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510(k) Data Aggregation
(280 days)
APTUS Foot System 2.8-3.5
The APTUS Foot System 2.8-3.5 is indicated for use in fractures, osteotomies and arthrodesis of the tarsals, metatarsals and phalanges.
The subject device sterile screws consist of sterile TriLock screws (locking), Cortical and Cancellous screws (non-locking). The APTUS TriLock Screws, Cortical Screws and Cancellous Screws that are compatible with the subject device plate are manufactured from titanium alloy conforming to ASTM F136. The APTUS K-Wires that are compatible with the subject device plates 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 device-specific instruments (templates) are manufactured from unalloyed titanium, Grade 4, conforming to ASTM F67 Standard Specification for Unalloyed Titanium for Surgical Implant Applications (UNSR50250, UNS R50400, UNS R50550, UNS R50700).
The subject device Medartis APTUS Foot System 2.8-3.5 consisting of following plates and systems: 2.8 TriLock Plate Straight, 2.8 TriLock Plate Hole T Extended and 2.8 TriLock TMT-1 Medial Fusion Plates Large, APTUS Mid- and Hindfoot System 2.8/3.5 and Fusion System 3.5. The APTUS Mid- and Hindfoot System 2.8/3.5 includes TriLock 2.8 C Plates, 2.8 TriLock Calcaneus LCL Plates, 3.5 TriLock Calcaneus LCL Plates and 3.5 TriLock Calcaneus Step Plates. The subject device also includes sterile 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 APTUS Fusion System 3.5 includes 3.5 TriLock Wing Plates, 3.5 TriLock Butterfly Plates, 3.5 TriLock TNC Fusion Plates, 3.5 TriLock NCM Fusion Plates, 3.5 TriLock TNCM Fusion Plates, 3.5 TriLock Talonavicular Fusion Plates. Furthermore, 3.5 TriLock Medial Column Fusion Plates, 3.5 TriLock Distal Medial Column Fusion Plates, 3.5 TriLock Proximal Column Fusion Plates. The APTUS Fusion System 3.5 plates include screw holes designed to accommodate appropriately sized bone screws and K-wires presently marketed as part of the APTUS System. The 2.8 TriLock Straight Plates are generic straight plates and used with 2.8 mm screws. The 2.8 TriLock Plate Hole T Extended are generic T plates and used with 2.8 mm screws. The 2.8 TriLock TMT-1 Medial Fusion Plates Large plates have anatomical designs that are appropriate for either the left or the right foot. The subject device plates are manufactured from unalloyed titanium, Grade 4, conforming to ASTM F67 Standard Specification for Unalloyed Titanium for Surgical Implant Applications (UNSR50250, UNS R50400, UNS R50550, UNS R50700). The subject device sterile screws consist of sterile TriLock screws (locking), Cortical and Cancellous screws (non-locking).
The provided text describes the regulatory filing for the APTUS Foot System 2.8-3.5 and does not contain information related to a study proving the device meets acceptance criteria for an AI/software-based medical device. Instead, it details the substantial equivalence determination for a physical orthopedic implant system.
Therefore, I cannot extract the information required for acceptance criteria and study data for an AI/software device from this document.
The document states: "The mechanical test results show that the acceptance criteria were met. Clinical data were not provided in this submission." This indicates that mechanical testing was performed for the physical device components, but no clinical data (which might involve an AI component) was submitted.
As such, all the specific points requested (sample size, data provenance, expert ground truth, adjudication, MRMC study, standalone performance, ground truth type, training set size, training set ground truth) are not applicable to the provided text.
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(58 days)
APTUS Foot System
The APTUS® Foot System is intended for use in small bones, in particular in fractures, osteotomies and arthrodesis of the tarsals, metatarsals and phalanges.
The subject devices are metallic bone staples to be marketed under the name 'Staple All-in-One'' as part of the APTUS® Foot System. The subject device staples are provided in designs to address clinical needs depending on the size and surface of the bone to be fused, and include two sizes and two angulations (or offsets). Each subject device is provided as a set, comprising the staple and a set of attached instruments. The instruments consist of two drill guide, and a positioning instrument. The drills and drill guide are snapped off of the set prior to use of the staple. The positioning instrument is snapped off of the staple after implantation. The subject device staples and instruments are made of stainless steel conforming to ISO 5832-1 and ASTM F139.
The provided text is a 510(k) summary for the Medartis AG APTUS® Foot System, which is a medical device for bone fixation. It describes the device, its intended use, and how it was deemed substantially equivalent to a predicate device.
It does NOT contain information about any AI/ML-driven device or study results proving acceptance criteria for such a device. The document explicitly states:
"Non-clinical testing data submitted, referenced, or relied upon to demonstrate substantial equivalence included: sterilization validation according to ISO 11137-1, and ISO 11137-3; bacterial endotoxin testing according to ANSI AAMI ST72; sterile barrier shelf life testing according to ISO 11607-1, ISO 11607-2, ASTM F1980, ASTM D4332, ASTM D4169, ASTM F2096, DIN EN 868-5, and ASTM F88/F88M; biocompatibility testing according to ISO 10993-12, ISO 10993-15, and ISO 10993-18: and comparative mechanical testing according to ASTM F564. Clinical data were not provided in this submission."
Therefore, I cannot fulfill your request for information regarding acceptance criteria and a study proving an AI/ML device meets them, as the provided text is for a traditional medical device (a bone fixation staple) and does not involve AI or clinical performance studies for its clearance.
To answer your question accurately, I would need a document that describes the clinical performance evaluation of an AI/ML-driven medical device.
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(206 days)
APTUS Foot System
The APTUS® Foot System is intended for use in small bones, in particular in fractures, osteotomies and arthrodesis of the tarsals, metatarsals and phalanges.
The subject device plates are provided in a variety of anatomical designs, in various lengths, widths and thicknesses. The plate thickness varies from 1.6 mm to 2.0 mm depending on the design. The screw holes of the subject device plates are designed to accommodate appropriately sized subject device screws, or screws presently marketed as part of the APTUS System and previously cleared under K091479. The subject device plates also are compatible with K-wires cleared under K092038. The subject device plates are used with TriLock locking screws and cortical (nonlocking) screws. All subject device screws are self-tapping and self-drilling and provided in diameters of 2.0, 2.8 and 3.5 mm, and in various lengths from 8 to 45 mm.
The subject device plates are made of commercially pure titanium, Grade 4, conforming to ASTM F67 Standard Specification for Unalloyed Titanium for Surgical Implant Applications (UNS R50250, UNS R50400, UNS R50550, UNS R50700). The subject device screws are made of titanium alloy conforming to ASTM F136 Standard Specification for Wrought Titanium-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401).
This document is a 510(k) Premarket Notification from Medartis AG for their APTUS® Foot System. It aims to demonstrate substantial equivalence to previously marketed devices. While it describes performance data, it does not explicitly define acceptance criteria as a standalone statement with pass/fail thresholds. Instead, the "performance data" section outlines the types of testing conducted to support substantial equivalence to predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance:
Since explicit acceptance criteria are not provided, I will infer them based on the types of tests conducted and the general objective of demonstrating substantial equivalence to predicate devices regarding safety and effectiveness. The reported device performance is based on the information provided in the "PERFORMANCE DATA" section.
| Acceptance Criteria (Inferred from testing) | Reported Device Performance (Summary) |
|---|---|
| Dimensional Analysis: Conformity to specified dimensions for plates and screws. | Conducted to demonstrate substantial equivalence; implies conformity. |
| Engineering Analysis: Structural integrity and design parameters. | Conducted to demonstrate substantial equivalence; implies acceptable engineering. |
| Finite Element Analysis (FEA): Simulation of stress, strain, and deformation under load. | Conducted to demonstrate substantial equivalence; implies acceptable mechanical behavior. |
| Mechanical Testing: | |
| * ASTM F543 - Metallic Bone Screws Test Methods: | |
| * Insertion Torque: Acceptable torque for screw insertion. | Tested (subject and predicate screws). |
| * Maximum Torque: Acceptable maximum torque before failure. | Tested (subject and predicate screws). |
| * Pull-Out Testing: Sufficient resistance to pull-out forces. | Tested (subject and predicate screws). |
| * Dynamic Mechanical Testing: Acceptable fatigue strength and durability for plate designs. | Tested (subject and predicate plate designs). |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not explicitly stated for any of the tests. The document only mentions "subject device screws were tested" and "Dynamic mechanical testing of the subject and predicate plate designs also was performed."
- Data Provenance: Not explicitly stated. The tests were performed to support a 510(k) submission for a device manufactured by Medartis AG, located in Basel, Switzerland. The data would have been generated as part of their product development and regulatory submission process. It is generally retrospective for the purpose of a 510(k) submission, meaning the tests were conducted on pre-market devices to gather data for equivalence.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Not Applicable. This submission does not involve a clinical study or a judgmental process requiring expert consensus on a test set (e.g., image interpretation). The "ground truth" for the mechanical and engineering performance data is established by the results of the standardized tests (e.g., ASTM F543) themselves and the comparative analysis against predicate devices.
4. Adjudication Method for the Test Set:
- Not Applicable. No human adjudication method was described as the performance data consisted of dimensional, engineering, finite element analysis, and mechanical testing, not clinical outcomes requiring expert review.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
- No. An MRMC comparative effectiveness study was not done. This submission focuses on the mechanical and design equivalence of a bone fixation system, not on an algorithm or imaging device that would typically involve human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- Not Applicable. This device is a bone fixation system, not a software algorithm. Therefore, a standalone algorithm performance study is not relevant.
7. The Type of Ground Truth Used:
- The "ground truth" for this device's performance is based on engineering standards, material specifications, and objective mechanical test results. For example:
8. The Sample Size for the Training Set:
- Not Applicable. This submission is for a physical medical device (bone fixation system), not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established:
- Not Applicable. As there is no training set for an AI/ML algorithm, the concept of establishing ground truth for it does not apply here.
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(55 days)
APTUS FOOT SYSTEM
The APTUS® Foot System is intended for use in small bones, in particular in fractures, osteotomies and arthrodesis of the tarsals, metatarsals and phalanges.
The APTUS® Foot System consists of small titanium fixation plates, conventional screws and locking screws. The system is intended to be used for internal fixation of small bones in the foot.
The provided text is a 510(k) summary for the Medartis AG APTUS® Foot System, which is a device for internal fixation in small bones. This type of regulatory submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving performance against specific acceptance criteria through a clinical or technical study as might be done for novel devices or software.
Therefore, many of the requested details, particularly those related to performance studies, acceptance criteria, sample sizes, and ground truth establishment, are not applicable to this submission. The 510(k) summary explicitly states that the equivalence is based on "the same intended use," "same operating principle," "same basic design," "same or very similar materials," and "similar packaging and is sterilized using the same materials and processes." It does not describe any new performance studies with specific acceptance criteria.
Below is a response outlining what information can be gleaned from the provided text and indicating where the requested information is not present.
Acceptance Criteria and Study for the Medartis AG APTUS® Foot System
The provided 510(k) summary for the Medartis AG APTUS® Foot System (K091479) focuses on demonstrating substantial equivalence to previously cleared predicate devices. It does not contain information about specific acceptance criteria or an independent study to prove the device meets such criteria in the way that would be described for a novel medical device, especially an AI-powered one. The approval is based on the device's similarity to existing, legally marketed implants.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Not explicitly stated as performance criteria for this device) | Reported Device Performance (as demonstrated by substantial equivalence) |
|---|---|
| Intended Use: (Implied: To be suitable for use in small bones, fractures, osteotomies, arthrodesis of tarsals, metatarsals, phalanges) | Same Intended Use as predicate devices: The APTUS® Foot System is intended for use in small bones, in particular in fractures, osteotomies and arthrodesis of the tarsals, metatarsals and phalanges. This is demonstrated by conceptual equivalence to predicate devices with the same indications. |
| Operating Principle: (Implied: To provide internal fixation for bones) | Same Operating Principle as predicate devices: Provides internal fixation using plates and screws. |
| Basic Design: (Implied: To be a system of plates and screws for small bone fixation) | Same Basic Design as predicate devices: Consists of small titanium fixation plates, conventional screws, and locking screws. |
| Materials: (Implied: Materials suitable for surgical implantation and bone fixation) | Same or Very Similar Materials as predicate devices: Titanium. |
| Sterilization & Packaging: (Implied: To be sterile and packaged appropriately for medical devices) | Similar Packaging and Sterilization using the same materials and processes as predicate devices. |
Explanation: The "acceptance criteria" here are not performance metrics from a new study, but rather the points of comparison used to establish substantial equivalence to predicate devices. The device "meets" these criteria by being sufficiently similar.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. The provided 510(k) summary does not describe a performance study with a test set. Substantial equivalence was demonstrated through comparison to predicate devices, not through new clinical or performance data generation.
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 test set or ground truth establishment by experts is described in this 510(k) summary. This type of information is typically relevant for diagnostic AI/ML devices or novel therapies requiring new clinical evidence.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No test set or adjudication method 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 device is a physical bone fixation system, not an AI software or diagnostic tool that would involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This device is a physical bone fixation system, not an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not Applicable. No ground truth is described. The basis for approval is substantial equivalence to predicate devices, meaning the safety and effectiveness are inferred from devices already on the market with a similar design, materials, and intended use, whose performance has been established over time.
8. The sample size for the training set
- Not Applicable. No training set is described. This device is not an AI/ML algorithm.
9. How the ground truth for the training set was established
- Not Applicable. No training set or ground truth for it is described.
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