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GPC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System are indicated for treating fractures of various bones including the clavicle, pelvis, scapula, long bone ( humerus, ulna, radius, femur, tibia and fibula), and small bone (metacarpals, metatarsals, phalanges).

The system is indicated for use in adult patients only. All implants are for single use only.

GPC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System consists of various shape and sizes of plates featuring compression and locking holes, full-threaded-cortical, locking self-tapping screws.

The plates and screws are fabricated from Stainless Steel and Titanium.

GPC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System contains several models based on the size of the device and application site such as fixation/reconstruction of small fragment bones, forefoot, mid-foot, rear-foot, ankle, or other bones appropriate for the size of the device. The plate implants are in many models available: like, Reconstruction Plates, T-Plates, Anatomical Plates and Clavicle Hook Plates.

These all are mainly divided into

• Large Fragment Plates
• . Small Fragment Plates
• Mini Fragment Plates ●

The number of the holes varies from 2 to 22.

The Locking screw implants are in corresponding diameter ranges from 2.4mm, 3.5mm, 5.0mm and 6.5mm diameters with lengths varying as per the requirements and minimum length: 20 mm to maximum length 150mm

The Non-locking screw implants are in 3.5mm and 4.5mm diameter and length range from 10mm to 140mm. The non locking screws 3.5mm and 4.5mm were cleared previously in 510k number K092493

These implants are supplied non-sterile, the products have to be sterilized prior to use.

This document is a 510(k) premarket notification for a medical device, specifically orthopaedic bone plates and screws. For such submissions, the FDA typically evaluates substantial equivalence to legally marketed predicate devices, rather than requiring extensive clinical trials to demonstrate new performance metrics and acceptance criteria in the same way one might for a novel drug or a high-risk, de novo medical device.

Therefore, the requested information about "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of a new drug or novel medical device (e.g., sample size for test set, data provenance, expert adudication, MRMC studies, standalone performance, training set details) is not directly applicable or present in this type of 510(k) submission for a Class II orthopedic implant.

Instead, the "acceptance criteria" here are based on demonstrating that the new device is substantially equivalent to existing cleared devices in terms of:

• Indications for Use: The new device is intended for the same purpose as the predicate devices.
• Technological Characteristics: The new device has similar design, materials, and operating principles.
• Performance: The new device performs similarly to the predicate devices, often demonstrated through engineering analysis, material testing, and comparison of specifications rather than large-scale clinical outcome studies.

Let's address the points as best as possible given the provided document's context:

1. Table of Acceptance Criteria and Reported Device Performance

For this 510(k), the "acceptance criteria" are primarily established by the performance and characteristics of the predicate devices. The "study" proving acceptance is the demonstration of substantial equivalence through comparison and testing against relevant standards.

• ASTM F 136 (Titanium-6Aluminium-4Vanadium ELI)
• ASTM F 138 (18Cr-14Ni-2.5Mo stainless steel bar/wire)
• ASTM F 139 (18Cr-14Ni-2.5Mo stainless steel sheet/strip) | "We have complied to following material standards"
  "verified the purchased material compliance to these standards and copies of the relevant test results were provided in the submission." |
  | Plate Performance (Bending):
• Engineering analysis of bending moment and bending stiffness as per predicate performance/industry standards. | "The performance of the plates was demonstrated using an engineering analysis of bending moment and bending stiffness based on material properties and the plate shaft dimensions." |
  | Screw Performance (Pull-out Strength & Torque-to-Failure):
• Engineering analysis of pull-out strength and torque-to-failure as per predicate performance/industry standards. | "The performance of the screws was demonstrated using an engineering analysis of pull-out strength and torque-to-failure based on material properties and the screw dimensions." |
  | Indications for Use Equivalence:
• Treat fractures of clavicle, scapula, long bones (humerus, ulna, radius, femur, tibia, fibula), and small bones (metacarpals, metatarsals, phalanges) in adults. Single use. | "Similar intended use in New Device and Predicate device"
  "GPC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System are indicated for treating fractures of various bones including the clavicle, pelvis (note: pelvis included here but not in the original IU), scapula, long bone (humerus, ulna, radius, femur, tibia and fibula), and small bone (metacarpals, metatarsals, phalanges). The system is indicated for use in adult patients only. All implants are for single use only." |
  | Material Equivalence:
• Stainless Steel and Titanium. | "Same material used in New Device and Predicate device"
  "The plates and screws are fabricated from Stainless Steel and Titanium." |
  | Performance Standards Equivalence:
• (Implicitly, adherence to recognized orthopedic implant performance standards, e.g., for fatigue, corrosion, biomechanics, if applicable to the device type and specified by the predicate) | "Same performance standards used in both New Device as well as predicate device" (This suggests the device was tested against or designed to meet the same relevant standards as the predicates, beyond just material standards). |
  | Sterilization Method Equivalence:
• Must be consistent with the predicates for "non-sterile" and subsequent required sterilization prior to use (e.g., autoclave). | "Same method of sterilization used in both New Device as well as Predicate device"
  "These implants are supplied non-sterile, the products have to be sterilized prior to use." |
  | Dimensional Verification Equivalence:
• Dimensions (e.g., hole count, screw diameters, lengths) must be comparable to predicates. | "Same dimensions found in both New Device as well as Predicate device"
  "The number of the holes varies from 2 to 22. The Locking screw implants are in corresponding diameter ranges from 2.4mm, 3.5mm, 5.0mm and 6.5mm diameters with lengths varying as per the requirements and minimum length: 20 mm to maximum length 150mm. The Non-locking screw implants are in 3.5mm and 4.5mm diameter and length range from 10mm to 140mm." |

Based on the provided document, the following points are not applicable or not detailed, as this is a 510(k) for a device demonstrated through substantial equivalence and engineering analysis, not a clinical study of diagnostic performance or human-in-the-loop AI assistance:

• MRMC comparative effectiveness study: Not done/not applicable for this type of device submission.
• Standalone (algorithm only) performance: Not applicable.
• Ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to this type of engineering and material equivalence submission. The "ground truth" here is compliance with established material and performance standards, and similarity to predicate devices.
• Sample size for the training set: Not applicable (no AI/machine learning model).
• How the ground truth for the training set was established: Not applicable.

Regarding the other specific requested information:

2. Sample size used for the test set and the data provenance

• Test Set Sample Size: Not explicitly stated as a "test set" in the context of clinical data for performance evaluation. For material and mechanical testing, the "sample size" would refer to the number of components tested according to the relevant ASTM standards or internal protocols. This level of detail on the number of physical samples tested is typically in the underlying test reports, not summarized in the 510(k) summary provided.
• Data Provenance: The device manufacturer (GPC Medical Limited) is located in India. The "testing" involved non-clinical (material and engineering) analyses. The data provenance would be from the manufacturer's internal testing or accredited test labs. The submission explicitly states "copies of the relevant test results were provided in the submission" for material compliance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable in the context of this 510(k). "Ground truth" here is about compliance with engineering and material standards, which are established by consensus standard organizations (e.g., ASTM) and verified by qualified engineers/technicians in labs. It does not involve expert clinical readers establishing a "ground truth" for a diagnostic task.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable. There's no clinical adjudication process for this type of submission.

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

• No, this was not done. This device is a bone plate and screw system, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• No, this was not done.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

• The "ground truth" for this device's acceptance is based on:
  • Material Standards: Adherence to established ASTM material specifications for surgical implants.
  • Engineering Performance Standards: Meeting performance characteristics (e.g., bending moment, stiffness, pull-out strength, torque-to-failure) demonstrated through engineering analysis and potentially mechanical testing, comparable to the predicate devices and industry norms.
  • Predicate Device Equivalence: The characteristics and intended use being substantially similar to already legally marketed devices.

8. The sample size for the training set

• Not applicable. There is no "training set" as this is not an AI/machine learning device.

9. How the ground truth for the training set was established

• Not applicable.

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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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