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The Metasurg Nitinol Staple implant is indicated for fixation and arthrodesis of the associated bones and joints of the hands and feet.

The Metasurg Nitinol Staple implants are intended for single use only.

The Metasurg Nitinol Staple Implant is a one piece single use nickel titanium alloy bone fixation device intended to be permanently implanted. The device is indicated for the fixation of osteotomies and joint arthrodesis of the hands and feet. The implant consists of two legs connected by a bridge and is offered in multiple combinations of bridge widths and leg lengths to accommodate various anatomies.

This document does not contain information about studies measuring device performance against acceptance criteria in the way a diagnostic AI device would. This 510(k) pertains to a Metasurg Nitinol Staple Implant, which is a physical, implantable medical device for bone fixation, not an image analysis or diagnostic software.

The document states that substantial equivalence was established through:

• "A design, dimensional comparison"
• "standardized tests"

However, it does not provide details of what those standardized tests were, the specific acceptance criteria for those tests, or the results. It merely states that these comparisons and tests were performed "to establish substantial equivalence in terms of intended use and indications for use, material, design and function to the legally marketed predicate devices."

Therefore, I cannot populate the table or answer the specific questions related to AI device performance evaluation, such as sample sizes for test/training sets, expert adjudication, MRMC studies, or standalone algorithm performance.

The information provided is typical for a 510(k) submission for a physical medical device, focusing on substantial equivalence to predicate devices based on design, materials, and intended use, rather than a detailed performance study with acceptance criteria as would be presented for a diagnostic algorithm.

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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 Metasurg DigiFuse implant is indicated for the fixation of osteotomies and reconstruction of the lesser phalanges during procedures to correct deformities of the toes and fingers.

• Hammer toe deformity
• Claw toe deformity
• Mallet toe deformity
• Other deformities of the feet and hands
  The Metasurg DigiFuse implants are intended for single use only.

The Metasurg DigiFuse Implant is a one-piece threaded device made of titanium intended to be implanted into the medullary bone of the lesser digits. The implant is offered in 4 variations consisting of the combination of 2.0mm and 2.5mm threads and 0° and 10° blades.

The provided text describes a 510(k) summary for the Metasurg DigiFuse Implant and the FDA's decision letter. This document focuses on establishing substantial equivalence to predicate devices based on technological characteristics and design/dimensional comparisons. It does not contain information about a clinical study with acceptance criteria and device performance as typically expected for advanced diagnostic or AI-driven medical devices.

Therefore, many of the requested elements for a study proving device acceptance criteria cannot be extracted from this specific document.

Here's a breakdown of what can be inferred or is explicitly stated, and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Not Applicable.
This document outlines a regulatory submission based on substantial equivalence to predicate devices, not a clinical study with performance metrics against predefined acceptance criteria. The "acceptance criteria" here are implicitly related to the similarity of intended use, material, and design to the predicate devices.

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

Not Applicable.
There is no mention of a "test set" in the context of clinical data or image analysis. The comparison is based on the design and dimensional characteristics of the device itself relative to predicate devices.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not Applicable.
No ground truth establishment by experts is described as this is not a study evaluating human or algorithm performance against a known truth.

4. Adjudication Method

Not Applicable.
No adjudication method is relevant as there are no judgments being made by experts on a test set.

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

Not Applicable.
No MRMC study was conducted or mentioned, as this is a device clearance based on substantial equivalence, not a comparative effectiveness study involving human readers or AI assistance.

6. Standalone (Algorithm Only) Performance Study

Not Applicable.
This device is an implant, not an algorithm. Therefore, no standalone algorithm performance study was done.

7. Type of Ground Truth Used

Not Applicable.
No ground truth (expert consensus, pathology, outcomes data) was used in the context of a performance study as described here. The "truth" for substantial equivalence is the existing regulatory status and established characteristics of the predicate devices.

8. Sample Size for the Training Set

Not Applicable.
There is no mention of a "training set" as this is not a machine learning or AI-driven device.

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

Not Applicable.
No ground truth for a training set was established.

Summary of what the document does provide in relation to regulatory acceptance:

• Basis for Acceptance: Substantial equivalence to predicate devices.
• Key Comparison Points: Similar indications, physical dimensions, and material (titanium and/or stainless steel).
• Predicate Devices:
  • OsteoMed Ext. 2.0/2.4 Cannulated Screw System (K062863)
  • Wright Medical Pro-Toe (K101165)
  • NEWDEAL K-Wire (K022599)
• Regulatory Conclusion: The FDA determined the device is substantially equivalent to legally marketed predicate devices.

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The MetaSurg cannulated titanium hemi implant is indicated for use in the treatment of degenerative arthritis in the 1st metatarsal joint along with the following clinical conditions: Hallux Limitus or Hallux Rigidus, Hallux Valgus and pain or instability in the metatarsophalangeal joint.

The MetaSurg cannulated titanium hemi implant is intended for press fit, uncemented use.

The MetaSurg cannulated titanium hemi implant is intended for single use only.

The MetaSurg cannulated titanium hemi implant is designed to be an anatomical replacement for the base of the phalanax. The implant is offered in 5 sizes ranging from 15 - 23mm in diameter.

The provided document is a 510(k) summary for a medical device called the MetaSurg Cannulated Titanium Hemi Implant. This summary focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than presenting a study with specific performance metrics such as accuracy, sensitivity, or specificity. Therefore, many of the requested criteria for studies that evaluate device performance (like AI algorithms) are not applicable or cannot be extracted from this type of regulatory submission.

Here's a breakdown based on the information available:

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

The document does not specify "acceptance criteria" in terms of performance metrics typical for AI or diagnostic devices (e.g., accuracy, sensitivity, specificity). Instead, it focuses on demonstrating substantial equivalence to predicate devices based on:

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

Not applicable. This is a 510(k) submission for a physical implant, not a study involving a "test set" of data for performance evaluation in the context of AI or diagnostic accuracy. The substantial equivalence determination is based on device characteristics and intended use.

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

Not applicable. This type of evaluation is not performed for physical implants demonstrating substantial equivalence. The "ground truth" for the predicate devices would have been established through clinical use and regulatory clearance, which is then used as a reference point for the new device.

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

Not applicable. No test set or adjudication method is described for this type of submission.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a surgical implant, not an AI-assisted diagnostic tool or an imaging device requiring human reader interpretation in the context of an MRMC study.

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

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

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

For the purpose of substantial equivalence, the "ground truth" is effectively the regulatory clearance and established safety and effectiveness of the predicate devices: Vilex hemi implant (K023684) and BioPro hemi implant (K041595). The new device is compared against these already-cleared devices based on their characteristics and intended use. No new clinical 'ground truth' in the sense of diagnostic accuracy is established in this document.

8. The sample size for the training set

Not applicable. This device is a physical implant, not an AI model requiring a training set.

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

Not applicable. No training set is involved.

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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.

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 6 sizes ranging from 7mm - 12mm in diameter. The implant is used in the treatment of excessive motion of the talus relative to the calcaneus.

This is a 510(k) summary for the Metasurg Subtalar Implant, a metallic bone fixation fastener. The document establishes substantial equivalence to other legally marketed devices and outlines the intended use and device description.

It's important to note that this document states substantial equivalence to legally marketed devices, but does not provide specific acceptance criteria or an analytical study proving the device meets those criteria. The provided text is a regulatory clearance document, not a performance study report.

Therefore, many of the requested details about acceptance criteria, device performance, and study methodology cannot be extracted from this document.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

• Cannot be provided. This document does not detail specific acceptance criteria for performance (e.g., mechanical strength, wear resistance, biocompatibility thresholds) nor does it report the Metasurg Subtalar Implant's direct performance against such criteria in a test setting. The 510(k) process relies on demonstrating substantial equivalence to a predicate device, which implies the new device is as safe and effective as the predicate, but doesn't necessarily require reporting new performance data against specific, quantifiable acceptance criteria 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)

• Cannot be provided. This document does not describe any specific test set or clinical study conducted for the Metasurg Subtalar Implant.

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. There is no test set or ground truth described in this regulatory clearance document.

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

• Not applicable. There is no test set or adjudication process described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not applicable. This device is an implant, not an AI-assisted diagnostic tool, and this document does not describe any MRMC studies.

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

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

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

• Not applicable. No specific ground truth is mentioned as this is a regulatory submission based on substantial equivalence, not a clinical trial report.

8. The sample size for the training set

• Not applicable. This involves an implant, not a machine learning model with a training set.

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

• Not applicable. This involves an implant, not a machine learning model, and therefore no training set or its ground truth establishment is discussed.

Summary of Device Information from the Document:

• Device Trade Name: Metasurg Subtalar Implant
• Classification Name: Smooth & threaded metallic bone fixation fasteners (21 CFR 888.3040, Product Code HWC, Class II)
• Common Name: Subtalar Arthrorisis Implant
• Device Description: A one-piece device made of titanium, implanted into the sinus tarsi of the foot. Offered in 6 sizes (7mm - 12mm diameter).
• Intended Usage/Indications for Use: Treatment of the hyperpronated foot and stabilization of the subtalar joint. Designed to block forward, downward, and medial displacement of the talus, allowing normal subtalar joint motion but blocking excessive pronation and its sequela. Intended for single use only.
• Material: Titanium Alloy (Ti-6AL-4V ELI)
• Substantial Equivalence: Documentation was provided to demonstrate substantial equivalence to other legally marketed devices. This is the primary "proof" used for 510(k) clearance, implying the device is as safe and effective as its predicate.

This 510(k) summary focuses on demonstrating that the Metasurg Subtalar Implant is substantially equivalent to devices already on the market. It does not provide detailed performance study data against specific acceptance criteria for the new device itself. Such data would typically be found in engineering testing reports (e.g., for mechanical properties) or clinical study reports, which are not included in this summary.

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