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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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