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The StealthFix Intraosseous Fixation System is indicated for fixation of bone fractures, fusions, or for bone reconstructions, including:

• · Arthrodesis in hand or foot surgery
• · Mono or bi-cortical osteotomies in the foot or hand
• · Fracture management in the foot or hand
• · Distal or proximal metatarsal or metacarpal osteotomies
• · Fixation of osteotomies for Hallux Valgus treatment such as scarf, chevron, etc.

The StealthFix Intraosseous Fixation System is an orthopedic intraosseous staple system consisting of staple and screw implants. The staples consist of two legs or posts connected by a bridge. The staples are available in post diameters of 2.5mm(mini), and 4.5mm(standard). The 2.5mm staples are provided with a bridge span of 10mm and range in post length from 8mm to 12mm. The 3.5mm staples are provided with a bridge span of 15mm and range in post length from 14mm to 20mm. The 4.5mm staples are available in bridge spans of 15mm and range in post length from 14mm to 32mm. The system provides crossing screws for optional fixation with the standard staple implants. Standard staples are designed with a screw slot to accept a crossing screw. The screws are available partially and fully threaded and are 3.5mm in diameter with lengths ranging from 16mm to 38mm in 2mm increments. The partially threaded screws are headed. The fully threaded and headless. The system provides accessory instruments designed for preparation of the and insertion of implants into bone, including implant specific inserters and targeting arms. The implants of the system are available packaged both sterile for single use. The instruments are provided non-sterile, reusable or single be cleaned and sterilized by the end user prior to use. The system also provides some instruments sterile packaged, individually and in sets. Sterile instruments are for single use only.

This document describes the 510(k) summary for the StealthFix Intraosseous Fixation System. It outlines the device, its intended use, and its substantial equivalence to a predicate device.

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are based on demonstrating substantial equivalence to a legally marketed predicate device (K220181). This typically means showing that the new device is as safe and effective as the predicate and does not raise new questions of safety or effectiveness.

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

• Test Set Sample Size: Not explicitly stated as a separate "test set" in the context of clinical or performance data for a diagnostic device. The evaluation primarily relied on engineering analysis, materials comparison, and cadaveric testing.
• Data Provenance:
  • Engineering Analysis: Based on design comparisons and calculations.
  • Cadaveric Testing: Implied to be prospective testing carried out for usability evaluation.
  • Endotoxin Testing: Laboratory testing on device samples.

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

• Number of Experts: Not applicable in the context of this 510(k) summary, as it does not involve a diagnostic algorithm requiring expert-established ground truth on a test set. The assessment is based on physical and engineering properties, and direct comparison to a predicate device.
• Qualifications of Experts: Not specified or relevant for this type of submission.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. The evaluation is not based on interpreting results from a test set that requires expert adjudication.

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: Not applicable. This is a medical device (intraosseous fixation system), not a diagnostic artificial intelligence (AI) device.

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

• Standalone Performance: Not applicable. This is a medical device (intraosseous fixation system), not a diagnostic artificial intelligence (AI) device.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

• Type of Ground Truth: The "ground truth" in this context is established through:
  • Material Specifications: Conformance to ASTM standards for Ti-6Al-4V alloy and Stainless Steel.
  • Design Documentation: Verification of identical staple designs and comparison of screw designs to the predicate device.
  • Engineering Principles: Analysis demonstrating mechanical equivalence or non-inferiority of new screw designs.
  • Performance Standards: Meeting endotoxin limits.
  • Functional Assessment: Cadaveric testing for usability.
  • Predicate Device Performance: The safety and effectiveness of the predicate device (K220181) serves as the benchmark.

8. The Sample Size for the Training Set

• Training Set Sample Size: Not applicable. This device does not involve a "training set" in the context of machine learning or AI.

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

• Ground Truth Establishment for Training Set: Not applicable. This device does not involve a "training set."

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MODUS IMF Screws 2.0 are indicated for temporary use as a supplementary method in reduction and fixation of dislocated or fractured bone fragments, condylar fractures and restoration of occlusion in orthognathic or orthodontic procedures.

The MODUS IMF Screws 2.0 are provided in two screw types with different plateau geometries and various lengths. Both designs are self-drilling with cross heads and include holes for insertion of a wire parallel to the cross head as well as grooves for the attachment of elastic bands.

The provided text is a 510(k) Summary for the MODUS® IMF Screws 2.0. This document outlines the regulatory submission for a medical device and describes its intended use and equivalence to existing devices. It does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert evaluations related to a study.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes used for the test set and data provenance.
3. Number and qualifications of experts for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study results.
6. Standalone (algorithm only) performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

The document is a regulatory submission focused on demonstrating substantial equivalence to predicate devices, not on presenting performance study data against defined acceptance criteria.

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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 Modus® Modular Distraction Osteogenesis System is a subcutaneous distractor system intended for use in fractures, osteotomies and arthrodeses including: treatment of hemifacial microsomia, mandibular hypoplasia, microglossia, defects of the alveolar ridge, atrophic bone segments in the mandible and maxilla, mandibular symphysis widening, growth disturbances of the ascending corpus/ascending ramus, and LeFort I, and LeFort II/III advancements.

The Modus plates are used with the Modus Distraction Cylinders for various applications of the maxillofacial bone structures. The Modus plates are offered in a variety of sizes and are designed to fit the anatomy of the mandible and/or maxilla and allow adjustment of the vector by intra-operative bending if indicated. The Modus Distraction Cylinders are used with the Modus plates and screws for gradual bone distraction osteogenesis and for corrective osteotomies of the mandible and maxilla. The Modus distraction cylinders are available in uni-directional or bi-directional with multiple distraction lengths. Flexible extensions are to be used with distraction cylinders if needed. The extensions allow additional access for distraction of the surgical site. The implant plates and ARS distractors are made of CP titanium Grade 4 and comply with ASTM F 67 standards for unalloyed titanium for surgical implant applications. The MDO distraction cylinders and flexible extensions are made of implant steel that complies with ASTM F 138 or ASTM F 139.

The provided text is a 510(k) summary for the "Modus® Modular Distraction Osteogenesis System," a medical device for bone distraction. This document does not contain any information about acceptance criteria or a study proving the device meets those criteria, nor does it refer to an AI component or software.

Therefore, I cannot provide the requested information. The entire 510(k) summary focuses on administrative information, device description, materials, and substantial equivalence to predicate devices, which is a regulatory pathway for medical devices. There is no mention of performance studies, test sets, experts, or AI.

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The MODUS® Titanium Osteosynthesis System is intended for osteotomies and fractures involving any part of the craniofacial skeleton and requiring positional and functional stability. Indications include fixation in the nasoethmoidal, intraorbital, and frontal sinus areas; fixation of comminuted fractures of maxillo-facial and craniofacial areas; tumor surgery for defect bridging; reconstruction of bony structures by means of mesh materials; coverings for burr holes in the skull; trauma of nasal bones; surgical correction of dentofacial deformations; and reconstruction after tumor surgery.

The MODUS® Titanium Osteosynthesis System consists of implant plates, implant screws and instruments and is used for the internal fixation of fractures, correction osteotomies, the bridging of load bearing bone segments and distraction in the craniofacial skeleton. This submission includes modifications to the MODUS system plates that enhance clinical effectiveness due to improved strength or anatomical adaptation. All modifications discussed in this submission use previously cleared Medartis titanium screws.

The provided text is a 510(k) summary for a medical device modification. It primarily focuses on demonstrating substantial equivalence to a predicate device and does not contain information about acceptance criteria or a study designed to prove the device meets specific performance criteria.

Therefore, I cannot fulfill your request for the detailed information regarding acceptance criteria and the study proving the device meets them, including:

1. A table of acceptance criteria and the reported device performance
2. Sample size used for the test set and data provenance
3. Number of experts used to establish ground truth and their qualifications
4. Adjudication method
5. MRMC comparative effectiveness study details
6. Standalone performance study
7. Type of ground truth used
8. Sample size for the training set
9. How ground truth for the training set was established

The available text focuses on:

• Device Name: MODUS® Titanium Osteosynthesis System
• Manufacturer: Medartis, Inc.
• Predicate Device: MODUS® Titanium Osteosynthesis System from Medartis AG (originally Elekta Instruments, Inc. CMF-Titanium Cranio-Maxillo-Facial Fracture Fixation System, K946165; and MODUS® 2.5 Mandibular Trauma Set, K992683).
• Device Classification: Class II (21 CFR 872.4760), Product Code JEY.
• Intended Use: For osteotomies and fractures involving any part of the craniofacial skeleton requiring positional and functional stability. Specific indications listed include fixation in various craniofacial areas, fixation of comminuted fractures, tumor surgery defect bridging, reconstruction of bony structures with mesh, burr hole coverings, nasal bone trauma, dentofacial deformation correction, and post-tumor surgery reconstruction.
• Device Description: The system includes implant plates, implant screws, and instruments for internal fixation. The current submission is for modifications to system plates to enhance strength or anatomical adaptation, using previously cleared Medartis titanium screws. The materials (CP titanium) meet ASTM F 67 and ISO 5832-2 standards.
• Equivalence to Marketed Product: The modified implants are considered substantially equivalent to the predicate devices due to having the same intended use, operating principle, basic design, and materials.

No performance study details or acceptance criteria are presented in this 510(k) summary.

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