(70 days)
indicated for use for pediatric as well adult Metacarpal-Phalangeal fractures. For external fixation of hand fractures or for distraction of osteotomies for the purpose of distraction osteogenesis as fractures.
The micro distractor/external fixator introduced by NewMedical Technology, Inc., is a device which is substantially equivalent to other marketed external fixators /distractors. Its indications for use are substantially the same, that is, external fracture fixation and/or distraction. The NewMedical Micro Distractor/External Fixator described here is completely identical to the NewMedical Micro Bone Distractor/Fixator that has already been approved by the (FDA/Dental Devices Committee) for use in external fixation of mandibular fractures or for mandibular distraction, referring to NewMedical Technology, Inc. product (K030485).
The main advantages over other marketed devices from other vendors include its' smaller profile and lightweight construction. The recessed distraction actuating screw is tamper resistant and hence better for use in pediatric patients. The device can only be actuated with the use of a custom actuator which is provided in the kit with the device. Hence, this tamper resistant design is useful when the device is used as an external bone fixation device for the treatment of fractures. Similarly, the conversion to a static from a dynamic fixator does not reguire any adjustment or addition of parts. The alloy metals used provide for excellent stability.
In summary, the features incorporated into the NewMedical Micro Distractor/External Fixator have specific advantages over other substantially equivalent products to enhance ease of placement along with the care and comfort of the patient requiring external fixation/distraction of the mandible or small bones. Neither one of the above features will raise any safety concern because they don't change any of the basic design concepts compared to other similar approved devices.
The provided text is a 510(k) summary for the NewMedical Micro Bone Distractor/Fixator. It focuses on demonstrating substantial equivalence to predicate devices rather than reporting on a clinical or performance study with acceptance criteria.
The 510(k) summary does not include information about:
- A table of acceptance criteria and the reported device performance: This document does not establish specific performance criteria like accuracy, sensitivity, or specificity, as it's not a performance study. Its primary goal is to assert equivalence in intended use, materials, design, and operational principles.
- Sample size used for the test set and the data provenance: No test set comprising patient data (e.g., images for an AI device) is described.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: There is no mention of experts establishing ground truth for a test set.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: No adjudication method is discussed as there's no test set in the sense of a clinical trial or performance study.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No MRMC study is mentioned.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device is a physical medical device, not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Ground truth, in the context of a performance study, is not applicable or discussed here.
- The sample size for the training set: Not applicable as there is no AI algorithm being trained.
- How the ground truth for the training set was established: Not applicable.
What the document does provide is a claim of substantial equivalence based on mechanical and material properties compared to existing devices.
The key "criteria" for acceptance in this 510(k) process are:
- Intended Use Equivalence: "All of the named devices, and the NewMedical Micro Distractor/Fixator Device, are intended to be used as external fixation/ distraction devices for the stabilization/lengthening of bone and bone fragments." The device is indicated for "pediatric as well adult Metacarpal-Phalangeal fractures. For external fixation of hand fractures or for distraction of osteotomies for the purpose of distraction osteogenesis as fractures."
- Materials Equivalence: "The materials used... are two grades of Stainless steel. The material conforms to ASTM F 138-97." These are stated to be the same materials with a "long history of successful clinical usage" as predicate devices (Hoffman Mini Fixator, Synthes Mini-Lengthener and the Hand Bone Lengthener).
- Design Equivalence: "The basic design features... are substantially equivalent to the predicate devices. The subject device and the named derives accept various diameter pins. The subject device and the named devices operate using the same principle by utilizing screw mechanism that the surgeon adjusts to control the distraction/compression length. The subject device and the predicate devices use clamps attached to the distraction screw for holding the pins or threaded wires."
- Operational Principles Equivalence: "The basic operational principles for the named device and the subject device are similar - mainly in site preparation, pin placement and device operation. The bone distraction/compression is similar also."
The "study" referenced is the 510(k) submission itself, where the manufacturer asserts and documents these equivalences, rather than a clinical trial or performance study against specific, quantitative acceptance criteria. The FDA's role is to review this submission and concur with the claim of substantial equivalence, which they did in this case (indicated by the approval letter).
§ 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.