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The APTUS® Titanium Fixation System is intended for use in hand and forearm fractures, osteotomies and arthrodeses.

APTUS® Hand group:

• Management of the fractures of the distal, middle and proximal phalanges . and metacarpals
• Management of all types of transversal fractures, spiral fractures, fractures near joints with or without joint involvement, shaft factures, comminuted fractures, dislocation fractures, avulsion fractures
• DIP and PIP arthrodoses t

APTUS® Radius 2.5 group:

• Management via radio volar approach of extra-articular extension and . flexion fractures, articular extension and flexion fractures, correction osteotomies for badly healed radius fractures
• Management via dorsal approach of rare extension fractures that cannot be . adequately reduced via volar approach, procedures for which the soft tissue conditions make a volar approach very difficult or impossible, correction osteotomies requiring stabilization from the dorsal side, carporadial fusions.

The APTUS® Titanium Fixation System consists of implant plates and implant screws and is used for internal fixation of small bones.

APTUS Plates
Implant Modules are provided in sizes Hand 1.2, Hand 1.5, Hand 2.0, Hand 2.3 for miplant Modules are pro rised in oristius reconstruction plate system is used for fixation valious iniger segmonts. The distal for corrective osteotomies of the distal radius with of fractures or the under laccess. Variations of plate shapes include H frame, straight, T and L shaped.

APTUS Screws
Locking screws for the Radius and Hand 2.0 Lock product lines, designated TriLock™, utilize a spherical three point wedge locking design and are used with locking plates. Conventional bone screws have a double thread design and precisely cut sharp thread profile, tapering core diameter and atraumatic tip. The shorter screws have a small pitch in order to maintain optimal purchase in the bone, while the longer screws have a larger pitch in order to minimize the number of revolutions.

This 510(k) summary for the APTUS® Titanium Fixation System does not contain information about acceptance criteria, device performance testing, or clinical studies of the nature you've requested (e.g., sample sizes for test sets, expert ground truth, MRMC studies, standalone performance).

The document is a premarket notification (510(k)) submission to the FDA, which typically focuses on demonstrating substantial equivalence to existing legally marketed predicate devices, rather than presenting a full clinical trial or performance validation of the type you've outlined.

Here's how the provided information relates to your request:

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

• Not provided. This document highlights the "intended use" and "device description" but does not specify quantitative acceptance criteria for performance (e.g., strength, biocompatibility thresholds) or report specific performance metrics against such criteria. The basis for clearance is substantial equivalence to predicate devices, implying similar performance characteristics.

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

• Not provided. No performance test set or associated data provenance is mentioned.

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/Not provided. This type of information is typically for diagnostic or AI-driven devices where ground truth relies on expert interpretations. This document is for a medical implant (fixation system).

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

• Not applicable/Not provided.

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. MRMC studies are relevant for diagnostic devices involving human interpretation, often with AI assistance. This device is a bone fixation system, not a diagnostic tool with an AI component.

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

• Not applicable. This device does not have an algorithm component.

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

• Not applicable/Not provided in the context of device performance. For a fixation system, "ground truth" often refers to clinical success (e.g., fracture healing, absence of complications) which would be assessed in clinical studies, but such studies are not detailed here for this 510(k). The focus is on material properties and mechanical design mirroring predicates.

8. The sample size for the training set:

• Not applicable/Not provided. There is no "training set" as this device does not involve a machine learning algorithm.

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

• Not applicable/Not provided.

Summary of available information relevant to regulatory submission principles:

The 510(k) summary describes the APTUS® Titanium Fixation System as implants (plates and screws) for internal fixation of small bones in hand and forearm fractures, osteotomies, and arthrodeses.

The primary "proof" that the device meets regulatory requirements for marketing is its substantial equivalence to already legally marketed predicate devices. The document lists the following predicate devices:

• Profyle™ Titanium Hand and Small Fragment System (K961497) from Howmedica (Stryker)
• Stryker® Leibinger Universal Distal Radius System (K040022) from Stryker Leibinger
• Distal Radius Fracture Repair System (K002775, K023007, K030198) from Hand Innovations
• Fragment Plate System (K041081) from Hand Innovations

The equivalence is asserted "in indications and design principles." This implies that the materials, mechanical properties (even if not explicitly quantified in this summary), sterilization, and general design features are considered similar enough to the predicate devices that no new safety or effectiveness concerns are raised, negating the need for extensive new clinical studies for this specific clearance.

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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.

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