(73 days)
The Bone Plate and Bone Screw System and the DHS/DCS Plate System are provided non-sterile.
The Bone Plate and Bone Screw System is intended for use in fixation of fractures to the various bones, including the clavicle, pelvis, scapula, calcaneus, long bone (humerus, ulna, radius, femur, tibia, and fibula), and small bone (metacarpals, metatarsals, and phalanges).
The DHS/DCS Plate System is intended for use in fixation of fractures to the proximal femur. The system is indicated for use in trochanteric, pertrochanteric, intertrochanteric, and basilar neck fractures.
The Bone Plate and Bone Screw System & the DHS/DCS Plate System consist of non-sterile bone plate and bone screw implants. The plates are devices, which are fastened to bone for purpose of providing fixation. The plates are provided in various types according to different function. Thus there are four kind of styles : Dynamic Compression Plate (DCP), tubular, special and DHS/DCS. The shape of the plate is an adaptation of the plate to the local anatomy and doesn't denote any function. Thus the name depends on the biomechanical function the plate is performing. The plates are divided various types as following: DCP, Tubular, Special, DHS/DCS. The series in size of bone screw and bone plate except DHS/DCS are divided into mini, small and large. The size range of plates are in thickness from 1.0 to 6.0mm, width from 3.8 to 17mm, length from 17 to 359mm, and hole number from 2 to 22 holes.
On the other hand, the screws used cither to fasten plates or similar devices onto bone, or, as lag screws, to hold together fragments of bone. The screws are differentiated by the manner in which they are inserted into bone, their size, and the type of bone they are intended for. Thus there are four kind of style : cancellous, malleolar and cannulated screws. All screws have a hex::gonal recess this feature has proven itself to be of grate advantage at the time of the screw removal and insertion. The size range of screws is in thread diameter from 1.5 to 7.3 mm, total length from 6 to 150mm.
The DHS/DCS Plate System consists of DHS/DCS Plate, DHS/DCS Screw, DHS/DCS Compression Screw, and 4.5mm Cortex Screw (self-tapping). The DHS Plates are available with short and standard barrel which length is 25mm and 38mm respectively. And the barrel angles are available in 95°, 135°, 140°, 145° and. 150°. The self-tapping 4.5mm Cortex Screw can be used to fix the DHS/DCS Plate to the femoral shaft.
The DHS/DCS Screw is available in total length from 50 to 145 mm, thread length 22mm, shaft diameter 7.9mm, and outer diameter from 12.5 to 14mm. The thread of DHS/DCS Screw has a buttress type.
The DHS/DCS Compression Screw can be used to achieve fracture compression. Its dimension is available with thread length 26mm and outer diameter 4.0 mm.
The provided text is a 510(k) Summary for the INTAI Bone Plate and Bone Screw System & INTAI DHS/DCS Plate System. This type of regulatory document focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific performance acceptance criteria through a clinical study. Therefore, the information requested in your prompt regarding acceptance criteria, study details, sample sizes, expert ground truth, adjudication methods, MRMC studies, or standalone performance is not present in the provided text.
The document primarily describes the device, its intended use, and its material composition, then asserts its substantial equivalence to previously cleared devices (K983495 and K983873).
Here's a breakdown of what can be extracted and what is missing:
1. A table of acceptance criteria and the reported device performance
- Not present. The document does not specify any quantitative performance acceptance criteria (e.g., specific thresholds for mechanical strength, biocompatibility, or clinical outcomes) or report device performance against such criteria. The basis for clearance is "substantial equivalence" to predicate devices.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not present. The document does not describe any test set or clinical study to evaluate the device's performance in humans or in a simulated clinical setting. Therefore, sample sizes, data provenance, and study design details are not applicable or mentioned.
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 present. As there is no described test set or study involving expert evaluation, this information is not applicable.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not present. Not applicable given the lack of a described test set or study.
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 present. This device is a bone plate and screw system, not an AI-assisted diagnostic or therapeutic device. Therefore, an MRMC study or AI-related effectiveness analysis is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not present. This device is a bone plate and screw system, not an algorithm. Therefore, "standalone" algorithm performance is not relevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not present. No ground truth is established or discussed as there is no performance study described. The regulatory assessment relies on demonstrating substantial equivalence to predicate devices, meaning the new device is as safe and effective as a legally marketed device.
8. The sample size for the training set
- Not present. This device is a physical implant, not a machine learning model; therefore, the concept of a "training set" is not applicable.
9. How the ground truth for the training set was established
- Not present. Not applicable.
Summary of Device and Regulatory Claim:
- Device Name: INTAI Bone Plate and Bone Screw System & INTAI DHS/DCS Plate System
- Intended Use: For fixation of fractures to various bones (Bone Plate and Bone Screw System) and for fixation of fractures to the proximal femur (DHS/DCS Plate System).
- Material: Medical grade 316L stainless steel and Titanium Alloy (Ti-6AL-4V).
- Regulatory Claim: Substantial equivalence to SYNTEC-TAICHUNG NON-STERILE BONE PLATE AND SCREW (K983495) and SYNTEC-TAICHUNG NON-STERILE DHS/DCS PLATE SYSTEM (K983873). The FDA's letter (K063020) confirms this determination.
The 510(k) process for traditional medical devices like bone plates and screws typically relies on non-clinical performance data (e.g., mechanical testing, biocompatibility testing) and comparison to predicate devices, rather than clinical studies with "acceptance criteria" and "ground truth" as might be seen for diagnostic imaging or AI devices. The document does not elaborate on these non-clinical tests, only stating that the device is substantially equivalent.
§ 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.