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The TMC Implant Fixation System is intended for use in stabilization of fresh fractures, revision procedures, joint fusion and reconstruction of the feet. The system can be used in both pediatric (aged > 12-21) and adult (aged 22 and over) patients. In the foot, the system can be used for the following specific examples:

• Osteotomy of the 1st metatarsal for the treatment of deformity (e.g., hallux valgus) such as:

• Opening base wedge osteotomy
• Closing base wedge osteotomy
• Crescentic osteotomy
• Proximal Chevron osteotomy
• Distal Chevron osteotomy (Austin)
• Transverse osteotomy

• Arthrodesis of the tarsometatarsal (TMT) joints or the 1st metatarsophalangeal (MTP) joint for the treatment of deformity (e.g., hallux valgus, hallux rigidus, metatarsus adductus) and/or arthritis

• First metatarsal fracture fixation

• Flatfoot Osteotomies

• Lateral Column Lengthening (Evans Osteotomy)
• Plantar Flexion Opening Wedge Osteotomy of the Medial Cuneiform (Cotton Osteotomy)

• Mid / Flatfoot Fusions

• LisFranc Arthrodesis and/or Stabilization
• Intercuneiform Fusions
• Navicular-Cuneiform (NC) Fusion
• Talo-Navicular (TN) Fusion
• Calcaneo-Cuboid (CC) Fusion

• Medial Column Fusion

The TMC Implant Fixation System is comprised of straight, L-shaped, H-shaped, anatomically curved plates, intramedullary plates, cannulated and non-cannulated compression implants, and associated instruments. It includes 2.5 mm, 2.7 mm, 3.0 mm, and 3.3 mm diameter cannulated and non-cannulated, locking, and non-locking screws in lengths ranging from 10-36 mm. The plates, screws, and compression implants are intended for use in stabilization of fresh fractures, revision procedures, joint fusion and reconstruction of the feet. All implantable components are manufactured from implant grade titanium alloy (Ti-6Al-4V-ELI) per ASTM F136 and are provided sterile by gamma irradiation.

This document describes the regulatory clearance of a medical device, the "TMC Implant Fixation System," not an AI diagnostic device. Therefore, many of the requested categories for AI-specific studies are not applicable. I will extract the information that is relevant to the provided text.

Here's an analysis of the provided FDA 510(k) clearance letter:

1. Table of acceptance criteria and the reported device performance:

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

• Sample Size (Test Set): Not explicitly stated. The document refers to "testing and analysis" between the subject and predicate devices for mechanical properties. This typically involves a defined number of test specimens (e.g., plates, screws) for each test type, but the exact quantity is not detailed in this summary.
• Data Provenance: Not applicable in the context of clinical data for an AI device. The testing described is mechanical, performed on physical device samples.

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

• Not applicable. This device is a metallic bone fixation system, and the "ground truth" for mechanical testing is established by recognized engineering standards (like ASTM F382) and FDA guidance, not by expert interpretation of images or clinical outcomes in the same way an AI diagnostic device would.

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

• Not applicable. Mechanical testing results are objective measurements (e.g., force, displacement, cycles to failure) against predefined pass/fail criteria, not subjective human assessments requiring adjudication.

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 medical device for bone fixation, not an AI diagnostic tool. MRMC studies are used for evaluating diagnostic performance with and without AI assistance.

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

• No. This is a physical implant system, not a software algorithm.

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

• For mechanical performance: The ground truth refers to established engineering standards (ASTM F382) and FDA guidance for orthopedic implants. Performance is measured against physical properties like strength, fatigue resistance, and screw pullout force.

8. The sample size for the training set:

• Not applicable. This is not an AI/machine learning device that requires a training set.

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

• Not applicable.

Summary of the Study Proving Device Meets Acceptance Criteria:

The study proving the TMC Implant Fixation System meets acceptance criteria was a series of mechanical performance tests. The primary testing included:

• Static 4-point bend testing
• Dynamic 4-point bend testing
• Axial pullout testing

These tests were conducted in accordance with established standards:

• ASTM F382 Standard Specification and Test Method for Metallic Bone Plates was used for the 4-point bend testing.
• Modified acceptance criteria derived from the FDA Guidance for Orthopedic Non-Spinal Metallic Bone Screws and Washers – Performance Criteria for Safety and Performance Based Pathway (issued November 22, 2024) were used for the axial pullout testing.

The document states that "The testing and analysis demonstrated that the subject devices met all acceptance criteria and therefore are substantially equivalent to the predicate devices." This substantial equivalence determination suggests that the new device's mechanical performance is comparable to or better than that of the legally marketed predicate devices, thereby assuring its safety and effectiveness for its intended use.

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The 2.4mm Non-Locking (NL) Hexalobe Screws are intended to be used in conjunction with The Acumed Wrist Fixation System, which consists of plates, screws, and instruments designed to aid in implantation. The intended use of the 2.4mm NL Hexalobe Screw is to provide fixation of fractures, fusions, osteotomies, and nonunions of the distal radius and ulna when used in conjunction with The Acumed Wrist Fixation System.

The 2.4mm Non-Locking (NL) Hexalobe Screws are intended to be used in conjunction with The Acumed Wrist Fixation System, which consists of plates, screws, and instruments designed to aid in implantation. The intended use of the 2.4mm NL Hexalobe Screw is to provide fixation of fractures, fusions, osteotomies, and nonunions of the distal radius and ulna when used in conjunction with The Acumed Wrist Fixation System. The implant is manufactured from Titanium Alloy per ASTM F136-13(2021)e1. The implant is provided sterile and non-sterile and is for single use only.

The provided FDA 510(k) clearance letter and summary for "The Acumed Wrist Fixation System - 2.4mm Screws" (K252356) describe a medical device (bone screws), not an AI/software device. Therefore, the information requested regarding acceptance criteria and studies specifically for AI/software performance metrics (such as "sample size used for the test set," "data provenance," "number of experts," "MRMC comparative effectiveness study," "standalone performance," and "training set") is not applicable or cannot be extracted from this document.

The document discusses substantial equivalence based on non-clinical performance testing for a physical medical implant.

However, I can extract the acceptance criteria and the summary of the study results that demonstrate the device meets these criteria, as described in the provided text.

Acceptance Criteria and Study for The Acumed Wrist Fixation System - 2.4mm Screws (K252356)

The device, "The Acumed Wrist Fixation System - 2.4mm Screws," is a physical medical implant, not an AI/software device. Its acceptance criteria and performance evaluation are based on non-clinical engineering and materials testing, adhering to recognized consensus standards and FDA guidance documents for medical devices of this type.

1. Table of Acceptance Criteria and Reported Device Performance

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

• The document does not explicitly state the sample sizes (number of screws) used for each specific non-clinical test (e.g., torsional strength, driving torque, pullout calculations, or MR compatibility evaluations). These tests typically involve a predetermined number of test specimens according to the respective ASTM standards to ensure statistical validity.
• Data Provenance: Not applicable in the context of clinical data for an AI device. The data provenance here refers to the source of the physical test specimens (manufactured according to specifications) and the laboratory where the tests were conducted (implied to be in-house or by a certified testing facility).

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

• This question is not applicable as the document describes non-clinical engineering tests for a physical device, not an AI/software device requiring expert ground truth for image or data interpretation. Performance is assessed against engineering standards.

4. Adjudication Method for the Test Set

• This question is not applicable. Adjudication methods (e.g., 2+1, 3+1) refer to clinical expert consensus for ground truth establishment in studies involving human interpretation, which is not relevant to the non-clinical testing of this physical device. The "adjudication" in this context would be the interpretation and approval of test results against the specified ASTM standards by qualified engineers and regulatory specialists.

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

• No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of an AI system on human reader performance, which is not applicable to a physical bone screw. The submission states, "Clinical Testing was not required to support substantial equivalence (Not Applicable)."

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

• This question is not applicable as the device is a physical bone screw and not an algorithm or software. Its performance is inherent to its physical properties and design, tested independently of human intervention during the test itself (though human engineers conduct the tests).

7. The Type of Ground Truth Used

• The "ground truth" for the non-clinical tests described is defined by the specific requirements and methodologies outlined in the referenced ASTM consensus standards (e.g., ASTM F543-23 for mechanical properties, ASTM F2052, F2213, F2182, F2119 for MR compatibility). These standards provide quantifiable thresholds and test procedures that determine if a device performs as expected for its intended use. In essence, the "ground truth" is compliance with these established engineering and material science specifications.

8. The Sample Size for the Training Set

• This question is not applicable. The concept of a "training set" refers to data used to train an AI model. This device is a physical product and does not involve AI.

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

• This question is not applicable as there is no AI training set for this physical device.

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The EndoFix™Tissue Fixation System is an endoscopic tissue approximation system intended for anchoring the gallbladder to the stomach or duodenum to aid placement of a luminal apposing metal stent (LAMS) for EUS-guided gallbladder drainage.

The EndoFix™ Tissue Fixation System (TFS) is an endoscopic (through the scope) tissue approximation device consisting of two main components:

1. EndoFix Tissue Fixation Device – Enables the approximation of soft tissue in the gastrointestinal (GI) tract using a suture-based implant delivered through an 18 gauge echogenic needle.
2. Secure Suture Locking Device – Secures the implant assembly with an implant grade suture lock and cuts the suture once approximation is complete.

The EndoFix TFS is designed to place an implant for endoscopic tissue approximation to anchor the gallbladder to the stomach or duodenum to aid placement of a luminal metal apposing stent (LAMS). During use, the EndoFix Tissue Fixation Device is advanced through a ≥3.2 mm working channel of a commercially available echoendoscope (EUS). Under ultrasound guidance, the EndoFix TFS needle is advanced through the target tissues and the implant subassembly is deployed to approximate the luminal tissues (either transgastric or transduodenal based on clinical requirements). With applied suture tension, a Suture Lock is deployed to secure the tissues using the Secure Suture Locking Device. The implant subassembly and Suture Lock are considered permanent implants.

Each of the respective delivery systems used to deliver the implant assembly/Suture Lock are short term contact devices.

This FDA 510(k) clearance letter for the EndoFix™ Tissue Fixation System does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and a study proving those criteria are met. This document primarily focuses on establishing substantial equivalence to predicate devices for regulatory clearance.

Specifically, it does not include:

• A table of acceptance criteria with reported device performance metrics (e.g., success rates, tensile strength, specific measurements).
• Details about a "test set" for a performance study (sample size, data provenance, ground truth establishment, expert qualifications, or adjudication methods).
• Information on a multi-reader multi-case (MRMC) comparative effectiveness study or any effect size for human reader improvement.
• Distinction between standalone algorithm performance and human-in-the-loop performance, as this is a medical device, not an AI/software-only device in the context of typical AI performance criteria.
• Training set sample size or how its ground truth was established.

However, based on the provided text, I can infer and extract some relevant information regarding performance testing.

Inferable Acceptance Criteria and Reported Device Performance

The document lists categories of performance testing that were conducted with "acceptable results." While specific numerical acceptance criteria and reported performance values are not given, the implication is that the device met internal, pre-defined criteria for these aspects.

A table of acceptance criteria and reported performance cannot be fully constructed from the provided text because specific numerical values for criteria and performance are absent. However, based on the categories mentioned under "Performance Data," we can infer the types of criteria and the general statement of performance:

Study Details (as far as extractable):

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

   • The document mentions "bench testing" and a "preclinical animal study." For bench testing, sample sizes are not specified.
   • For the animal study, the model used was a "porcine model," indicating an animal test subject. The number of animals or specific cases within that study is not provided.
   • Data provenance: Porcine model (animal study), laboratory/bench for other tests. Retrospective/prospective is not specified, but animal studies are typically prospective experimental designs.

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

   • The document does not specify the number or qualifications of experts for establishing ground truth, as this device's performance assessment relies on physical and functional tests, and an animal study, rather than expert interpretation of medical images or data.

3. Adjudication method for the test set:

   • Not applicable/Not specified. The performance testing described (bench, animal study) does not involve adjudication processes typically used in clinical imaging or diagnostic studies.

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. This is a medical device, not an AI-assisted diagnostic tool subject to MRMC studies. The clearance is for the physical device itself.

5. 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, so "standalone" performance in the context of AI software is not relevant here.

6. The type of ground truth used:

   • For bench testing: Engineering specifications, physical measurements, functional demonstrations.
   • For the animal study: Observation of safety and performance (e.g., successful tissue approximation, LAMS deployment, absence of adverse events) within the porcine model. This could be considered "outcomes data" in an experimental animal model context.

7. The sample size for the training set:

   • Not applicable. This is a physical medical device. There is no "training set" in the context of machine learning algorithms. Its design would be informed by engineering principles and possibly prior animal/cadaver studies, but not a formal 'training set'.

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

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

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The Indications for Use for The Acumed Wrist Fixation System / Plates, is to provide fixation of fractures, fusions, osteotomies, and nonunions of the distal radius and ulna.

The Indications for Use for The Acumed Wrist Fixation System/ Screws, is to provide fixation of fractures, fusions, osteotomies, and nonunions of the distal radius and ulna.

The Acumed Wrist Fixation System is a new system designed for distal radius and ulna fracture fixation. The system is comprised of plates, screws, and instruments designed for aid in implantation of the distal. The intended use of The Acumed Wrist Fixation System is to provide fixation of fractures, fusions, osteotomies, and nonunions of the distal radius and ulna. The implants are manufactured from Titanium Alloy per ASTM F136-13(2021)e1 and Cobalt Chrome per ASTM F1537-20. The implants are provided sterile and non-sterile and are for single use.

This FDA 510(k) clearance letter is for a device, the Acumed Wrist Fixation System, which comprises plates and screws, not an AI/ML powered medical device. Therefore, the information requested in your prompt regarding acceptance criteria, study details, and AI-specific metrics (like MRMC studies, ground truth establishment for training sets, or expert qualifications for test sets) is not applicable to this document.

The document primarily focuses on demonstrating substantial equivalence to predicate devices through technological comparison, material safety, and mechanical performance testing, rather than studies involving human readers or AI algorithms.

Here's a breakdown of why this document does not contain the requested information:

• Device Type: This is a physical orthopedic implant (plates and screws), not a software or AI-driven diagnostic or therapeutic device.
• Acceptance Criteria/Performance: The "acceptance criteria" for such a device are typically defined by engineering standards (e.g., ASTM standards for mechanical properties, material biocompatibility), and the "performance" refers to how the device meets these physical and mechanical benchmarks. The document lists the specific ASTM standards used for testing (e.g., F382-24 for bone plates, F543-23 for bone screws) and states that "all generated passing results." However, it does not provide specific numerical criteria or reported values in a table as requested for AI performance metrics (e.g., sensitivity, specificity).
• Study Design (Test Set, Data Provenance, Experts, Adjudication, MRMC, Standalone): These concepts are fundamentally linked to evaluating AI algorithms for diagnostic or prognostic purposes, which involve processing data (images, signals) and making predictions that need to be compared against a human-established ground truth. Since this is a physical implant, these types of studies are not relevant.
• Ground Truth Type: For a physical implant, the "ground truth" relates to its material properties, biocompatibility, and mechanical integrity, which are assessed through engineering tests, not expert consensus on medical findings or pathology.
• Training Set Size/Ground Truth for Training: These are exclusively relevant to machine learning models, where a dataset is used to train the algorithm. A physical device does not have a "training set."

Summary of available information relevant to "studies" for this device:

1. Acceptance Criteria and Reported Device Performance:

   • Acceptance Criteria Basis: Compliance with various ASTM (American Society for Testing and Materials) standards and FDA Guidance Documents for orthopedic fracture fixation devices.
   • Specific Standards Mentioned:
     • ASTM F382-24: Standard Specification and Test Method for Metallic Bone Plates (for static and simulated dynamic 4-point bending testing of plates).
     • ASTM F543-23: Standard Specification and Test Methods for Metallic Medical Bone Screws (for torsional strength, driving torque, and theoretical axial pullout strength calculation of screws).
     • ASTM F384-17: Standard Specifications and Test Methods for Metallic Angled Orthopedic Fracture Fixation Devices (for single-cycle bend testing of pegs).
     • ASTM F3044-20: Standard Test Method for Evaluating the Potential for Galvanic Corrosion for Medical Implants (for corrosion testing).
     • ASTM F2052, F2213, F2182, F2119: Standards for MR safety evaluations (magnetically induced force, torque, radio frequency induced heating, and image artifact evaluations).
   • Reported Device Performance: The document states that evaluations "have all generated passing results," indicating conformity to the specified standards and guidance documents. Specific numerical performance data (e.g., exact bending strength values, torque values) are not provided in this summary but would be detailed in the full submission.

2. Sample Size/Data Provenance for Test Set:

   • Not applicable as this involves mechanical and material testing, not data analysis on a "test set" in the AI sense. The "samples" would be physical devices tested according to engineering protocols.

3. Number of Experts/Qualifications for Ground Truth:

   • Not applicable. Ground truth for mechanical testing is established by adherence to standardized testing protocols and measurement science, not expert clinical consensus.

4. Adjudication Method:

   • Not applicable.

5. MRMC Comparative Effectiveness Study:

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

6. Standalone Performance:

   • The "performance" described is inherently "standalone" in the sense that it refers to the physical device's characteristics under controlled laboratory conditions, without human interaction in a diagnostic loop.

7. Type of Ground Truth Used:

   • Engineering and material science standards (e.g., ASTM specifications for mechanical properties, material composition, and biocompatibility).

8. Sample Size for Training Set:

   • Not applicable. This is not an AI/ML device.

9. How Ground Truth for Training Set was Established:

   • Not applicable.

In conclusion, the provided FDA 510(k) clearance letter pertains to a non-AI medical device and therefore does not contain the specific information requested about acceptance criteria, study design, and performance metrics typically associated with AI/ML-powered medical devices. The "studies" for this device were non-clinical, mechanical, and material integrity tests to ensure safety and effectiveness in comparison to predicate devices.

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Inion CPS™ 1.5 Baby Bioabsorbable Fixation System implants are intended for use in trauma and reconstructive procedures in the craniofacial skeleton (e.g., infant craniofacial surgery, craniosynostosis, congenital malformations, craniotomy flap fixation), mid-face and maxilla.

The Inion CPS™ 1.5/2.0/2.5 Bioabsorbable Fixation System implants are intended for use in trauma and reconstructive procedures and to maintain the relative position of bone grafts or bone graft substitutes in the cranium, including craniotomy flap fixation.

Inion CPS™ and Inion CPS™ Baby implants are bioabsorbable plates, screws and mesh plates made of bioabsorbable co-polymers. Inion CPS™ 1.5/2.0/2.5 System implants are composed of L-lactic acid, D-lactic acid and Trimethylenecarbonate. Inion CPS™ 1.5 Baby System implants are composed of L-lactic acid, D-lactic acid and Poly-Glygolic acid. These polymers have a long history of safe medical use and they degrade in vivo by hydrolysis into alpha-hydroxy acids that are metabolised by the body. The implants retain sufficient strength to fulfil their intended function during the healing period of the fracture or osteotomy, and degrade gradually thereafter. Bioresorption of Inion CPS™ implants takes place within 2-4 years, and Inion CPS™ Baby implants within 2-3 years.

The systems consist of fixation plates, meshes and screws offered in different sizes and designed to be used with the Inion CPS™ bone drill bits, bone taps, self-drilling bone taps, countersinks, screw drivers, plate bending pliers and heating device. The instruments are nonsterile and reusable. They are intended to be cleaned and sterilized before initial use and after each use.

The implants are provided sterile by gamma irradiation. They are intended for single use and shall not be re-sterilized or re-used. Implants are non-pyrogenic and fully synthetic.

This FDA 510(k) clearance letter is for bioabsorbable fixation systems, not an AI/ML powered medical device. Therefore, many of the requested fields are not applicable. I will provide information from the document as it relates to the general acceptance criteria and the study that proves the device meets them, while noting when a specific AI/ML related field is not relevant to this type of device.

1. Table of Acceptance Criteria and 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)

• Test Set Description: Not directly applicable as this is not an AI/ML device with a specific "test set" in the context of algorithm validation. The "testing" refers to various evaluations:
  • Biocompatibility/Non-pyrogenicity Testing: Representative samples of the subject devices were selected for rabbit pyrogen tests. The exact number of samples or rabbits is not specified but it generally follows standard laboratory protocols. The provenance is likely from laboratory testing.
  • Clinical Evaluation: The clinical evaluation relied on published clinical studies.
    • Inion CPS™ Baby 1.5 Bioabsorbable Fixation System: 11 publications including 240 patients.
    • Inion CPS™ 1.5/2.0/2.5 System: 39 publications including 1755 patients.
  • Data Provenance for Clinical Studies: The document does not specify the country of origin of the data or whether the studies were retrospective or prospective, beyond being "published clinical studies."

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 device is a physical implant, not an AI/ML diagnostic tool that requires experts to establish ground truth for image interpretation or similar tasks. The "ground truth" for its performance is assessed through physical testing (material properties, pyrogenicity) and clinical outcomes reported in published literature.

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

Not applicable. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in AI/ML performance studies, where multiple human experts independently review cases and then resolve disagreements. This concept does not apply to the evaluation of a physical bioabsorbable fixation system.

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. MRMC studies are specific to evaluating human reader performance with and without AI assistance for tasks like medical image interpretation. This device is a physical surgical implant and does not involve "human readers" in this context.

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

Not applicable. This device does not have an algorithm for standalone performance.

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

The "ground truth" (or basis for acceptance) for this device is established through:

• Physical Properties: Material composition, degradation profile, and strength retention are measured against pre-defined specifications.
• Biocompatibility and Non-pyrogenicity: Demonstrated through laboratory testing (e.g., rabbit pyrogen tests) against established biological safety standards (ISO 10993-1, USP chapters).
• Clinical Outcomes Data: Safe and effective use, performance rates, and complication rates are evidenced by published clinical literature and post-market follow-up data.

8. The sample size for the training set

Not applicable. This device is not an AI/ML model that requires a training set.

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

Not applicable. This device is not an AI/ML model that requires a training set with established ground truth.

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1. CAVUX Facet Fixation System (CAVUX FFS):
   CAVUX Facet Fixation System (CAVUX FFS) is posterior spinal instrumentation with integrated screw fixation intended to provide immobilization and stabilization of spinal segments.

• CAVUX FFS is placed bilaterally through a posterior surgical approach and spans the interspace with points of fixation at each end of the construct.
• CAVUX FFS is intended for temporary stabilization as an adjunct to posterior cervical fusion in skeletally mature patients.
• CAVUX FFS is indicated for patients requiring a revision for an anterior pseudarthrosis at one level, from C3 to C7, with autogenous and/or allogenic bone graft.

2. CORUS-LX Implant:
   CORUS-LX Implant is posterior spinal instrumentation with integrated screw fixation intended to provide immobilization and stabilization of spinal segments.
   CORUS-LX is placed bilaterally through a posterior surgical approach and spans the facet interspace with points of fixation at each end of the construct.
   CORUS-LX is intended to provide temporary stabilization as an adjunct to a 1 or 2 level interbody lumbar fusion with autogenous and/or allogenic bone graft and must be accompanied with an FDA cleared intervertebral body fusion device implanted at the same spinal level(s), and may be used with a pedicle screw and rod system implanted at the same spinal level(s).
   CORUS-LX is indicated for the treatment of patients with lumbar degenerative disc disease (DDD) from L4 to S1 in skeletally mature patients who have failed conservative care.

CAVUX FFS and CORUS-LX Implant are posterior spinal instrumentation with integrated screw fixation intended to provide immobilization and stabilization of spinal segments. CORUS-LX LevelOne is a kit that contains CORUS-LX Implant and accessories.

The devices are placed through a posterior surgical approach and achieve facet fixation by spanning the facet interspace at each level with points of fixation at each end of the construct. The devices are manufactured from medical grade titanium alloy (6Al4V) and supplied sterile for single use only with pre-attached disposable delivery instruments. The implants are fenestrated and to be used with autogenous bone and/or allogenic bone graft. The design incorporates "windows" through the implant to permit visualization of the graft material and, over time, formation of new bone.

This document is an FDA 510(k) Clearance Letter for the CAVUX Facet Fixation System and CORUS-LX Implant. It is important to note that a 510(k) clearance is based on a determination of substantial equivalence to existing legally marketed predicate devices, not on a new demonstration of safety and effectiveness through clinical trials with specific acceptance criteria and performance data.

Therefore, the input document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria. The letter explicitly states:

"No new performance testing was supplied in this submission given that the subject implants have been previously cleared for the same intended use."

And further, the "Basis of Substantial Equivalence" section clarifies:

"The purpose of this submission is to modify the indications for use of the subject devices (originally cleared under K220951 and K230840) to align with language used in a more recent predicate clearance (K241035). The subject and predicate devices have similar indications for use, and the same intended use, technological characteristics, materials of construction, principles of operation, and design features and characteristics."

This means that the clearance is based on the devices being sufficiently similar to devices already on the market (the predicates) for which safety and effectiveness have been established. It does not provide details of a new study with specific acceptance criteria for the devices mentioned in this letter.

Based on the provided document, the requested information cannot be extracted. The document focuses on regulatory clearance via substantial equivalence, not on a primary study demonstrating performance against specific acceptance criteria for a new device.

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KHEIRON® Spinal Fixation System including patient specific K-ROD is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar, and sacral spine: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), spinal stenosis, spinal tumor, pseudarthrosis and failed previous fusion.

When used for posterior, non-cervical, pedicle screw fixation in pediatric patients, KHEIRON® Spinal Fixation System including patient specific K-ROD is indicated as an adjunct to fusion to treat progressive spinal deformities (i.e., scoliosis, kyphosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, KHEIRON® Spinal Fixation System including patient specific K-ROD is intended to treat pediatric patients diagnosed with spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion.

This system is intended to be used with autograft and/or allograft.

Pediatric pedicle screw fixation is limited to a posterior approach.

Patient specific K-ROD devices are compatible with NuVasive Reline System components and Seaspine Mariner System components that are compatible with ø5.5mm and/or ø6.0mm rods as well as screws ø4.5mm or larger and at least 25mm in length.

S.M.A.I.O.'s patient specific K-ROD is part of the 510(k) cleared KHEIRON® Spinal Fixation system (K211981, K232650) designed for stabilization and correction of chronic instability or deformity of the thoracic, lumbar, and sacral spine. The patient specific K-ROD is manufactured from Ti-6Al-4V ELI per ASTM F136 and is available in diameters of 5.5 and 6.0 mm.

The Seaspine Mariner System is a 510(k) cleared pedicle screw system (K222110) that consists of a variety of screws, hooks, rods, lock screws, transverse connectors, rod-to-rod connectors, iliac connectors, and general instruments. Implant components are available in a variety of sizes and can be rigidly locked into a variety of different configurations to suit the individual pathology and anatomical conditions of the patient. The Seaspine Mariner System is designed to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the posterior thoracic, lumbar, and sacral spine. The Seaspine Mariner System is also used to treat severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebral joint in skeletally mature patients receiving fusion by autogenous bone graft.

The purpose of this Special 510(k) Device Modification is to extend indication of S.M.A.I.O.'s patient specific K-ROD (K211981, K232650) for use with the Seaspine Mariner System (K222110).

This FDA 510(k) clearance letter pertains to a spinal fixation system, which is a medical device, not an AI/software device. Therefore, the provided text does not contain the information needed to answer the questions about AI/software device acceptance criteria and study details (such as sample size, ground truth expert qualifications, MRMC studies, standalone performance, training set details, etc.).

The letter explicitly states:
"We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent...".
It refers to the device as "KHEIRON® Spinal Fixation System, including patient specific K-ROD".

The performance data mentioned (Dynamic compression bending – ASTM F1717, Static torsion – ASTM F1717, Static axial gripping capacity – ASTM F1798, Static torsional gripping capacity – ASTM F1798) are mechanical tests performed to verify the physical properties and compatibility of the spinal fixation system components. These are not related to AI model performance or clinical accuracy studies typically seen with software as a medical device (SaMD).

Therefore, I cannot fulfill the request as the provided document does not contain the type of information required for an AI/software device.

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The Momentum Posterior Spinal Fixation System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion of the thoracolumbar and sacroiliac spine. When used as a posterior spine system, Momentum is intended for the following indications: degenerative disc disease, spinal stenosis, spondylolisthesis, spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis), trauma (i.e., fracture or dislocation), tumor, pseudoarthrosis and failed previous fusion.

When used in conjunction with G21 V-Steady Bone Cement, the Momentum Posterior Spinal Fixation System is intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. Momentum™ Posterior Spinal Fixation System Screws augmented with G21 V-Steady Bone Cement are limited for use at spinal levels where the structural integrity of the spine is not severely compromised. Iliac screws are not intended to be used with bone cement.

In order to achieve additional levels of fixation, the Momentum Posterior Spinal Fixation System can also be connected to the Cortium® Universal OCT Spinal Fixation System or neon3® universal OCT spinal stabilization system via transition rods or connectors. Please refer to the Cortium or neon3 Instructions for Use for a list of indications for use.

The Momentum® Posterior Spinal Fixation System is a standard pedicle screw and rod systems designed for fixation and correction in the thoracolumbar and sacroiliac spine. This 510(k) submission adds hooks, various connectors, and monoaxial screws to the previously cleared system from K231809 and K191932.

The subject hooks are intended to provide deformity correction according to patient anatomical needs. The subject connectors are intended to provide additional options to improve stability. The subject monoaxial fenestrated screws are identical below the tulip to the previously cleared fenestrated screws with the addition of the option to use G21 V-Steady bone cement. The Momentum® Posterior Spinal Fixation System is manufactured from titanium alloy Ti-6Al-4V ELI per ASTM F136 and ISO 5832-3 and cobalt chromium Co-Cr-28Mo per ASTM F1537 and ISO 5832-12.

This document is a 510(k) premarket notification decision letter for a medical device called the "Momentum® Posterior Spinal Fixation System." It does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML powered device.

The letter simply states that the FDA has reviewed the submission and determined the device to be "substantially equivalent" to legally marketed predicate devices. This determination is based on a comparison of the device's indications for use, technological characteristics, and performance data (mechanical strength testing results) to existing predicate devices.

Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and study data for an AI/ML powered device based solely on the provided text. The document concerns a traditional implantable medical device, not an AI/ML product.

To reiterate, the provided text does not contain any of the following information:

1. A table of acceptance criteria and the reported device performance: Not applicable, as this is not an AI/ML device with performance metrics like sensitivity, specificity, etc.
2. Sample sizes used for the test set and the data provenance: Not applicable for an AI/ML model. The "test set" here refers to mechanical testing of physical components, not a data-driven model.
3. Number of experts used to establish the ground truth...: Not applicable, as ground truth is not established in the context of an AI/ML model for this device.
4. Adjudication method: Not applicable.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable.
6. Standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

The performance data mentioned (ASTM F1717 Dynamic Compression Bending) refers to mechanical testing of the spinal fixation system components to ensure their structural integrity and durability, not the performance of an AI/ML algorithm.

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The intended use of the Virata Spinal Fixation System in a posterior or anterolateral approach is to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine.

The indications for use are as follows:

• degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies,
• spondylolisthesis,
• trauma (i.e., fracture or dislocation),
• spinal stenosis,
• deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis),
• spinal tumor,
• pseudarthrosis, and/or
• failed previous fusion.

When used for posterior non-cervical screw fixation in pediatric patients, the Virata Spinal Fixation System is also indicated as adjunct to fusion to treat:

• Adolescent Idiopathic Scoliosis (AIS)
• Neuromuscular scoliosis
• Congenital scoliosis

The Virata Spinal Fixation System can be used with components of the Mariner and Malibu Systems such as rods and connectors. The Virata Spinal Fixation System is intended to be used with autograft or allograft.

Virata Spinal Fixation Navigated Instruments:
The Virata Spinal Fixation Navigated Instruments are intended to be used in the preparation and placement of Virata screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are designed for use with the Medtronic StealthStation® System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.

The Virata Spinal Fixation System is a pedicle screw-based system that utilizes modular and preassembled screws. The modular screw shanks and the shanks of the preassembled screws are available in solid and cannulated configurations, in a variety of length and diameter size options. The rods are provided in a variety of lengths, diameters, and material options in both straight and pre-contoured configurations that can also be bent with instrumentation to more optimally accommodate the anatomy.

The Virata Spinal Fixation System consists of single-use implants intended to build constructs within the body to act as a temporary or permanent posterior, non-cervical pedicle fixation system, or an anterolateral fixation system to correct spinal disorders and provide stabilization of the spine to permit the biological process of spinal fusions to occur.

Screws are placed in the pedicles of the vertebral body using a posterior approach. The construct is connected using rods to span across screws implanted at various levels. The construct is secured using a set screw tightened to a predetermined torque value which is threaded into the top of the screw to secure the rod. All modular tulips and the tulips of preassembled screws of the system are designed to accept a rod through the opening in the top of the tulip, except the closed polyaxial modular tulip and the tulip of closed preassembled screws for which the rod is passed through an opening on the side of the tulip. The Virata Spinal Fixation System implants are manufactured from titanium alloy Ti-6Al-4V ELI (per ASTM F136), and cobalt chrome alloy (Co-28Cr-6Mo per ASTM F1537).

The system includes the associated non-sterile instruments that facilitate the placement, adjustment, and removal, if necessary, of the system implants as well as trays and caddies that may be used for storage, protection, and organization prior to and during the steam sterilization process for the non-sterile components. Non-sterile instruments also include instrumentation compatible with navigation arrays to allow for navigated implant placement.

The provided document, an FDA 510(k) clearance letter for the Virata Spinal Fixation System, is for a medical device (spinal implant) and not an AI/software-as-a-medical-device (SaMD). Therefore, the information typically required for describing acceptance criteria and a study proving a digital device meets those criteria (such as analysis of test sets, ground truth establishment, expert adjudication, MRMC studies, standalone performance, and training data) is not applicable or present in this document.

Instead, the document focuses on the mechanical performance and substantial equivalence of the physical spinal fixation system to existing predicate devices.

Here's the relevant information that can be extracted from the provided text, adapted to the context of a physical medical device:

1. Table of Acceptance Criteria and Reported Device Performance

For the Virata Spinal Fixation System, acceptance criteria are generally implied by demonstrating safe and effective mechanical performance as compared to predicate devices, typically by meeting or exceeding standards outlined in ASTM (American Society for Testing and Materials) standards. The document doesn't explicitly list numerical acceptance criteria values or specific reported device performance metrics beyond stating that testing was conducted and the device was found substantially equivalent.

However, the types of tests performed indicate the areas where mechanical performance was evaluated:

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

• Sample Size: The document does not specify the exact number of test samples (e.g., screws, rods, constructs) used for each mechanical test. Mechanical testing typically involves a sufficient number of samples to ensure statistical validity for the properties being evaluated, as per the ASTM standards.
• Data Provenance: Not applicable in the context of mechanical testing of a physical implant. The "test set" here refers to the physical devices manufactured for testing. The testing was conducted by SeaSpine Orthopedics Corporation as part of their 510(k) submission.

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

Not applicable. For mechanical testing of a physical device, "ground truth" is established by the physical properties and performance characteristics measured according to standardized test methods (e.g., ASTM standards), not by human expert opinion or interpretation in the way it is for digital health technologies.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like "2+1" or "3+1" are relevant for reconciling differing expert opinions in clinical or diagnostic assessments, not for objective mechanical performance tests.

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

No. An MRMC study is relevant for evaluating the impact of an assist device (like AI) on human diagnostic performance. The Virata Spinal Fixation System is a physical implant, not a diagnostic or AI-assisted device. While it includes "Navigated Instruments," these are physical tools designed for use with a separate "Medtronic StealthStation® System" (a stereotactic surgery system), and the testing presented here focuses on the mechanical performance of the fixation system itself, not a comparative effectiveness study involving human readers' diagnostic accuracy.

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

Not applicable. This is not an algorithm or software device.

7. The Type of Ground Truth Used

For the mechanical performance testing, the "ground truth" is defined by the objective physical measurements and adherence to the specified performance parameters and failure modes outlined within the respective ASTM standards (F1717 and F1798). Compatibility and substantial equivalence to existing predicate devices (SeaSpine Mariner Pedicle Screw System, NuVasive GSB Global Spinal Balance System) also serve as a form of "ground truth" benchmark.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" in the context of mechanical testing for a physical implant.

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

Not applicable. There is no "training set" or "ground truth" establishment in this context.

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The non-absorbable suture anchors are intended to reattach soft tissue to bone in orthopedic surgical procedures.

The CONMED Argo Knotless® Anchor may be used in either arthroscopic or open surgical procedures. After the suture is anchored to the bone, it may be used to reattach soft tissue, such as ligaments, tendons, or joint capsules to the bone. The suture anchor system thereby stabilizes the damaged tissue, in conjunction with appropriate postoperative immobilization throughout the healing period.

The CONMED Argo Knotless® Anchor is an implantable bone anchor, that is supplied single use, sterilized via ethylene oxide (ETO) to a SAL of 10-6. The threaded anchor and the suture eyelet are manufactured of PolyEtherEtherKetone (PEEK) material. Each size features a single use driver, a threaded anchor, suture eyelet, a 1.0mm UHMWPE Hi-FiTM, non-absorbable retention suture, and loader tab. The retention suture holds the PEEK eyelet in place on the driver and can be incorporated into the repair if desired. A maximum of six (6) Hi-Fi #2 suture, or 1.3mm Hi-Fi ribbon suture, or (2) two limbs of Hi-Fi tape, or one (1) bioresorbable reinforced implant can be threaded through the eyelet. The repair sutures are then tensioned and cleated on the driver cleat, if deemed necessary by the surgeon. These anchor configurations require a pre-prepared bone hole which can be created with Class I, Exempt instrumentation.

Analysis of the Provided Text for Device Acceptance Criteria and Study Details

The provided text from the FDA 510(k) clearance letters for "The Acumed Wrist Fixation System" (K251296) and "CONMED Argo Knotless® Anchor" (K251530) pertains to medical devices that are physical implants, not AI-powered or software-based devices requiring performance studies with human readers or AI algorithms.

Therefore, the information requested in your prompt (e.g., acceptance criteria for AI performance, sample sizes for AI test sets, number of experts for ground truth, MRMC studies, standalone AI performance, training set details) is not present in these documents.

These 510(k) summaries describe:

• The Acumed Wrist Fixation System: Metallic bone fixation appliances. Clearance is based on substantial equivalence to pre-1976 devices. Performance data is not detailed in this specific excerpt, as it's a general clearance letter.
• CONMED Argo Knotless® Anchor: An implantable bone anchor made of PEEK. Clearance is based on substantial equivalence to a predicate device (Argo Knotless™ SP Anchor, K220757). The performance testing listed (Insertion, Ultimate Pull Displacement Resistance, Cyclic, User Validation, Packaging, Sterilization, Pyrogen, Biocompatibility, Shelf-life) are all engineering and materials-based tests for a physical implant, not diagnostic accuracy or AI performance evaluations.

Conclusion:

Based on the provided FDA 510(k) clearance letters, it is not possible to answer the questions related to AI device acceptance criteria, study methodologies (like MRMC, human reader studies, or ground truth establishment for AI), or training data for AI models. The devices described are physical orthopedic implants, and their clearance is based on mechanical and material performance, as well as substantial equivalence to previously cleared devices.

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