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The proposed Mini Fragment Plates are intended for essentially non load bearing stabilization and fixation of small bone fragments in fresh fractures, revision procedures, joint fusion, and reconstructions of small bones of the hand, foot, wrist, ankle, humerus, scapula, finger, toe, pelvis, and craniomax, illofacial skeleton.

The proposed Mini Fragment Plates are 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: Fragment Plates that are provided in the following design configurations: Straight, Y, Right Hockey Stick, and Left Hockey Stick. Pegs; Screws; and K-Wires. 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, Drill bits.

The provided text is for a 510(k) premarket notification for "Mini Fragment Plates", a type of orthopedic implant. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with acceptance criteria in the context of device performance metrics like sensitivity, specificity, or reader studies.

Therefore, the requested information, such as acceptance criteria, reported device performance, sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth types and establishment, are not present in the provided document.

Instead, the document details:

• Device Name: Mini Fragment Plates
• Manufacturer: Hand Innovations, LLC
• Predicate Device: Fragment Plate System (K041081)
• Classification: Class II
• Indications for Use: Stabilization and fixation of small bone fragments in fresh fractures, revision procedures, joint fusion, and reconstructions of small bones of the hand, foot, wrist, ankle, humerus, scapula, finger, toe, pelvis, and craniomaxillofacial skeleton.
• Device Description: Orthopedic plates and fasteners (Straight, Y, Right Hockey Stick, Left Hockey Stick), pegs, screws, K-wires, reusable instruments (peg drivers, standard surgical tools), and non-reusable instruments (F.A.S.T. Guide Technology™ Drill Guide, drill bits).
• Biocompatibility: Not required as the material (Ti-6Al-4V ELI per ASTM F 136-00) is the same as the previously approved predicate device and has a long history of safe use.
• Summary of Substantial Equivalence: The proposed Mini Fragment Plates have the same indications for use, intended use, basic shape/design, operating principle, and materials as the predicate device. The changes do not alter the fundamental scientific technology.

This document is a regulatory submission focused on confirming that the new device is "substantially equivalent" to an already approved device, meaning it doesn't raise new questions of safety and effectiveness. It does not involve performance testing against specific clinical or system-level acceptance criteria in the way a novel diagnostic or AI-driven device would.

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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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