(65 days)
Synthes Locking Condylar Plate (LCP) System is intended for buttressing multifragmentary distal femur fractures including: supracondylar, intra-articular and extra-articular condylar fractures, fractures in normal or osteopenic bone, and non-unions and malunions.
Synthes LCP System is a plate and screw system. The primary feature of the plate and screw system is that the locking screws engage with the head and shaft of the plate to form a locked, fixed angle construct. The system features a limited-contact profile, dynamic compression unit (DCU) and locking screw holes. The plate accepts 7.3 mm locking screws, 7.3 mm conical screws, 5.0 mm locking screws, 5.0 mm cannulated screws, and 4.5 mm cortex screws. A screw nut is also utilized with this system.
This document is a 510(k) summary for the Synthes Locking Condylar Plate (LCP) System, indicating it's a medical device submission to the FDA. The information provided is primarily for regulatory clearance and focuses on substantial equivalence to a predicate device, rather than explicit acceptance criteria and detailed study results demonstrating performance against those criteria.
Therefore, many of the requested details about acceptance criteria, device performance metrics, sample sizes, expert qualifications, and study designs (like MRMC or standalone) are not present in the provided text.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. A table of acceptance criteria and the reported device performance
- Cannot be answered from the provided text. The document describes the device, its intended use, and indicates that it has been found "substantially equivalent" to a predicate device. This regulatory determination does not typically involve explicit, publically stated acceptance criteria in the form of performance metrics (e.g., sensitivity, specificity, accuracy) that would be presented in a table alongside reported device performance. Instead, substantial equivalence implies that the device performs as safely and effectively as the predicate device.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Cannot be answered from the provided text. The document does not describe any specific clinical or performance studies for the LCP system that would involve a "test set" in the context of AI/software performance. The 510(k) process for hardware like this generally relies on bench testing, mechanical testing, and comparison to existing devices, rather than data-driven performance metrics against a test set.
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)
- Cannot be answered from the provided text. As there is no mention of a "test set" or data-driven performance evaluation requiring expert ground truth, this information is not applicable or available in the document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Cannot be answered from the provided text. Similar to points 2 and 3, this information is not applicable as no test set requiring adjudication 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
- Cannot be answered from the provided text. This device is a medical implant (plate and screw system), not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study or AI-related performance metrics are irrelevant to this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Cannot be answered from the provided text. This is a physical medical device, not an algorithm. Standalone performance as described (algorithm only) is not relevant.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Cannot be answered from the provided text. Given that this is a hardware device submission, "ground truth" in the context of data analysis or diagnosis is not applicable. For a physical implant, "performance" would likely be assessed through mechanical testing (e.g., fatigue, strength), biocompatibility, and manufacturing quality. The "ground truth" for its function would be its demonstrated mechanical properties and ability to stabilize fractures as intended. These details are not elaborated in this summary.
8. The sample size for the training set
- Cannot be answered from the provided text. This is not a data-driven or AI device, so there is no "training set" in the context of machine learning.
9. How the ground truth for the training set was established
- Cannot be answered from the provided text. As there is no training set, this question is not applicable.
Summary of available information:
- Device Name: Synthes Locking Condylar Plate (LCP) System
- Submitted by: Synthes (USA)
- Date of Submission: Received January 10, 2000
- FDA Clearance Date: March 15, 2000
- Regulatory Status: Class II medical device, 510(k) cleared based on substantial equivalence.
- Predicate Device: Synthes Distal Femur Plate (DFP) System, (K982222)
- Device Description: A plate and screw system where locking screws engage with the plate to form a locked, fixed-angle construct. Features limited-contact profile, dynamic compression unit (DCU), and locking screw holes. Accepts various screw sizes (7.3 mm locking, 7.3 mm conical, 5.0 mm locking, 5.0 mm cannulated, and 4.5 mm cortex screws) and utilizes a screw nut.
- Intended Use: Buttressing multifragmentary distal femur fractures, including supracondylar, intra-articular and extra-articular condylar fractures, fractures in normal or osteopenic bone, and non-unions and malunions.
- Material: Stainless Steel.
The document states "We have reviewed your Section 510(k) notification... and we have determined the device is substantially equivalent...". This implies that the device meets the regulatory requirements for safety and effectiveness by demonstrating equivalence to a legally marketed predicate device. The performance is inferred to be similar to the predicate device, which would have undergone its own rigorous testing. However, the specific "acceptance criteria" and detailed "study" results that directly quantify the LCP system's performance against numerical targets are not provided in this 510(k) summary.
§ 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.