(259 days)
The HALLU® Lock Plates are intended for fixation of fractures, osteotomies or arthrodesis of the first metatarso-phalangeal joint. Including cases of:
- Hallux rigidus
- Severe hallux valgus (IM angle >20° and HV angle >40°)
- Deformity from rheumatoid arthritis
- Failed previous surgical procedure
- Traumatic arthritis
- Neuromuscular instability.
The HALLU® Lock plates must be fixed with the SURFIX® fixed angle locking system and with the SURFTX®-Alpha variable angle locking system of 2.7mm or 3.0mm diameter (screws and lock-screws).
Addition of a Newdeal® QWIX® screw crossing the joint is strongly recommended for optimal arthrodesis consolidation
The Newdeal HALLU® Lock Plate System is a low profile Titanium plate dedicated to first metatarso-phalangeal arthrodesis. The HALLU Lock C plates are pre-bent with 10° valgus and 10° dorsiflexion. The HALLU Lock S plates are available with 10° valgus and 10° or 5° dorsiflexion. Pre-operative bending is possible to completely fit to the anatomical shape of the joint. Their fixation is provided by SURFIX and SURFIX ALPHA locking screws.
The provided text describes a medical device, the "Newdeal HALLU® Lock Plate System," which is a bone fixation appliance. It is a 510(k) summary, indicating that it aims to demonstrate substantial equivalence to an existing device rather than presenting entirely new clinical trial data for novel acceptance criteria.
Therefore, the structure of the response will reflect the information available in a 510(k) summary for a substantially equivalent device, focusing on mechanical testing rather than extensive clinical studies.
Here's the information as requested, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical Equivalence to Predicate Device (HALLU® Plate System, K021626) | Mechanical tests have been carried out. Results have shown that the mechanical properties of the modified HALLU® Lock Plate System are equivalent to the properties of the unmodified device, HALLU® Plates, K021626. |
2. Sample Size Used for the Test Set and Data Provenance
The provided text describes mechanical testing, not a clinical study involving human subjects or data related to patient outcomes. Therefore, information regarding "sample size used for the test set" in the context of clinical data, "data provenance (e.g. country of origin of the data, retrospective or prospective)," "number of experts," "adjudication method," "MRMC study," "standalone performance," "type of ground truth (e.g., pathology, outcomes data)," "training set sample size," and "how ground truth for training set was established" are not applicable to this type of submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable (as per explanation in point 2). The ground truth for mechanical testing is typically based on established biomechanical standards and measurements, not expert clinical consensus.
4. Adjudication Method for the Test Set
Not applicable (as per explanation in point 2).
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 plate, and the submission focuses on mechanical equivalence. An MRMC study is relevant for diagnostic imaging AI, which is not the subject here.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
Not applicable. This device is a physical implant, not an algorithm or AI system.
7. The Type of Ground Truth Used
For the mechanical testing performed, the ground truth would be established through objective physical measurements and engineering analyses under controlled laboratory conditions, demonstrating that the new device's mechanical properties (e.g., strength, stiffness, fatigue resistance) fall within acceptable predefined limits or are equivalent to the predicate device.
8. The Sample Size for the Training Set
Not applicable. There is no mention of a "training set" as this is not an AI/machine learning device.
9. How the Ground Truth for the Training Set was Established
Not applicable (as per explanation in point 8).
§ 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.