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The External Fixation Mini Rail System is intended for external fixation and is indicated for stabilization of fractures and osteotomy, foot arthrodesis, adult and pediatric leg lengthening, and correction of bone deformity in the lower extremities. The External Fixation Mini Rail System is intended to be used in pediatric patients that are children aged 2 years to less than 12 years and adolescents aged 12 through 21 years (up to but not including the 22nd birthday).

The External Fixation Mini Rail System consists of pins, rail, wires and pins clamps. The mini rail frame serves as the structural base for fixation distraction. The pin clamps allow rotational and translational positioning of bone segments. The system is meant to offer a solution for compression and gradual distraction of the metatarsals and 1st metatarsophalangeal (MTP) joint. The system also includes instrumentation for implantation such as wires, drivers, sawblades, wrenches, templates and cut guides.

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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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The Life Spine External Fixation System is intended for Adults:

Fusion of the foot including: Triple arthrodesis Isolated hindfoot arthrodesis Midfoot arthrodesis Joints involved include tibiotalar, talonavicular, calcaneocuboid, pantalar, tibio-talocalcaneus, naviculocuneiform, metatarsal cuneiform (first, second, third - e.g. Lapidus, MT), metatarsal cuboid

Treatment of fractures including:

Treatment of LisFranc fracture/dislocations in diabetic and Charcot neuropathy patient Fractures and/or comminuted fractures (open or closed) of the calcaneus, talus, cuboid, navicular, cuneiforms, and/or metatarsals (including jones fractures), ankle and distal tibia

Additional fixation adjunct to internal fixation of the distal tibia, calcaneus, talus, navicular, cuboid, cuneiforms, and/or metatarsals in patients with significant comorbidities (i.e. diabetes) that may preclude use of isolated internal fixation

Reconstruction of deformities including: Neuropathic deformities Charcot reconstruction with or without corrective osteotomies Diabetic Charcot Reconstruction Prevention and treatment of contracture of joints and tendons in equinus

Treatment of infection unions, nonunions, or malunions

Offloading and or immobilization of ulcers and/or wounds of the foot or ankle

Stabilization associated with tendon or ligament surgeries. Tendon lengthening, repairs, and transfers both deep and or superficial around the foot and ankle including posterior tibial , tibialis anterior, flexor digitorum longus, achilles, flexor hallucis longus, peroneus longus, extensor hallucis longus, extensor digitorum longus

Tumor and neoplasm resection and reconstruction

Stabilization associated with rotation flaps, free flaps, advancement flaps, fasciocutaneous flap, split thickness skin grafting, biological graft alternatives.

Pseudoarthrosis or non-unions of long bones.

Correction of bony or soft tissue deformities Correction of segmental or nonsegmental bony or soft tissue defects Use on long bones including tibia and fibula Use with or without IM nail in the ankle in Charcot patients

The Life Spine External Fixation System is a component system of rings, struts, threaded rods, pins, wires and connectors intended to be used as a means to stabilize bone segments for indications within the foot and ankle. The External Fixture system is fabricated of both Radel, Stainless Steel (316L) and Aluminum. The implant components are fabricated and manufactured from the following:

1. Stainless Steel (316L)

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

The provided document is a 510(k) Premarket Notification from the FDA regarding the Life Spine External Fixation System. It confirms that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain the detailed acceptance criteria for a specific device's performance, nor does it describe a study specifically designed to prove the device meets such criteria in terms of diagnostic accuracy or clinical outcomes.

Instead, this document focuses on demonstrating substantial equivalence based on:

1. Indications for Use: The new device has similar intended uses to predicate devices.
2. Technological Characteristics: The new device has similar geometry, design, and sizing to predicate devices.
3. Materials: The new device uses materials (Stainless Steel, Radel, Aluminum) comparable to those in predicate devices.
4. Performance Data (Mechanical Testing): Mechanical testing was performed according to ASTM F1541 to show the physical performance of the device is equivalent to predicate devices. This is not a clinical study or a study measuring diagnostic accuracy.

Therefore, I cannot extract the information required in your request (acceptance criteria, device performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth details) because this 510(k) summary does not contain that type of information. It's a regulatory document for a physical medical device (an external fixation system), not a diagnostic or AI-driven device a requesting such information would typically apply to.

In summary, the document states:

• Acceptance Criteria & Reported Performance: No specific acceptance criteria for diagnostic performance or clinical outcomes are provided. The "performance" discussed is in terms of mechanical testing for substantial equivalence, not clinical efficacy or diagnostic accuracy.
• Sample Size and Data Provenance: Not applicable for clinical or diagnostic performance studies. The document refers to "mechanical testing according to ASTM F1541".
• Number of Experts & Qualifications: Not applicable as this is not a study requiring expert interpretation or ground truth establishment in a clinical sense.
• Adjudication Method: Not applicable.
• MRMC Comparative Effectiveness Study: No such study is mentioned or implied.
• Standalone Performance: Not applicable for a non-AI surgical device.
• Type of Ground Truth: Not applicable beyond mechanical property validation against standards.
• Training Set Sample Size: Not applicable.
• Ground Truth for Training Set: Not applicable.

The document's "Performance Data" section mentions: "Mechanical testing according to ASTM F1541 including Static and Dynamic Compressions, Dynamic Axial Compression Testing, Static Torsion Testing and Static 4-point Bending was presented to demonstrate the substantial equivalency of the External Fixation System." This indicates the type of study performed, but not the specific design or results in a way that answers your questions about clinical performance or AI evaluation.

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The AOS External Fixation System is indicated for external fixation of open or closed long bone fractures where soft tissue injury precludes the use of other fracture treatment. The AOS External Fixation System is intended to be non-weight bearing.

The AOS External Fixation System is an external fixation device comprised of rods, rod-to-rod clamps, pin-to-rod clamps and threaded pins used for the management of bone fractures and reconstructive orthopedic surgery. The system is a modular system designed to provide options in frame construction, simplicity in frame components, and ease of use. The system is comprised of titanium and stainless steel clamps (rod-to-rod and pin-to-rod), stainless steel fixation pins and carbon fiber connector rods. The AOS External Fixation system is a non-sterile single use fixation device. The rod-to-rod clamps are designed to clamp to the 9.5mm carbon fiber rod and connect two rods together. The rod-to-pin clamps are designed to clamp to the 9.5mm carbon fiber rod and to the 5.0mm stainless steel half pins and the 5.0mm shaft on the 6.0mm center threaded pin. The stainless steel threaded half pins are 5mm in diameter and in lengths of 180mm and 210mm. The stainless steel thread center pins have a 6.0mm thread diameter, 5.0mm shaft diameter and are 280mm in length. The 5.0mm threaded half pin and the center threaded pins have twist flutes so that they are self-drilling. The connecting rods are carbon fiber reinforced plastic rods with an overall diameter of 9.5mm and are in length of 250mm, 300mm and 400mm.

The provided document is a 510(k) summary for the AOS External Fixation System. It does not describe a study that uses acceptance criteria to prove device performance in a way that aligns with the questions asked, which are typically relevant for AI/ML-based diagnostic or prognostic devices.

The AOS External Fixation System is a physical medical device, specifically an external fixation system for bone fractures. Its clearance is based on substantial equivalence to predicate devices, not on meeting specific performance metrics through a clinical or algorithmic study with defined acceptance criteria for accuracy, sensitivity, specificity, etc.

Therefore, many of the requested details, such as sample size for test/training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, and types of ground truth, are not applicable to this type of device submission.

Here's an attempt to answer based on the provided document, highlighting what is not applicable:

Acceptance Criteria and Device Performance

Study Details

1. Sample size used for the test set and the data provenance: Not applicable. This was a substantial equivalence submission for a physical device, not a performance study of an algorithm on a test set.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically defined for AI/ML studies (e.g., disease diagnosis) was not established for this submission. The "ground truth" for substantial equivalence is the existing, legally marketed predicate devices.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is an external fixation system, not an AI-assisted diagnostic tool.
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.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): The "ground truth" for this submission is established by the functional characteristics, materials, and intended use of the predicate devices being legally marketed and deemed safe and effective. The device is shown to be substantially equivalent to these predicates.
7. The sample size for the training set: Not applicable. There is no training set for a physical device.
8. How the ground truth for the training set was established: Not applicable.

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1. BONE FRACTURE FIXATION
2. OSTEOTOMY
3. ARTHODESIS
4. CORRECTION OF DEFORMITY
5. REVISION PROCEDURES WHERE OTHER DEVICES HAVE BEE UNSUCCESSFUL
6. BONE RECONSTRUCTION PROCEDURES

Not Found

Analysis of the provided document (K052605, External Fixation) reveals that it is a 510(k) premarket notification for an external fixation system. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving efficacy or performance against specific quantitative acceptance criteria through clinical studies. Therefore, the information requested regarding acceptance criteria, study details, and data provenance for a device performance study is not typically found in these types of documents.

Here's a breakdown of why the requested information is not present and what is available:

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

• Not Applicable: 510(k) submissions for devices like external fixation systems (which are typically Class II, as indicated by the regulation number 21 CFR 888.3030) do not usually include a table of quantitative acceptance criteria and reported device performance derived from a study designed to prove these criteria. The approval is based on demonstrating substantial equivalence to a predicate device. This often involves comparing design features, materials, and intended use, and sometimes non-clinical (e.g., mechanical) testing to ensure the device meets safety and performance standards equivalent to the predicate. However, these are typically engineering specifications rather than clinical performance metrics relative to a specific efficacy target.

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

• Not Applicable: Since no human clinical study demonstrating performance against specific acceptance criteria is described, there's no "test set" in the context of clinical data. If non-clinical bench testing was performed, details about the "sample size" would refer to the number of devices tested, and provenance would relate to the testing facility and methodology, but this document does not provide such details.

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: "Ground truth" established by experts is relevant for studies involving diagnostic or interpretive tasks (e.g., image analysis). An external fixation system is a therapeutic device, and its performance is typically assessed through mechanical properties, biocompatibility, and clinical outcomes (e.g., fracture healing rates). The 510(k) summary provided does not detail any such clinical study or expert consensus for ground truth.

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

• Not Applicable: Adjudication methods are relevant when there are subjective assessments or disagreements among experts, such as in clinical trials with multiple reviewers. This information is not relevant to the type of submission or device described.

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

• Not Applicable: An MRMC study is specific to diagnostic imaging devices, often involving AI assistance. This device is an external fixation system, not a diagnostic imaging device with AI components.

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

• Not Applicable: This question pertains to AI/algorithm performance studies. The device is a physical medical implant/device, not an algorithm.

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

• Not Applicable: As established earlier, the concept of "ground truth" as requested is not applicable to a 510(k) submission for an external fixation device. Performance is typically gauged by successful mechanical function and clinical outcomes which, if studied in detail, would involve patient follow-up and clinical assessments, but this level of detail for a performance study is not in a 510(k) summary.

8. The sample size for the training set:

• Not Applicable: There is no "training set" in the context of an external fixation device being submitted via a 510(k). This term applies to machine learning algorithms.

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

• Not Applicable: Similar to point 8, this is not relevant to an external fixation device.

In summary, the provided document K052605 is a 510(k) premarket notification for an External Fixation system. The approval is based on demonstrating substantial equivalence to a predicate device, as confirmed by the FDA letter. It does not contain information about clinical performance studies with specific quantitative acceptance criteria, test sets, ground truth establishment, or AI-related metrics like those requested.

The core of a 510(k) for such a device is typically focused on:

• Indications for Use: Clearly stated as Bone Fracture Fixation, Osteotomy, Arthodesis, Correction of deformity, Revision procedures where other treatments/devices have been unsuccessful, and Bone reconstruction procedures.
• Technological Characteristics: Comparison of materials (metallic fasteners), design, and performance with a predicate device.
• Substantial Equivalence: A conclusion by the FDA that the new device is as safe and effective as a legally marketed predicate device.

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External Fixation System components are intended to be used on adults or pediatric patients as required and are intended to be used for fracture fixation (open and closed); post-traumatic joint contracture which has resulted in loss of range of motion; fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction: pseudoarthrosis or non-union of long bones; limb lengthening by epiphyseal or metaphyseal distraction of bony or soft tissue deformity; correction of segmental bony or soft tissue defects; joint arthrodesis; and management of comminuted intra-articular fractures of the distal radius.

External fixation devices, such as the external fixation bar clamps described herein, are specially designed components used in the management of bone fractures and reconstructive, as well as corrective, orthopedic surgery. The metal alloys used in their manufacture are chosen to address a wide range of applications. These devices have been designed to allow for the appropriate amount of rigidity and stability.

The provided text is a 510(k) Summary for External Fixation Systems. This type of document is for medical devices that are found to be substantially equivalent to a predicate device and typically does not include detailed studies with acceptance criteria, sample sizes, expert ground truth adjudication, or AI performance metrics.

The document states:

• "The principle of operation of these reprocessed devices is very similar to that of the predicates. There are no changes in intended use, performance specifications or method of operation. The reprocessed devices utilize similar designs, the same materials and technological characteristics when compared to the predicate devices."
• "The intended use of the reprocessed external fixation bar clamps is identical to that of the Smith & Nephew Unilateral Fixator (K994143) and the Smith & Nephew Unilateral Wrist Fixator for Distal Radius Fractures (K994143). The design and the function of the subject devices are very similar to the predicate devices and they are manufactured from the same materials."

Based on this, the device is considered substantially equivalent to existing predicate devices (Smith & Nephew Unilateral Fixator K994143 and Smith & Nephew Unilateral Wrist Fixator for Distal Radius Fractures K994143) because there are no changes in intended use, performance specifications, or method of operation. Therefore, a new study to prove device performance against specific acceptance criteria, in the way a novel AI device might, is not presented or required for a 510(k) submission of this nature.

Thus, I cannot provide the specific information requested in the format of a table of acceptance criteria, reported device performance, sample sizes, expert qualifications, or AI-related metrics because the document does not contain this type of study. The demonstration of safety and effectiveness for this device relies on its substantial equivalence to previously cleared devices.

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When used with other components this device stabilizes open and/or unstable fractures of long bones including intracapsular, intertrochanteric, supracondylar, or condylar. It is also used for joint fusions and limb lengthening of deformity corrections which involve cutting the bone.

This device is the ring component of an external fixation device. Pin/wire clamps and distractors are attached to the ring to complete a rigid construct utilized to stabilize long bone fractures or in limb lengthening or correction of bony deformities. These rings are fabricated from two beryllium-aluminum alloy rings encased in an injection-molded polycarbonate plastic.

The provided text describes a 510(k) premarket notification for a medical device called an "External Fixation Ring." This submission is for a new device claiming substantial equivalence to existing predicate devices. However, this submission does not include any information about acceptance criteria or a study proving device performance in the context of an AI/ML-driven medical device.

The document details:

• Device Name: External Fixation Ring
• Submitter: RIGID FX Orthopedics, Inc.
• Classification: Single/multiple component metallic bone fixation appliances and accessories (21 CFR section 888.3030)
• Description: Ring component of an external fixation device, made of two beryllium-aluminum alloy rings encased in injection-molded polycarbonate plastic.
• Intended Use: Stabilizes open and/or unstable fractures of long bones, joint fusions, and limb lengthening/deformity corrections.
• Technological Characteristics: Material (beryllium-aluminum alloy) differs from predicates (aluminum alloy or carbon fiber composite).
• Nonclinical Tests: "This device has similar load carrying capabilities as solid rings made of aluminum alloy." This is the only mention of performance testing, and it's a general statement, not a detailed study.
• Predicate Devices: Several external fixation systems are listed as equivalent devices.

Therefore, it is impossible to complete the requested table and answer the study-related questions as the provided input does not contain the necessary information. The submission mainly focuses on the device description, intended use, comparison to predicate devices, and a high-level statement about nonclinical testing for mechanical properties. There is no mention of an AI/ML component, acceptance criteria for an algorithm, or any study design/results related to software performance.

To answer the prompt, I would need a different type of document, specifically one that outlines a clinical or non-clinical study for an AI/ML-driven medical device, including its performance metrics and acceptance criteria.

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The intended use of the external fixation device is the same as that expressed in the predicate device 510k.

The intended use of the external fixator is unilateral external fixation, device which is intended for use in the treatment of bone conditions including limb lengthening, osteotomies, arthrodesis, fracture fixation and other bone conditions amenable to treatment by use of the external fixation modality.

The external fixator like the predicate device includes various size frames, bars, pin clamps, pins, accessories and instruments. The pin clamps enable the frame to be coupled to bone by securing the pins for the intended use. The various components within the system are provided to accommodate various anatomies and injuries.

This is a 510(k) premarket notification for an external fixator device, which is a hardware device. The provided text is a regulatory submission for a medical device and does not contain information about software algorithms, AI, or performance studies in the context of digital health or AI/ML-enabled devices. Therefore, I cannot extract the requested information.

Here's why:

• Device Type: The document describes an "External Fixator," which is a physical, mechanical medical device used for orthopedic conditions. It is not a software device or an AI/ML system.
• Approval Process: The 510(k) summary explicitly focuses on demonstrating substantial equivalence to a predicate device (another external fixator) based on similar design characteristics and intended use. This is a common pathway for traditional medical devices.
• Missing Information: The document does not discuss:
  • Acceptance criteria related to AI/ML performance metrics (e.g., sensitivity, specificity, AUC).
  • Any study involving a "test set," "training set," "ground truth," "experts," "adjudication," or "human readers."
  • "Multi reader multi case (MRMC) comparative effectiveness study" or "standalone performance."

In summary, the provided text is for a physical medical device and does not contain the kind of information requested about AI device performance studies.

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