Search Results

BRM TOOL Screws
The BRM TOOL Screws are indicated for use for aligned bone fracture repair and arthrodesis, osteotomy, joint fusion and bone fragment fixation appropriate with the size of the screw.

BIOPLAN Subtalar Implants
The BIOPLAN Subtalar Implant is indicated for use in the treatment of the hyperpronated foot and stabilization of the subtalar joint. It is designed to block forward and medial displacement of the talus, thus allowing normal subtalar joint motion but blocking excessive pronation and the resulting sequela.

• Flat foot treatment in children and adolescents
• Congenital flat foot
• Non successful long term orthopaedic treatment (shoes, insoles ...)
• Tarsal coalitions
• Painfully flat foot
• Supple deformity in posterior tibial tendon dysfunction
• Paralytic flat foot
• Subtalar instabilitv

The BRM TOOL Screws are interfragmentary compression osteosynthesis screws, i.e., devices used in surgical orthopedic interventions to provide support to the bone structure, with the aim to reduce fractures in several parts of the skeleton, particularly of bone epiphyses. The application field excludes spinal, rib cage and skull bones. The BRM TOOL Screws are available in Titanium alloy. The BIOPLAN Subtalar Implants are used for the correction of the flatfoot pathology. The BIOPLAN Subtalar Implants are available in Titanium alloy and PEEK options.

This document is an FDA 510(k) clearance letter and summary for a medical device (BRM Screw Family). It does not contain any information about a study proving the device meets acceptance criteria related to AI or algorithmic performance.

The "Performance Testing" section states: "Testing included static strength and fatigue strength testing, pushout and pull-out testing, as well as insertion and extraction torque testing. Results were determined to meet the pre-defined acceptance criteria per ASTM F543 and ASTM F1264."

This refers to mechanical and material performance of the screws themselves, not the performance of an AI algorithm. Therefore, the requested information (acceptance criteria for an AI device, sample sizes, expert qualifications, MRMC studies, etc.) is not present in the provided text.

To answer your request, I would need a document describing the clinical or algorithmic performance study of a device, rather than a 510(k) clearance for a physical medical device like bone screws.

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The intended use/indications for use of the predicate devices identified remain the same as previously cleared in their respective 510(k)s. The respective 510(k)s for the devices can be referenced in the predicate device section above.

The purpose of this submission is the addition of MR Conditional information to the labeling for the predicate devices. The addition of MR labeling to the subject devices does not impact indications, materials, design features or dimensions, packaging or sterilization.

This is a 510(k) summary for a submission that adds MR Conditional information to the labeling of several existing medical devices. The submission does not introduce new devices or changes to the fundamental design, materials, or indications for use of the listed devices. Therefore, the "acceptance criteria" and "device performance" in this context relate to the MR compatibility of the devices according to established standards.

Here's the breakdown:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not explicitly stated in the provided text. For MR compatibility testing, the "sample size" typically refers to the number of device models/configurations tested. It's implied that "the devices" (referring to the listed product lines and their components) were tested.
• Data Provenance: The nature of this testing (MR compatibility) suggests it was conducted in a controlled environment as a prospective evaluation of the devices. The country of origin of the data is not specified but would likely have been where the testing laboratory is located, presumably in a country with recognized testing standards (e.g., USA or Europe).

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

• This type of submission (MR compatibility of implants) does not typically involve human expert "ground truth" derived from clinical images. The "ground truth" here is objective measurements against engineering standards for MR safety and compatibility. The "experts" would be the engineers and physicists conducting the tests and interpreting the results according to ASTM standards and FDA guidance. Their qualifications would be expertise in MR safety testing and relevant engineering fields.

4. Adjudication Method for the Test Set

• Not applicable. This is not a study requiring adjudication of human-interpreted data. The results are based on objective physical measurements and adherence to specified test protocols.

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

• No, an MRMC comparative effectiveness study was not done. This submission is for device labeling updates based on physical properties (MR compatibility), not for evaluating the clinical effectiveness of a diagnostic or therapeutic algorithm with human readers.

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

• No, a standalone algorithm performance study was not done. This submission is about the physical properties of medical implants in an MRI environment, not about an AI algorithm.

7. The Type of Ground Truth Used

• The "ground truth" used is defined by internationally recognized engineering standards for MR compatibility: ASTM F2052 (displacement force), ASTM F2213 (torque), ASTM F2182 (RF-induced heating), and ASTM F2119 (image artifact). The FDA Guidance "Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment" also serves as a framework for the "ground truth" criteria.

8. The Sample Size for the Training Set

• Not applicable. This submission is about MR compatibility testing of existing devices, not about developing or training an AI algorithm. Therefore, there is no "training set."

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

• Not applicable, as there is no training set.

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The LIFE SPINE Subtalar implant is indicated for use in the treatment of the hyperpronated foot and stabilization of the subtalar joint. It is designed to block forward, downward and medial displacement of the talus, thus allowing normal subtalar joint motion but blocking excessive pronation and the resulting sequela.

The LIFE SPINE Subtalar implants are intended for single use only.

The LIFE SPINE Subtalar Implant System is a one piece titanium implant for treating hyperpronation of the foot. The system includes instruments (trial sizers, k-wires, and driver) to facilitate placement of the implant. Implants are manufactured from titanium alloy (Ti 6Al-4V ELI).

All implants are intended for single use only and should not be reused under any circumstances. Do not use any of the Subtalar Implant System components with components from any other system or manufacturer. The Subtalar Implant System components should never be reused under any circumstances.

This document is a 510(k) premarket notification for a medical device called "The LIFE SPINE Subtalar Implant System". It describes the device, its intended use, and claims substantial equivalence to predicate devices. However, it does not contain any information about acceptance criteria or a study proving that the device meets acceptance criteria.

The document primarily focuses on regulatory approval based on substantial equivalence, which often relies on demonstrating that a new device is as safe and effective as a legally marketed predicate device, rather than requiring extensive performance studies against specific acceptance criteria.

Therefore, I cannot provide the requested information from this document.

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The IFS Subtalar Implant is intended to treat hyperpronated foot and stabilize the subtalar joint. It is intended to block forward, downward and medial displacement of the talus, thus allowing normal subtalar joint motion but blocking excessive pronation and the resulting sequela.

The IFS Subtalar Implant is a one-piece device made of Ti 6Al-4V ELI intended to be implanted into the sinus tarsi of the foot. The implant is designed in 6 diameter and length sizes (7mm through 12mm and 13mm through 18mm, respectively). The implant which is used in the treatment of excessive motion of the talus relative to the calcaneus acts as a spacer for the joint, maintaining the joint space, allowing for range of motion, but limiting excessive pronation.

The provided text, a 510(k) summary for the IFS Subtalar Implant, focuses on demonstrating substantial equivalence to predicate devices rather than presenting a study with specific acceptance criteria and detailed performance metrics for the device itself. Therefore, detailed information required by your request about acceptance criteria, study design, expert involvement, and ground truth establishment is not available in the provided document.

Here's a breakdown of what can and cannot be extracted from the text:

1. Table of Acceptance Criteria and Reported Device Performance:

• Not Available. This document describes the device's design, material, and intended use, and compares it to predicate devices. It does not contain a table of performance metrics (e.g., accuracy, sensitivity, specificity) against predefined acceptance criteria for the device itself. The "acceptance criteria" here are implicitly related to demonstrating substantial equivalence, not to statistical performance of an AI or diagnostic device.

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

• Not Applicable/Not Available. The provided document is a 510(k) submission for a medical implant (bone fixation fastener), not a study evaluating an AI or diagnostic device. There is no "test set" in the context of evaluating an AI's performance. The review focuses on the device's design, materials, and intended use as compared to existing devices.

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

• Not Applicable/Not Available. Same as above, there is no "test set" or "ground truth" establishment in the context of typical AI/diagnostic device evaluation. The "experts" involved are likely the FDA reviewers assessing the 510(k) submission and the engineers/clinical staff from Internal Fixation Systems, Inc. who designed, developed, and documented the device.

4. Adjudication Method for the Test Set:

• Not Applicable/Not Available. No test set as described for an AI/diagnostic device.

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/Not Available. This is a hardware implant, not an AI-powered diagnostic tool. MRMC studies are irrelevant here.

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

• Not Applicable/Not Available. This is not an algorithm.

7. The Type of Ground Truth Used:

• Not Applicable/Not Available. No ground truth in the context of an AI/diagnostic device evaluation. The "ground truth" for this device would be its physical properties, biocompatibility, and mechanical performance, which are assessed through engineering tests and material analysis (though details are not in this summary).

8. The Sample Size for the Training Set:

• Not Applicable/Not Available. This is a physical implant, not an AI model. There is no concept of a "training set."

9. How the Ground Truth for the Training Set was Established:

• Not Applicable/Not Available. No training set.

Summary based on the provided document:

The IFS Subtalar Implant's acceptance criteria for market clearance (510(k)) were based on demonstrating substantial equivalence to existing legally marketed predicate devices, specifically:

• Nexa Subtalar Arthrorisis Implant (K032902)
• Osteomed Subtalar Implant System (K031155)

The study proving this involved a comparison of technological characteristics, focusing on:

• Design: Similar overall diameters and lengths.
• Function: Intended to treat hyperpronated foot, stabilize the subtalar joint, and block excessive pronation, acting as a spacer.
• Material: Made of Ti 6Al-4V ELI, which is a common material for such implants and likely comparable to the predicates.
• Intended Use: Identical or very similar to the predicate devices (treating hyperpronated foot and stabilizing the subtalar joint).

The document explicitly states: "The IFS Subtalar Implant is substantially equivalent to the predicate devices with respect to the design, function, and material. The implants have the same overall diameters, lengths, and material composition. ... There are no significant differences between the subtalar implant and the other implants as listed in the Substantially Equivalent Devices. The IFS Subtalar Implant and the predicate devices have similar design attributes, material, and intended use thus is substantially equivalent."

This is a regulatory pathway for medical devices that are similar in technology and intended use to devices already on the market, meaning a full clinical trial demonstrating novel safety or effectiveness might not be required. The "study" in this context is the detailed comparison and justification provided in the 510(k) submission to the FDA.

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The OsteoSpring FootJack™ Subtalar Implant System is indicated for use in the treatment of hyperpronated foot and stabilization of the subtalar joint. It is designed to block the anterior and inferior displacement of the talus, thus allowing normal subtalar joint motion but limited excessive pronation and resulting sequela. The OsteoSpring FootJack Implant System . implants are intended for single patient use only.

The OsteoSpring FootJack™ subtalar implant is intended to be implanted into the sinus tarsi of the foot. It will be available in a range of sizes. The implant is a solid, one-piece, conical, thread shaped and cannulated design.

Acceptance Criteria and Study for the OsteoSpring FootJack™ Subtalar Implant System

Based on the provided 510(k) summary (K112658), the OsteoSpring FootJack™ Subtalar Implant System did not undergo clinical studies to prove its acceptance criteria. Instead, it relied on non-clinical testing and claims of substantial equivalence to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not applicable. No clinical test set involving patient data was used. The testing was non-clinical.
• Data Provenance: Not applicable. The data comes from in-vitro (Finite Element Analysis and Static Compression Testing) studies, not from human subjects or clinical settings, hence no country of origin or retrospective/prospective classification applies.

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

Not applicable. The non-clinical tests (Finite Element Analysis and Static Compression Testing) assess physical and mechanical properties, not interpretations of clinical data that would require expert consensus.

4. Adjudication Method for the Test Set

Not applicable. No clinical test set requiring adjudication was performed.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The device is an implant, not an AI or imaging diagnostic tool that would typically involve human readers.

6. Standalone Performance Study (Algorithm Only)

Not applicable. This device is a physical implant, not an algorithm. Therefore, "standalone performance" in the context of an algorithm does not apply.

7. Type of Ground Truth Used

For the mechanical performance, the "ground truth" was established by the physical and engineering properties of the device as measured by the static compression testing and simulated by the Finite Element Analysis. For the claim of substantial equivalence, the "ground truth" was the characteristics and performance data of the identified predicate devices against which the new device was compared.

8. Sample Size for the Training Set

Not applicable. This device did not involve any machine learning algorithms or AI that would require a training set.

9. How Ground Truth for the Training Set Was Established

Not applicable. As there was no training set for an algorithm, no ground truth needed to be established for it.

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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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The NuGait™ Subtalar Implant System restricts excessive subtalar pronation in the downward, forward, and medial planes, providing for a more normal subtalar joint motion in patients. The NuGait Subtalar Implant System is intended for the following pathological conditions resulting from disease, injury, or other trauma: • Hypermobile pes valgus; • Posterior tibial • tendon dysfunction; • Severe pronation; • Subtalar instability; • Hypermobile flexible congenital flat foot.

The NuGait Subtalar Implant System consists of a one-piece arthroereisis implant designed to stabilize the subtalar joint of the hyperpronated foot and associated instrumentation. The NuGait implant is constructed of Ti-6Al-4V ELI titanium alloy and is offered in 5 sizes to fit a range of anatomies. The subject device is also cannulated to allow precise insertion when used with a guide wire and system instrumentation. The outer surface of the implant features a helical thread to aid fixation within the sinus tarsi. Each NuGait is packaged individually and sterilized via gamma radiation. These devices are intended for single use only.

This document is a 510(k) premarket notification for a medical device (NuGait™ Subtalar Implant System) and, as such, outlines the basis for substantial equivalence to a predicate device rather than presenting a study proving a device meets specific acceptance criteria in the typical sense of a clinical trial for a new drug or novel medical device.

Therefore, the information requested in your prompt regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment cannot be fully provided from the given document. This document focuses on demonstrating that the new device is as safe and effective as an already legally marketed device through technological characteristics and non-clinical data.

Here's an analysis based on the provided text, addressing the points where information is available and noting where it is not:

1. Table of acceptance criteria and the reported device performance

The document does not present a table of quantitative acceptance criteria for device performance in the way one might expect for a diagnostic or efficacy study. Instead, the basis for approval is "substantial equivalence" to a predicate device.

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

• Sample Size for Test Set: Not applicable. No clinical test set data was used or required for this 510(k). The evaluation relied on non-clinical (engineering/bench) testing and comparison to a predicate device.
• Data Provenance: Not applicable for a clinical test set. The non-clinical data would have been generated internally by Ascension Orthopedics, Inc.

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

• Not applicable. There was no clinical test set requiring expert-established ground truth.

4. Adjudication method for the test set

• Not applicable. No clinical test set was used.

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 device is a subtalar implant, not an AI-assisted diagnostic tool or system designed for human readers.

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

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

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

• Not applicable for clinical ground truth. The "ground truth" for this submission is based on the established safety and effectiveness of the legally marketed predicate device (Sub-Talar Lok™ Arthroereisis Implant System) and the demonstration that the NuGait™ device has comparable intended use, technological characteristics, and material properties, supported by non-clinical bench testing (e.g., bending strength).

8. The sample size for the training set

• Not applicable. This device is a physical implant, not a machine learning model requiring a training set.

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

• Not applicable. This device is a physical implant, not a machine learning model.

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The Metasurg subtalar implant is indicated for use in the treatment of the hyperpronated foot and stabilization of the subtalar joint. It is designed to block forward, downward and medial displacement of the talus, thus allowing normal subtalar joint motion but blocking excessive pronation and the resulting sequela.

Indications include:

• Severe pronation .
• Calcaneal valgus deformity .
• Plantarflexed talus .
• Failed correction with long term orthotic treatment .
• Congenital and painful flatfoot deformity .
• . Repair of tarsal coalitions
• Subtalar instability .
• Posterior tibial tendon dysfunction .
• Paralytic flat foot deformity .

The Metasurg subtalar implants are intended for single use only.

The Metasurg Subtalar Implant is a one-piece device made of titanium intended to be implanted into the sinus tarsi of the foot. The implant is offered in 5 sizes ranging from 8mm to 12mm in diameter. The implant is used in the treatment of the talus relative to the calcaneus.

The provided K111265 document is a 510(k) summary for the Metasurg Subtalar Implant. It describes the device, its intended use, and states that substantial equivalence has been demonstrated to other legally marketed devices.

However, the document does not contain any information regarding acceptance criteria or the results of a specific study proving the device meets acceptance criteria. 510(k) summaries typically focus on proving substantial equivalence to a predicate device based on similarities in intended use, technology, and performance, often relying on non-clinical testing (e.g., mechanical testing, biocompatibility) or comparison with existing clinical data of the predicate. They generally do not include detailed clinical study reports with specific acceptance criteria and performance metrics for the new device as would be seen in a PMA or a detailed clinical trial publication.

Therefore, I cannot provide the requested table or detailed information about a study proving the device meets acceptance criteria because that information is not present in the provided text.

Based on the available document, I can infer the following about the regulatory intent, although direct "acceptance criteria" as you've defined them for a clinical study are not present:

Implied "Acceptance Criteria" for 510(k) Equivalence (not performance criteria):

• Similar intended use
• Similar technological characteristics
• Similar material composition (titanium alloy) | Documentation is provided which demonstrates the Metasurg Subtalar Implant to be substantially equivalent to other legally marketed devices. The device is a one-piece titanium implant for the sinus tarsi, intended to treat hyperpronated foot and stabilize the subtalar joint by blocking excessive pronation. Made of Titanium Alloy (Ti 6Al-4V ELI). |
  | Biocompatibility:
• Material commonly used in implants | Titanium Alloy (Ti 6Al-4V ELI) is a well-established and accepted biocompatible material for implantable devices, implying it meets biocompatibility requirements. (No specific test results provided in this summary). |
  | Mechanical Performance:
• Meets strength/durability for intended use | While not detailed, for orthopedic implants, there's an implicit requirement for sufficient strength and durability. The K111265 typically relies on non-clinical performance data (e.g., mechanical testing) to show it performs as safely and effectively as a predicate. (No specific test results reported in this summary). |

Regarding the specific questions you asked, based solely on the provided K111265 document:

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

   • As explained above, the document does not present specific clinical acceptance criteria or performance metrics from a dedicated study. The "performance" described is in the context of demonstrating substantial equivalence to a predicate device.

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

   • No clinical "test set" or associated data provenance is mentioned in this 510(k) summary. 510(k)s often rely on non-clinical (e.g., bench) testing and comparison to existing predicate devices rather than new clinical trials.

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):

   • This information is not applicable and not present, as no clinical test set or ground truth establishment process is described.

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

   • Not applicable; no clinical test set or adjudication process is mentioned.

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 medical device (implant), not an AI diagnostic/imaging device that would typically undergo MRMC studies involving human readers.

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

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

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

   • Not applicable. No clinical ground truth is described in this 510(k) summary. The "ground truth" for a 510(k) is effectively the safety and efficacy track record of the predicate device, which the new device aims to be equivalent to.

8. The sample size for the training set:

   • Not applicable; implants do not typically have "training sets" in the context of AI or machine learning.

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

   • Not applicable.

In summary, the provided 510(k) summary (K111265) for the Metasurg Subtalar Implant focuses on demonstrating substantial equivalence to a predicate device based on material, design, and intended use, rather than presenting results from a clinical study with specific acceptance criteria for performance.

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

The Trilliant Surgical 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 implant is cylindrical in shape and incorporates a center cannula designed for use with a guide wire to facilitate proper placement of the implant. It is available in six sizes, Ø7mm to Ø12mm in 1mm increments.

The provided document, a 510(k) summary for the Trilliiant Surgical Subtalar Implant (K103183), describes the device and its substantial equivalence to predicate devices. However, it does not contain information related to acceptance criteria, device performance metrics, or the specific study details you've requested for proving acceptance criteria.

This 510(k) summary focuses on demonstrating that the Trilliiant Surgical Subtalar Implant is substantially equivalent to already legally marketed devices based on its intended use, design, materials, and function. The summary explicitly states:

• "No clinical studies were performed" (Section 8. Clinical Test Summary).
• "The following tests were conducted: Compression testing comparing predicate and Trilliant Surgical Subtalar Implant." (Section 7. Non-clinical Test Summary).

Therefore, I cannot provide the detailed information requested in your prompt regarding acceptance criteria, study methodologies, and performance metrics as it is not present in the provided text.

Here's a breakdown of why each requested point cannot be answered based on the input:

1. A table of acceptance criteria and the reported device performance: Not provided. The document only mentions "compression testing" without detailing acceptance criteria or quantitative performance results.
2. Sample sized used for the test set and the data provenance: Not provided. The document mentions compression testing but doesn't specify sample sizes or data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no clinical studies are reported.
4. Adjudication method for the test set: Not applicable, as no clinical studies are reported.
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 medical device (implant), not an AI-powered diagnostic tool, and no clinical studies are reported.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical medical device, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable, as no clinical studies are reported. "Compression testing" would typically have a physical standard or engineering specification as a reference.
8. The sample size for the training set: Not applicable, as no AI/algorithm development is described.
9. How the ground truth for the training set was established: Not applicable, as no AI/algorithm development is described.

In summary, the provided 510(k) document is for a medical implant and relies on substantial equivalence to predicate devices, supported by non-clinical (compression) testing, rather than extensive clinical efficacy or AI-specific validation studies.

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The Arthrex ProStop™ Plus Arthroereisis Subtalar Implants are indicated as an internal support to primary surgical interventions in the treatment of flat foot, providing structural support at minimum during the first three months of healing.

The Arthrex ProStop™ Plus Arthroereisis Subtalar Implant is a fully threaded, cannulated, tapered screw. It is similar in design to the predicate device MBA Resorb Implant, K051611.

This document is a 510(k) summary for the Arthrex ProStop Plus Arthroereisis Subtalar Implant. It describes the device and its intended use, and claims substantial equivalence to a predicate device. However, it does not contain the specific information requested in the prompt regarding acceptance criteria, a study proving device performance, sample sizes, expert qualifications, or details about standalone performance or training sets. This is typical for a 510(k) summary, which focuses on demonstrating substantial equivalence rather than presenting detailed clinical study results and acceptance criteria in the manner requested.

Therefore, I cannot populate the table or answer the specific questions based solely on the provided text. The document primarily focuses on regulatory approval based on demonstrating equivalence rather than a detailed performance study against specific acceptance criteria.

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