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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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