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The Grappler Suture Anchor PCFD Tether System is intended for the fixation of soft tissue to bone including:

Foot/Ankle: Medial Stabilization (Deltoid and Spring Ligament Repair for addressing Progressive Collapsing Foot Deformity), Hindfoot Repair (Correction of Peritalar Subluxation/Dislocation, Hindfoot Valgus Deformity or Subfibular Impingement for Addressing Progressive Collapsing Foot Deformity), Interosseous Talocalcaneal Ligament Repair to address Progressive Collapsing Flatfoot Deformity

The Grappler Suture Anchor PCFD Tether System consists of suture anchors, suture, and the accompanying instrumentation for the intended use of soft tissue damage repair. The subject PCFD Tether line extension consists of two PEEK suture anchors connected by UHMWPE suture. The talar anchor diameter is ⌀4.5mm and the calcaneal anchor diameter is ⌀3.5mm, the length of each anchor is 12mm. The suture tape is a doubled-over USP 2 equivalent tape. The implant construct comes pre-loaded on two inserter handles. Device specific drill guides are provided for tunnel creation.

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The Monkey Rings™ External Fixation System is intended to be used in adults and 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 Monkey Rings External Ring Fixation System is intended to treat the following patient indications in pediatric patients and adults for the treatment and fixation of:

• Open and closed fractures
• 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, infected union, non-union, or malunion of long bones
• Limb lengthening by epiphyseal, diaphyseal, or metaphyseal distraction
• Correction of bony or soft tissue deformity (e.g., orthoplastic surgery)
• Correction of segmental bony or soft tissue defects
• Joint arthrodesis
• Management of comminuted intra-articular fractures
• Bone transport

The Monkey Rings External Ring Fixation System is indicated in adults for:

• Osteotomy
• Revision procedure where other treatments or devices have been unsuccessful
• Bone reconstruction procedures
• Fusions and replantations of the foot
• Charcot foot reconstruction
• Offloading and/or immobilization of ulcers and/or wounds of the foot and ankle
• Lisfranc dislocations
• Ankle distraction (arthrodiastasis)
• Septic fusion

The Monkey Rings External Ring Fixation System is a modular, ring-based external fixation system intended for the treatment and fixation of a variety of orthopedic conditions in pediatric and adult patients. The system is designed to stabilize bone segments during fracture management, deformity correction, or limb lengthening procedures. It consists of multiple components, including rings, connecting rods, struts, bolts, fasteners, clamps, plates, pins, and Kirschner wires (K-wires), which can be assembled in various configurations to provide either static fixation or gradual adjustment of bone position. The modular design allows surgeons to tailor the construct to meet specific anatomical and clinical needs.

The subject components included in this submission are the Universal Joint Struts and updated sterilization parameters for the system. The Universal Joint Strut is a newly introduced component designed to allow precise modification of strut length and controlled repositioning of the fixation rings over time. Its universal joint mechanism provides enhanced angular flexibility, enabling improved intraoperative adjustability and postoperative frame modification while maintaining structural stability and fixation integrity. All other components of the Monkey Rings External Ring Fixation System, including rings, connecting rods, and associated fixation hardware, were previously cleared and remain unchanged in design and function.

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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 APEX 3D™ Total Ankle Replacement System is indicated as a total ankle replacement in primary surgery for patients with ankle joints damaged by severe rheumatoid, post traumatic, or degenerative arthritis. Revision surgery for these patients is also indicated for patients with sufficient bone stock present. In the United States, components are intended for cemented use only.

The APEX 3D Total Ankle Replacement System has been cleared under K192994. The purpose of this submission is to introduce a new diffusion bonded talar dome to the APEX 3D Total Ankle Replacement System. The APEX 3D Total Ankle Replacement System is a cemented, fixed-bearing device comprised of a tibial component, a talar component, and a UHMWPE component used for ankle joint replacement. Based on patient anatomy, a number of component sizes and design configurations can be selected for best fit.

The provided document is an FDA 510(k) clearance letter for the APEX 3D Total Ankle Replacement System. This document does not describe AI/ML-driven medical devices or related acceptance criteria studies.

The 510(k) summary explains that the submission is to introduce a new diffusion-bonded talar dome to an already cleared total ankle replacement system. The performance testing described is focused on the physical and mechanical properties of the implant materials and manufacturing processes, such as:

• Porous Structure Characterization
• Diffusion Bonded Tensile Strength
• Diffusion Bonded Static Shear Strength
• Diffusion Bonded Fatigue Shear Strength
• Diffusion Bonded Abrasion Resistance
• Metallurgical Analysis
• Accelerated Corrosion Soak

The document explicitly states: "Clinical data are not needed to support the safety and effectiveness of the subject device."

Therefore, I cannot provide the information requested in your prompt regarding acceptance criteria and studies for an AI/ML-driven device, as this document pertains to a mechanical orthopedic implant, not an AI/ML product.

To answer your request, I would need a different source document that details the performance study of an AI/ML-driven medical device.

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The Monkey Bars Pin to Bar External Fixation System is intended to be used in adult and pediatric patients (specifically, children and adolescents aged 2 through 21 years) for provisional fixation of open and/or unstable fractures in the lower and upper extremities and pelvis. It may also be used for temporary fixation of peri-articular or intra-articular fractures. Additionally, the device can be used on fractures where soft tissue injury or an infected fracture site may preclude the use of other fracture fixation treatments.

The device is used for the external stabilization of bone fractures. It consists of: Carbon fiber composite bars, 11mm diameter by 150mm to 500mm lengths, titanium combination clamp, aluminum 5 & 8 hole multi-pin clamps, aluminum straight and 30 degree angled posts, stainless steel 3mm, 4mm and 5mm thread diameter pins with 5mm diameter shanks that come in blunt tip and self tapping with 125mm through 230mm overall lengths and 20mm through 65mm thread lengths, stainless steel transfixing pin with 5mm shank, 7.2mm thread diameter, and 325mm overall length, and stainless steel instruments for implantation. The pins are implanted into bone and then they are connected using the clamps, rods and posts to form a rigid construct which holds the bone fragments rigidly in place. The pins are offered in various lengths and thicknesses.

The provided text describes the "Monkey Bars Pin to Bar External Fixation System" and its substantial equivalence to predicate devices, but it does not contain information about the acceptance criteria or a study proving that an AI/software device meets these criteria.

Instead, the document is a 510(k) summary for a physical medical device (an external fixation system), and it focuses on demonstrating substantial equivalence to legally marketed predicate devices through performance testing, primarily mechanical testing, rather than a clinical study or AI/software validation.

Therefore, I cannot provide the requested information in the format given, as the input document does not contain details about:

1. A table of acceptance criteria and the reported device performance for an AI/software device. The "Performance Testing" section mentions "Minimal Construct Static Compression Testing" and "predetermined acceptance criteria or were otherwise considered acceptable," but it doesn't quantify these criteria or results in a table for an AI system.
2. Sample size used for the test set and data provenance for an AI/software device.
3. Number of experts and qualifications for establishing ground truth for an AI/software device.
4. Adjudication method for an AI/software device.
5. Multi-reader multi-case (MRMC) comparative effectiveness study.
6. Standalone (algorithm-only) performance.
7. Type of ground truth used (expert consensus, pathology, outcomes data, etc.) for an AI/software device.
8. Sample size for the training set for an AI/software device.
9. How the ground truth for the training set was established for an AI/software device.

The document explicitly states: "Clinical data are not needed to support the safety and effectiveness of the subject device." This further confirms that the provided text is not about an AI/software device's clinical performance.

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The Phantom Fibula Nail System is intended for use in the fixation of fibular fractures and osteotomies.

The Phantom Fibula Nail System consists of nails, screws, and accessories for the intended use of fibula repair. The implants are provided in multiple sizes and lengths.

This FDA 510(k) summary does not contain information about the acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML device, as the Phantom Fibula Nail System is a physical medical device (intramedullary fixation rod) and not an AI/ML product.

Therefore, the requested information components (1 through 9) related to AI/ML device performance, ground truth, and study design are not applicable to this document. The document describes the substantial equivalence of the physical device to a predicate device through performance testing of the device components (e.g., ASTM F1264 for nails, ASTM F543 for screws, ASTM F1875 for corrosion).

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The APEX 3D Total Ankle Replacement System is indicated as a total ankle replacement in primary surgery for patients with ankle joints damaged by severe rheumatoid, post-traumatic, or degenerative arthritis. Revision surgery for these patients is also indicated for patients with sufficient bone stock present. In the United States, components are intended for cemented use only.

The APEX 3D Total Ankle Replacement System is a cemented, fixed-bearing device comprised of a tibial component, a talar component, and a UHMWPE component used for ankle joint replacement. Based on patient anatomy, a number of component sizes and design configurations can be selected for best fit.

The provided document is a 510(k) summary for a medical device (APEX 3D Total Ankle Replacement System), which focuses on demonstrating substantial equivalence to a predicate device. It addresses the device's indications for use, description, and the performance testing conducted to assure substantial equivalence.

However, the document does NOT contain information related to software or AI device performance, acceptance criteria, or ground truth establishment relevant to the questions asked about AI/software validation.

Therefore, I cannot extract the requested information from the provided text. The document explicitly states:

• "Clinical data are not needed to support the safety and effectiveness of the subject device." This indicates that there was no clinical study, including any involving AI or human readers, performed for this submission.
• The tests listed are all non-clinical performance tests on the physical components of the ankle replacement system (e.g., fatigue, material characterization, micromotion, magnetic resonance compatibility). None of these involve software or AI performance metrics.

To answer your request, if this were an AI/software device submission, the acceptance criteria and study details would typically involve metrics like sensitivity, specificity, AUC, human reader performance studies (MRMC), ground truth assessment by experts, sample sizes for training and testing, and adjudication methods. None of this information is present in the provided document.

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