Search Results

The Distal Radius Fracture Repair System is intended for the fixation of fractures and osteotomies involving the distal radius.

The Distal Radius Fracture Repair System (DRFRS) was previously cleared under 510(k) No. K030198. The system consists of a volar stabilization plate, bone screws, fixation pegs, dorsal intrafocal nail-plate, three fixed angle bone pegs and two locking screws. This 510(k) is being submitted as a modification to the original 510(k) No. K030198 in order to add accessories to the DRFRS.

The Distal Volar Radius Plate (DVR) consists of a stabilization plate, bone screws, and fixation pegs. The 3.5 mm screws are used to affix the proximal segment of the plate to the diaphysis. Pegs or screws are used for the distal bone fragment(s).

The Distal Dorsal Nail-Plate (DNP) is a bone stabilization device consisting of an intrafocal nail-plate to which three-fixed angle bone pegs and two locking screws are attached. It has a narrow distal plate-like section that lies on the surface of the distal fragment and a proximal nail-like section that is introduced into the diaphysis of the radius through the fracture site. Fixed angle pegs are used to fix the distal fragment(s) to the plate section and locking screws are used to lock the proximal fragment inside the radial shaft.

Other components used in the implantation process are identified as the DNP Jig Set of Stainless Steel SST 17-4. These items consist of the DNP Jig drill guide, screw jig and screw guide.

A standard awl, which is a manual surgical instrument, used to enlarge t or tunnel by rotary movement is a catalog item manufactured by K-Medic (catalog no. KM-48-336).

This submission describes two accessories that are being added to the Distal Radius Fracture Repair Systems, fragment plates and a "K-Type" wire.

The fragment plates are essentially smaller implementations of the existing Distal Dorsal Nail-Plates and Distal Volar Radius Plates. The fragment plates are intended for the attachment of small bone fragment plates will be available in the four versions: right, left, straight, and "Y."

The fragment plates are made from the same titanium (ASTM F 136 - 96) as the existing Distal Dorsal Nail-Plates and Distal Volar Radius Plates cleared via K030198. The plates are intended to be fastened to bone using the 2.5 mm titanium screws that were cleared via K030198.

The K-Wires that will be supplied with the Distal Radius Fracture Repair System are primarily intended for intraoperative use to temporarily locate bone plates or for interfragmental fixation.

Even though the K-Wire is intended primarily for intraoperative use, if desired by the surgeon, the K-Wires may permanently implanted. The K-Wires are made from the same titanium (ASTM F 136 - 96) as the existing pins and screws.

Three variations of the right and left distal volar plates have been added to accommodate the anatomies of larger and smaller patients. The list of manual surgical instruments included in the Distal Radius Fracture Repair System has been updated.

The provided document describes a medical device, the "Distal Radius Fracture Repair System," and its clearance process with the FDA. However, it does not contain any information about acceptance criteria or a study proving the device meets performance metrics via a machine learning algorithm or AI component.

Here's why the requested information cannot be extracted from the given text:

• Device Type: The device is a surgical implant system (plates, screws, nails, etc.) used for fixing bone fractures, not a software or AI-driven diagnostic/detection system.
• Performance Data Focus: The "Summary of Performance Data" section explicitly states that the device complies with certain ASTM standards (related to material specifications and fixation pins/wires) and was found substantially equivalent to a predicate device through a "15-point technological comparison of features and a 3-parameter comparison of mechanical performance." This refers to traditional engineering and biomechanical testing, not AI performance metrics.
• No Mention of AI/ML: There is no mention of an algorithm, AI, machine learning, diagnostic performance (e.g., sensitivity, specificity), ground truth, training sets, test sets, or expert readers/adjudication.

Therefore, I cannot provide the requested table and information as it pertains to AI/ML device performance. The document describes a traditional medical device clearance process focused on material standards, mechanical performance, and substantial equivalence to a predicate device.

Ask a specific question about this device

The Distal Radius Fracture Repair Kit is intended for the fixation of fractures and osteotomies involving the distal radius.

The Distal Radius Fracture Repair System was previously cleared under 510(k) No. K023007. The system consists of a volar stabilization plate, bone screws, fixation pegs, dorsal intrafocal nail-plate, three fixed angle bone pegs and two locking screws. This 510(k) is being submitted as a modification to the original 510(k) No. K023007 to update and standardize the sterilization cycle. The Distal Volar Radius Plate (DVR) consists of a stabilization plate, bone screws, and fixation pegs. The 3.5 mm screws are used to affix the proximal segment of the plate to the diaphysis. Pegs or screws are used for the distal bone fragment(s). The Distal Dorsal Nail-Plate (DNP) is a bone stabilization device consisting of an intrafocal nail-plate to which three-fixed angle bone pegs and two locking screws are attached. It has a narrow distal plate-like section that lies on the surface of the distal fragment and a proximal nail-like section that is introduced into the diaphysis of the radius through the fracture site. Fixed angle pegs are used to fix the distal fragment(s) to the plate section and locking screws are used to lock the proximal fragment inside the radial shaft. Other components used in the implantation process are identified as the DNP Jig Set of Stainless Steel SST 17-4. These items consist of the DNP Jig (left or right), drill guide, screw jig and screw guide. A standard awl, which is a manual tool, used to increase the size of a hole or tunnel by scraping in rotation is a standard catalog item manufactured by from K-Medic under catalog no. KM-48-336. The components of this system will be packaged together and will also be available individually. The materials used for the various components in Distal Radius Fracture Repair System include Titanium TI-6AL-4V ELI and Stainless Steel 440C and SST-17-4. The components within this system will be provided as non-sterile for steam sterilization by health care professionals prior to use. The system is packaged in a high tempered plastic sterilization tray.

This is a 510(k) summary for a medical device (Distal Radius Fracture Repair Kit/System), not an AI/algorithm-driven device. Therefore, the requested information about acceptance criteria and studies proving the device meets those criteria, particularly regarding performance metrics like those for AI, is not applicable in the context of this document.

The document primarily focuses on demonstrating substantial equivalence to a previously cleared device (K023007) based on material, intended use, manufacturing, and sterilization process.

Here's why the requested information cannot be provided from the given text:

• No Acceptance Criteria for AI/Performance: The submission is for a traditional surgical implant system (plates, screws, pegs). There are no performance metrics or acceptance criteria related to accuracy, sensitivity, specificity, or other AI-specific measures. The "performance" discussed is in the context of the physical properties and function of the orthopedic implants, not an AI algorithm.
• No Study Data for AI/Performance: Consequently, there are no studies detailed that would "prove the device meets acceptance criteria" in terms of AI performance. The focus is on demonstrating that the modified device (primarily changes to sterilization cycle) is as safe and effective as the predicate device.
• No AI, therefore no ground truth, training/test sets, or experts for AI: Because this is not an AI device, there are no concepts of "training set," "test set," "ground truth," "number of experts," or "adjudication methods" in the context of AI performance evaluation.
• No MRMC Comparative Effectiveness Study: A Multi-Reader Multi-Case (MRMC) study is relevant for evaluating the impact of AI assistance on human reader performance, which is not applicable here.
• No Standalone Algorithm Performance: This is a physical device, not an algorithm, so standalone algorithm performance is irrelevant.

Summary of what can be extracted from the document:

1. Device: Distal Radius Fracture Repair System (implants and instruments)
2. Intended Use: Fixation of fractures and osteotomies involving the distal radius.
3. Key Change in this Submission (K030198): Update and standardize the sterilization cycle.
4. Substantial Equivalence Claim: The modified device is substantially equivalent to the previously cleared Distal Radius Fracture Repair System (K023007) regarding intended use, materials, biocompatibility, and overall performance characteristics.
5. Study (Implicit): The "study" here is the demonstration of substantial equivalence, relying on:
   • Comparison to Predicate Device: A detailed comparison table (page 4) highlighting similarities in features like manufacturer, packaging, sterilization method (non-sterile, recommend steam), intended use, implant period (permanent), material of construction (Titanium, Stainless Steel), available configurations, number of pegs/screws, peg/screw lengths, and specialized instruments.
   • Sterilization Validation (Not detailed in the provided text, but implied by the "update and standardize the sterilization cycle" statement): The manufacturer would have conducted validation studies (e.g., microbial challenges, sterility assurance level (SAL) testing) to ensure the new sterilization cycle is effective, but these studies are not described in this summary.

In essence, this document is a regulatory submission for a physical medical device, not an AI/machine learning product. Therefore, the requested information tailored to AI evaluation is not present.

Ask a specific question about this device

The Distal Radius Fracture Repair Kit is intended for the fixation of fractures and osteotomies involving the distal radius.

The Distal Radius Fracture Repair System consists of the Distal Volar Fracture Repair System, which was previously cleared under 510(k) No. K002775. The system comprises volar stabilization plate, bone, screws, and fixation pegs. This 510(k) is being submitted as a modification to the original 510(k) No. K002775 to allow for the dorsal fixation of stable fractures of the distal radius. The Distal Dorsal Nail Plate (DNP) (left and right) is an implantable orthopedic nail-plate device used for the fixation of distal radius fractures. This device permits fixation of distal radius fractures with a minimal incision on the dorsal side while avoiding the tendon adhesion problems. The device consists of a plate portion, which offsets into a nail portion, all cut out of a solid piece of titanium (Titanium TI-6AL-4V ELI anodized Type II). The plate portion is narrow (~6mm) and long (~16mm) and has 3 threaded holes for the attachment of pegs with bending load capacity. These holds are appropriately angled so the pegs fan out and support the distal fracture fragment near the articular surface. The nail portion starts thick and tapers into a long, flexible section. At the start of the taper there are 2 crossing holes spaced about 9 mm apart. The holes are sized to fit 2.5 mm screws, which are used to anchor the nail-plate to the radius proximal of the fracture. The pegs, standard or threaded, and the 2.5mm screws are driven with the Peg Driver. The anchor screws and pegs are available in different lengths to accommodate most patient anatomies and fracture morphologies. Other components used in the implantation process are identified as the DNP Jig Set of Stainless Steel SST 17-4. These items consist of the DNP Jig (left or right), drill guide, screw jig and screw quide. A standard awl, which is a manual tool, used to increase the size of a hole or tunnel by scraping in rotation is a standard catalog item manufactured by from K-Medic under catalog no. KM-48-336. The components of this system will be packaged together and will also be available individually. The materials used for the various components in Distal Dorsal Nail Plate and Jig Set include Titanium TI-6AL-4V ELI and Stainless Steel SST 17-4. The components within this system will be provided as non-sterile for steam sterilization by health care professionals prior to use.

This submission, K023007, concerns a modification to an existing device, the Distal Radius Fracture Repair System, specifically adding components for dorsal fixation of distal radius fractures. As such, the study described is a comparison to a predicate device to demonstrate substantial equivalence, rather than a clinical trial proving specific performance criteria in a patient population. Therefore, many of the typical acceptance criteria and study design elements for AI/device performance do not apply in this context.

Here's a breakdown of the information based on the provided text, and where certain requested details are not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

For this type of device (metallic bone fixation appliance), acceptance criteria are primarily related to substantial equivalence to a legally marketed predicate device, focusing on intended use, materials, biocompatibility, and overall performance characteristics. Performance is assessed through comparison of features rather than quantitative metrics like sensitivity/specificity.

The FDA's letter (K023007) states: "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent... You may, therefore, market the device..." This indicates that the device met the implicit acceptance criteria for substantial equivalence based on the comparison provided.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not applicable. This is a comparison of device characteristics and intended use to a predicate device, not a performance study involving a test set of data (e.g., patient images or clinical outcomes). The "test set" is effectively the set of characteristics of the proposed device compared feature-by-feature to the predicate.
• Data Provenance: Not applicable for a traditional test set. The data presented is a description of the proposed device's design and materials, and a specification comparison to a predicate device.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

• Not applicable. Ground truth, in the sense of expert-established diagnoses or outcomes, is not relevant for this type of submission which focuses on substantial equivalence of a physical medical device. The "ground truth" here is the design and manufacturing specifications of the devices being compared.

4. Adjudication Method for the Test Set

• Not applicable. There is no "adjudication" in the sense of resolving discrepancies between expert readings or device outputs. The comparison is objective based on device specifications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No, a MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices (e.g., AI for image interpretation) to compare human performance with and without AI assistance. This submission describes a physical orthopedic implant.
  • Effect Size: Not applicable as no such study was conducted.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• No, a standalone performance study was not done. This concept applies to AI algorithms operating independently, which is not relevant for an orthopedic implant.

7. The Type of Ground Truth Used

• The "ground truth" used for this submission is the device's design specifications, material composition, intended use, and functional characteristics, as described by the manufacturer, and compared against the established specifications and intended use of the legally marketed predicate device. This is a regulatory "ground truth" for substantial equivalence rather than a clinical ground truth.

8. The Sample Size for the Training Set

• Not applicable. There is no concept of a "training set" for this type of device submission. This is not an AI/machine learning device.

9. How the Ground Truth for the Training Set Was Established

• Not applicable. As there is no training set, there is no ground truth established for one.

Ask a specific question about this device