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GPC Intraheal Intramedullary Nailing System are provided non-sterile. GPC Intraheal Intramedullary Nailing System are indicated for treating fractures of various bones as given below:

Multi Angle Femoral Nail: The indications for Use of Multi Angle Femoral Nails are as given below:

• To Stabilize Femoral shaft fractures, Subtrochanteric Fractures, Ipsilateral Neck and Shaft Fracturers, Impending Pathologic Fractures, Nonunions and Malunions.

Proximal Hip Stabilizing Nail 3: The indications for Use of Proximal Hip Stabilizing Nail 3 are as given below: Short Nail Indications: -

• Fixation of stable and unstable intertrochanteric fractures, including but not limited to nonunion, malunion .
• and tumor resections .
  Long Nail Indications: -
• . Indications may include fractures resulting from trauma, nonunion, pathological fractures, impending pathological fractures, tumor resections and revision procedures.

Elastic Nails:
The Elastic Nail is indicated for fixation of diaphyseal fractures of the medullary canal is narrow or flexibility of the implant is paramount. This includes upper extremity fractures and lower extremity fractures in paediatic or small statured patients. In paediatric application, the flexibility of the elastic nail allows it to be inserted at a point which avoids disruption of the bone growth plate.

K-Wires:
K-wires are indicated to perform as fixation and stabilization unit of bone fractures or as guide at insertion of implants into the skeletal system
All implants are for single use only.

GPC Intraheal Intramedullary Nailing System are manufactured in various shapes and sizes. The intramedullary nails are fixed with corresponding sizes of locking bolts and end caps. GPC Intraheal Intramedullary Nailing System are manufactured using stainless steel or titanium materials for surgical implant applications.
The different sizes and model numbers of GPC Intraheal Intramedullary Nailing System are based on the site of application such as fixation or reconstruction of the bones. These intramedullary nails are available in different diameters and lengths to suit the patient anatomy and size of the bones.
GPC Intraheal Intramedullary Nailing System are typically divided into following three categories:

• 1. Femoral Nails and corresponding locking bolts and end cap for fixation
• 2. Elastic Nails and corresponding end caps for fixation
• 3. K wire for fixation
     The specific names of the GPC Intraheal Intramedullary Nails are as given below:
     Multi Angle Femoral Nail Proximal Hip Stabilizing Nail 3 (Also called as PHN3) Elastic Nail K.Wire

The provided text details a 510(k) premarket notification for a medical device (GPC Intraheal Intramedullary Nailing System), not a study evaluating an AI/software device. Therefore, the information required to answer the prompt (acceptance criteria, study design, sample size, ground truth establishment, expert qualifications, etc., especially in the context of an AI device's performance evaluation) is not present in the document.

The document focuses on demonstrating substantial equivalence to predicate devices based on:

• Indications for Use: Similar intended use.
• Materials: Use of standard surgical implant materials (Stainless Steel, Titanium).
• Performance Standards: Compliance with relevant ASTM standards for mechanical properties (e.g., bending, fatigue, torsion, pull-out for nails, screws, and wires).
• Dimensions: Similar dimensions with minor differences deemed not to raise safety concerns.
• Sterilization: Same method.

No information regarding acceptance criteria for a device's diagnostic performance, nor a study proving it meets such criteria, is provided. The document explicitly states that "Clinical information was not necessary to demonstrate substantial equivalence" because the device is of similar design, pattern, and intended use to already marketed predicate devices.

Therefore, I cannot populate the table or answer the specific questions related to the acceptance criteria and the study that proves the device meets them, as this information is not contained within the provided text.

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GPC Variable Angle Locking Two Column Volar Distal Radius Plating System is intended for fixation of complex intra- and extra-articular fractures and osteotomies of the distal radius and other small bones. The system is indicated for use in adult patients only. All implants are for single use only.

GPC Variable Angle Locking Two Column Volar Distal Radius Plates are machined metal plates designed for fixation of various fracture modes of the distal portion of the Variable Angle Locking Two Column Volar Distal Radius Plates allow fragment-specific fracture fixation by providing the flexibility to lock screws in the head or shaft of the plate in trajectories that can diverge from the central axis of the plate hole. The variable angle locking mechanism improves the plate-screw construct stability. GPC Variable Angle Locking Two Column Volar Distal Radius Plates are manufactured using titanium material for surgical implant applications.

Following are the types of the GPC Variable Angle Locking Two Column Volar Distal Radius Plates:

• Variable Angle Locking Two-Column Volar Distal Radius Plate, Width 22 mm, 6 Head Holes (with option of Left and Right Variants)
• Variable Angle Locking Two-Column Volar Distal Radius Plate, Width 25.5 mm, 7 Head Holes (with option of left and right variants)
• Variable Angle Locking Two Column Volar Distal Radius Plate- Narrow, Width 19.5 mm, 6 Head Holes (with option of left and right variants)

Corresponding Screws for fixation:

• Variable Angle Locking Screw 2.4 mm, Star drive Lengths: 6mm to 30mm in 2mm increments
• FixLOCK Self-Tapping Screw 2.4 mm, Star drive Length 6mm to 30mm in 2mm increments
• Self-Tapping Cortex Screw 2.7 mm, Star drive Length: 12mm to 24mm

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

The provided document describes a 510(k) premarket notification for the GPC 2.4 mm Variable Angle Locking Two Column Volar Distal Radius Plates. This notification aims to demonstrate substantial equivalence to legally marketed predicate devices, rather than establishing de novo safety and effectiveness. Therefore, the information provided focuses on the comparison to the predicate device and non-clinical testing against established standards, not on a study proving the device meets specific acceptance criteria in a clinical context with human users or AI.

However, based on the provided text, we can extract details related to the "device performance" as demonstrated through non-clinical testing.

Here's an analysis based on the information provided, framed as if the non-clinical tests are the acceptance criteria for substantial equivalence:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" with numerical targets for the mechanical tests. Instead, it states that the device "Conforms" to the specified ASTM standards, implying successful performance according to the methodology and requirements of those standards.

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

• Sample Size: The document does not specify the sample size (number of plates or screws) used for each mechanical test.
• Data Provenance: The tests are non-clinical, conducted by the manufacturer, GPC Medical Ltd. The country of origin of the data would be India, where the manufacturer is located. The tests are prospective in the sense that they were conducted specifically for this submission.

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

This question is not applicable to the provided context as the "ground truth" here is established by engineering standards and direct physical measurement of mechanical properties, not by human expert interpretation. There were no human readers or expert consensus involved in determining if the device "conforms" to a bending fatigue test.

4. Adjudication method for the test set

This question is not applicable. Adjudication methods like 2+1 or 3+1 are used for clinical studies with expert reviewers establishing ground truth, which is not the case here. The "adjudication" for mechanical tests involves comparing measured values against specified thresholds within the ASTM standards.

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

This question is not applicable. The device is a physical medical implant (bone plate and screws), not an AI software/algorithm. Therefore, no MRMC study or AI assistance evaluation was performed or is relevant.

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

This question is not applicable, as the device is not an algorithm or AI.

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

For the non-clinical performance tests, the "ground truth" is defined by the specifications and methodologies of the applicable ASTM standards (ASTM F382 for plates and ASTM F543 for screws). The device's performance is compared directly against these engineering standards. For the comparison of characteristics, the "ground truth" is the specifications and characteristics of the identified predicate devices.

8. The sample size for the training set

This question is not applicable. This is a medical implant, not a machine learning model, so there is no "training set."

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

This question is not applicable, as the device is not a machine learning model.

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The GPC BRAND Posterior, Non cervical Pedicle Screw Spinal System is intended for use in the noncervical spine. The GPC BRAND Posterior, Non cervical Pedicle Screw Spinal System is used as an adjunct to fusion, using autograft or allograft, in the treatment of the following instabilities and deformities in skeletally mature patients:

1. Degenerative Disc Disease (DDD, defined as back pain of discogenic origin with degeneration of disc confirmed by history & radiographic studies)
2. Spondylolisthesis
3. Trauma (Fracture or Dislocation)
4. Spinal Stenosis
5. Scoliosis, Kyphosis and/or lordosis
6. Pseudoarthrosis
7. Failed Previous Fusion
   The system is indicated for use in adult patients only. All implants are for single use only.

The Monoaxial & Polyaxial screw consists of a body, bushing, and ball head screw. Inner Screw, rods and transverse connectors assemblies complete the spinal construct. The body portion of the screw rotates about the ball head on the screw, which provides increased motion over a fixed post or monoaxial screw. An increase in motion facilitates the capture of rods that are not perfectly aligned.
The Screws, Rods &Transverse Connectors are fabricated from Titanium.
The system contains several models based on the size of the device and application site such as fixation/reconstruction spine.

• Single Lock Monoaxial Screw
• Single Lock Polyaxial Screw
• Transverse connector
• Rod
  The diameter of these screw varies from 4mm to 7mm with length 25mm to 50mm.
  The corresponding connector are small & large in size.
  The diameter of Rod is 5.5mm with length 75mm to 150mm
  These implants are supplied non-sterile; the products have to be sterilized prior to use.

The document describes a 510(k) premarket notification for the "GPC Brand Posterior, Non cervical Pedicle Screw Spinal System". This type of submission aims to demonstrate that a new device is substantially equivalent to a legally marketed predicate device, and thus does not typically involve extensive clinical studies with specific acceptance criteria as would be found for a novel device requiring a PMA. Instead, the focus is on a comparison to existing devices and adherence to relevant performance standards.

Based on the provided document, here's a breakdown of the requested information:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" in the sense of predefined thresholds for performance metrics. Instead, it relies on demonstrating compliance with recognized industry standards for spinal implants, and equivalence to predicate devices. The "reported device performance" is essentially that the device met these standards and was found equivalent.

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

The document refers to "non-clinical testing" performed against ASTM standards. It does not specify a "sample size" in terms of human subjects or a clinical test set. Instead, it refers to mechanical testing of the physical implants. The provenance is internal testing by the manufacturer (GPC Medical Limited) to verify compliance with the standards. This is not a clinical study in humans, but rather laboratory testing of the device components.

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

This is not applicable to this type of submission. There was no clinical "test set" requiring expert ground truth establishment for diagnostic accuracy or clinical outcomes. The "ground truth" for the non-clinical testing was defined by the ASTM standards themselves (e.g., specific loads, displacement limits).

4. Adjudication method for the test set

Not applicable. There was no clinical test set or subjective assessment requiring adjudication.

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 applicable. This is a spinal implant, not an AI-powered diagnostic device. No MRMC study was performed.

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

Not applicable. This is a spinal implant, not an algorithm.

7. The type of ground truth used

For the non-clinical testing, the "ground truth" was defined by the specifications of the referenced ASTM standards (ASTM F136 for material, ASTM F1717 for mechanical performance). These standards provide established methodologies and criteria for evaluating spinal implant constructs. For substantial equivalence, the "ground truth" was the characteristics of the legally marketed predicate devices.

8. The sample size for the training set

Not applicable. This device is a physical spinal implant, not an AI or machine learning model that requires a training set.

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

Not applicable, as there was no training set.

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1. Indication for Use: Multi Angle Tibial Nail is intended to stabilize fracture of the proximal & distal tibia and the tibial shaft, open and closed tibial shaft fractures, certain pre and post isthmic fractures and tibial malunions & nonunions.
2. Indications for Use: Ga-mma Nail is indicated for use in stabilizing various types of intertrochanteric fractures of proximal femur.

The GPC Intramedullary Nailing Systems include intramedullary nails and corresponding screws/end caps/locking bolts for fastening these intramedullary nails to the fractured bones.

The provided text describes a 510(k) premarket notification for "GPC Intramedullary Nailing Systems". This submission demonstrates substantial equivalence to predicate devices based on non-clinical testing and comparison of characteristics, rather than a clinical effectiveness study involving human subjects or an AI standalone or AI-assisted performance evaluation.

Therefore, many of the requested categories regarding acceptance criteria for AI performance, clinical study details, and expert involvement are not applicable to this document.

Here's a breakdown of the information that is available and the information that is not.

1. A table of acceptance criteria and the reported device performance

The acceptance criteria are implicitly defined by compliance with the given material and performance standards, and comparison to the predicate devices. The "reported device performance" is framed as demonstrating equivalence to the predicate devices in these areas rather than specific quantitative performance metrics against a defined threshold.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. This submission relies on non-clinical (bench) testing and comparison to predicate devices, not a test set of patient data, retrospective or prospective.

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 applicable. This submission does not involve ground truth assessment by experts in the context of a test set for clinical performance. The "ground truth" for equivalence is established by compliance with engineering and material standards and direct comparison of specifications and bench testing results to the predicate devices.

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

Not applicable. There is no test set for clinical performance or adjudication process 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

Not applicable. This is not an AI/software device and no MRMC study was conducted.

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

Not applicable. This is a medical device (intramedullary nailing systems), not an algorithm or software. Its performance is assessed through material and bench testing.

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

The "ground truth" for this device's performance is established by:

• Compliance with material standards (ASTM F 136, ASTM F 138).
• Compliance with performance standards (ASTM F 1264 for Tibial Nail, ASTM F 384 for Ga-mma Nail).
• Demonstration of equivalence in physical characteristics (dimensions, materials) and intended use compared to legally marketed predicate devices.
• The results of non-clinical (bench) testing showing comparable performance to the predicate devices (as detailed in the "executive summary" which is not fully provided here, but referenced).

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device.

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

Not applicable. This is not an AI/machine learning device.

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