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The APTUS® Titanium Fixation System is indicated for use in hand and forearm fractures 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 near joints with or without joint
• involvement, shaft fractures, comminuted fractures, dislocation fractures, avulsion fractures
• · DIP and PIP arthrodeses
• APTUS® Radius 2.5 group:
• · Management via radio volar approach of extra-aticular extension and flexion fractures, articular extension and flexion fractures, correction osteotomies for badly healed radius fractures
• Management via dorsal approach of ractures 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.

APTUS® 2.0/2.3 Four Corner Fusion Plate
The APTUS® 2.0/2.3 Four Corner Fusion Plate, an addition to the APTUS® Titanium Fixation System, is designed specifically for fusion of carpal bones including: hamate, capitate, lunate, triquetrum and is for use in patients suffering pain and/or loss of function due to osteoarthritis, post-traumatic arthritis, fractures, revision of failed partial wrist fusions, carpal instability, or rheumatoid arthritis. The fusion plate is used in conjunction with locking and non-locking screws that fix the plate to the carpal bones of the hand.

APTUS® K-Wire System
The APTUS® K-Wire System is intended for use in fixation of bone reconstruction, and as guide pins for insertion of other implants.

APTUS® 1.5 TriLock
The APTUS® 1.5 TriLock is indicated 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, fractures near joints with or without joint
• involvement, shaft fractures, comminuted fractures, dislocation fractures, avulsion fractures
• DIP and PIP arthrodeses
• APTUS® Radius 2.5 group:
• · Management via radio volar approach of extra-aticular extension and flexion fractures, articular extension and flexion fractures, correction osteotomies for badly healed radius fractures
• Management via dorsal approach of ractures 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.

APTUS® Ulna Plates
APTUS® Ulna Plates are indicated for fractures and osteotomies, in particular for the ulna.

APTUS® Wrist 2.5 System
APTUS® Wrist 2.5 System is indicated for use in hand and forearm fractures and arthrodeses.

APTUS® Wrist Arthrodesis Plates APTUS® Wrist Arthrodesis Plates are indicated for wrist arthrodesis.

APTUS® Forearm Shaft Plates
APTUS® Forearm Shaft Plates are indicated for management of fractures and osteotomies of the radius and ulna shaft.

The Sterile Products of the APTUS System is a plating, screw, and K-wire system for internal fixation of the hand, wrist, and/ or forearm. All plates have anatomical designs that are appropriate to their intended use. The subject device plates includes crew holes designed to accommodate appropriately sized bone screws.

Sterile Products of the APTUS System plate, screw, and K-wire system are the previously cleared predicate and additional predicate devices. The overal dimens of the subject device plates have the same lengths, widths, and thicknesses as the previously cleared predicate and additional predicate device screws have the same design as the previously cleared Medartis APTUS Screws under K051567, K103332, and K142906. These include both locking (cortical) screws. The subject device K-wires have design as the previously cleared APTUS K-Wires System under K092038. The K-wires are provided with a diameter of 1.2, 1.6, or 1.8 mm. All have a length of 150 mm. Single-ended trocar points are provided in 1.2 mm and 1.6 mm diameters, and single-ended bayonet (lancet) points are provided at all 3 diameters.

This submission includes all plates screws, and K-wires that have been previously cleared under the predicate devices by Medartis AG, however, they will be provided in a sterile condition.

All subject device plates are manufactured from unalloyed titanium conforming to ASTM F67.

All subject device screws are manufactured from titanium alloy conforming to ASTM F136.

All subject device K-wires are manufactured from stainless steel conforming to ASTM F138.

All subject devices are associated with the predicate device and/or an additional predicate device mentioned in the predicates and product list sections.

This document is a 510(k) Premarket Notification from the FDA regarding a medical device called "Sterile Products of the APTUS System." It describes the device, its intended use, a comparison to previously cleared predicate devices, and a summary of non-clinical testing.

However, this document does NOT contain information about acceptance criteria or a study that proves the device meets those criteria in the context of an AI/ML medical device. The product is a bone fixation system (plates, screws, and K-wires), and the 510(k) submission is primarily focused on demonstrating substantial equivalence to already marketed devices, especially regarding the sterilization process and packaging of these physical implants.

The questions you've asked (e.g., sample size for test set, number of experts for ground truth, MRMC studies, standalone performance) are highly relevant to the validation of AI/ML-enabled medical devices that perform tasks like image analysis, diagnosis, or prediction. This document describes a physical implantable device, not an AI/ML algorithm.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study proving the device meets them in the context of AI/ML, as this information is not present in the provided text. The document is about hardware (bone fixation systems) and its sterilization, not software or AI performance validation.

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APTUS® Cannulated Compression Screws and headed Cannulated Compression Screws are intended for the treatment of fractures, osteotomies and arthrodesis of bones with the appropriate screw size.

APTUS® K-Wire System is intended for use in fixation of bone fractures, for bone reconstruction, and as guide pins for insertion of other implants.

The subject device includes APTUS Cannulated Compression Screws in thread diameters 1.7 mm, 2.2 mm, 3.0 mm, 5.0 mm, and APTUS headed Cannulated Compression Screws in diameters 2.2 mm, 3.0 mm, 5.0 mm, and 7.0 mm. APTUS Cannulated Compression Screws are headless screws that incorporate threads with different pitch on the head and tip of the screws; this difference in pitch provides compression as the screw is inserted. APTUS headed Cannulated Compression Screws have conventional bone screw heads that apply compression between the threads and the head. Both types of screws provide compression of the bone segments upon insertion of the screw. Additionally, all subject device screws have a triangular SpeedTip® shape designed to improve cutting and insertion torque and an internal hexalobular instrument face.

The APTUS Cannulated Compression Screws and APTUS headed Cannulated Compression Screws come in partially threaded and fully threaded designs. The 1.7 mm diameter screws are provided in overall lengths ranging from 8 mm to 20 mm. The 2.2 mm diameter screw are provided in overall lengths ranging from 10 mm to 40 mm. The 3.0 mm diameter screws are provided in overall lengths ranging from 10 mm to 40 mm. The 4.0 mm diameter screws are provided in overall lengths ranging from 16 mm to 60 mm. The 5.0 mm diameter screws are provided in overall lengths ranging from 24 mm to 70 mm. The 7.0 mm diameter screws are provided in overall lengths ranging from 30 mm to 140 mm.

The subject device 1.7 mm, 2.2 mm, 4.0 mm, 5.0 mm, and 7.0 mm thread diameter APTUS Cannulated Compression Screws and APTUS headed Cannulated Compression screws are used with the corresponding subject device K-wires (0.6, 0.8, 1.1, 1.25, 1.6, and 2.2 mm, respectively). The subject device screws also are compatible with the Medartis K-wires cleared under K092038. Similarly, the subject device K-wires are compatible with the APTUS Cannulated Compression Screws cleared under K133460 and K110658.

This submission also includes the corresponding washers for APTUS headed Cannulated Compression Screws.

The subject device cannulated compression screws and washers are manufactured from titanium allov conforming to ASTM F136 Standard Specification for Wrought Titanium-61 anadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401). The subject device K-wires are manufactured from stainless steel conforming to ASTM F138 Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673).

All subject devices are provided non-sterile to the end user. The subject devices are single-use only.

This document describes a 510(k) premarket notification for Medartis AG's APTUS Cannulated Compression Screws, APTUS headed Cannulated Compression Screws, and APTUS K-Wire System. This is a submission for medical devices that are typically evaluated based on substantial equivalence to predicate devices, rather than strict performance against predefined acceptance criteria for a new clinical indication. Therefore, the information you've requested regarding acceptance criteria and a study proving those criteria are met is not directly applicable in the context of this 510(k) submission as it would be for a novel diagnostic AI device.

Instead, the submission focuses on demonstrating that the new devices are "substantially equivalent" to already legally marketed predicate devices. This is typically done through comparisons of:

• Intended Use/Indications for Use: Ensuring the new device is used for the same purpose and in similar patient populations as the predicate.
• Technological Characteristics: Comparing materials, design, operating principles, and performance.
• Performance Data: This is usually non-clinical testing (e.g., mechanical, biocompatibility, sterilization) to show that any differences in technological characteristics do not raise new questions of safety or effectiveness. Clinical data are often not required for 510(k) submissions unless deemed necessary to address a specific safety or effectiveness concern.

Given this context, I will address your points based on the information provided in the document, interpreting "acceptance criteria" through the lens of "substantial equivalence" as demonstrated by the non-clinical performance data.

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

Since this is a 510(k) submission for substantial equivalence rather than a device with a novel performance claim requiring specific clinical acceptance criteria, the document does not present a table of acceptance criteria in the manner you might expect for a diagnostic AI device. Instead, "acceptance criteria" are implicitly met by demonstrating that the device performs equivalently to the predicates in specific engineering tests.

The document states that performance data relied upon "include: biocompatibility referenced from K133460, K110658, K092038, and K193633; moist heat sterilization (to be performed by the end user) also referenced from K133460, K110658, and K193633; X-ray beam sterilization, packaging, and sterile barrier shelf life referenced from K191848 and K 193633; and mechanical testing according to ASTM F543 Standard Specification and Test Methods for Metallic Medical Bone Screws."

This implies that the "acceptance criteria" are compliance with recognized standards and demonstrated equivalence to predicate devices.

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

The document primarily refers to non-clinical testing (biocompatibility, sterilization, mechanical testing). For such tests, the "sample size" is typically defined by the requirements of the specific ASTM standards or other test protocols. The document does not specify the exact number of devices tested for each non-clinical performance test (e.g., how many screws were subjected to ASTM F543).

• Data Provenance: The document does not specify the country of origin for the non-clinical test data. Given Medartis AG is based in Switzerland and their consultant PaxMed International, LLC is in the USA, it's likely the testing was conducted in ISO-accredited labs in one of these regions or globally. The data would be considered prospective in the sense that the tests were conducted specifically for this submission to demonstrate the device's characteristics against a standard or predicate.
• Clinical data: The document explicitly states: "Clinical data were not provided in this submission." Therefore, there is no "test set" of patient data for clinical evaluation.

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. Since no clinical data was provided and the evaluation relies on non-clinical testing and substantial equivalence to predicates, there was no "ground truth" to be established by clinical experts in the context of this 510(k) submission.

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

Not applicable, as there was no clinical 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

Not applicable. This device is a bone fixation fastener and K-wire system, not an AI or diagnostic imaging device.

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

Not applicable. This is not an algorithm or AI device.

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

For the non-clinical performance data, the "ground truth" or reference is established by recognized industry standards (e.g., ASTM F543) and the established safety and effectiveness profile of the predicate devices. The mechanical properties are compared against benchmark values or the performance of the predicate. Biocompatibility relies on the known properties of the materials used in accordance with established standards.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that requires a training set.

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

Not applicable. This is not an AI/machine learning device.

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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.

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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The APTUS® Foot 2.8-3.5 System is intended for use in fractures, osteotomies and arthrodesis of the tarsals, metatarsals and phalanges.

The subject device includes: various designs of bone plates (23 plates); wedges and screws for use with various plates for use in performing an opening wedge osteotomy (8 wedges); 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 4.0 Cancellous Screws in various lengths.

The subject device plates are provided in multiple anatomic designs that vary in length, width, and thickness. The overall dimensions of the plates vary in width from approximately 12 mm to 29 mm, and in length from approximately 25 mm to 92 mm. The plates vary in thickness from 1.6 mm to 2.5 mm.

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 overall lengths ranging from 8 mm to 60 mm. The subject device non-locking cancellous screws have a diameter of 4 mm and overall lengths ranging from 10 mm to 60 mm. The 2.8 Cortical Screws (non-locking), the 3.5 Cortical Screws (non-locking), and the 4.0 Cancellous Screws (non-locking) all 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 under 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, and a new design of 4.0 Cancellous Screws, with a diameter of 4.0 mm and lengths of 10 mm to 60 mm.

The subject device also includes wedges that are used to support fixation of an opening wedge osteotomy. The wedges are stabilized by corresponding wedge screws that are placed through a plate. The subject device wedges are provided in two size series. The small wedges are 7 mm wide and vary in thickness from 4 mm to 7 mm. The large wedges are 10 mm wide and vary in thickness from 6 mm to 12 mm. The corresponding wedge screws are provided in two sizes: the small wedge screw is used to attach a wedge using an HD7 plate hole (2.8 mm screw hole), and the large wedge screw is to attach a wedge using an HD15 plate hole (3.5 mm screw hole).

The subject device plates, wedges, and screws are manufactured from unalloyed titanium conforming to ASTM F67 or titanium alloy conforming to ASTM F136.

Here's an analysis of the provided text regarding the acceptance criteria and study for the APTUS® Foot 2.8-3.5 System:

Summary of Acceptance Criteria and Device Performance (Based Only on Provided Text):

The provided text does not explicitly state quantitative acceptance criteria or a direct study that proves the device meets specific acceptance criteria in a numerical or statistical manner as might be seen for an AI/CADe device. Instead, the "acceptance criteria" are implied to be the demonstration of substantial equivalence to predicate devices through various tests and comparisons.

Detailed Information on the Study:

The provided text describes a non-clinical study primarily focused on demonstrating substantial equivalence for a medical orthopedic device (bone fixation system), not an AI/CADe system. Therefore, many of the requested categories (e.g., test set sample size, data provenance, number of experts for ground truth, MRMC study, standalone performance) are not directly applicable or are not detailed in the context of this device's regulatory submission.

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

   • Test Set Sample Size: Not explicitly stated as a "test set" in the context of clinical data or AI model evaluation. For the mechanical testing, it refers to "worst-case simulated fracture or osteotomy constructs" and "comparative dynamic testing." The exact number of constructs or tests performed isn't specified.
   • Data Provenance: Not applicable in the human/data sense. The "data" comes from engineering analysis and mechanical testing performed by the manufacturer, Medartis AG (Switzerland).

2. 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 not a study involving human interpretation of data where expert ground truth would be established in this manner. The "ground truth" here is based on engineering principles, ASTM standards, and direct comparison to existing, cleared predicate devices.

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

   • Not applicable. This is not a study involving human interpretation of data requiring adjudication.

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:

   • No, a multi-reader multi-case study was not done. This is a submission for a mechanical orthopedic device, not an AI/CADe product.

5. 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.

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

   • The "ground truth" or basis for comparison for this device's performance relies on established engineering standards (ASTM F543), comparison to the mechanical performance of legally marketed predicate devices, biocompatibility standards, and manufacturing process consistency. It's a technical and regulatory "ground truth" rather than a clinical or pathological one.

7. The sample size for the training set:

   • Not applicable. There is no "training set" in the context of an AI model for this device.

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

   • Not applicable. There is no "training set" for this device.

Conclusion from the document:

The study demonstrating the device meets the acceptance criteria is primarily a non-clinical engineering and comparative analysis study. It relies on:

• Biocompatibility and sterilization data from previously cleared devices (predicates K091479, K191848, K181425).
• Engineering analysis.
• Cantilever construct fatigue bend testing of existing products against the predicate.
• Comparative dynamic testing of "worst-case simulated fracture or osteotomy constructs" for subject device plates against specific predicate plates (K061808, K052614).
• Mechanical testing of subject device screws according to ASTM F543 against specific predicate screws (K000684, K052614).
• Demonstration of identical materials and manufacturing processes to the primary predicate device (K091479).

The "study" collectively concludes that based on these non-clinical data, the performance of the APTUS® Foot 2.8-3.5 System was judged to be substantially equivalent to the referenced predicate devices, thereby meeting the necessary criteria for FDA clearance. Clinical data were not provided in this submission.

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APTUS® Clavicle System is indicated for treatment of fractures, osteotomies, malunions and non-unions of the clavicle.

This submission includes a total of 22 bone plates for internal fixation of the clavicle.

Superior Lateral Plates are provided in 12-hole and 14-hole designs for the left and right clavicle, with pre-bent flaps that allow for additional anteroposterior screw fixation. The Superior Lateral Plates include an oblong hole in the plate for an optional plate insert that is provided in two (2) designs: one insert design is for suture fixation of the coracoclavicular ligament, and one insert design is for placement of an additional cortical screw. The Superior Lateral Plates have a curved shape, a maximum thickness of 3.4 mm. and an overall length between approximately 78 mm and 100 mm.

Superior Lateral Shaft Plates are provided in an 11-hole design for the left and right clavicle. The Superior Lateral Shaft Plates are designed for stable fixation of fractures on the lateral third of the midshaft without compromising the capsule and the acromioclavicular (AC) joint. The Superior Lateral Shaft Plates have a curved shape, a maximum thickness of 3.4 mm, and an overall length of approximately 94 mm.

Superior Midshaft Plates are provided in 6-hole, 10-hole, and 12-hole designs for the left and right clavicle. The 8-hole plates are provided with three (3) different S-shaped curvatures. The plates have a maximum thickness of 3.4 mm and an overall length between approximately 84 mm and approximately 141 mm.

Anterior Midshaft Plates are provided in 6-hole, 8-hole, and 10-hole designs for midshaft fractures of the clavicle. The Anterior Midshaft plates are designed for use on either the left or right clavicle. The plates have a maximum thickness of 3.4 mm, and an overall length between approximately 8 mm and approximately 118 mm.

The Anterior Lateral Plate is provided in a 6-hole design for lateral fractures of the left or right clavicle. The plate has a maximum thickness of 3.4 mm, and an overall length of approximately 80 mm.

All of the subject device plates and the plate inserts for the Superior Lateral Plates are manufactured from titanium alloy conforming to ASTM F136.

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 and were previously cleared in K091479 and K103332. The subject device plates also are compatible with 1.6 mm diameter Medartis APTUS® K-Wires previously cleared in K092038.

The provided document is a 510(k) summary for the Medartis APTUS Clavicle System. It details the device's substantial equivalence to predicate devices, focusing on design, intended use, and technological characteristics. However, it explicitly states that clinical data were not provided in this submission. The performance data consists solely of non-clinical testing.

Therefore, the document does not contain information about acceptance criteria for device performance based on clinical outcomes or studies that typically involve human subjects or expert assessment.

Here's a breakdown of what can be extracted or inferred from the provided text, and what is explicitly stated as not available:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample size: Not applicable for clinical test sets as "Clinical data were not provided in this submission." For non-clinical mechanical testing, the mechanically weakest subject device plate was selected for three groups of the subject device plates. Specific numbers of plates tested are not provided.
• Data provenance: Non-clinical (laboratory testing). No country of origin for non-clinical test data is specified. The study is not retrospective or prospective in a clinical sense as it is entirely non-clinical.

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

• Not applicable. No clinical ground truth was established by medical experts for this submission as "Clinical data were not provided in this submission." The ground truth for non-clinical testing is based on engineering principles and material science.

4. Adjudication method for the test set:

• Not applicable. No clinical test set or adjudication by experts was performed.

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 a medical device (bone fixation system), not an AI diagnostic or assistive device. Therefore, no MRMC study or AI-related comparative effectiveness was conducted or is relevant.

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

• No. This is a medical device (bone fixation system), not an algorithm or software. No standalone algorithm performance was assessed.

7. The type of ground truth used:

• Non-clinical: Engineering measurements and material property standards (e.g., ASTM F136 for titanium alloy, ASTM F67 for unalloyed titanium, ASTM F138/F139 for stainless steel). The "ground truth" for substantial equivalence was based on comparisons of design, materials, intended use, and mechanical performance to predicate devices already on the market.

8. The sample size for the training set:

• Not applicable. This is a traditional medical device submission, not an AI/machine learning device that would typically have a "training set."

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

• Not applicable. No training set or associated ground truth was established as this is not an AI/machine learning device.

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