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510(k) Data Aggregation
(97 days)
APTUS Ulna Plates are indicated for fractures and osteotomies, in particular for the ulna.
The purpose of this submission is to obtain marketing clearance for an additional device design to expand the range of the Medartis APTUS® Ulna Plates, previously cleared under K 103332. The subject device APTUS Distal Ulna Plates is available in four (4) designs with 10 or 12 screw holes. All plates have anatomical designs that are appropriate for either the right ulna. The 10 and 12 hole plates have a length of 53 mm and 66 mm, respectively. The maximum thickness of the plates is 1.6 mm and the maximum width is 15 mm.
The subject device plates include screw holes designed to accommodate appropriately sized bone screws and K-wires presently marketed as part of the APTUS System. The subject device plates are compatible with screws and K-wires previously cleared in K051567 (TriLock), K103332 (cortical), and K092038 (K-wires).
The subject device plates are manufactured from unalloyed titanium, Grade 4, conforming to ASTM F67, and are provided non-sterile and sterile.
This FDA 510(k) summary for the APTUS 2.5 TriLock Distal Ulna Plates does not describe a study involving an AI/Machine Learning device or a diagnostic device. Instead, it describes a medical implant device (bone fixation plates) and its equivalence to previously cleared predicate devices based on mechanical performance data.
Therefore, many of the requested details, such as those related to AI/ML device testing (e.g., test set sample size, ground truth establishment, MRMC studies, training set details), are not applicable to this document.
However, I can extract information relevant to the performance data provided for this specific type of device.
Here's a breakdown of the available information:
1. Acceptance Criteria and Reported Device Performance
For this type of device (bone fixation plates), the "acceptance criteria" and "device performance" are typically related to mechanical integrity and biocompatibility, not diagnostic accuracy.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Mechanical Strength & Durability: The device must withstand forces without failure and maintain integrity over time, demonstrating equivalence to predicates in: | Mechanical Testing: Fatigue Bending Test and Static Bench Testing were performed. |
| - Bending strength (to prevent fracture/deformation) | Result: "Based on the results of the testing, the performance of the subject device was judged to be substantially equivalent to the primary predicate K103332." |
| - Fatigue resistance (to withstand repetitive loading) | (Specific numerical results are not provided in this summary, but the conclusion of substantial equivalence implies they met comparative benchmarks.) |
| Biocompatibility: The materials must be safe for implantation in the human body. | Biocompatibility: The device uses identical materials and manufacturing processes as previously cleared predicate devices (K103332, K193633, K193554, K192984, K192297, K142906), thus demonstrating substantial equivalence regarding biocompatibility. |
2. Sample Size and Data Provenance
- Sample Size for Test Set: The document does not specify the sample size for the mechanical testing (e.g., how many plates were tested). It simply states that "Mechanical testing Fatigue Bending Test and Static Bench Testing" were performed.
- Data Provenance: The mechanical testing was "non-clinical testing data," meaning it was benchtop testing, not involving human subjects. The country of origin for this testing data is not explicitly stated, but the manufacturer (Medartis AG) is based in Switzerland. The data is retrospective in the sense that it supports a new device's clearance based on established methods and comparison to existing predicates.
3. Number of Experts and Qualifications for Ground Truth
- Not Applicable. This is not a diagnostic AI/ML device that requires expert review for ground truth establishment. The "ground truth" for mechanical testing is derived from engineering principles and standards.
4. Adjudication Method for Test Set
- Not Applicable. This is not a diagnostic AI/ML device study requiring adjudication of expert opinions.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Not Applicable. This is not a diagnostic AI/ML device. "Clinical data were not provided in this submission."
6. Standalone Performance (Algorithm only)
- Not Applicable. This is a physical medical device, not an algorithm.
7. Type of Ground Truth Used
- For mechanical testing: Engineering standards and established benchmarks (comparison to predicate device performance).
- For biocompatibility: Material standards and proven safety of identical materials used in cleared predicate devices.
8. Sample Size for Training Set
- Not Applicable. This is not an AI/ML device with a "training set."
9. How Ground Truth for Training Set was Established
- Not Applicable.
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(90 days)
APTUS® Ankle Trauma System 2.8/3.5 is indicated for fractures, osteotomies, malunions and non-unions of the distal tibia and fibula.
The subject device includes various designs for internal fixation of the distal tibia and distal fibula; additional lengths of 3.5 TriLock Screws (locking screws, other lengths cleared in K110908); a new design of 3.5 Cortical Screws (non-locking) in various lengths; and a new design of concave washer for use with Medartis 3.5 Cortical Screws. The subject device plates are provided in multiple anatomic designs that vary in length, width, and thickness. The plat designs include: 3.5 TriLock Distal Tibia L Plates and T Plates; 2.8/3.5 TriLock Distal Tibia Plates Medial; 2.8/3.5 TriLock Distal Tibia Plates Anterolateral; 2.8/3.5 TriLock Distal Fibula Plates Lateral, with and without Flap; 2.8 TriLock Distal Fibula Plates Crossed; and 2.8 TriLock Distal Fibula Plates Straight. The subject device plates are used with TriLock locking screws and non-locking screws (cortical and cancellous), including subject device screws and previously cleared Medartis screws. Compatible TriLock locking screws and non-locking cortical screws have a diameter of 2.8 mm and 3.5 mm, and overall lengths ranging from 8 mm to 60 mm. The 2.8 Cortical Screws (non-locking) and 3.5 Cortical Screws (non-locking) have a double-lead thread design. All TriLock Screws (locking) have a double-lead thread design. The subject device plates also are compatible with Medartis K-Wires cleared in K092038. The subject device screws include screws with the same design as 3.5 TriLock Screws cleared in K110908, with a diameter of 3.5 mm and provided in additional lengths of 10 mm, 12 mm, and 14 mm. The subject device screws also include a new design of 3.5 Cortical Screws provided with a diameter of 3.5 mm and lengths of 10 mm to 60 mm. The subject device plates, washer, and screws are manufactured from unalloyed titanium conforming to ASTM F67 or titanium alloy conforming to ASTM F136. The subject device components are provided non-sterile to the end user.
The provided document is a 510(k) summary for the Medartis AG APTUS® Ankle Trauma System 2.8/3.5. This document describes the device, its intended use, and its substantial equivalence to previously cleared predicate devices. It focuses on the non-clinical performance data (biocompatibility, sterilization, engineering analysis, and mechanical testing) to demonstrate equivalence.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in terms of specific performance metrics with numerical targets. Instead, it relies on demonstrating substantial equivalence to predicate devices through various non-clinical tests and comparisons of technological characteristics. The "reported device performance" is essentially that it met the requirements of these non-clinical tests and is comparable to predicate devices.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility | Referenced from previously cleared devices (K091479, K103332, K192297, and K191848). Implied to meet established biocompatibility standards. |
| Sterilization (for non-sterile components) | To be sterilized by moist heat (by the end-user), referenced from previously cleared devices (K091479, K103332, K192297, and K191848). Implied to meet sterilization efficacy. |
| Sterilization (for sterile components) | X-ray beam sterilization, referenced from K191848. Implied to meet sterilization efficacy. |
| Packaging and Sterile Barrier Shelf Life | Referenced from K191848. Implied to meet standards for maintaining sterility over time. |
| Engineering Analysis (Structural Integrity/Design Validation) | Performed. Details not provided, but implies the design is sound and comparable to predicate devices. |
| Mechanical Testing (e.g., strength, fatigue) | Performed according to ASTM F382 (Standard Specification for Metallic Bone Plates) and ASTM F543 (Standard Specification and Test Methods for Metallic Medical Bone Screws). The document explicitly states the primary predicate device K013248 "is in support of substantial equivalence in terms of comparison mechanical testing" and additional predicate devices are for "comparative mechanical testing." |
| Material Composition | Plates: Unalloyed titanium conforming to ASTM F67 or titanium alloy conforming to ASTM F136. Screws: Ti-6Al-4V alloy, ASTM F136. Washer: Titanium alloy conforming to ASTM F136. This aligns with predicate and reference devices. |
| Indications for Use | Demonstrated as substantially equivalent to predicate devices, noting minor differences that do not impact substantial equivalence. |
| Technological Characteristics (Design, Components, Manufacturing) | Demonstrated as substantially equivalent to predicate devices, noting similar designs, compatible components, and identical manufacturing processes and materials for Medartis AG devices. |
2. Sample Size Used for the Test Set and the Data Provenance
The document explicitly states: "Clinical data were not provided in this submission." This means there was no human-patient-based test set. All data presented (biocompatibility, sterilization, mechanical testing, engineering analysis) are non-clinical.
- Sample Size for Test Set: Not applicable, as no clinical test set was used.
- Data Provenance: Non-clinical (laboratory/bench testing, engineering analysis). No country of origin for human data as none was used.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable, as no clinical test set requiring expert ground truth was used.
4. Adjudication Method for the Test Set
Not applicable, as no clinical test set requiring adjudication was used.
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 device is a metallic bone fixation system, not an AI-powered diagnostic or assistive tool.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical implant, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the non-clinical performance evaluation is based on established engineering and materials standards (e.g., ASTM F382, ASTM F543, ASTM F67, ASTM F136), and documented performance of legally marketed predicate devices.
8. The Sample Size for the Training Set
Not applicable, as no machine learning algorithm requiring a training set was used.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no machine learning algorithm requiring a training set was used.
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(58 days)
APTUS® Forearm Shaft Plates are intended for management of fractures and osteotomies of the radius and ulna shaft.
APTUS® Wrist 2.5 System is intended for use in hand and forearm fractures, osteotomies and arthrodeses.
The subject device includes a total of 10 bone plates for internal fixation of the radius and ulna, and hook plates for fixation of avulsed fragments of the distal radius or ulna. All plates have anatomical designs that are appropriate for either the left or right forearm.
The plates for the shaft of the radius and ulna have similar designs, are provided in designs with 10, 14, 18, or 22 holes, with overall lengths ranging from 80 mm to 160 mm. All plates for the radius and ulna have a maximum width of 10 mm, a maximum thickness of 3.4 mm, and the width and thickness taper at the ends of the plates. The radius shaft plates have a slight curvature to match the anatomy of the radius; the ulna shaft plates are straight.
The subject device hook plates are provided in two designs: a design with two curved hooks and six (6) holes, and a design with four (4) curved hooks and twelve (12) holes. The hook plates have approximate overall dimensions of 8.5 mm width by 17.5 mm length, or 18.5 mm width by 17.5 mm length; both plates are 0.6 mm thick.
The subject device plates include screw holes designed to accommodate appropriately sized bone screws and K-wires presently marketed as part of the APTUS® System. The compatible screws are 2.8 mm in diameter (shaft plates) and 1.5 mm in diameter (hook plates) and were previously cleared in K091479, K103332, and K142906. The subject device plates also are compatible with 1.6 mm diameter Medartis APTUS® K-Wires previously cleared in K092038.
All subject device plates are manufactured from unalloyed titanium conforming to ASTM F67.
This is a 510(k) premarket notification for a medical device (bone fixation plates), not an AI/ML-powered device. Therefore, the sections for AI/ML-specific criteria (e.g., sample size for test/training sets, number of experts for ground truth, MRMC study, standalone performance) are not applicable and cannot be extracted from the provided text.
The document discusses acceptance criteria and proof of device performance in the context of demonstrating substantial equivalence to predicate devices, which is common for traditional medical devices under 21 CFR 888.3030.
Here's an analysis based on the available information:
Acceptance Criteria and Study to Prove Device Meets Criteria
The acceptance criteria for this medical device (APTUS® Forearm Shaft Plates and APTUS® Wrist 2.5 System) are implicitly tied to demonstrating substantial equivalence to legally marketed predicate devices, primarily K142906, APTUS® Wrist 2.5 System, and reference devices K000684, K103332, and K151468. The study aims to show that the new device is as safe and effective as these predicates.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implicit from Substantial Equivalence Justification) | Reported Device Performance / Justification |
|---|---|
| Intended Use Equivalence | The subject device and predicate/reference devices have the same intended use: internal fixation of bones of the upper extremity. Minor differences in IFUs (e.g., specific language for radius/ulna shaft, additional bones, osteopenic bone) do not impact substantial equivalence as they all express equivalent intended use. |
| Technological Characteristics Equivalence (Design Principles) | The subject device and predicate/reference devices have similar technological characteristics and design principles, including screw holes for locking and non-locking screws. |
| Material Equivalence | The subject device plates, K142906, and K103332 are manufactured from identical unalloyed titanium (ASTM F67). The reference device K000684 uses titanium alloy, but this difference is deemed not to impact safety or effectiveness. |
| Physical Dimensions Equivalence | The subject device, predicate, and reference devices encompass a similar range of physical dimensions (overall width, length, thickness) appropriate for the anatomy. Specific mention of similar designs and dimensions for radius/ulna shaft plates (subject device and K000684) and hook plates (subject device and K142906). |
| Compatibility with Screws/K-Wires | The subject device plates accommodate appropriately sized bone screws (2.8mm for shaft, 1.5mm for hook plates) and 1.6mm K-wires previously cleared as part of the APTUS® System (K091479, K103332, K142906, K092038). |
| Biocompatibility | Biocompatibility referenced from K142906 and K103332; all subject device components are manufactured using identical materials and processes as previously cleared Medartis devices. |
| Sterilization | Sterilization referenced from K142906 and K103332; identical packaging materials and sterilization methods are used. |
| Mechanical Performance | Mechanical testing performed according to ASTM F382. |
2. Sample size used for the test set and the data provenance
Not applicable in the context of this 510(k) summary. This submission relies on engineering analysis and mechanical testing of the device itself and comparison to predicates, not a "test set" of patient data for an AI/ML algorithm.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth for an AI/ML algorithm's test set is not relevant here. The "ground truth" for this submission is demonstrating that the device meets defined engineering specifications and is substantially equivalent to existing, safe, and effective devices.
4. Adjudication method for the test set
Not applicable. There is no AI/ML test set requiring 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
No. This is not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
No. This is not an AI/ML algorithm.
7. The type of ground truth used
The "ground truth" for this submission is based on:
- Established engineering standards: ASTM F382 for mechanical testing.
- Regulatory compliance: Adherence to 21 CFR 888.3030.
- Comparison to predicate devices: Demonstrating similar intended use, technological characteristics, materials, dimensions, and performance as devices already cleared by the FDA. This implicitly means the predicate devices' safety and efficacy, established through their own clearance processes, serve as a reference.
8. The sample size for the training set
Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device.
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(52 days)
APTUS® Wrist 2.5 System is intended for use in hand and forearm fractures, osteotomies, and arthrodeses.
The subject device plates have anatomic designs and are provided in two designs, each for the left and right radius: Lunate Facet Plate and Distal Radius Rim Plate. The Lunate Facet Plates have a maximum thickness of 1.6 mm, and maximum overall dimensions of approximately 19 mm x 47 mm before bending to conform to the anatomy of the distal radius. The Distal Radius Rim Plates have a maximum thickness of 1.8 mm, and maximum overall dimensions of approximately 22 mm x 53 mm before bending to conform to the anatomy of the distal radius. The screw holes of the subject device plates are designed to accommodate appropriately sized bone screws (locking and non-locking) presently marketed as part of the APTUS System and previously cleared under K142906, K103332, and K051567. The subject device plates also are compatible with K-wires cleared under K092038. The subject device plates are made of unalloved titanium. Grade 4, conforming to ASTM F67 Standard Specification for Unalloyed Titanium for Surgical Implant Applications (UNS R50250, UNS R50400, UNS R50550, UNS R50700).
Here's an analysis of the provided text regarding acceptance criteria and supporting studies:
This document is a 510(k) summary for the APTUS® Wrist 2.5 System, a bone fixation device. As such, it primarily focuses on demonstrating substantial equivalence to a predicate device rather than setting new, unique performance acceptance criteria for an AI-powered diagnostic device. Therefore, the questions related to AI performance, human reader improvement with AI, ground truth establishment, training sets, and adjudication methods are largely not applicable in this context.
The document describes the device's characteristics and performance data related to its mechanical properties compared to a predicate device to establish substantial equivalence.
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in the sense of specific thresholds for performance metrics that the device must meet to be approved. Instead, it describes comparative performance testing to demonstrate substantial equivalence to a legally marketed predicate device. The implied acceptance criterion is that the subject device's performance is at least equivalent to, or superior to, the predicate device in relevant mechanical tests, and that any differences do not raise new issues of safety or efficacy.
| Acceptance Criteria (Implied) | Reported Device Performance (Subject Device vs. Predicate) |
|---|---|
| Biocompatibility | Substantially equivalent (referenced from K142906) |
| Static Mechanical Testing (21 CFR 888.3030) | Performed according to ASTM F382; results support equivalence. |
| Dynamic Mechanical Testing (Fatigue) | Subject device constructs were superior to predicate device constructs in a simulated fracture model. |
| Design Characteristics | Similar design characteristics, same materials, similar range of physical dimensions. Minor differences in technological characteristics (e.g., specific anatomic shapes, thicknesses) do not raise new safety/efficacy issues. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document refers to "non-clinical testing data," "engineering analysis," "static mechanical testing," and "dynamic mechanical testing." It does not specify sample sizes for these tests (e.g., number of plates tested) nor the country of origin or type (retrospective/prospective) of this engineering data. This is common for mechanical testing, where instead of "samples" in a clinical sense, a sufficient number of test articles are manufactured and tested to ensure statistical validity and representativeness of the production process. Clinical data was explicitly not provided in this submission.
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. This is a mechanical device, not a diagnostic device requiring expert interpretation for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is a mechanical device, not a diagnostic device requiring adjudication of human readings.
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 device is a bone fixation system and does not involve AI or human readers for diagnostic interpretation.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device does not involve an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the mechanical performance of this device would be established through objective, standardized laboratory measurements against known engineering principles and ASTM standards. For biocompatibility, it's based on established material properties and biological response data for Titanium Grade 4. The comparison is made against the performance of a predicate device established through similar testing.
8. The sample size for the training set
Not applicable. This is a mechanical device, not a machine learning model.
9. How the ground truth for the training set was established
Not applicable. This is a mechanical device, not a machine learning model.
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(246 days)
APTUS® Wrist 2.5 System is intended for use in hand and forearm fractures, osteotomies and arthrodeses.
APTUS Wrist 2.5 System consists of titanium locking plates. The plates are secured using previously cleared titanium screws (K103332 and K051567), both locking and non-locking. This submission includes additional lengths of non-locking screws. Plates have a low overall height, rounded edges, polished surfaces and incorporate TriLock Technology with use of TriLock (locking) screws. All plates are made from unalloyed titanium conforming to ASTM F67, and all screws are made from titanium alloy conforming to ASTM F136.
I am sorry, but the provided text is a 510(k) summary for a medical device (APTUS® Wrist 2.5 System), which describes its intended use, device description, and substantial equivalence to predicate devices. It does not contain information about acceptance criteria, device performance, study details for a diagnostic or AI-powered device, or any of the other specific points you requested (sample size, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth establishment, or training set size).
Therefore, I cannot provide the requested table and study description based on the information given.
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