device rather than a comprehensive performance study against pre-defined acceptance criteria.

Therefore, most of the requested information (items 1 through 9) cannot be extracted from the given text.

Here's an explanation of why and what information can be extracted:

Information NOT available in the text:

• 1. A table of acceptance criteria and the reported device performance: This document is a premarket notification (510(k)), which focuses on demonstrating substantial equivalence to a predicate device. It does not typically include a formal table of acceptance criteria and results from a performance study for the new device in the same way a clinical trial report would.
• 2. Sample size used for the test set and the data provenance: No performance study employing a test set of data is described.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no test set or ground truth establishment is described.
• 4. Adjudication method for the test set: Not applicable.
• 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 device is a drill bit, not an AI diagnostic tool.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• 7. The type of ground truth used: Not applicable.
• 8. The sample size for the training set: Not applicable.
• 9. How the ground truth for the training set was established: Not applicable.

Information that can be extracted or inferred from the text regarding the device and its submission process:

• Device Name: Exactech Sterile Modular Drill Bit
• Regulatory Pathway: 510(k) Premarket Notification (K960720)
• Classification: Class I device, Bit, Drill, under 21 CFR 888.4540.
• Intended Use/Indications: "indicated for use in general orthopedic procedures to predrill bone in preparation for bone screw placement"
• Predicate Device: DePuy Drill Bit
• Claim of Equivalence: The Exactech Sterile Modular Drill Bit is "of a similar design to devices that were on the market before May 28, 1976" and "of a similar design to other devices on the market that have been determined to be equivalent to devices on the market prior to May 28, 1976." Specific similarities and dissimilarities with the DePuy drill system are described (e.g., cross pin, bayonet locking, flex shafts, diameters, lengths, stiffness, locking ends, drivers).
• Evidence for Equivalence: Advertisements, brochures, catalog information from predicate companies, design drawings, material specifications, and photos of the Sterile Modular Drill Bit were provided to the FDA.
• Material: Custom 455® stainless steel.
• Sterilization: Supplied sterile, sterilized by gamma irradiation at a contract sterilization facility based on AAMI Process Control guidelines.
• Manufacturing/Packaging Sites: Exactech® Inc., Gainesville, FL.
• Contract Sterilization Sites: Sterigenics International (Westerville, Ohio and Charlotte, North Carolina).

Regulation Number and Section

§ 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.