Search Results

The Distal Volar Radius Anatomical Plate System is intended for the fixation of fractures and osteotomies involving the distal radius.

The modified Distal Volar Radius Anatomical Plate System is a set of orthopedic plates and fasteners supplied in a sterilization tray together with several reusable and disposable tools. The set of orthopedic plates and fasteners provided in the sterilization tray consists of the following implantable devices: • Distal Volar Plates • Distal Dorsal Nail Plate • Pegs • Screws. Included in the sterilization tray are the following re-useable instruments: • Peg drivers • Other standard surgical tools. In addition, the following are non-reusable instruments included in the sterilization tray: • F.A.S.T. Guide Technology Drill Guide; and • Drill bits

The provided text describes a medical device, the "Distal Volar Radius Anatomical Plate System," seeking 510(k) clearance. However, the document does not contain specific acceptance criteria for device performance or the study details that would prove the device meets such criteria.

The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device, not on meeting predefined performance criteria through a detailed clinical or performance study with acceptance thresholds.

Here's an analysis based on the information provided, highlighting the absence of the requested details:

Acceptance Criteria and Device Performance

Not applicable/Not provided in the document. The document states:

• "Performance standards have not been established by the FDA under section 514 of the Food, Drug and Cosmetic Act."
• "The modified Distal Volar Radius Anatomical Plate System is substantially equivalent to the predicate Distal Volar Radius Repair System. The equivalence was confirmed through pre-clinical testing."

This indicates that the submission relied on demonstrating equivalence to an already legally marketed device rather than proving performance against specific quantitative acceptance criteria in a study. The "pre-clinical testing" mentioned is likely mechanical testing to show similar physical properties to the predicate, not a study with performance metrics in a clinical context.

Table of Acceptance Criteria and Reported Device Performance

Study Details

Based on the provided text, the specific study details for proving performance against acceptance criteria (as would be typical for an AI/diagnostic device) are not present. The submission relies on "pre-clinical testing" to demonstrate substantial equivalence, which typically involves mechanical and material testing rather than studies involving ground truth from experts or multi-reader reviews in a clinical setting.

Therefore, the following points will indicate "Not applicable" or "Not provided" as the information is absent in this 510(k) summary.

1. Sample size used for the test set and the data provenance: Not provided (no clinical test set described). The "pre-clinical testing" typically involves material samples or mechanical models.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/Not provided (no independent ground truth establishment described, as the focus is on substantial equivalence confirmed by pre-clinical testing).
3. Adjudication method for the test set: Not applicable/Not provided.
4. 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 is a medical implant, not an AI diagnostic device).
5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable (Not an algorithm-based device).
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable/Not provided (No ground truth, in the clinical sense, is discussed for performance evaluation). Instead, the "truth" for this submission is established by the accepted performance and safety profile of the predicate device.
7. The sample size for the training set: Not applicable/Not provided (No AI model training described).
8. How the ground truth for the training set was established: Not applicable/Not provided.

Ask a specific question about this device

Ask a specific question about this device

The Small Bone Fixation System is indicated for the fixation of extra-articular fractures of the long bones of the hand including the metacarpals and the proximal and middle phalanges, and the metatarsal bones of the foot.

The Small Bone Fixation System is a sterile, single use, disposable device that is delivered non-toxic. The Small Bone Fixation System consists of the Slotted Awl Assembly, the Implantable Nail Handle Assembly, polymer Nail Cap and Exchange Guide and Bend Tube.

Prior to use, the implantable nail assembly is nested in the slotted awl assembly. The slotted awl assembly has a trocar point. The implantable nail has a blunt point that is positioned just behind the trocar point of the slotted awl. The sharp point of the slotted awl assembly is passed through a small incision. A hole is drilled into the metacarpal bone by twisting the assembled handles back and forth. After gaining access to the intramedullary space, the slotted awl handle is held stationary while the implantable nail is then advanced distally from the base of the metacarpal bone.

The awl handle is then withdrawn and removed for advancement of the implantable nail. The implantable nail is then cut adjacent to the nail handle. Using the bending tube end of the exchange guide and bend tube the implantable nail is bent to 90° with the apex of the bend at the implantable nail insertion site. The nail is trimmed so that the end is below the skin. The small piece remaining will facilitate removal of the implantable nail subsequent to healing. The implantable nail will remain implanted for approximately six weeks. Upon healing of the fracture, the implantable nail is percutaneously removed.

In the event that it is desired to reform the implantable nail or implant a smaller nail, this may be accomplished without losing access to the medullary canal. The exchange guide is advanced along the implantable nail into the medullar space. Once the medullar space is accessed, the nail is removed. Another nail may be placed into the medulla by inserting it into the groove of the exchange guide. After the nail has been inserted into the medullar space, remove the exchange guide.

An optional locking device may be used to minimize rotation of the implantable nail. The device consists of a pointed stainless steel cannula mounted to a polymeric handle. After the implantable nail is bent to a 90-degree angle, the locking sleeve is positioned over the end of the implantable nail and manually advanced downward through the cortical perforation and into the metaphysis. The locking device is then advanced until tactile feedback confirms ratchet engagement. The locking device may be further advance to the desired depth. When resistance is felt, the locking nail is impacted into its final position with a few sharp taps. The nail and locking sleeve are simultaneously trimmed. The polymer nail cap may be placed over the end of the nail during the healing period.

Here's an analysis of the provided text regarding the Small Bone Fixation System, focusing on acceptance criteria and the study proving it:

Summary of Acceptance Criteria and Device Performance for the Small Bone Fixation System

The provided documentation does not detail specific, quantitative acceptance criteria for the device's clinical performance (e.g., fracture healing rates, complication rates). Instead, the acceptance criteria are rooted in compliance with recognized consensus standards and demonstrating substantial equivalence to predicate devices through technological characteristics, biocompatibility, and bench testing.

1. Table of Acceptance Criteria and Reported Device Performance

Study Details:

The provided document describes a 510(k) premarket notification which, by its nature, relies on demonstrating substantial equivalence to a predicate device rather than conducting extensive de novo clinical trials to prove safety and effectiveness from scratch.

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

• Test Set Sample Size: Not applicable in the context of this 510(k) submission. The "test set" here refers to the actual device itself being evaluated against standards and predicate comparison, not a human clinical trial test set.
• Data Provenance: The data provenance is primarily from bench testing and biocompatibility assessments conducted by Hand Innovations, Inc. (the manufacturer). It is internal company data derived from their design, material selection, and testing processes. There is no mention of data from human subjects or external clinical studies.

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

• Not applicable. Ground truth, in the traditional sense of clinical outcomes or expert consensus on medical images, is not established for a clinical test set in this 510(k) submission. The "ground truth" for material properties and technological characteristics is established by the specifications of the ASTM standards themselves and the design documentation/testing of the manufacturer.

4. Adjudication Method for the Test Set:

• Not applicable. There is no mention of an adjudication process in the context of a clinical test set. The substantial equivalence determination is made by the FDA's Office of Device Evaluation based on the submission dossier.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

• No. An MRMC comparative effectiveness study was not performed. This type of study typically involves comparing the diagnostic or prognostic performance of different medical devices or AI algorithms when interpreted by multiple human readers, often with or without AI assistance. This submission focuses on the physical and material equivalence of a surgical implant.

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

• No. This device is a physical surgical implant, not an algorithm or software-as-a-medical-device (SaMD). Therefore, the concept of "standalone algorithm performance" is not relevant.

7. The Type of Ground Truth Used:

• The "ground truth" for this submission is primarily technical specifications defined by recognized consensus standards (ASTM standards) for materials and fixation pins/wires. Additionally, the technological characteristics of legally marketed predicate devices serve as a "ground truth" for comparison.
• Biocompatibility uses "long history of biocompatibility" of the selected materials as part of its evidence base.

8. The Sample Size for the Training Set:

• Not applicable. This device is a physical medical device, not an AI/ML algorithm that requires a "training set" of data.

9. How the Ground Truth for the Training Set was Established:

• Not applicable, as there is no training set for this device.

Ask a specific question about this device

The Fragment Plate System is intended for essentially non load-bearing stabilization and fixation of small bone fragments in fresh fractures, revision procedures, joint fusion, and reconstruction of small bones of the hand, foot, wrist, ankle, humerus, scapula, finger, toe, pelvis, and craniomaxillofacial skeleton.

The Fragment Plate System is comprised of a variety of titanium plates with shapes and sizes designed for internal fixation of small bone fragments. The set also includes screws, pins, and k-wires. The screws and pins are have a center drive head and are 2.5 mm in diameter. The plates will include "Y," straight, right, and left configurations. Manual surgical instruments are supplied with the system to facilitate implantation.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Fragment Plate System:

1. Table of Acceptance Criteria and Reported Device Performance

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

This document describes a premarket notification (510(k)) where substantial equivalence is claimed. It does not present clinical study data with a "test set" in the traditional sense for evaluating device performance in patients.

Instead, the "test set" equivalent primarily involves:

• Bench Testing: Used for the 13-point technological comparison to demonstrate substantial equivalence to the predicate device. The specific sample sizes for these bench tests are not provided in the document.
• Compliance with Standards: The document states compliance with ASTM material and fixation standards. These standards themselves define sample sizes and testing methodologies, but the report doesn't detail the specific number of samples tested by Hand Innovations to meet these standards.

Data Provenance: Not applicable in the context of a clinical test set. The data presented is from internal bench testing and compliance assessments, not patient data.

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

Not applicable. This device's clearance is based on substantial equivalence to a predicate device and compliance with material standards, not on a clinical ground truth established by medical experts for a test set of patient data.

4. Adjudication Method for the Test Set

Not applicable. No clinical ground truth requiring adjudication by experts was established for a test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

Not applicable. This is a medical device (fragment plate system) for surgical fixation, not an AI-powered diagnostic or assistive tool for human readers (e.g., radiologists). Therefore, no MRMC study or AI-related comparative effectiveness was conducted or reported.

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

Not applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" in this context is established by:

• Predicate Device: The performance and safety profile of the "Distal Volar Fracture Repair System" by Hand Innovations, Inc. is the primary ground truth for comparison.
• Industry Standards: The specifications and performance requirements outlined in ASTM F366 and ASTM F136 serve as a ground truth for material properties and fixation characteristics.
• Historical Biocompatibility: The "long history of safe usage" of the implantable materials establishes a form of historical ground truth for biocompatibility.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device, so there is no "training set."

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

Not applicable. No training set for an algorithm was used.

Ask a specific question about this device

The Small Bone Fixation System is indicated for the fixation of extra-articular fractures of the long bones of the hand including the metacarpals and the proximal and middle phalanges.

The Small Bone Fixation System is a sterile, single use, disposable device that is delivered non-toxic. The Small Bone Fixation System consists of the Slotted Awl Assembly, the Implantable Nail Handle Assembly, polymer Nail Cap and Exchange Guide and Bend Tube.

Prior to use, the implantable nail assembly is nested in the slotted awl assembly. The slotted awl assembly has a trocar point. The implantable nail has a blunt point that is positioned just behind the trocar point of the slotted awl. The sharp point of the slotted awl assembly is passed through a small incision. A hole is drilled into the metacarpal bone by twisting the assembled handles back and forth. After gaining access to the intramedullary space, the slotted awl handle is held stationary while the implantable nail is then advanced distally from the base of the metacarpal bone.

The awl handle is then withdrawn and removed for advancement of the implantable nail. The implantable nail is then cut adjacent to the nail handle. Using the bending tube end of the exchange guide and bend tube the implantable nail is bent to 90° with the apex of the bend at the implantable nail insertion site. The nail is trimmed so that the end is below the skin. The small piece remaining will facilitate removal of the implantable nail subsequent to healing. The implantable nail will remain implanted for approximately six weeks. Upon healing of the fracture, the implantable nail is percutaneously removed.

In the event that it is desired to reform the implantable nail or implant a smaller nail, this may be accomplished without loosing access to the medullary canal. The exchange guide is advanced along the implantable nail into the medullar space. Once the medullar space is accessed, the nail is removed. Another nail may be placed into the medulla by inserting it into the groove of the exchange guide. After the nail has been inserted into the medullar space, remove the exchange guide.

An optional locking device may be used to minimize rotation of the implantable nail. The device consists of a pointed stainless steel cannula mounted to a polymeric handle. After the implantable nail is bent to a 90-degree angle, the locking sleeve is positioned over the end of the implantable nail and manually advanced downward through the cortical perforation and into the metaphysis. The locking device is then advanced until tactile feedback confirms ratchet engagement. The locking device may be further advance to the desired depth. When resistance is felt, the locking nail is impacted into its final position with a few sharp taps. The nail and locking sleeve are simultaneously trimmed. The polymer nail cap may be placed over the end of the nail during the healing period.

This document describes a 510(k) premarket notification for a medical device and, as such, focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with specific acceptance criteria and performance metrics in the way a clinical trial for a novel AI or diagnostic device would.

Based on the provided text, the "acceptance criteria" and "device performance" are primarily framed around compliance with recognized consensus standards and demonstrating "substantial equivalence" to existing, legally marketed devices.

Here's an analysis of the provided information, structured around the requested points, with observations where information is not explicitly available:

Acceptance Criteria and Device Performance

2. Sample size used for the test set and the data provenance:

• The document describes bench testing for material and mechanical properties, not a clinical "test set" in the sense of patient data. There is no mention of a specific sample size for a test set of patient data.
• Data provenance for the bench testing is not specified beyond "Hand Innovations design review policy." There is no mention of country of origin or whether a "test set" involved retrospective or prospective data from human subjects.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. This device is a mechanical fixation system, not a diagnostic or AI device that requires expert-established ground truth for a test set of patient data. The "ground truth" here is compliance with engineering and material standards.

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

• Not applicable as there is no mention of a test set involving human judgment or interpretation.

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 is a medical device for bone fixation, not an AI or diagnostic tool that would involve human readers or AI assistance.

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

• Not applicable. This is a mechanical medical device, not an algorithm. Bench testing was performed on the device itself.

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

• The "ground truth" for this submission is adherence to recognized consensus standards (ASTM F138, F899, F86, F366) for material properties and manufacturing practices, and technological equivalence to predicate devices. There is no mention of clinical outcomes data in the context of this 510(k) submission for establishing ground truth.

8. The sample size for the training set:

• Not applicable. This device does not involve a "training set" in the context of machine learning or algorithms. Its design and manufacturing follow established engineering principles and quality system regulations.

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

• Not applicable for the same reason as point 8.

Ask a specific question about this device

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

The Intramedullary Fixation System is indicated for the fixation of extra-articular fractures of the long bones of the hand including the metacarpals and the proximal and middle phalanges. The optional locking device may be used to minimize axial and rotational motion of the implantable nail during healing.

The Intramedullary Fixation System for the Hand is a sterile, single use, disposable device that is delivered non-toxic. The Intramedullary Fixation System for the Hand consists of the Slotted Awl Assembly, the Implantable Nail Handle Assembly, and Exchange Guide and Bend Tube. Prior to use the implantable nail assembly is nested in the slotted awl assembly. The slotted awl assembly has a trocar point. The implantable nail has a blunt point that is positioned just behind the trocar point of the slotted awl. The sharp point of the slotted awl assembly is passed through a small incision. A hole is drilled into the metacarpal bone by twisting the assembled handles back and forth. After gaining access to the intramedullary space, the slotted awl handle is held stationary while the implantable nail is then advanced distally from the base of the metacarpal bone. The awl handle is then withdrawn and removed for advancement of the implantable nail. The implantable nail is then cut adjacent to the nail handle. Using the bending tube end of the exchange guide and bend tube the implantable nail is bent to 90° with the apex of the bend at the implantable nail insertion site. The nail is trimmed so that the end is below the skin. The small piece remaining will facilitate removal of the implantable nail subsequent to healing. The implantable nail will remain implanted for approximately six weeks. Upon healing of the fracture, the implantable nail is percutaneously removed. In the event that it is desired to reform the implantable nail or implant a smaller nail, this may be accomplished without loosing access to the medullary canal. The exchange guide is advanced along the implantable nail into the medullar space. Once the medullar space is accessed, the nail is removed. Another nail may be placed into the medulla by inserting it into the groove of the exchange guide. After the nail has been inserted into the medullar space, remove the exchange guide. An optional locking device may be used to minimize rotation of the implantable nail. The device consists of a pointed stainless steel cannula mounted to a polymeric handle. After the implantable nail is bent to a 90-degree angle, the locking sleeve is positioned over the end of the implantable nail and manually advanced downward through the cortical perforation and into the metaphysis. The locking device is then advanced until tactile feedback confirms ratchet engagement. The locking device may be further advance to the desired depth. When resistance is felt, the locking nail is impacted into its final position with a few sharp taps. The nail and locking sleeve are simultaneously trimmed.

Here's a breakdown of the acceptance criteria and study information for the Intramedullary Fixation System for the Hand, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not explicitly stated as a numerical sample size for a clinical test set. The submission focuses on bench testing and material standards compliance.
• Data Provenance: The 'data' primarily comes from:
  • Bench tests: Conducted to establish safety and efficacy.
  • Material standards compliance: Based on the properties of the materials used in the device.
  • Comparison to a predicate device: The K-wire manufactured by MicroAire Surgical Equipment.
• Retrospective or Prospective: Not applicable as a clinical study with retrospective/prospective patient data is not described. The studies were laboratory-based (bench testing) and materials analysis.

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

• Number of Experts: Not applicable. Ground truth, in this context, refers to established engineering standards, material properties, and comparative performance against a predicate device.
• Qualifications of Experts: Not applicable for establishing ground truth in this type of submission. The 'expertise' lies in the established ASTM standards and the technical assessment by the manufacturers and presumably, the FDA reviewers.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. There was no human interpretation or adjudication described for the bench test results or material compliance. The results would be objectively measured against predefined criteria or the predicate device's performance.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not done.
• Effect Size of AI: Not applicable, as this device submission predates widespread AI integration in medical devices of this type and does not involve AI.

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

• Standalone Performance: No, a standalone algorithm performance study was not done. This device is a mechanical implant, not an AI or software algorithm.

7. The Type of Ground Truth Used

• Type of Ground Truth:
  • Engineering Standards: Adherence to recognized ASTM standards for materials and fixation pins/wires.
  • Predicate Device Performance: Performance data from the legally marketed predicate device (K-wire by MicroAire Surgical Equipment) served as a benchmark for equivalence in bench testing (stiffness/yield, cutting geometry, drilling).
  • Biocompatibility Data: Established history of biocompatibility for the materials used.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This device is a physical implant, not an AI or machine learning model that requires a "training set." The design and manufacturing processes are iterative, but there is no specific "training set" in the computational sense.

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

• Ground Truth Establishment for Training Set: Not applicable. As there is no training set, there is no ground truth established for one. The design and validation relied on established engineering principles, material science, and comparison to existing, proven devices.

Ask a specific question about this device

Ask a specific question about this device