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The Solana Surgical LLC, CrossCheck Plating System is indicated for stabilization and fixation of fresh fractures, revision procedures, joint fusion and reconstruction of small bones in the hand, feet, wrist, and ankles, fingers and toes. The system may be used in both pediatric and adult patients. The device is intended for single use.

The Solana Surgical, LLC CrossCHECK Plating System consists of a variety of bone plates and screws to be used in fixation fractures, osteotomies, and fusions in the extremities of the ley and arm including the hand and foot. The various plate designs use either 3mm or 3.5mm screws. Screws include both locking and non-locking designs. Lag screws and cross-hole plates are included for compression. Plate designs include MTP, Lapidus, and 2-7 Hole Utility plates. All plates and screws are manufactured from ASTM F136 Ti-6A1-4V ELI alloy. The design of the Solana Surgical implant is similar to the predicate devices. No new materials or processes are used in the development of this implant.

The provided text describes Solana Surgical, LLC's CrossCheck Plating System, a device for stabilizing and fixing bone fractures, osteotomies, and fusions in the extremities. The 510(k) summary indicates that the device's substantial equivalence determination is based on a comparison to predicate devices, focusing on materials, design, and intended use.

Here's an analysis of the acceptance criteria and the study based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided 510(k) summary does not specify the sample size used for the mechanical testing (devices tested) or the provenance of any data (country of origin, retrospective/prospective). It only states "Examples from the predicate device systems were used for comparison." This suggests a comparative physical testing approach rather than a data-driven clinical study with a "test set" of patient data.

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

This information is not provided in the document. The study described is primarily a mechanical device performance test against established ASTM standards and a comparison to predicate devices, not a study requiring expert consensus or clinical ground truth establishment in the traditional sense.

4. Adjudication Method for the Test Set

This information is not applicable and therefore not provided. The study described is a laboratory-based mechanical performance test, not a clinical study involving human assessment or expert adjudication of outcomes.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or described. The 510(k) summary focuses on the mechanical and material equivalence of the device to existing predicate devices through laboratory testing. It does not involve human readers or AI assistance.

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

No, a standalone (algorithm only) performance study was not done. This device is a bone plate and screw system, a physical medical device, not a software algorithm or an AI-based system.

7. The Type of Ground Truth Used

The "ground truth" for this device's evaluation is primarily based on established engineering standards and material specifications, specifically:

• ASTM F382: Standard Specification and Test Method for Metallic Bone Plates.
• ASTM F543-07: Standard Specification and Test Methods for Metallic Medical Bone Screws.
• Material Specification: ASTM F136 Ti-6A1-4V ELI alloy for the manufacturing material.

The performance of predicate devices also serves as a benchmark for comparison during the testing. This is a technical, rather than a clinical or pathological, ground truth.

8. The Sample Size for the Training Set

This information is not applicable and therefore not provided. As this is a physical medical device and not an AI/software system, there is no "training set."

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

This information is not applicable and therefore not provided. There is no training set for this type of device submission.

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The Solana Surgical LLC, Lesser Metatarsal Head Implant System is intended for use as a hemiarthroplasty implant for the metatarsophalangeal joint, for the treatment of degenerative and post-traumatic arthritis, hallux limitus, hallux valgus, hallux rigidus, and an unstable or painful metatarsophalangeal (MTP) joint. The device is intended for single use to be used with bone cement or press fit without bone cement.

The Solana Surgical Implant is a one-piece device made of Cobalt Chromium (with titanium plasma spray coated stem) intended to replace the articulating surface of the metatarsal bone at the lesser metatarsal phalangeal (MTP) joint. The implant is available in a range of sizes (3) to match the geometry of the lesser metatarsal phalangeal joint. Design features include an articulating surface and a stem which extends proximally in the intramedullary canal of the distal lesser metatarsal. The design of the Solana Surgical implant is similar to the predicate devices. No new materials or processes are used in the development of this implant.

This looks like a 510(k) premarket notification for a medical device called the "Lesser Metatarsal Head Implant System." This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed clinical study data with acceptance criteria for device performance as would be expected for a novel device or a PMA.

Therefore, the information requested in your prompt related to acceptance criteria, specific performance metrics, sample sizes for test/training sets, expert adjudication, MRMC studies, or standalone performance studies is not typically found in a 510(k) summary like this one.

Here's a breakdown of why and what information is available:

Response to your Request:

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

• Not Applicable. This 510(k) summary does not include specific acceptance criteria for a device performance study in the way a clinical trial or performance study for an AI/diagnostic device would. The "performance" being evaluated is primarily the mechanical strength and material properties in comparison to predicate devices, not clinical efficacy or diagnostic accuracy.
• The summary states: "An engineering analysis was performed to evaluate the mechanical strength of subject and predicate device implant stems." and "The titanium plasma spray coating process as applied to the Solana Surgical device has been thoroughly evaluated for morphological and strength characteristics." These are the "reported device performance" aspects, but without specific quantitative acceptance criteria disclosed 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)

• Not Applicable / Not Provided. No clinical test set data from actual patients is described or used in this 510(k) summary to prove performance against specific clinical acceptance criteria. The evaluation is focused on engineering analysis and comparison to predicate devices.

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. No ground truth establishment by experts is described, as there are no clinical test sets or diagnostic performance claims requiring expert interpretation.

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

• Not Applicable. No test set requiring expert adjudication is 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 a mechanical implant, not an AI software or diagnostic tool. No MRMC study was conducted.

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

• Not Applicable. This is a mechanical implant, not an algorithm.

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

• Not Applicable. No clinical ground truth is established or used for performance evaluation in this 510(k) summary. The "ground truth" for the engineering evaluation would be established engineering principles, material science standards, and comparison with the known properties of the predicate devices.

8. The sample size for the training set

• Not Applicable. This is a mechanical implant; there is no "training set" in the context of machine learning or AI.

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

• Not Applicable. No training set exists for this type of device submission.

Summary of Available Information from the Provided Text:

• Device Name: Lesser Metatarsal Head Implant System
• Purpose: Hemiarthroplasty implant for the metatarsophalangeal joint.
• Materials: Cobalt Chromium (with titanium plasma spray coated stem).
• Design: One-piece device with an articulating surface and a stem for intramedullary canal insertion.
• Comparison Basis: Substantially equivalent to predicate devices (OsteoMed: K073065, Vilex: K102401) based on:
  • Similar materials
  • Similar indications for use
  • Comparable sizing
  • Similar intended use (single use, surgical implantation longer than 30 days)
  • Engineering analysis of mechanical strength (comparison of subject and predicate device implant stems).
  • Evaluation of the titanium plasma spray coating process for morphological and strength characteristics.

This document serves to demonstrate that the new device is as safe and effective as a legally marketed predicate device, primarily through engineering comparisons and material analysis, rather than extensive clinical efficacy studies with predefined acceptance criteria.

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The Solana Surgical, LLC FuseForce Implant System is intended to provide fixation for fractures, fusions or osteotomies of the bones of the hand and foot such as: LisFranc arthrodesis, Akin Osteotomy, Scarf and Chevron osteotomies

The Solana Surgical FuseForce Implant is a one-piece device made of Nickel Titanium Alloy intended to be implanted in the bones of the hand or foot. The implant is available in a range of sizes (12) ranging from 8 mm X 8 mm to 25 mm X 22 mm including both straight top and step top configurations. The design of the Solana Surgical implant is similar to the predicate device. No new materials or processes are used in the production of this implant. The device is provided in a sterile package which includes associated single use (disposable) instruments.

Acceptance Criteria and Study Details for Solana Surgical FuseForce Implant System

This document outlines the acceptance criteria for the Solana Surgical FuseForce Implant System and details the studies performed to demonstrate its compliance.

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for the FuseForce Implant System were based on its comparison to a legally marketed predicate device, the Memometal Memory Staples (K070031), and the Memometal EasyClip stable. The device was required to perform at least equivalently to the predicate in mechanical performance and corrosion resistance.

2. Sample Sizes and Data Provenance

• Test Set Sample Size: For both mechanical and corrosion testing, six subject devices and six predicate devices were evaluated for each test.
  • Mechanical Testing: 8mm x 8mm nitinol staples (worst-case for pullout, static, and fatigue bending).
  • Corrosion Testing: 25mm x 22mm nitinol staples (largest surface area, worst-case for corrosion susceptibility).
• Data Provenance: The data was generated through bench testing performed by Solana Surgical, LLC. The specific country of origin for the testing itself is not explicitly stated, but the company is based in Memphis, TN, USA. The data is prospective as it involves direct testing of the manufactured devices.

3. Number, Qualifications, and Adjudication of Experts for Ground Truth

• This device is a mechanical implant, and the ground truth for its performance is established through objective, standardized mechanical and material testing protocols (ASTM F564 and ASTM F2129).
• Therefore, the concept of "experts establishing ground truth" in the cognitive or interpretive sense, as seen in imaging studies, is not applicable here. The "ground truth" is defined by the objective measurements obtained from the testing.
• No human experts were used to establish ground truth in the context of interpretation or consensus for these purely mechanical and material property tests.

4. Adjudication Method

• Not applicable as the ground truth is established through objective, quantitative measurements from mechanical and material testing, not through expert interpretation requiring adjudication.

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

• No, an MRMC comparative effectiveness study was not performed. This type of study is typically relevant for diagnostic imaging devices where human interpretation plays a role and the AI's impact on reader performance is being evaluated. The FuseForce Implant System is a mechanical implant, not a diagnostic AI.

6. Standalone (Algorithm Only) Performance Study

• Not applicable. The FuseForce Implant System is a physical medical device, specifically a bone fixation staple. It does not employ an AI algorithm, and therefore, a "standalone algorithm performance" study is irrelevant.

7. Type of Ground Truth Used

• The ground truth used was objective performance data derived from standardized mechanical and material property testing against established ASTM (American Society for Testing and Materials) standards:
  • ASTM F564 (for mechanical properties: pullout, static bending, fatigue bending)
  • ASTM F2129 (for corrosion resistance)

8. Sample Size for the Training Set

• Not applicable. This device is a physical implant, not an AI algorithm that requires a training set. The performance is based on the material properties and design of the manufactured product.

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

• Not applicable, as there is no training set for this type of device.

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The Solana Surgical LLC, Gaitway Implant System is intended to treat the hyperpronated foot and stabilize the subtalar joint. It is intended to block forward and medial displacement of the talus, thus blocking excessive pronation and the resulting sequela.

The Solana Surgical Gaitway Implant is a one-piece device made of Titanium Alloy intended to be implanted in the Sinus Tarsi of the foot. The implant is available in a range of sizes (5) ranging from 6.5 mm to 11.5 mm. The design of the Solana Surgical implant is similar to the predicate devices. No new materials or processes are used in the production of this implant.

The provided text is for a 510(k) summary for a medical device called the "Gaitway Implant System," a subtalar arthroereisis implant. The primary goal of a 510(k) submission is to demonstrate substantial equivalence to a legally marketed predicate device, rather than to prove device performance against specific acceptance criteria through a clinical study in the same way a PMA (Pre-Market Approval) study would.

Therefore, many of the typical acceptance criteria and study details for a software-based or diagnostic device are not applicable to this type of submission. This 510(k) focuses on equivalence in material, geometry, and intended use.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

This table is not applicable in the traditional sense of a clinical study with performance metrics for diagnosis or treatment efficacy like sensitivity, specificity, or accuracy. The "acceptance criteria" for a 510(k) for an implantable device like this revolved around demonstrating substantial equivalence to predicate devices in terms of:

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

• Sample Size: Not applicable. This 510(k) is based on a comparison to predicate devices, not a clinical trial with a "test set" of patients in the way a diagnostic device would have a test set of images or cases. The evaluation is primarily bench testing of material properties and design comparison.
• Data Provenance: Not applicable. There is no patient data involved in demonstrating substantial equivalence in this context. The data comes from engineering specifications and comparisons to existing devices.

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

• Not applicable. There is no "ground truth" to establish for a test set of patients or data in this type of 510(k) submission. The evaluation is based on engineering principles and regulatory equivalence.

4. Adjudication Method for the Test Set

• Not applicable. No test set or human adjudication process is described or required for this type of submission.

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

• No. An MRMC study is relevant for diagnostic devices where human readers interpret medical images or data. This is an implantable device, and such a study is not part of its 510(k) pathway.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done

• No. This is an implantable medical device, not an algorithm or software. Therefore, "standalone performance" in that context is not applicable. The device itself performs its intended function in the body.

7. The Type of Ground Truth Used

• Not applicable. For this 510(k), the "ground truth" equivalent would be established engineering and material science principles, and the regulatory understanding of what constitutes a safe and effective implant based on the performance of legally marketed predicate devices. There's no pathology, expert consensus, or outcomes data used to establish ground truth for a test set in this application.

8. The Sample Size for the Training Set

• Not applicable. This submission does not involve machine learning or AI algorithms with "training sets."

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

• Not applicable. As above, no training set is involved.

Summary of the Study that Proves the Device Meets Acceptance Criteria (Substantial Equivalence):

The "study" described in the 510(k) summary is a comparative analysis of the Solana Surgical Gaitway Implant System against three legally marketed predicate devices:

1. Memometal SubFix Arthroereisis Implant (K093820)
2. Instratek, INC. Sub-Talar Lok, Model 7-11 mm (K080280)
3. Arthrex Pro Stop Plus (K071456)

The primary method of demonstrating that the device meets "acceptance criteria" (i.e., is substantially equivalent) involves:

• Direct Comparison: The applicant explicitly states that "The design of the Solana Surgical implant is similar to the predicate devices."
• Material Equivalence/Superiority: The device is constructed of Titanium Alloy, which is "identical to the Memometal and Instratek devices." It is also stated that it "greatly exceeds the mechanical strength characteristics of the Arthrex device" (which is PLLA).
• Geometric Equivalence: All compared devices (Solana Surgical and predicates) are "conical in shape so as to fit into the anatomy of the sinus tarsi" and are "cannulated to accept a guide wire."
• Indications for Use Equivalence: The indications for use of the Gaitway Implant System are presented, and the summary implies their consistency with the predicate devices: "Each device is placed into the sinus tarsi of the foot, allowing normal subtalar joint motion while blocking excessive pronation."
• Manufacturing and Usage Parameter Equivalence: All devices are for single use, surgical implantation longer than 30 days, and placed into the subtalar sinus tarsi.

The conclusion drawn by the applicant, and presumably accepted by the FDA based on the approval letter, is: "Given the similar geometry and equivalent or greater strength, the Solana Surgical device should not introduce new concerns of safety or effectiveness."

The FDA's letter (K122738) confirms their review and determination that the device is substantially equivalent to legally marketed predicate devices for the stated indications for use. This regulatory determination serves as the "proof" that the device meets the necessary acceptance criteria for market clearance under the 510(k) pathway.

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The Solana Surgical LLC, Sola Fix Twist Screw Implant System is intended to provide fixation for fracture, fusion, osteotomy or reconstruction of the bones of the hand and foot.

The Solana Surgical Implant is a one-piece device made of Titanium Alloy intended to be used as a screw for bone fixation, fusion, osteotomy or reconstruction of the hand and foot. The implant is available in a range of sizes (6) including 2.0mm diameter and length range of 11-16mm. The screw driving portion of the screw is intended to separate from the screw head once the screw seats to the bone.

This document is a 510(k) summary for a medical device called the "Sola Fix Twist Screw Implant System" by Solana Surgical, LLC. The summary focuses on establishing substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria for a novel AI/software product. Therefore, much of the requested information regarding AI device studies (like sample sizes for test/training sets, expert consensus, MRMC studies, etc.) is not applicable.

Here's an analysis based on the provided text, adapted to the context of a mechanical device submission:

Acceptance Criteria and Device Performance

Since this is a submission for a mechanical implant, the "acceptance criteria" are typically defined by recognized standards for mechanical testing and comparison to an already marketed predicate device. The "device performance" is demonstrated by meeting these standards and showing comparable characteristics.

Important Note: The document explicitly states: "Based on the evaluations performed, the design and indications of the Solana Surgical screw are substantially equivalent to the predicates identified in the 510(k) submission. No new materials or processes are used in the development of this implant." This is the overarching "performance" claim for a 510(k) for a mechanical device – demonstrating substantial equivalence, not novel performance metrics.

Study Information (as applicable to a mechanical device)

Given this is a 510(k) for a mechanical bone fixation screw, the concepts of "test set," "training set," "experts," "adjudication," "MRMC studies," and "standalone performance" as they relate to AI/software are not applicable. The "study" here refers to the mechanical and comparative analyses performed.

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

   • Test Set Sample Size: Not applicable in the context of AI/software. For mechanical testing, the "sample size" would refer to the number of screws subjected to testing (e.g., N=5 or N=10 per test). This specific number is not provided in the summary but would be detailed in the full 510(k) submission.
   • Data Provenance: Not applicable in the AI/software sense. The data comes from in vitro mechanical testing performed in a lab setting, likely by or for Solana Surgical, LLC.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for mechanical devices is established through adherence to engineering standards (e.g., defining load limits, dimensions) and comparison to a legally marketed predicate. There isn't an "expert consensus" on an image or clinical case.

3. Adjudication method for the test set: Not applicable. Adjudication is not relevant for compliance with mechanical engineering standards.

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: Not applicable. This is not an AI-powered device.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI algorithm. Its performance is inherent in its mechanical properties.

6. The type of ground truth used: For this type of device, the "ground truth" is adherence to established mechanical engineering standards (ASTM F543) and factual engineering/dimensional data for comparison to the predicate. The "truth" is whether the device meets the specified mechanical properties and is sufficiently similar to an already approved device.

7. The sample size for the training set: Not applicable. There is no training set for a mechanical device.

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

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The Solana Surgical LLC, Metatarsal Decompression Implant is intended for use as a hemi-arthroplasty implant for the first metatarsophalangeal joint, for the treatment of degenerative and post-traumatic arthritis, hallux valgus, hallux rigidus, and an unstable or painful metatarsophalangeal (MTP) joint.

The device is intended for single use to be used with bone cement or press fit without bone cement.

The Solana Surgical Implant is a one-piece device made of Cobalt Chromium (with titanium plasma spray coated stem) or Titanium, intended to replace the articulating surface of the metatarsal bone at the metatarsalphalangeal (MTP) joint. The implant is available in a range of sizes to match the geometry of the metatarsal phalangeal joint. Design features include an articulating surface and a stem which extends proximally in the intramedullary canal of the distal metatarsal. The design of the Solana Surgical implant is similar to the predicate devices. No new materials or processes are used in the development of this implant.

The provided text is a 510(k) summary for the Solana Surgical Metatarsal Decompression Implant. It details the device's description, indications for use, and a comparison to predicate devices, ultimately concluding substantial equivalence. However, it does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details.

Therefore, I cannot fulfill your request for that specific information based on the provided text.

The document primarily focuses on establishing substantial equivalence to previously cleared devices rather than providing detailed clinical or performance study results against predefined acceptance criteria.

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The Solana Surgical LLC, Hemi Phalangeal Implant System is intended for use as a hemi-arthroplasty implant for the metatarsophalangeal joint, for the treatment of degenerative and post-traumatic arthritis, hallux valgus, hallux rigidus, and an unstable or painful metatarsophalangeal (MTP) joint.

The device is intended for single use to be used with bone cement or press fit without bone cement.

The Solana Surgical Implant is a one-piece device made of Cobalt Chromium (with titanium plasma spray coated stem) intended to replace the articulating surface of the phalangeal bone at the metatarsalphalangeal (MTP) joint. The implant is available in a range of sizes (3) to match the geometry of the metatarsal phalangeal joint. Design features include an articulating surface and a stem which extends distally in the intramedullary canal of the proximal phalanx. The design of the Solana Surgical implant is similar to the predicate devices. No new materials or processes are used in the development of this implant.

The provided text describes a medical device, the Solana Surgical Hemi Phalangeal Implant System, and its substantial equivalence to predicate devices, but it does not contain any information regarding acceptance criteria, device performance, or a study proving it meets acceptance criteria.

The document is a 510(k) summary and an FDA clearance letter, which focuses on establishing substantial equivalence based on similarities in:

• Intended use: Hemi-arthroplasty implant for the metatarsophalangeal joint to treat degenerative and post-traumatic arthritis, hallux valgus, hallux rigidus, and unstable/painful MTP joint.
• Device description: One-piece device made of Cobalt Chromium (with titanium plasma spray coated stem).
• Materials: Industry standard materials, no new materials.
• Design features: Articulating surface and a stem extending distally into the intramedullary canal.
• Sizes: Available in a range of 3 sizes.
• Usage: Single use, with or without bone cement.

Therefore, I cannot provide the requested table or details about a study demonstrating acceptance criteria, as this information is not present in the provided text. The document is about regulatory clearance for a medical implant, not a performance study of an AI/software device.

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The Solana Surgical LLC, Metatarsal Decompression Implant is intended for use as a hemi-arthroplasty implant for the first metatarsophalangeal joint, for the treatment of degenerative and post-traumatic arthritis, hallux valgus, hallux rigidus, and an unstable or painful metatarsophalangeal (MTP) joint.

The device is intended for single use to be used with bone cement.

The Solana Surgical Implant is a one-piece device made of Cobalt Chromium, intended to replace the articulating surface of the first metatarsal at the metatarsalphalangeal (MTP) joint. The implant is available in a range of sizes to match the geometry of the metatarsal head. Design features include an articulating surface and a stem which extends proximally in the intramedullary canal of the metatarsal. The design of the Solana Surgical implant is similar to the predicate devices. No new materials or processes are used in the development of this implant.

This K090127 document is a 510(k) summary for a medical device called the "Metatarsal Decompression Implant" by Solana Surgical, LLC. It is a premarket notification to the FDA to demonstrate substantial equivalence to previously marketed predicate devices.

Based on the provided text, there is no information regarding acceptance criteria or a study that proves the device meets specific performance criteria in the way you've outlined for an AI or diagnostic device. This document is for a physical implant, not a software or AI device.

Therefore, I cannot provide the requested information in the format of a table for acceptance criteria and reported device performance, nor can I answer questions about sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details. These concepts are not applicable to the content of this 510(k) submission.

The document primarily focuses on:

• Device Description: A one-piece Cobalt Chromium implant for the first metatarsal at the MTP joint.
• Indications for Use: Hemi-arthroplasty for degenerative/post-traumatic arthritis, hallux valgus, hallux rigidus, and unstable/painful MTP joint. Single-use with bone cement.
• Comparison to Predicate Device: Emphasizes similarities in intended use, materials, design characteristics, and standard materials used, leading to an assertion of substantial equivalence.
• Regulatory Information: Device classification, product code, and predicate devices.

The FDA's eventual letter confirms substantial equivalence, which is a regulatory determination based on comparing the new device to existing legally marketed devices, rather than a performance study against specific acceptance criteria for a new type of functionality.

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