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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 Spiral Shape Dental Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function.

It is intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

Spiral Shape Dental Implant System is an internal hex implant system which comes in 3.3, 3.7, 4.2, 5.0, and 6.0 diameter. The implants come in lengths of 8, 10, 11.5, 13 and 16 (no 6.0 diameter in 16). Both straight and angled abutments are available.

The implant is a conical shape one with a grit blasted and acid etched surface. Standard abutments, standard narrow abutments, standard shoulder abutments, standard wide shoulder abutments, multiunit abutments, ball attachments, healing caps and standard 15° and 25° abutments are included in the system.

The provided text describes a medical device submission (K162299) for the "Spiral Shape Dental Implant System". It details the device's indications for use, its description, and a summary of testing conducted to demonstrate substantial equivalence to predicate devices. However, the document does not contain information about acceptance criteria or a study proving the device meets specific performance criteria in the context of image analysis, AI, or diagnostic efficacy.

The testing summarized (Dynamic fatigue testing, Surface analysis, Sterilization validation, Package integrity testing, Biocompatibility, Endotoxin testing) are standard engineering and material science tests for dental implants, not performance studies for a diagnostic or AI-driven device.

Therefore, I cannot provide answers to the questions you've posed, as they relate to a type of study and data (e.g., AI performance, expert ground truth, MRMC studies) that are not present in the provided FDA submission document for a dental implant system.

The document primarily focuses on demonstrating that the new dental implant system is substantially equivalent to existing legally marketed predicate devices based on:

1. Indications for Use: (described as: "The Spiral Shape Dental Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. It is intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading.")
2. Materials: Ti-6AL-4V ELI.
3. Design: Conical shape, grit blasted and acid etched surface, internal hex connection, various diameters and lengths.
4. Fatigue Performance: Tested according to ISO 14801.

The provided text describes a 510(k) submission for a dental implant system, not a device involving image analysis, AI, or diagnostic performance evaluation with acceptance criteria like sensitivity, specificity, or AUC. Therefore, the requested information elements related to AI/algorithm performance, sample sizes for test/training sets, expert ground truth, MRMC studies, and standalone performance are not applicable to this document.

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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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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.

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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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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The DCAS i allows the user to look up, keep, and manage all the medical images used in cardiology with Angio, ECHO, and IVUS images as the basic ones. It allows the user to view, arrange, and manage the needed image by only controlling it in a simple way. Also, as the user can arrange images as he or she wants regardless of the sort of the images, the user can compare and analyze the images of all the equipments of cardiology on this system. The user can record the images of the patient wanted on a CD or DVD. Here, the exclusive viewer allows the user to check the recorded images of the patient in all sorts of environment. In addition, the user can edit and convert the DICOM Cine images into AVI and static images to use them for editing various images and framing a report. Only the user authorized by using the Internet can use this system based on the Web, and in an environment with a wireless network built, the user can look up data through a mobile device. DCAS i images can be used for reference purposes only and cannot be used for precise readings.

The DCAS i is an equipment for providing medical treatment services of a good quality in cardiology and developing into an advanced medical institution through innovative work improvement, in order to keep up with the rapidly changing era of medical information. The DCAS i, which has an improved high-speed image processing engine, processes in the method of multi-threading to display multiple DICOM Cine images in a simultaneous way. It allows the user to look up, keep, and manage all the medical images used in cardiology with XA, ECHO, and IVUS images as the basic ones. The DCAS i sends even high-capacity images within only a few seconds and expresses them on the basis of the GIGABIT network environment of its own. The enhanced convenience of its user interface allows the user to view, arrange, and manage the needed image by only controlling it in a simple way. Also, as the user can arrange images as he or she wants regardless of the sort of the images, the user can compare and analyze the images of all the equipments of cardiology on this system. The user can record the images of the patient wanted on a CD or DVD by only controlling a few times. Here, the exclusive viewer allows the user to check the recorded images of the patient in all sorts of environment. In addition, the user can edit and convert the DICOM Cine images into AVI and static images, and this makes it easier to edit various images and frame a report. Only the user authorized by using the Internet can use this system based on the Web as needed, and in an environment with a wireless network built, the user can look up data through a mobile device.

The provided 510(k) summary for the DCAS i device, a Picture Archiving and Communications System, does not contain information related to acceptance criteria or a study proving the device meets specific performance criteria.

Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (Centricity Cardiology CA1000) based on shared intended use and similar technical characteristics. This type of submission relies on the established safety and effectiveness of the predicate device, rather than requiring new performance studies with acceptance criteria for the new device.

Therefore, I cannot provide the requested information in the format specified. The document explicitly states:

• "DCAS i images can be used for reference purposes only and cannot be used for precise readings." (pages 5 and 9) This indicates that the device is not intended for diagnostic interpretation that would typically require rigorous performance studies and associated acceptance criteria.
• The comparison is primarily focused on features and functionalities (e.g., DICOM-Compliant, Architecture, Server, Security, Storage, Web-Based Access, Image Compression, Multi-frame support, Image Control, Play Control, Zoom, Search Patient, Search Case Date, Search Modality, Sort, Common Measurement XA Analysis, Us Analysis) as well as the new addition of mobile applications, rather than quantitative performance metrics.

In summary, based on the provided text, the 510(k) submission for DCAS i does not include the details requested in the prompt regarding acceptance criteria, study design, sample sizes, ground truth establishment, or expert involvement.

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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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DISPOSABLE, STERILE UMBILICAL CORD CLAMP
TO BE USED FOR OBSTETRICS USE ONLY.
UMBILICAL CORD CLAMP WITH SIDE FASTENERS
TO PREVENT THE UMBILICAL CORD FROM GOING
OUT OF THE BLOCKING COMBS
IRREVERSIBLE CLOSURE TO PREVENT ACCIDENTAL
OPENING.

Not Found

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study proving that a device meets those criteria. The document is a 510(k) clearance letter from the FDA for an Umbilical Cord Clamp, dated December 12, 1997. It primarily confirms the device's substantial equivalence to a pre-amendment device and outlines regulatory requirements. The second page details the device name and its indications for use.

Therefore, I cannot provide the requested information, including:

1. A table of acceptance criteria and reported device performance.
2. Sample size and data provenance for a test set.
3. Number and qualifications of experts for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study results or effect size.
6. Standalone algorithm performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

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DISPOSABLE STERILE VAGINAL SPECULUM USED TO EXAMINE THE INTERIOR OF THE VAGINA DURING GYNECOLOGICAL PROCEDURES HAS A REGULATING SCREW TO ALLOW A GRADUAL OPENING

Vaginal Speculum

This document is a 510(k) clearance letter from the FDA for a Vaginal Speculum (HOSPITAL'S SPEC). It does not contain information about acceptance criteria or a study proving the device meets said criteria.

The letter states that the device is "substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976." This means the FDA determined the device is as safe and effective as a legally marketed predicate device, rather than requiring a new study with specific acceptance criteria.

Therefore, the requested information cannot be extracted from the provided text. The document is primarily a regulatory communication confirming that the device can be legally marketed.

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