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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® Proximal Humerus System is indicated for fractures, osteotomies and non-unions of the proximal humerus.

The 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 four (4) plate designs to expand the range of Medartis APTUS® Proximal Humerus Fixation devices previously cleared in K120108, and two (2) additional K-wire designs, to expand the range of Medartis APTUS® K-Wires previously cleared in K092038. The subject plates are provided in 10-hole and 14-hole designs, each in anatomic designs for the right and left proximal humerus. The subject plates range in length from approximately 180 mm (10-hole plate) to approximately 230 mm (14-hole plate). The proximal region of the subject plates is identical to the devices previously cleared in K120108. This submission includes a spiral locking blade for use with the subject plates that is similar to the spiral blades cleared in K120108. The subject plates are to be used with previously cleared 3.5 mm diameter locking screws and non-locking (cortical) screws. The subject device plates and spiral blades are made of unalloyed titanium conforming to ASTM F67.

The subject device K-wires have a diameter of 2.0 mm and an overall length of 150 mm, and are provided with a trocar tip or lancet (bayonet) tip. The subject device K-wires are also compatible with the subject plates, and with the proximal humerus plates cleared in K120108. The subject K-wires are made of stainless steel conforming to ASTM F138.

The provided document describes a 510(k) premarket notification for a medical device, the APTUS® Proximal Humerus System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving that the device meets specific acceptance criteria based on studies involving human subjects or AI performance metrics.

Therefore, many of the requested details, such as acceptance criteria, reported device performance (in terms of sensitivity, specificity, etc.), sample sizes for test sets (for AI), number of experts for ground truth, adjudication methods, MRMC studies, standalone AI performance, type of ground truth used (for AI), training set sample size, and ground truth establishment for training sets, are not applicable to this type of regulatory submission as presented in the document.

The performance data mentioned in the document are focused on non-clinical mechanical testing to demonstrate the structural integrity and equivalence of the new device components to existing predicate devices.

Here's an breakdown of the available information based on your request:

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

• Acceptance Criteria: Not explicitly stated as pass/fail thresholds for clinical performance or AI metrics. The acceptance is based on demonstrating "substantial equivalence" to predicate devices through mechanical testing and comparison of design, materials, and intended use. The implicit acceptance criterion is that the new components perform at least as well as, or are equivalent to, the predicate devices in terms of mechanical properties.
• Reported Device Performance:

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

• Not applicable. This submission focuses on non-clinical mechanical testing, not a clinical trial or AI evaluation with a test set of patient data. Therefore, there's no "test set" in the sense of patient data.

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. No ground truth established with experts for clinical or AI performance. The "ground truth" here is the established mechanical performance of the predicate devices.

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

• Not applicable. No adjudication method for clinical or AI performance is described.

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 is not an AI device. No MRMC study was performed or is relevant to this submission.

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)

• The "ground truth" in this context refers to the established mechanical and material properties of the predicate devices. The subject device's performance was compared against these established properties to demonstrate substantial equivalence.

8. The sample size for the training set

• Not applicable. This is not an AI device.

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

• Not applicable. This is not an AI device.

Summary from the document regarding the study:

The study conducted for the APTUS® Proximal Humerus System was a non-clinical evaluation designed to demonstrate substantial equivalence to previously cleared predicate devices. It involved:

• Biocompatibility assessment: Referenced from previous K-clearances (K120108 and K092038), stating that the materials (unalloyed titanium and stainless steel) are identical, supporting biocompatibility equivalence.
• Mechanical testing: Performed according to ASTM F382, demonstrating substantial equivalence to predicate devices K120108 and K041860. This standard likely involves various tests of mechanical properties relevant to bone fixation devices.
• Engineering analysis calculations: Specifically for out-of-plane bending moments of inertia, showing equivalence.
• Comparative dynamic testing: In a simulated fracture model, also demonstrating substantial equivalence to K120108 and K041860.

This approach is standard for 510(k) submissions for orthopedic implants, where the focus is on physical and mechanical properties, material equivalence, and design similarity to already validated devices, rather than clinical performance trials or AI specific evaluations.

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