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GPC BONE PLATES AND BONE SCREWS ARE PROVIDED NON-STERILE. GPC BONE PLATES AND SCREWS ARE INTENDED TO TREAT FRACTURES OF VARIOUS BONES, INCLUDING THE CLAVICLE, PELVIS, SCAPULA, LONG BONES(HUMERUS, RADIUS, ULNA, FEMUR, TIBIA AND FIBULA), AND SMALL BONES-LIKE METALCARPALS, METATARSALS AND PHALANGES.

GPC DHS/DCS PLATE SYSTEM IS PROVIDED NON-STERILE. THE GPC DHS/DCS PLAT SYSTEM IS INTENDED FOR USE IN FIXATION OF FRACTURES OF THE PROXIMAL FEMUR. THE GPC DHS/DCS PLATE SYSTEM IS INDICATED FOR USE IN TROCHANTERIC, PERTROCHANTERIC, INTERTROCHANTERIC AND BASILAR NECK FRACTURE

THE BONE PLATES.AND BONE SCREW SYSTEM AND DHS/DCS PLATE SYSTEM CONSIST OF NON-STERILE BONE PLANTE AND BONE SCREW IMPLANTS. THE PLATES ARE DEVICES WHICH ARE USED TO FASTEN THE BONES FOR THE PURPOSE OF FIXATION OF FRACTURED BONES. THE BONE PLATES CAN BE DISTINGUISHED IN TERMS OF THEIR FUNCTION, i.e. THE PLATE ON WHICH THIS IS TO BE FIXED.

Generally there are following types of bone plates:

• Dynamic Compression Type,
• Tubular Type
• Special (for particular bones)
• Mini fragment
• Used with Dynamic Hip screw and Used with Dynamic Condylar . Screw

These bone plates are generally designed on the basis of the bone contour and anatomy.

Following are further categories of bone plates:
DCP (Small DCP, Narrow DCP, Lengthening Narrow, Broad DCP, Lengthening Broad Plates)
Tubular Plates (Quarter Tubular, Semi Tubular and One Third Tubular Plates)
Special Plates (L-Shaped, T-Shaped, Spoon, Lateral Tibial Head Buttress, Condylar Buttress, Hook, Cobra Head, Angled Plates for various Osteotomy locations. Reconstructions plates)
Mini Fragment (Straight, L-Shaped, T-Shaped, condylar plates, reconstruction plates)
DHS/DCS (DHS Barrel Plate with various angles and in short / large barrel length, DCS Plate)

THESE DEVICE CAN BE MADE IN FOLLOWING MATERIALGRADES STAINLESS STEEL ALLOY in compliance to ASTM F 138, ASTM F 139 TITANIUM ALLOY in compliance to ASTM F 136

The GPC Bone Plates are divided mainly into Mini Fragment Plate system Small Fragment Plate System Large Fragment Plate System The thickness of these plates varies from 1.0mm to 6.0mm The width of these plates varies from 3.0mm to 17mm The length of these plates varies from 15mm to 360mm The number of holes of these plates vary from 2 to 22 holes

The GPC Bone Screws are differentiated by the manner in which they are fastened on the bone, their function, their size and the type of bone they are intended to be used for. Four Types of Screws;
Cortical (cortex) Screw
Cancellous Screw
Malleolar Screw
Cannulated

These screw variants can be provided with locking compression thread types as well as regular types. Type of Recess: Hexagonal Diameter Range: 1.5mm to 7.3mm Length Range: 6mm to 150mm

DHS / DCS Plate system consists of a DHS Plate or DCS Plate (Dynamic Hip Screw Type or Dynamic Compression Screw Type) This plate is fastened on femoral shaft using 4.5mm cortex screw (self tapping) and the barrel is fastened using DHS Screw having diameter ranging from 12.5mm to 14.0mm Barrel Length: 25mm or 38mm Barrel Angle: 95 degree, 135 degree, 140 degree, 145 degree, 145 degree and 150 degree Compression is achieved using 4.0mm Diameter Compression Screw.

This K092493 submission for GPC Bone Plates and Bone Screws & GPC DHS/DCS Plate System does not contain information about acceptance criteria or a study that proves the device meets specific performance metrics in the way a clinical trial would for an AI/ML device.

This document describes the submission of a conventional medical device (bone plates and screws) for 510(k) clearance, which relies on demonstrating substantial equivalence to a predicate device, rather than a prospective study to prove performance against predetermined acceptance criteria for new functionality.

Therefore, many of the requested categories are not applicable to this type of submission. Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: Not explicitly stated as performance metrics in terms of outcomes or diagnostic accuracy, which would be common for AI/ML devices. Instead, acceptance criteria are implied by conformity to recognized industry standards for mechanical properties and material composition.
• Reported Device Performance: Demonstrated through compliance with these standards.

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size: Not applicable in the context of this 510(k) submission. The testing performed is mechanical and material testing of the device components, not a clinical study with a "test set" of patient data.
• Data Provenance: Not applicable. The testing is performed on the physical devices themselves in a laboratory setting ("external laboratory as well in-house inspections").

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

• Not applicable. Ground truth, in the AI/ML sense, is not established for this type of device. The "ground truth" for mechanical testing is adherence to predefined engineering standards and specifications.

4. Adjudication Method for the Test Set:

• Not applicable. There is no ambiguous data or "readings" that require adjudication. Pass/fail criteria are based on objective measurements against engineering standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

• No, an MRMC study was not done. This type of study is used to assess the impact of a diagnostic tool (often AI-based) on human reader performance, which is not relevant for a bone plate and screw system.

6. If a Standalone Study (i.e., algorithm only without human-in-the-loop performance) was done:

• The equivalent "standalone" performance here is the mechanical and material testing conducted on the devices themselves. This testing evaluates the device's inherent properties and adherence to standards without human interaction influencing the device's function once implanted. The document states: "The devices have been thoroughly tested through external laboratory as well in-house inspections for the specifications."

7. The Type of Ground Truth Used:

• Engineering Standards and Specifications: The "ground truth" for this submission is compliance with the recognized ASTM standards listed (e.g., F 382, F 384, F 543, F 136, F 138, F 139). These standards define acceptable material properties and mechanical performance for bone plates and screws.

8. The Sample Size for the Training Set:

• Not applicable. As a conventional medical device (physical implant), there is no "training set" in the context of AI/ML or a typical clinical study.

9. How the Ground Truth for the Training Set was Established:

• Not applicable. There is no training set for this type of device.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The study proving the device meets the "acceptance criteria" (which are defined as compliance with recognized standards) consists of non-clinical bench testing and material analyses. The document explicitly states:

• "GPC Bone Plates and Bone Screws & GPC DHS/DCS Plate System have been tested for the following non-clinical tests which have been performed to assess the performance of the devices according to the standards applied for conformance to the requirements."
• Specific standards mentioned are ASTM F 382, ASTM F 384, ASTM F 543 for device performance, and ASTM F 136, ASTM F 138, ASTM F 139 for material specifications.
• The testing was performed by "external laboratory as well in-house inspections."

The conclusion drawn from this testing is that the device is "safe and effective for the intended use" and "substantially equivalent to the predicate device Microware the bone plates and bone screw system and DHS/DCS plate system."

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