SELF-COUNTERSINKING BONE SCREW

• K Number: K013534
• Device Name: SELF-COUNTERSINKING BONE SCREW
• Manufacturer: BIOMET ORTHOPEDICS, INC.
• Date Cleared: 2001-12-17 ( 55 days)
• Product Code: HWC , 87H
• Regulation Number: 888.3040
• Type: Traditional
• Panel: OR
• Reference & Predicate Devices: K962823 , K963192 , K923256 , K922332

Intended Use

The Self-Countersinking Bone Screw is indicated for the following conditions:

• Fixation of fractures in long bones such as the fibula, tibia, humerus, radius and ulna as well as fractures in the patella
• Fixation of small bones such as those in the foot, ankle, wrist, and elbow
• Ligament reconstruction
• Arthrodesis of the foot, ankle, wrist, and elbow
• Small bone osteotomies
• Osteochondritis dissecans

Device Description

The Self-Countersinking Bone Screw is a titanium screw that has cutting flutes in its head that allows it to cut into the bone, thus countersinking itself. The screw is also cannulated to allow insertion over a guide wire. The threads are self-drilling and self-tapping.

The screw will be available with diameters of 2.7mm and 4.3mm. The 2.7mm screws will have lengths from 8mm to 16mm (in 1mm increments) and 18mm to 36mm (in 2mm increments). All lengths of the 2.7mm screw are available fully threaded, with a short partial thread of 1/3 screw length and with a long partial thread of 1/2 screw length. The 2.7mm screw has a cannulation that will accept a 1.1mm guide wire.

The 4.3mm screw will have lengths from 10mm to 36mm (in 2mm increments) available fully threaded, with a short partial thread of 1/3 screw length and with a long partial thread of 1/2 screw length. The 4.3mm screw is also available in lengths of 38mm to 50mm (in 2mm increments) and 55mm to 65mm (in 5mm increments) and will be offered fully threaded, with a short partial 16mm thread and a long partial 32mm thread. The 4.3mm screw has a cannulation that will accept a 1.6mm guide wire.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called the "Self-Countersinking Bone Screw." This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through clinical trials and specific performance metrics with acceptance criteria.

Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria, a specific study proving the device meets those criteria, or details about ground truth, expert adjudication, or MRMC studies.

Here's why and what information can be extracted:

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

• Not Applicable. The document explicitly states: "Clinical Testing: Clinical testing was not used to establish substantial equivalence to predicate devices." Instead, mechanical testing was performed to establish substantial equivalence. No specific acceptance criteria or performance metrics in the way you've defined them (e.g., sensitivity, specificity, accuracy) are reported for the device as a standalone product.

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

• Not Applicable. Since no clinical testing was performed for substantial equivalence, there is no test set or associated data provenance. Mechanical testing was performed, but details about sample sizes or specific data from these tests are not provided in this summary.

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):

• Not Applicable. No clinical test set or ground truth derived from experts was used for this submission.

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

• Not Applicable. No clinical test set requiring adjudication was used.

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 bone screw, not an AI or imaging diagnostic device. Therefore, no MRMC study or AI-related comparative effectiveness study was performed or is relevant.

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

• Not Applicable. This is a mechanical bone screw, not an algorithm.

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

• Not Applicable. For mechanical testing, the "ground truth" would be engineering specifications and measurement results. However, details of these are not provided in this summary. For biological or clinical outcomes, no such data was used for this 510(k) summary.

8. The sample size for the training set:

• Not Applicable. There is no "training set" in the context of an AI/diagnostic device for this product.

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

• Not Applicable. There is no "training set" or corresponding ground truth for this product.

Summary of what the document does state regarding demonstrating equivalence:

• Non-Clinical Testing: "Mechanical testing was performed to establish substantial equivalence to the predicate devices."
• Clinical Testing: "Clinical testing was not used to establish substantial equivalence to predicate devices."
• Summary of Technologies: "The Self-Countersinking Bone Screw's technological characteristics (materials, design, sizes, and indications) are similar to or identical to the predicate devices."

The entire submission is based on demonstrating that the Self-Countersinking Bone Screw is "substantially equivalent" to existing, legally marketed predicate devices (Synthes 3.0mm/3.5mm/4.0mm Cannulated Screws, DePuy-Ace 4.0mm Cannulated Cancellous Screw, Alphatec 2.7mm/3.5mm/4.0mm Cortical Lag Screws) in terms of its indications for use, technological characteristics (materials, design, sizes), and performance demonstrated through non-clinical (mechanical) testing. The FDA letter confirms that a substantial equivalence determination was made based on this information.

Regulation Number and Section

§ 888.3040 Smooth or threaded metallic bone fixation fastener.

(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.