(55 days)
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.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.