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Fine Osteotomy™ is a system intended for open- and closed-wedge osteotomies, treatment of bone and joint deformities, fixation of fractures and malalignment caused by injury or disease, such as osteoarthritis, of the distal femur and proximal tibia.

Fine Osteotomy disposable instrumentation is intended to assist in pre-operative planning and/or in guiding the marking of bone and/or guiding of surgical instruments in non-acute, non-joint replacing osteotomies around the knee.

Fine Osteotomy is a patient-specific device.

The Fine Osteotomy™ System is a patient-specific orthopedic device designed to assist surgeons in planning and performing precise osteotomies around the knee. It utilizes patient imaging data to create 3D anatomical models used for the design of cutting guides and fixation implants tailored to the individual anatomy. The system includes single-use cutting guides manufactured from PA 12 polymer and fixation components made of titanium alloy (Ti-6Al-4V ELI). The implants are designed to support stable bone fixation following the osteotomy. The device operates without an energy source and relies on mechanical alignment and rigid fixation principles. Minor refinements have been incorporated to improve compatibility with surgical planning and instrument design, without affecting the intended use or fundamental function of the system. The device is supplied non-sterile and includes a combination of patient-specific and reusable components.

This FDA 510(k) clearance letter for the Fine Osteotomy™ system does not contain the detailed information required to describe the acceptance criteria and the specific study that proves the device meets those criteria.

The document primarily focuses on the regulatory aspects of the 510(k) submission, confirming substantial equivalence to a predicate device. While it mentions "non-clinical testing" was performed, it provides a high-level summary and lacks the specific data points requested in your prompt.

Here's a breakdown of why the requested information cannot be extracted from this document:

• Acceptance Criteria and Reported Device Performance: The document states, "All tests confirmed that the device meets applicable requirements and continues to perform as intended." However, it does not specify what those "applicable requirements" or performance metrics are, nor does it provide a table of actual results against specific acceptance criteria.
• Sample Size and Data Provenance: The document does not mention sample sizes for any tests, nor the country of origin of data, or whether it was retrospective or prospective.
• Experts for Ground Truth Establishment: There is no mention of experts, ground truth establishment, or any details related to human interpretation or readings.
• Adjudication Method: Not applicable as there's no mention of expert review or ground truth establishment requiring adjudication.
• Multi-Reader Multi-Case (MRMC) Study: The document explicitly states, "No clinical testing was necessary, as the modifications do not alter the intended use, safety, or effectiveness of the device." Therefore, no MRMC study was conducted. There is no information about human readers or AI assistance.
• Stand-alone (Algorithm Only) Performance: While the device has a software component("support usability through a software update"), the document does not break down performance specific to an algorithm's standalone performance. It focuses on the overall system (hardware and software).
• Type of Ground Truth Used: Not applicable, as no ground truth for diagnostic accuracy is discussed. The testing mentioned appears to be related to mechanical/dimensional properties and software verification.
• Training Set Sample Size: No information about a training set is provided, as the document mainly describes the device and its regulatory clearance process, not its development or training of any AI/ML components.
• How Ground Truth for Training Set was Established: Not applicable as no training set is discussed.

Conclusion:

This 510(k) clearance letter for Fine Osteotomy™ is a regulatory approval document. It confirms that the device is substantially equivalent to a previously cleared predicate and that non-clinical testing was sufficient to demonstrate this. However, it does not provide the detailed scientific study results, acceptance criteria, ground truth methodology, or clinical performance metrics (especially for diagnostic accuracy or human-AI interaction) that you are requesting. These details would typically be found in a more comprehensive clinical study report or a detailed design verification and validation document, which are not part of this public FDA clearance letter.

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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 TriMed Distal Xtremities System is indicated for use in stabilization of fractures, malunions and non-unions of the small bones of the foot.

The TriMed Distal Xtremities System includes 2.0mm and 2.3mm locking screws and six new plate configurations designed for distal extremity fixation. The titanium plates vary in hole count and geometric profile (straight and T-shaped) to accommodate a range of anatomical and clinical needs. The Distal Xtremities plates represent variations in design to TriMed's current Xtremities plate, with additional sizes and removal of the PEEK inserts.

The provided FDA 510(k) Clearance Letter for the TriMed Distal Xtremities System does not contain any information about an acceptance criteria table, a study proving the device meets acceptance criteria, or any details related to AI/algorithm performance.

The document describes a medical device (bone fixation appliances) and its regulatory clearance process, which relies on demonstrating substantial equivalence to a predicate device based on material properties, design comparisons, and non-clinical engineering analyses (FEA analysis, theoretical calculations, and retrospective review of physical testing data for screws).

Therefore, I cannot provide the requested information for acceptance criteria and study proving meeting those criteria from the given text.

The following points are what the document does include regarding performance evaluation:

• Non-Clinical and/or Clinical Tests Summary & Conclusions (21 CFR 807.92(b)):
  • Subject device screws were evaluated against TriMed predicate screws for performance and found to be substantially equivalent. Analysis included theoretical calculations along with retrospective review of physical testing data to show that the new 2.0 and 2.3mm screws did not create a new worst case within the TriMed screw families. Therefore physical testing of the new screws was not necessary.
  • FEA analysis was completed comparing material performance between the new Distal Xtremities plates and the current Easy Lock and Xtremities plates. The analysis showed that the dimensional differences and the change in plate materials does not impact performance.
  • Engineering analysis and physical test data show that the Distal Xtremities Screws are substantially equivalent to other TriMed screws used in the fixation of small bones of the foot. FEA analysis comparing the Distal Xtremities Plates to the predicates, showed that the dimensional and material changes did not impact mechanical performance.

This content indicates that the "study" proving the device meets the criteria was primarily non-clinical engineering analysis (FEA, theoretical calculations, and retrospective review of existing physical test data), not a clinical study involving human or AI performance. The criteria for acceptance were likely based on demonstrating comparable mechanical performance and material properties to the predicate devices.

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The OSSIOfiber® Interference Screws, are indicated for fixation of tissue, including ligament or tendon to bone, or a bone/tendon to bone in adults and children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by fixation. Interference fixation is appropriate for surgeries of the knee, shoulder, elbow, ankle, foot, and hand/wrist where the sizes offered are patient appropriate; Specifically:

• Shoulder: Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
• Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair, Flexor Hallucis Longus for Achilles Tendon reconstruction, tendon transfers in the foot and ankle
• Knee: Repair/Reconstruction of the Anterior Cruciate Ligament, Posterior Cruciate Ligament, Medial Collateral Ligament, Lateral Collateral Ligament, Patellar Tendon, Posterior Oblique Ligament, Iliotibial Band Tenodesis, MPFL
• Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collament Reconstruction
• Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction, Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty), Carpal Ligament Reconstructions and repairs, tendon transfer in the hand/wrist

The OSSIOfiber® Interference Screw is an orthopedic implant made of poly (L-lactide-co-D,L-lactide) (PLDLA) reinforced with continuous mineral fibers. The OSSIOfiber® Interference Screws are cannulated and fully threaded, available in diameters ranging from 6 to 12 mm and lengths from 23 to 28 mm. The polymer content degrades by hydrolysis into alpha-hydroxy acids that are metabolized by the body. The fibers are made from minerals that are found in natural bone. As the OSSIOfiber® implants degrade, the load transfers to the surrounding anatomy throughout the healing period of the implantation site. Substantial degradation takes place within approximately 18 months as shown in pre-clinical studies, thus eliminating the requirement for future hardware removal surgery.

The OSSIOfiber® Interference Screw is supplied sterile, for single patient use only.

The OSSIOfiber® Interference Screw is designed to be used with commonly available orthopedic surgical tools such as ISO 9714 compatible instrumentation such as ISO 9714 compatible instrumentations.

This document does not describe a study that uses AI or machine learning. It describes a medical device called the OSSIOfiber® Interference Screw and its clearance through the FDA 510(k) process. This process focuses on demonstrating substantial equivalence to a legally marketed predicate device, primarily through non-clinical (laboratory/mechanical) testing rather than clinical studies with human subjects or AI performance evaluations.

Therefore, many of the requested categories for AI/ML study acceptance criteria and performance data cannot be filled from the provided text.

Here's an analysis of what information can be extracted or inferred from the text related to the device's acceptance criteria and study, with explanations for the missing AI/ML specific data:

Device: OSSIOfiber® Interference Screw

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) clearance letter does not specify explicit numerical acceptance criteria in the typical format (e.g., "pull-out strength > X N"). Instead, it states that the device was found to be "at least as safe and effective" and demonstrated "at least equivalent performance" to the predicate devices. The performance is assessed comparatively.

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

• Sample Size: Not explicitly stated. The document mentions "Pull-out testing," "Torsional strength," and "driving torque testing" but does not provide the number of samples tested for each.
• Data Provenance: The studies are "non-clinical data" and "in-vitro degradation." This implies laboratory testing rather than human clinical data. The country of origin of the data is not specified, but the submitter is "Ossio Ltd." in Caesarea, Israel. The studies are prospective in the sense that they were conducted for the purpose of this 510(k) submission, not gathered retrospectively from patient treatments.

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

Not applicable. This information is relevant for studies involving human interpretation (e.g., image analysis by radiologists). The described studies are non-clinical (mechanical and biocompatibility testing). Ground truth in this context would be defined by standard engineering and biocompatibility testing protocols, not expert consensus.

4. Adjudication Method for the Test Set

Not applicable. No adjudication method is described because the studies are non-clinical engineering tests.

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 clearance based on non-clinical performance and substantial equivalence, not an AI/ML diagnostic or assistive software. There is no AI component described.

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

Not applicable. This section is for AI/ML algorithms. No such algorithm is described.

7. The Type of Ground Truth Used

For mechanical testing (pull-out, torsional strength, driving torque): The "ground truth" is established by direct physical measurement according to validated test methods and engineering standards. The performance of the predicate device serves as the benchmark for comparison.

For biocompatibility: Ground truth is established by the results of ISO 10993 testing, which uses established biological endpoints and criteria.

8. The Sample Size for the Training Set

Not applicable. This is for AI/ML studies. No training set is mentioned as there is no AI/ML component.

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

Not applicable. This is for AI/ML studies.

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The ANTHEM® Fracture System is indicated for fixation of fractures, osteotomies, arthrodesis and reconstruction of bones for the appropriate size of the device to be used in adult patients, including the clavicle, scapula, humerus, radius, ulna, small bones (metacarpals, metatarsals, phalanges), wrist, pelvis, femur, tibia, fibula, ankle, and foot. The clavicle hook plate may be used for dislocations of the acromioclavicular joint. Distal femur, distal humerus, proximal ulna, and proximal radius plates are indicated for diaphyseal, metaphyseal, epiphyseal, supracondylar, intra-articular, extra-articular, condylar, periprosthetic, and comminuted fractures, and for non-unions and malunions. Mini fragment plates are also indicated for fixation of fractures of the acetabulum, patella, and bone fragments, replantation, malunions and nonunion, and for non-load bearing stabilization and reduction of long bone fragments. Metaphyseal plates are indicated for non-load bearing stabilization and reduction of long bone fragments, and for fixation of bones including the radius and ulna.

In addition to adult patients, small fragment, mini fragment, proximal tibia, clavicle, metaphyseal, distal humerus, proximal ulna, proximal radius, and distal fibula plates are indicated for use in infant, child, and adolescent pediatric subgroups and small stature adults. Distal femur plates are indicated for use in the diaphyseal and metaphyseal areas of long bones in adolescent pediatric patients. Distal radius, distal tibia, metaphyseal, and mini fragment plates are indicated for use in adolescents (12-21 years of age). Plating can be used in patients with osteopenic bone.

The ANTHEM® Fracture System is a family of plates, screws, and washers designed to be used for internal bone fixation. The implants are available in various sizes and shapes, and may be contoured or straight, with various lengths to accommodate patient anatomy. The subject ANTHEM® plates are manufactured from titanium alloy per ASTM F136 or stainless steel as specified in ASTM F138 and F139. Plates are also available additively manufactured from titanium alloy powder per ASTM F3001.

I am sorry, but based on the provided FDA clearance letter for the ANTHEM® Fracture System, I cannot extract the information you requested regarding acceptance criteria and the study that proves the device meets those criteria, specifically concerning human-in-the-loop performance, ground truth establishment, or training set details.

This document is a 510(k) clearance letter for a physical medical device (bone fixation system) and focuses on demonstrating substantial equivalence to predicate devices, primarily through engineering analysis and mechanical testing of the physical components. It does not appear to involve any AI/software component that would require the kind of performance study details you are asking for (e.g., sample size for test/training sets, expert adjudication, MRMC studies, standalone algorithm performance, or different types of ground truth like pathology or outcomes data).

Therefore, I cannot populate the table or answer the specific questions about AI/software performance studies. The "Performance Data" section solely refers to mechanical testing according to ASTM F382 and biocompatibility, which are standard for physical implants.

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The OsteoCentric® Unifi MI® TCS Plating System is intended for fixation of fractures, osteotomies, and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, tibia, and fibula, including but not limited to periarticular and intraarticular fractures.

The OsteoCentric® UnifiMI® TCS Plating System consists of implants and instruments designed for fixation to treat fractures, deformations, revisions and replantations of bone and bone fragments. The purpose of the submission is for a line extension of the OsteoCentric Bone Plate and Screw System, which includes 2.7mm angle iron plates, additional screw sizes, and the inclusion of titanium as a material. The principal benefit of the proposed 2.7mm angle iron new plate geometry is that it allows for a stronger and more stable plate in a smaller form factor. Having a stronger and more stable plate in a smaller form factor has the potential clinical benefits of aiding the user in minimizing the incision required for the procedure and providing an option to the surgeon user that allows for the same strength and stability as a much larger plate, without having to disrupt as much soft tissue. This line extension has the same Indications for Use as the original system. This Line Extension will be known as the OsteoCentric® UnifiMI® TCS Plating System. The system features angle plates and bone screws for fixation that are locking or non-locking, and a set of instruments to facilitate installation and removal of the implants. The plates have screw holes, which allow for attachment to the bones or bone fragments. The plates are fabricated from medical grade stainless steel per ASTM F138 or Titanium per ASTM F136. Plates and screws are provided non-sterile. Instruments are provided non-sterile with instructions for sterilization.

This 510(k) clearance letter for the OsteoCentric® UnifiMI® TCS Plating System describes an orthopedic plating system, not an AI/software device. Therefore, the information typically found in a study proving acceptance criteria for an AI-based medical device (such as those involving performance metrics like sensitivity, specificity, or AUC, and details about training/test sets, expert ground truth, and reader studies) are not applicable to this document.

The document focuses on demonstrating substantial equivalence to predicate devices for a physical medical device (bone plates and screws) by assessing its mechanical performance.

Here's a breakdown based on the provided document, addressing the closest applicable points:

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

The document broadly states: "Engineering analysis was performed to demonstrate that the new bone plates and screws did not present a new worst-case. The data demonstrates that the subject device is substantially equivalent to the predicates."

While specific quantitative acceptance criteria and their corresponding reported performance values are not explicitly laid out in a table in this summary, the implicit acceptance criterion is:

• Acceptance Criterion: The mechanical strength and stability of the new 2.7mm angle iron plates and additional screw sizes must be equivalent to or better than the predicate devices, and not present a "new worst-case" scenario.
• Reported Device Performance: The data demonstrates substantial equivalence to the predicates in terms of mechanical strength and stability.

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

• Sample Size: Not explicitly stated in the public summary document. For mechanical testing of physical devices, this typically refers to the number of individual plates/screws tested.
• Data Provenance: Not applicable in the context of data acquisition for AI/software. The "data" here refers to the results of mechanical engineering tests (e.g., fatigue testing, static testing) performed on the physical devices. This testing would be done in a lab setting.

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

• Not applicable as this is a physical device clearance based on engineering testing, not clinical data requiring expert review for ground truth. The "ground truth" here is established by standardized mechanical testing methodologies (e.g., ASTM standards) and engineering principles.

4. Adjudication method for the test set:

• Not applicable. Mechanical test results are objective measurements (e.g., force, displacement), not subjective interpretations requiring adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done:

• No. This is a physical device, and MRMC studies are relevant for software/AI devices where human readers' performance with and without AI assistance is evaluated.

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

• Not applicable. This is not an algorithm.

7. The type of ground truth used:

• The "ground truth" for demonstrating substantial equivalence for this physical device is based on engineering analysis and standardized mechanical testing results. The performance of the subject device (strength, stability) is compared against the known performance characteristics of the predicate devices, likely derived from similar benchtop testing or regulatory submissions.

8. The sample size for the training set:

• Not applicable. There is no "training set" as this is not an AI/machine learning device.

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

• Not applicable. No training set is involved.

Summary specific to this device type (physical orthopedic implant):

The "acceptance criteria" for this type of device primarily revolve around mechanical performance and material biocompatibility to ensure it is as safe and effective as existing legally marketed predicate devices. The study proving this involves:

• Non-Clinical Testing: "Engineering analysis was performed to demonstrate that the new bone plates and screws did not present a new worst-case." This would typically include:
  • Mechanical Testing: Such as static compression/tension/torsion tests, fatigue testing, push-out/pull-out tests for screw fixation. These tests are often conducted according to relevant ASTM or ISO standards for bone plates and screws.
  • Material Characterization: Ensuring the Titanium and Stainless Steel meet medical-grade specifications (ASTM F136, ASTM F138).
• Comparison to Predicates: The test results are then compared to the performance envelopes of the predicate devices. The "acceptance" is achieved if the new device's performance falls within an acceptable range, demonstrating it is "substantially equivalent" and does not introduce new safety or effectiveness concerns due to its mechanical properties or new geometry.

The document implicitly states that the acceptance criterion was met as the data demonstrated substantial equivalence to the predicates, particularly in showing that the "new bone plates and screws did not present a new worst-case."

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The KLS Martin Ixos system is indicated for use in forearm fractures, osteotomies, and arthrodeses. This system is intended for adults, as well as adolescents (12-21 years) and children (2-12 years) in which growth plates have fused or in which growth plates will not be crossed by fixation.

The KLS Martin Ixos System consists of metallic plates used in conjunction with bone screws and locking pins intended for the internal fixation, alignment, stabilization, and reconstruction of the distal radius and/or ulna. Plates are manufactured from Ti-6Al-4V and are available in various shapes and dimensions. The system also includes the necessary instruments to facilitate placement of the implants. The manufacturing process, sterilization methods, materials and packaging are identical to those of the cleared predicate device, KLS Martin LINOS Wrist System (K222624).

The provided FDA 510(k) clearance letter for the KLS Martin Ixos System does not contain the information requested regarding acceptance criteria and the study that proves the device meets those criteria for an AI/software device.

This document describes a metallic bone fixation appliance, not a software or AI medical device. The "Non-Clinical and/or Clinical Tests Summary & Conclusions" section explicitly states "Clinical Performance Data: Not Applicable" and details mechanical performance testing (in accordance with ASTM F382) and MR compatibility testing (per various ASTM standards). These are standard tests for orthopedic implants to demonstrate their static and dynamic strength, and safety in an MRI environment.

Therefore, I cannot extract the following information as it is not present in the provided text:

• A table of acceptance criteria and the reported device performance (for AI/software).
• Sample size used for the test set and the data provenance
• Number of experts used to establish the ground truth
• Adjudication method
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
• The type of ground truth used (expert consensus, pathology, outcomes data, etc)
• The sample size for the training set
• How the ground truth for the training set was established

The document focuses on demonstrating substantial equivalence to predicate orthopedic implants based on:

• Same intended use/indications for use.
• Similar technological characteristics: manufactured from the same materials (Ti-6Al-4V), using the same manufacturing methods, and having similar principles of operation.
• Performance data: Non-clinical comparative static and dynamic mechanical performance testing against a secondary predicate (Stryker VariAx 2 distal radius plates) and MR compatibility testing.

In summary, the provided document is a 510(k) clearance for a physical medical device (bone plate system), not an AI/software device, and thus does not include the type of performance evaluation details (e.g., ground truth, reader studies, training data) relevant to AI/software.

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The indications for use of these internal fixation devices include:

• Open and closed femoral fractures
• Pseudoarthrosis and correction osteotomy
• Pathologic fractures, impending pathologic fractures and tumor resections
• Supracondylar fractures, including those with intraarticular extension
• Fractures involving osteopenic and osteoporotic bone
• Fractures distal to a total hip prosthesis
• Periprosthetic fractures
• Nonunions and malunions

The struts of the T2 Alpha Femur Retrograde Nailing System are intended to be used only with the nails of this system; they are not to be used as stand-alone devices.

T2 Alpha Femur Retrograde Nailing System, previously cleared in K203819, consists of sterile implants (intramedullary nails in various diameter and sizes, compression screw and end caps), as well as nonsterile instruments (targeting devices).

The subject of this 510(k) submission is to introduce new devices of the T2 Alpha Femur Retrograde Nailing System. This line extension consists of anatomically pre-contoured struts and interlinking dowels designed to be used in combination with the existing nails of the T2 Alpha Femur Retrograde System for the treatment of complex fractures of the distal femur.

All struts are manufactured from Ti6Al4V ELI (Type II anodization) and are available in different sizes and left/right versions; these will be provided both non-sterile and sterile packaged. Interlinking dowels to the femoral nail are manufactured from CoCr and will be provided sterile packaged.

This appears to be a 510(k) clearance letter for an orthopedic implant, not an AI/Software as a Medical Device (SaMD). The document describes the "T2 Alpha Femur Retrograde Nailing System," which is a physical device used for internal fixation of femoral fractures.

Therefore, the information requested in your prompt regarding acceptance criteria, study details, expert ground truth, MRMC studies, standalone performance, and training/test set provenance does not apply to this clearance document. These criteria are typically evaluated for AI/SaMD products, where algorithmic performance and human-AI interaction are critical.

The provided document details:

• Device Type: Intramedullary fixation rod (physical implant).
• Performance Data: Non-clinical bench testing (fatigue strength, cut-out performance, stiffness, shear-off, pull-out, insertion, static bending, fretting corrosion, targeting accuracy, MR assessment, packaging) and references to clinical evidence from peer-reviewed scientific literature.
• Comparison to Predicate Devices: Focuses on material, manufacturing, intended use, and mechanical performance equivalence.

No mention of AI, algorithms, or software performance evaluation is present.

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The External Fixation Bone Distractor is intended for treatment of non-union or pseudoarthrosis of long bones and correction of bony or soft tissue defects or deformities.
The External Fixation Bone Distractor is indicated for adult and pediatric (greater than 2 through 21 years of age) patients.

The Paragon 28 External fixation Bone Distractor is a transverse bone transport system designed to assist in the controlled movement of a bone segment across a defect. The device can be used independently or in conjunction with the Monkey Rings External Fixation System (K232838) or Monkey Bars Pin to Bar External Fixation System (K242452) to form hybrid frames.

The provided FDA 510(k) clearance letter for the "External Fixation Bone Distractor" does NOT include information about acceptance criteria or a study that proves the device meets specific performance criteria through clinical data, especially not in the context of an AI/ML-driven medical device.

This document describes a traditional medical device (an external fixation system) and its clearance is based on substantial equivalence to existing predicate devices, rather than on meeting specific performance metrics derived from a study like an MRMC or standalone AI performance evaluation. The "Performance Testing" section explicitly states: "No additional bench testing was performed for the subject device. Instead, a worst-case analysis was conducted using existing data from other components within the device system." This means the clearance is based on engineering design analysis and comparison to mechanically similar, already cleared components, not on a study with clinical performance acceptance criteria.

Therefore, I cannot extract the requested information from the provided text. The questions posed relate to the evaluation of AI/ML-driven medical devices, which operate under different regulatory and performance evaluation paradigms.

To answer your request thoroughly, I will indicate that the information is not present in the provided document for each point.

Here's the breakdown, indicating the information is not present based on the provided FDA 510(k) letter:

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

• Information Not Present: The document does not specify quantitative acceptance criteria for clinical performance (e.g., sensitivity, specificity, accuracy) nor does it report performance metrics from a clinical study. The clearance is based on substantial equivalence and mechanical properties derived from "worst-case analysis" using existing data, not a specific performance study against defined clinical criteria.

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

• Information Not Present: No test set is mentioned, as there was no clinical performance study conducted or reported for this 510(k) submission. The document relies on existing data from other components and worst-case analysis for mechanical performance.

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)

• Information Not Present: This is not applicable. There was no test set with clinical ground truth established by experts.

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

• Information Not Present: This is not applicable. No test set involving human expert adjudication was used.

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

• Information Not Present: An MRMC study was not done. The device is a mechanical medical device, not an AI/ML-driven diagnostic or assistive tool.

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

• Information Not Present: A standalone performance study was not done. The device is a mechanical bone distractor, not an algorithm.

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

• Information Not Present: Ground truth, in the context of clinical performance evaluation for AI/ML devices, is not relevant here as it's a mechanical device. The "ground truth" for this device's clearance relates to its mechanical integrity and biocompatibility, established through engineering standards (ASTM F1541-17) and material properties.

8. The sample size for the training set

• Information Not Present: A training set is not applicable. This is a mechanical device, not an AI/ML system.

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

• Information Not Present: This is not applicable. No training set or associated ground truth establishment method is mentioned.

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