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The Arsenal Ankle Plating System is intended for use in trauma and reconstructive procedures of the small bones in the hand/foot, ankle, distal tibia, fibula, and other bones appropriate for the size of the device.

The Arsenal Ankle Plating System consists of plates of various shapes and sizes composed of implant grade titanium alloy intended for use in trauma and reconstructive procedures of the small bones in the hand/foot, ankle, distal tibia, fibula, and other bones appropriate for the size of the device. The system incorporates multiple locking and nonlocking screws of various lengths and diameters, washers, and the necessary instruments to facilitate the placement of these implants.

This document describes the premarket notification (510(k)) for the Arsenal Ankle Plating System. It is a medical device and not an AI/ML powered device, so the information requested to describe the acceptance criteria and the study that proves the device meets the acceptance criteria is not applicable in the context of an AI/ML powered device. The document refers to non-clinical testing for mechanical safety and performance characteristics, but does not pertain to AI/ML model performance.

Therefore, I cannot provide the requested information about acceptance criteria and study details as they relate to AI/ML powered devices.

However, I can extract the information provided about the non-clinical tests performed for this medical device, which are analogous to proving the device meets its acceptance criteria for mechanical and material properties:

Non-Clinical Test Summary (Analogous to Proving Device Meets Acceptance Criteria for Mechanical Properties):

The following tests were performed for the Arsenal Ankle Plating System:

• Single Cycle Bend Testing: Referencing ASTM F382.
• Axial Pullout Strength Testing: Referencing ASTM F543 and Guidance for Industry & Food and Drug Administration Staff for Orthopedic Non-Spinal Metallic Bone Screws and Washers - Performance Criteria for Safety and Performance Based Pathway.
• Torsional Property Testing: Referencing ASTM F543 and Guidance for Industry & Food and Drug Administration Staff for Orthopedic Non-Spinal Metallic Bone Screws and Washers - Performance Criteria for Safety and Performance Based Pathway.
• Driving Torque Testing: Referencing ASTM F543 and Guidance for Industry & Food and Drug Administration Staff for Orthopedic Non-Spinal Metallic Bone Screws and Washers - Performance Criteria for Safety and Performance Based Pathway.
• Sterilization Testing: Referencing ISO 17665-1:2006 and AAMI TIR30:2011.
• Biocompatibility Testing: Referencing ISO 10993-1.

Additionally, an engineering analysis was conducted for the plates to demonstrate substantial equivalence to the predicate devices. The results of these evaluations indicated that the Arsenal Ankle Plating System is equivalent to the predicate devices in terms of mechanical safety and performance.

Not Applicable Information (for AI/ML powered devices):

The following points are not applicable to the Arsenal Ankle Plating System as it is a traditional medical device, not an AI/ML powered one:

• A table of acceptance criteria and the reported device performance (in terms of AI metrics).
• Sample size used for the test set and the data provenance.
• Number of experts used to establish the ground truth for the test set and qualifications.
• Adjudication method for the test set.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done.
• If a standalone (i.e. algorithm only without human-in-the loop performance) was done.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc).
• The sample size for the training set.
• How the ground truth for the training set was established.

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The Arsenal Plating System is intended for use in trauma and reconstructive procedures of the small bones in the hand/ foot, ankle, and other bones appropriate for the device. The plates (implants), screws (implants), washers (implants), olive wires (instruments), and guide wires (instruments) are intended for single use only.

The Arsenal Plating System consists of plates of various shapes and sizes composed of implant grade titanium alloy intended for use in trauma and reconstructive procedures of the small bones in the hand/foot, ankle, and other bones appropriate for the size of the device. The system will incorporate multiple locking and non-locking screws of various lengths and diameters, washers, and the necessary instruments to facilitate the placement of these implants.

This document is a 510(k) Premarket Notification for the Arsenal Plating System. It focuses on demonstrating substantial equivalence to predicate devices based on non-clinical testing, rather than reporting on a study to meet acceptance criteria for a new device performance.

Therefore, the requested information about acceptance criteria and a study proving device performance in the context of an AI/medical imaging device is not applicable to this submission. This is a traditional medical device submission for orthopedic hardware.

Here's a breakdown of why and what information is available (or not available) based on the provided text:

Rationale for Not Meeting Request:

• Device Type: The Arsenal Plating System is an orthopedic hardware system (plates, screws, washers). It is not an AI/software device, imaging device, or diagnostic tool that would typically have acceptance criteria related to sensitivity, specificity, or reader performance.
• Submission Type: This is a 510(k) Premarket Notification. The primary goal of a 510(k) is to demonstrate that the new device is "substantially equivalent" to a legally marketed predicate device, not necessarily to prove absolute safety and effectiveness through extensive novel clinical trials against defined acceptance criteria (like an AI algorithm would).
• Clinical Studies: The document explicitly states: "No clinical studies were performed." This immediately indicates that there will be no data on human reader performance, ground truth establishment, or multi-reader multi-case studies.
• Non-Clinical Testing: The "studies" performed were mechanical bench tests (Single Cycle Bend Testing, Dynamic Bend Testing, Axial Pullout Strength Testing, Torsional Property Testing, Driving Torque Testing) designed to show equivalence in physical performance to the predicate devices, not diagnostic or AI performance.

Information based on the provided text (and why other requested sections are N/A):

1. Table of acceptance criteria and the reported device performance

   • Acceptance Criteria: Not explicitly stated as pass/fail criteria in the context of a new performance claim. The "acceptance" is implicitly that the device performs equivalently to the predicate devices in the listed mechanical tests.
   • Reported Device Performance:

     Test Type	Referencing Standard	Performance
     Single Cycle Bend Testing	ASTM F382	Results indicate the Arsenal Plating System is equivalent to predicate devices. (Specific quantitative results are not provided in this summary.)
     Dynamic Bend Testing	ASTM F382	Results indicate the Arsenal Plating System is equivalent to predicate devices. (Specific quantitative results are not provided in this summary.)
     Axial Pullout Strength Testing	ASTM F543	Results indicate the Arsenal Plating System is equivalent to predicate devices. (Specific quantitative results are not provided in this summary.)
     Torsional Property Testing	ASTM F543	Results indicate the Arsenal Plating System is equivalent to predicate devices. (Specific quantitative results are not provided in this summary.)
     Driving Torque Testing	ASTM F543	Results indicate the Arsenal Plating System is equivalent to predicate devices. (Specific quantitative results are not provided in this summary.)

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

   • Sample Size: Not specified for the mechanical tests. Typically, these involve a small number of physical samples of the device components.
   • Data Provenance: Not applicable. These are laboratory mechanical tests, not human data.

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)

   • N/A. This device does not have "ground truth" established by experts in the context of diagnostic performance. Mechanical tests are assessed against engineering standards.

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

   • N/A. Not relevant for mechanical testing.

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. The document explicitly states: "No clinical studies were performed." This is not an AI or diagnostic device.

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

   • N/A. This is not an algorithm or software device.

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

   • N/A. The "ground truth" for mechanical testing is adherence to established ASTM standards for material properties and mechanical performance.

8. The sample size for the training set

   • N/A. This device does not use a "training set" as it is not an AI/machine learning device.

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

   • N/A. As above, no training set.

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The Two-Step Implant System is intended for fixation of osteotomies and reconstruction of the bones of the foot and hand during procedures to correct deformities of the toes and fingers. Indications include: hammer toe deformity, claw toe deformity, mallet toe deformity, and other deformities of the foot and hand.

The Two-Step Implant System is used for fixation of the bones of the foot and hand. The system includes a cannulated, threaded, spaded implant that is offered in multiple threaded diameters, lengths, and spade diameters. The system includes k-wire implants in multiple sizes. Available implants and instrumentation can be packaged in a sterilization tray as a single system. System instrumentation includes spade pilot drills, spade drivers, thread pilot drills, reamers, impactor, and handles to facilitate the placement of the implants. The Two-Step Implant System implants and k-wires are intended for single use only.

I am sorry, but the provided text does not contain information about acceptance criteria or a study proving that a device meets those criteria. The document is a 510(k) summary for a medical device (Two-Step Implant System), which outlines its intended use, technological characteristics, and claims of substantial equivalence to predicate devices based on non-clinical performance testing. It explicitly states that "No clinical studies were performed."

Therefore, I cannot provide the requested information.

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The Trilliant Sniper Staple System is indicated for fixation of fractures and osteotomies of the hand, foot, and bones appropriate for the size of the device.

The Sniper Staple System consists of different-sized staples composed of Nitinol (Nickel-Titanium alloy) intended for fixation of fractures and osteotomies of the hand, foot, and bones appropriate for the size of the device. The system will be offered non-sterile in a tray for sterilization at the user's facility prior to use.

Here's an analysis of the provided text regarding acceptance criteria and the supporting study, structured as requested. It's important to note that this document describes a medical device (bone staple), not an AI/algorithm-based device. Therefore, many of the requested fields pertinent to AI (like human reader improvement with AI assistance, training set details, or ground truth for AI) will not be applicable.

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

For a medical device like the Sniper Staple System, acceptance criteria are typically demonstrated through performance testing against established consensus standards.

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

• Sample Size: The document does not specify the exact number of staples or test specimens used for each non-clinical test (elastic static bending, pull-out, transformation temperature, corrosion resistance). It only states that "The following tests were performed."
• Data Provenance: Not applicable as these are non-clinical (laboratory/bench) tests on manufactured device samples, not patient data.

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. For non-clinical performance testing of a physical medical device, "ground truth" is established by adherence to recognized engineering and material science standards (ASTM in this case), and the results are quantified through laboratory measurements. Expert opinions in the context of clinical interpretation are not relevant here.

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

Not applicable. Adjudication methods are typically relevant for clinical studies or image interpretation tasks where there's variability in human assessment. These are objective engineering tests.

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 physical bone staple device, not an AI/imaging diagnostic tool.

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

Not applicable. This is a physical bone staple device, not an algorithm. The "standalone" performance here refers to the device's material and mechanical properties as tested against standards.

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

The "ground truth" for the non-clinical tests is defined by the objective pass/fail criteria and quantitative measurements specified within the referenced ASTM (American Society for Testing and Materials) standards. These standards prescribe specific methodologies, acceptable ranges, and performance benchmarks for metallic bone staples and Nitinol materials.

8. The sample size for the training set

Not applicable. This refers to a physical medical device, not a machine learning model.

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

Not applicable. This refers to a physical medical device, not a machine learning model.

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The Minimally Invasive Bunion Plating System is intended for fixation of osteotomies and corrective procedures of the hallux and associated disorders such as hallux valgus.

The Minimally Invasive Bunion Plating System consists of left and right plates composed of implant grade titanium intended for fixation of osteotomies and corrective procedures of the hallux and associated disorders such as hallux valgus. The system will incorporate both locking and non-locking screws, cannulated screws, and the necessary instruments to facilitate the placement of these implants.

This document is a 510(k) Premarket Notification from the FDA regarding a medical device, the "Minimally Invasive Bunion Plating System". It aims to establish substantial equivalence to a legally marketed predicate device, not to prove the device meets specific acceptance criteria through a study demonstrating performance.

Therefore, the requested information regarding acceptance criteria and a study proving the device meets them cannot be extracted from this document for the following reasons:

• No Acceptance Criteria or Performance Study: This document does not describe acceptance criteria related to a specific performance study (e.g., accuracy, sensitivity, specificity, or clinical outcomes) for the device's function in terms of an AI/algorithm. This is a traditional medical device (bunion plating system), not an AI/algorithm device. The "acceptance criteria" here are the FDA's regulatory criteria for market clearance (substantial equivalence), not performance metrics against a clinical ground truth.
• No Clinical Study Performed: The document explicitly states under Section V. "Clinical Test Summary": "No clinical studies were performed." This means there is no study data to report for points 1, 5, 6, 7, 8, or 9.
• Focus on Substantial Equivalence: The entire submission is built on demonstrating substantial equivalence to a predicate device based on similarities in intended use, design, materials, and mechanical safety/performance, supported by non-clinical (mechanical) testing. It does not involve a study of an AI/algorithm's performance against a human expert's assessment or a defined ground truth.

Therefore, I cannot populate the requested table or answer the specific questions about AI/algorithm performance studies. The information provided is for a physical medical device (bone plates and screws), not a software/AI device.

The "Non-Clinical Test Summary" section mentions:

• Non-Clinical Test Summary:
  • Single Cycle Bend Testing referencing ASTM F382
  • Dynamic Bend Testing referencing ASTM F382
  • "The results of these evaluations indicate that the Minimally Invasive Bunion Plating System is equivalent to the predicate devices."

This is the extent of "testing" mentioned, and it pertains to mechanical properties, not an AI's diagnostic or predictive performance.

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The Trilliant Surgical Sniper Staple System is indicated for fixation of fractures and osteotomies of the hand, foot, and bones appropriate for the size of the device.

The Sniper Staple is a mechanical osteosynthesis device allowing for fixation and compression of the bone fragments in order to encourage early bone healing. The staple is fabricated from a nickel-titanium alloy (Nitinol) and possesses super-elastic properties at room temperature. The staple offering is composed of staples consisting of a 1.5 mm x 1.2 mm diameter "U" shaped wire. The "U" shaped staple is available in 8 mm x 8 mm and 10 mm x 10 mm sizes.

This document is a 510(k) premarket notification for a medical device called the "Sniper Staple System." It is a submission to the FDA to demonstrate substantial equivalence to legally marketed predicate devices, not a study proving the device meets specific acceptance criteria in the context of an AI/algorithm-based device.

Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, ground truth establishment, expert involvement, and AI/MRMC studies is not applicable to this type of document.

However, I can extract the relevant information from the document in the context of a traditional medical device (a surgical staple).

Here's the information that can be extracted:

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

For a traditional medical device like a surgical staple, "acceptance criteria" are typically defined by recognized standards and mechanical testing rather than a numerical performance metric like sensitivity/specificity for an AI. The document describes several non-clinical tests performed.

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

• Sample Size: Not specified in the document. For mechanical testing, sample sizes are typically determined by the specific ASTM standards referenced (e.g., F564, F2082, F2129).
• Data Provenance: Not applicable. These are laboratory-based mechanical and biological (pyrogenicity) tests performed on the device itself, not data from human subjects or clinical records.

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. Ground truth as typically understood for AI/diagnostic algorithms is not relevant here. The "truth" is established by the physical properties and performance of the device as measured by standardized engineering and biological tests.

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

• Not applicable. This concept pertains to human review of medical data for ground truth establishment, which is not relevant for this device's testing.

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 is a traditional surgical staple, not an AI or diagnostic imaging device.

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

• No. This is a physical medical device, not an algorithm.

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

• For mechanical tests: Engineering standards (ASTM F564, F2082, F2129) define acceptable performance.
• For biocompatibility/safety test: Biological standards (e.g., maximum endotoxin level for pyrogenicity).

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.

Summary from the document for the Sniper Staple System:
The device's substantial equivalence to predicate devices is based on non-clinical testing, including:

• Four-point Bending (ASTM F564)
• Pull-out Testing (ASTM F564)
• Bend and Free Recovery Testing (ASTM F2082)
• Corrosion testing (ASTM F2129)
• Pyrogenicity testing (Limulus amebocyte lysate (LAL) assay)

The document states, "The results of these evaluations indicate that the Sniper Staple is equivalent to predicate devices," and for pyrogenicity, "The testing demonstrated that the subject device meets the recommended maximum endotoxin level of 20 EU per device." No clinical studies were performed. The conclusion for equivalence is based on similarities in principles of operation, technology, materials, and indications for use.

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The Gridlock Ankle Plating System is intended for use in trauma and reconstructive procedures of the hand/foot, ankle, distal tibia, fibula, and other bones appropriate for the size of the device.

The plates (implant), screws (implant), olive wires (instrument), and guide wires (instrument) are intended for single use only.

Gridlock Ankle Plating System consists of various shape and size plates for the management of orthopedic osteotomies, reconstruction, and trauma. Features include a low profile, limited contact, capability of dynamic/manual compression, and angulated-locking threaded screw holes. The system also consists of multiple locking/standard screw lengths and diameters and the necessary instruments to facilitate the placement of these implants.

The provided document, a 510(k) summary for the "Gridlock Ankle Plating System," does not describe a study involving an algorithm or artificial intelligence (AI) for diagnostic purposes. Instead, it details the system's design, materials, and non-clinical mechanical performance tests to demonstrate substantial equivalence to existing predicate devices for bone fixation.

Therefore, the requested information regarding acceptance criteria and studies proving the device meets those criteria, specifically concerning AI performance, cannot be extracted from this document. The document focuses on the physical characteristics and mechanical properties of a surgical implant system.

Here's an analysis of what is present in the document related to "acceptance criteria" and "studies," acknowledging it's not in the context of AI performance:

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

The document doesn't provide a specific table of acceptance criteria with numerical targets and reported performance values in the way one might expect for a diagnostic AI. However, it implicitly uses a standard for equivalence to predicate devices based on mechanical testing.

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

• Sample Size: Not explicitly stated for each test (Screw Torque to Failure, Plate 4-Point Bending). These are likely conducted on a defined number of devices according to the ASTM standards.
• Data Provenance: Not applicable as these are non-clinical, in-vitro mechanical tests, not based on patient data.

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. Ground truth in this context refers to mechanical properties measured during laboratory testing, not medical diagnoses made by experts.

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

• Not applicable. This pertains to expert review of diagnostic findings, not mechanical testing.

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 MRMC comparative effectiveness study was done. The device is a surgical implant, not a diagnostic tool where human readers would interpret results with or without AI assistance. The "Clinical Test Summary" explicitly states: "No clinical studies were performed."

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

• Not applicable. The device is a physical bone fixation system, not an algorithm.

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

• The "ground truth" for this device's performance evaluation is based on established mechanical standards (ASTM F543 for Screw Torque to Failure and ASTM F382 for Plate 4-Point Bending). The comparison is made against the performance of predicate devices tested under similar conditions.

8. The sample size for the training set:

• Not applicable. This refers to an AI training set, which is not relevant to this device.

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

• Not applicable. This refers to an AI training set, which is not relevant to this device.

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The Tiger Cannulated Screw System is indicated for fixation of fractures, non-unions, arthrodeses, and osteotomies of bones appropriate for the size of the device.

The Tiger Cannulated Screw System is a headed and headless, cannulated, self-drilling, self-tapping screw system for the management of bone orthopedic osteotomies and trauma. The system consists of Ø2.0-Ø7.0 mm screws and washers, and the necessary instruments to facilitate the placement of these implants. The purpose of this submission is to add Ø5.5 mm and Ø7.0 mm headed cannulated screws to the Tiger Cannulated Screw System and to modify the indications for use statement for previously cleared devices (K081510 / K112737).

This document is a 510(k) premarket notification for the "Tiger Cannulated Screw System". It primarily discusses the substantial equivalence of this device to previously marketed predicate devices rather than presenting a study demonstrating the device meets specific acceptance criteria in a clinical or AI-related context.

Therefore, many of the requested sections (2, 3, 4, 5, 6, 7, 8, 9) regarding AI-specific study details, ground truth, expert involvement, and sample sizes for training/test sets are not applicable to this document as it pertains to a traditional medical device (bone screws) and not an AI/ML device.

However, I can extract information related to non-clinical testing and the comparison to predicate devices, which serve as the "acceptance criteria" for this type of submission.

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

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 for this type of device. The non-clinical tests (ASTM F543-07) involve mechanical testing of the screws, not data from human patients or a test set in the AI sense. The number of screws tested for each mechanical property would typically be specified in the full test report, but it's not detailed in this 510(k) summary.

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 relies on engineering and material standards for mechanical properties rather than expert clinical assessment of patient data.

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

• Not applicable. This refers to methods for resolving discrepancies in expert labeling of AI datasets, which is not relevant here.

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 mechanical device, not an AI-assisted diagnostic or therapeutic tool. No MRMC study was performed.

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

• Not applicable. This device is a surgical implant, not an algorithm.

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

• For the non-clinical tests, the "ground truth" or reference standard would be the defined specifications and performance characteristics of the predicate devices and the requirements of the ASTM F543-07 standard.

8. The sample size for the training set:

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

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

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

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The Gridlock Plating System is intended for use in trauma and reconstructive procedures of the small bones in the hand/foot, ankle, and other bones appropriate for the size of the device.

The plates (implant), screws (implant), olive wires (instrument), and guide wires (instrument) are intended for single use only.

Gridlock Plating System consists of various shape and size plates for the management of orthopedic osteotomies, reconstruction, and trauma. Features include a low profile, limited contact, capability of dynamic/manual compression, and angulated-locking threaded screw holes. The system also consists of multiple locking/standard screw lengths and the necessary instruments to facilitate the placement of these implants.

The provided text describes a 510(k) submission for the Gridlock Plating System, a medical device for orthopedic trauma and reconstructive procedures. Based on the document, here's an analysis of the acceptance criteria and study information:

Acceptance Criteria and Reported Device Performance

The submission focuses on establishing substantial equivalence to predicate devices rather than meeting specific performance criteria against a predefined standard. The acceptance criteria essentially revolve around demonstrating that the new components (additional plates and screws) within the Gridlock Plating System do not alter the fundamental safety and effectiveness profile such that new clinical testing would be required.

Study Details

The provided document largely lacks information on clinical studies or detailed performance trials in the way one might expect for a novel device or one requiring extensive performance validation against acceptance criteria with empirical data.

1. Sample size used for the test set and the data provenance:

   • No clinical test set was used. The document explicitly states: "No clinical studies were performed."
   • Data provenance: Not applicable.

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

   • Not applicable. No clinical test set or ground truth establishment by experts was performed for this 510(k) submission. The assessment relies on engineering analysis and comparison to predicate device characteristics.

3. Adjudication method for the test set:

   • Not applicable. No clinical test set or adjudication process was performed.

4. 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 such study was performed. This device is a metallic bone plating system, not an AI-assisted diagnostic or imaging device, so MRMC studies involving human readers and AI assistance are not relevant.

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

   • Not applicable. This device is a physical implant, not a software algorithm.

6. The type of ground truth used:

   • Engineering Analysis and Substantial Equivalence to Predicate Devices: The "ground truth" for this submission is based on the established safety and effectiveness of the legally marketed predicate devices (OsteoMed Foot Plating System K091614, and previous versions of Gridlock Plating System K121452, K123525). The new components are asserted to be similar enough to fall under the same safety and effectiveness profile.

7. The sample size for the training set:

   • Not applicable. No training set for an algorithm was used.

8. How the ground truth for the training set was established:

   • Not applicable. No training set was used.

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The Gridlock Plating System is intended for use in trauma and reconstructive procedures of the small bones in the hand/foot, ankle, and other bones appropriate for the size of the device.

The plates (implant), screws (implant), olive wires (instrument), and guide wires (instrument) are intended for single use only.

Gridlock Plating System consists of various shape and size plates for the management of orthopedic osteotomies, reconstruction, and trauma. Features include a low profile, limited contact, capability of dynamic/manual compression, and angulated-locking threaded screw holes. The system also consists of multiple locking/standard screw lengths and diameters and the necessary instruments to facilitate the placement of these implants.

The provided text describes a physical medical device (Gridlock Plating System), not an AI/software device. Therefore, the questions related to AI/software performance criteria, ground truth, expert consensus, and multi-reader studies are not applicable.

This 510(k) submission is for a Special 510(k), meaning it's for a modification to a previously cleared device (Gridlock Plating System, K121452). The change from the predicate is the addition of two specific plates for the first metatarsal phalangeal joint. The submission aims to demonstrate substantial equivalence to the predicate device.

Here's the relevant information based on the provided text, modified to address the nature of the device:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria were based on substantial equivalence to predicate devices, particularly regarding mechanical performance.

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

• Test Set Sample Size: Not explicitly stated as a "sample size" in the context of clinical data. For mechanical testing, the number of samples tested per condition is not provided.
• Data Provenance: The mechanical testing was performed in a laboratory setting. There is no mention of data from human subjects or retrospective/prospective studies.

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

Not Applicable. For a physical medical device proving mechanical equivalence, "ground truth" related to expert assessment of data is not relevant. The relevant "experts" would be engineering/materials scientists conducting and interpreting the mechanical tests according to standards.

4. Adjudication Method for the Test Set

Not Applicable. Adjudication methods (like 2+1, 3+1) are used for resolving discrepancies in expert assessment of clinical data, which is not relevant here.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

No. No clinical studies were performed. This submission relies on mechanical testing and substantial equivalence to a predicate device.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

Not Applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance demonstration is based on established engineering standards (ASTM F382-99) and comparison against the known performance of legally marketed predicate devices. In essence, the "truth" is that the new plates perform mechanically equivalently to the previously cleared plates.

8. The Sample Size for the Training Set

Not Applicable. No training set for an algorithm is involved.

9. How the Ground Truth for the Training Set Was Established

Not Applicable. No training set for an algorithm is involved.

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