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APTUS® Cannulated Compression Screws and headed Cannulated Compression Screws are indicated for the treatment of fractures, osteotomies and arthrodesis of bones with the appropriate screw size in the shoulder, elbow, wrist, hand, knee, and the foot and ankle.

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

The purpose of this submission is to obtain marketing clearance for APTUS® Cannulated Compression Screw, and APTUS® K-Wire System designs to expand the range of Medartis APTUS fixation devices previously cleared in K133460. K110658. K092038 and K202589.

This submission includes for APTUS® Cannulated Compression Screws (non-sterile):

• additional thread lengths for previously cleared thread diameters (2.2 mm, 3.0 mm, and 4.0 mm) - fully threaded screws for two previously cleared thread diameters (2.2 mm and 3.0 mm)

Additionally, the purpose of this submission is to obtain marketing clearance for various APTUS® Kwire designs (non-sterile and sterile) to expand the range of the Medartis APTUS® K-Wire System, previously cleared in K092038, K133460 and K202589, to include longer versions in two (2) diameters (0.8, 1.1 mm). The K-wires are compatible with the subject device cannulated compression screws and APTUS® Cannulated Compression Screws previously cleared in K110658, K133460 and K202589.

All subject device cannulated compression screws are manufactured from titanium alloy conforming to ASTM F136, Standard Specification for Wrought Titanium-6Aluminum- 4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401), the same material for screws previously cleared in K110658, K133460 and K202589.

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), the same material for K-wires previously cleared in K092038, K133460 and K202589.

The provided text describes a 510(k) premarket notification for a medical device (APTUS Cannulated Compression Screws Line Extension and APTUS K-Wire System Line Extension). This type of submission focuses on demonstrating substantial equivalence to a predicate device, primarily through non-clinical performance data.

Crucially, this document does NOT contain information about an AI/ML device, nor does it detail acceptance criteria or a study design for evaluating AI/ML performance.

The "Performance Data" section explicitly states: "Non-clinical testing data submitted, referenced, or relied upon to demonstrate substantial equivalence include: Mechanical testing according to ASTM F543-17 Standard Specification and Test Methods for Metallic Medical Bone Screws, ASTM F1839-08(2021) Standard Specification for Rigid Polyurethane Foam for Use as a Standard Material for Testing Orthopaedic Devices and Instruments and FDA Guidance "Orthopedic Non-Spinal Metallic Bone Screws and Washers – Performance Criteria for Safety and Performance Based Pathway". Based on the results of the testing, the performance of the subject device was judged to be substantially equivalent to the predicate devices K202589, K110658 and K963192. Clinical data were not provided in this submission."

Therefore, I cannot extract the information required to answer your specific questions (e.g., acceptance criteria for AI performance, sample size for test sets of an AI, number of experts, MRMC studies, standalone AI performance, ground truth establishment, training set details) because the provided text is for a hardware medical device (screws and K-wires) and does not involve AI or any form of algorithmic performance evaluation with clinical data.

I am unable to provide the requested table and study details because the provided input does not describe an AI/ML medical device or its performance evaluation.

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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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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 APTUS K-Wire System consists of stainless steel wires of various dimensions and characteristics intended to be used for fixation of bone fractures, for bone reconstruction, and as guide pins for insertion of other implants.

This 510(k) summary for the Medartis AG APTUS® K-Wire System (K092038) does not contain the information requested in your prompt regarding acceptance criteria and a study proving the device meets those criteria.

The document is a premarket notification for a medical device seeking clearance to market based on substantial equivalence to existing devices. It focuses on administrative information, device description, and a claim of equivalence to previously cleared predicate devices.

Here's a breakdown of what the document does provide, and why it doesn't meet your request:

Information Present in the Document:

• Manufacturer Name: Medartis AG
• Device Name: APTUS® K-Wire System
• Intended Use: "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."
• Classification: Class II, Product Code HTY, Regulation 21 CFR 888.3040 (Smooth or threaded metallic bone fixation fastener)
• Device Description: "The APTUS K-Wire System consists of stainless steel wires of various dimensions and characteristics intended to be used for fixation of bone fractures, for bone reconstruction, and as guide pins for insertion of other implants."
• Equivalence Claim: The document states the APTUS K-Wire System is substantially equivalent to previously cleared devices based on sharing the same intended use, operating principle, basic design, similar materials, and similar packaging/sterilization.

Why the Document Doesn't Meet Your Request:

The provided text describes a substantially equivalent pathway to FDA clearance for K092038. This pathway does not typically require the manufacturer to establish entirely new performance acceptance criteria and conduct extensive studies (like clinical trials or standalone performance studies with expert ground truth) to prove the device meets those criteria, as you would for a novel device or a PMA submission.

Instead, the core of a 510(k) relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device. This is done by showing:

• Same intended use.
• Similar technological characteristics. (e.g., materials, operating principles, design).
• If there are differences in technological characteristics, demonstrating via performance data (e.g., bench testing, non-clinical tests) that these differences do not raise new questions of safety and effectiveness.

Therefore, the document explicitly states: "Medartis AG demonstrated that, for the purposes of FDA's regulation of medical devices, the APTUS K-Wire System is substantially equivalent to previously cleared devices." This suggests that the "proof" of meeting safety and effectiveness is tied to the predicate device's established performance, rather than the generation of new, extensive performance data against explicit, novel acceptance criteria for this specific device.

To directly answer your numbered points based only on the provided text:

1. A table of acceptance criteria and the reported device performance: Not provided. The document states substantial equivalence based on material, design, and intended use similarities, not specific performance metrics against defined acceptance criteria.
2. Sample size used for the test set and the data provenance: Not applicable/Not mentioned. No specific "test set" for performance evaluation is described in the context of substantial equivalence to the predicate.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/Not mentioned. Ground truth for a test set is not discussed.
4. Adjudication method for the test set: Not applicable/Not mentioned.
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 K-Wire system, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a K-Wire system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable/Not mentioned.
8. The sample size for the training set: Not applicable/Not mentioned.
9. How the ground truth for the training set was established: Not applicable/Not mentioned.

In summary, this 510(k) submission doesn't contain the type of performance study details you're looking for, as its basis for clearance is demonstrating substantial equivalence to a predicate, not demonstrating performance against specific, newly defined acceptance criteria through a clinical or algorithmic performance study.

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