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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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The Hammer Toe System implants are intended for fixation of osteotomies and reconstruction of the lesser phalanges during procedures to correct deformities of the lesser toes and fingers. Indications include: hammer toe deformity, claw toe deformity, mallet toe deformity, and other deformities of the foot and hand.

The Hammer Toe Implant is a threaded/spaded device used for bone fixation in the phalanges of the lesser digits in the foot and hand. The implant, which is a cannulated, threaded and spaded device, is offered in multiple diameters and lengths. The system will also consist of K-wires (K121008) to be used in the delivery of the implant and also for use of temporary stabilization of outlying joints.

Here's a summary of the acceptance criteria and the study information for the Trilliant Hammer Toe Implant, based on the provided text:

Acceptance Criteria and Reported Device Performance

Study Information

1. Sample size used for the test set and the data provenance: Not applicable. The study was non-clinical (mechanical testing) and did not use patient data. The test material was polyurethane foam.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The ground truth was established by physical properties and mechanical testing standards (ASTM F543).

3. Adjudication method for the test set: Not applicable.

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 MRMC study was performed. This is a medical device (implant), not an AI diagnostic tool.

5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: No standalone algorithm performance was assessed. This is a medical device (implant), not an AI diagnostic tool.

6. The type of ground truth used: Mechanical properties and performance evaluated against ASTM F543 standards, demonstrating equivalence to predicate devices. This is a form of engineering or physical ground truth.

7. The sample size for the training set: Not applicable. No training set was involved as this was a non-clinical mechanical performance study for a physical implant.

8. How the ground truth for the training set was established: Not applicable.

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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 and screws are intended for single use only.

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

Materials:
CP Titanium per ASTM F67 Titanium alloy per ASTM F136

The provided document is limited to a 510(k) summary for the Gridlock Plating System, a medical device. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting extensive clinical efficacy studies typically associated with AI/ML diagnostic tools.

Therefore, the document does not contain information relevant to AI/ML device acceptance criteria or studies proving device performance in the context you've outlined. Specifically:

• No AI/ML components: The Gridlock Plating System is a metallic bone fixation appliance, not an AI/ML diagnostic or assistive device.
• No acceptance criteria for AI/ML performance: The testing described (static four-point bending, dynamic bending, pull-out, torque) are mechanical performance tests for implants, not metrics like sensitivity, specificity, or accuracy relevant to AI/ML.
• No data provenance, ground truth, expert review, MRMC studies, or training/test sets: These concepts are entirely absent because the device is a physical implant, not a software algorithm.
• No clinical studies: The document explicitly states, "No clinical studies were performed." Substantial equivalence was based on non-clinical (mechanical) testing.

In summary, the Gridlock Plating System is a traditional medical device, and the provided 510(k) summary does not contain any information related to the acceptance criteria or study methodologies typically associated with AI/ML-powered devices.

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The Trilliant Surgical K-wires are intended for use in fixation of bone fractures, for bone reconstructions, and as guide pins for insertion of other implants.

K-wires are sharpened or blunt, smooth stainless steel pins. They come in different sizes and are used to hold bone fragments together (pin fixation) or to provide an anchor for skeletal traction. Two diameters, Ø0.045" (Ø1.143 mm) and Ø0.062" (Ø1.57 mm), of the Trilliant Surgical K-Wires are offered to accommodate various patient anatomies, injuries and/or conditions, and physician preference.

Materials: 316L Stainless Steel per ASTM F138

Function: The K-wires are used to hold bone fragments together (pin fixation), to provide an anchor for skeletal traction and as guide pins for insertion of other implants.

The provided text indicates that no clinical studies were performed for the Trilliant Surgical K-wires. Therefore, there is no information available regarding acceptance criteria or a study proving that the device meets such criteria.

The submission states:

• Clinical Test Summary: "No clinical studies were performed"
• Conclusions Nonclinical and Clinical: "This summary concludes that Trilliant Surgical K-wires are as safe, as effective, and performs as well as the predicate device(s)."

This implies that the substantial equivalence determination was based on non-clinical data, such as a comparison of design, materials, and intended use with a legally marketed predicate device (K-Medic External Fixation Devices - K030336), rather than a performance-based clinical study.

Given the information provided in the input, I cannot fill in the requested table or detail a study that proves the device meets acceptance criteria.

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The Disco Subtalar Implant is indicated for use in the treatment of the hyperpronated foot and stabilization of the subtalar joint. It is intended to block the forward, and medial displacement of the talus, thus allowing normal subtalar joint motion but limiting excessive pronation.

The Disco Subtalar Implant consists of a threaded implant, designed to be inserted between the posterior and middle facets of the subtalar joint, and corresponding instrumentation to facilitate insertion. The leading end of the implant is cylindrical in shape and is approximately half of the overall length of the device, with the remaining length being spherical. The full length of the implant incorporates a center cannula designed for use with a guide wire to facilitate proper placement of the implant. Internal threads are machined in the spherical end of the implant and are for use with a removal tool.

The Disco Subtalar Implant's 510(k) summary does not contain information about acceptance criteria or a study proving that the device meets acceptance criteria in the manner typically understood for AI/ML-based medical devices (e.g., performance metrics like sensitivity, specificity, or AUC against a ground truth). This is a traditional medical device, not an AI/ML diagnostic tool.

Instead, the submission focuses on demonstrating substantial equivalence to predicate devices through non-clinical performance and design characteristics, rather than clinical efficacy studies.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not applicable. The "tests" mentioned are non-clinical (static compression and pull-out testing on the device itself), not studies on a test set of patient data.
• Data Provenance: Not applicable. The data comes from mechanical testing of the device.

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

• Not applicable. Ground truth, in the context of diagnostic AI/ML devices, relates to patient outcomes or expert interpretations. For this mechanical device, "ground truth" relates to engineering specifications and material properties, which are verified through standard engineering tests.

4. Adjudication Method for the Test Set

• Not applicable. There was no 'test set' of patient data requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

• No. The document explicitly states: "No clinical studies were performed." This is a mechanical implant device, not a diagnostic tool typically evaluated with MRMC studies.

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

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

7. The Type of Ground Truth Used

• For mechanical properties: Engineering standards and specifications (e.g., ASTM F136 for material, established benchmarks for static compression and pull-out strength based on predicate devices).
• For intended use/function: Clinical consensus on the biomechanics of subtalar joint stabilization and correction of hyperpronation, as embodied by the predicate devices.

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.

Summary of Device Acceptance:

The acceptance of the Disco Subtalar Implant by the FDA (as indicated by the 510(k) clearance K111834) was based on its successful demonstration of substantial equivalence to already legally marketed predicate devices (Trilliant Twist Subtalar Implant - K103183 and ProStop - K071456).

The study that "proves the device meets the acceptance criteria" in this context is the non-clinical testing summary where:

• Static compression and pull-out testing was performed.
• The results indicated that the Disco Subtalar system is equivalent to predicate devices in these mechanical properties.
• The device's materials (Ti-6Al-4V alloy per ASTM F136), function, intended use, and design (despite a geometry change from the predicate) were also considered substantially equivalent.

The FDA's decision letter confirms this equivalence, allowing the device to be marketed. No clinical studies were required or performed for this 510(k) submission, as per standard regulatory pathways for certain types of mechanical implants claiming substantial equivalence.

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