Search Results

The Cannulated Screws Neoortho are generally intended for fracture fixation of various bones and bone fragments, such as femoral neck, intercondylar femoral, malleolus, pilon tibial, calcaneus, talus, tibial plateau, tarsal, metatarsal, wrist, metacarpal, carpal, scaphoid and radius fracture. The Cannulated Screws Neoortho are also intended for fixation arthrodesis, iliosacral dislocations, and hallux valgus corrections. Accessories implants: The washer is used to increase bone contact area for distributing the forces/load and prevent the screw head from sinking into the bone.

The Neoortho Cannulated Screws include nine cannulated screw specifications and associated washers, which are manufactured from stainless steel and titanium alloy. The cannulated screw is a self-tapping screw with a cancellous or cortical thread that can be guided into a position via a guided wire. They are used to aid in the alignment and stabilization of fractures to the skeletal system.

The technological characteristic of the Neoortho Cannulated Screws are similar to the predicate devices including design, dimensions, and materials. The Neoortho cannulated screws and washers are fabricated from stainless steel per ASTM F138 and Ti-6Al-4V alloy per ASTM F136. The stainless steel and Ti-6Al-4V are commonly used material in orthopedic implants.

The provided text describes a 510(k) premarket notification for "Cannulated Screws Neoortho" and details the non-clinical tests performed to demonstrate substantial equivalence to predicate devices. It does not contain information about an AI device or details relating to acceptance criteria and studies typically associated with AI/ML medical devices. The document focuses on mechanical and sterilization properties for an orthopedic implant.

Therefore, I cannot provide an answer based on the prompt's request for AI device acceptance criteria, performance, and study details like sample size for test/training sets, expert qualifications, or MRMC studies.

Ask a specific question about this device

Intramedullary Nail and Screws for Femur - NEONAIL is indicated for femoral fracture fixation including:

• · Open and closed femoral fractures;
• · Pseudoarthrosis and correction osteotomy;
• · Pathologic fractures, impending pathologic fractures, and tumor resections;
• · Ipsilateral femur fractures;
• · Fractures distal to the hip joint; and
• Nonunions and malunions.

Intramedullary Nail and Screws for Tibia - NEONAIL is intended to provide temporary stabilization of various types of fractures, malunions or nonunions of the tibia. Intramedullary Nail and Screws for Tibia - NEONAIL is indicated for tibial fracture fixation, which may include:

• · Open and closed tibial fractures;
• · Pseudoarthodlosis and correction osteotomy;
• · Pathologic fractures, impending pathologic fractures and tumor resections; and
• · Nonunions and malunions.

The Intramedullary Nail and Screws for Humerus – NEONAIL is intended to provide temporary stabilization of various types of proximal and/or diaphyseal fractures of the humerus. Types of fractures include nonunions, malunions, malalignments, pathological fractures, and impending pathological fractures. Examples of specific indications include: AO classification Type A fractures, dislocated; AO classification Type B fractures, dislocated; AO classification Type C fractures with intact calotte; and humeral fractures according to the Neer Classification.

An intramedullary nail is a metal rod implanted into the medullary cavity of a bone to treat fractures that occur in long bones of the body. Intramedullary Nail and Screws – NEONAIL consists of metal rods, bone screws, and end caps. All components are made from Ti-6AI-4V alloy. The rods are cannulated and are provided with screw holes to accommodate screws of various diameters and lengths. The rods are available in a range of sizes used for specific anatomic locations and fracture configurations.

The document describes the device Intramedullary Nail and Screws - NEONAIL, which is an orthopedic implant for fracture fixation.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

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

Study Proving Acceptance Criteria:

The study proving the device meets the acceptance criteria is a non-clinical study focusing on engineering analysis, dimensional analysis, and mechanical testing. The core strategy is demonstrating substantial equivalence to legally marketed predicate devices.

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

• Sample Size: The document does not specify a numerical sample size for the mechanical testing of each individual nail or screw type. It refers to testing the "worst case nail for each indication" and "worst case screws available." This implies a selection of representatives rather than a broad statistical sample of every product variant.
• Data Provenance: The document does not explicitly state the country of origin or whether the data is retrospective or prospective. Given it's a non-clinical engineering and mechanical testing study, "retrospective" or "prospective" as typically applied to patient data is not directly applicable. The data would have been generated in a controlled laboratory setting.

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

This section is not applicable. The study is a non-clinical, engineering-focused evaluation. "Ground truth" in the context of expert consensus, pathology, or outcomes data is relevant for clinical or diagnostic device studies, not for the mechanical performance testing of an orthopedic implant. The "truth" here is determined by adherence to engineering standards (ASTM F1264, ASTM F543) and equivalence to predicate devices, which is evaluated by regulatory bodies based on submitted technical data.

4. Adjudication method for the test set

This section is not applicable. Adjudication typically refers to the process of resolving discrepancies among experts in clinical data review. For mechanical testing, the results are typically quantitative and objective measurements against defined standards, not subjective interpretations 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

This section is not applicable. The device is an orthopedic implant (intramedullary nail and screws) used for fracture fixation, not a diagnostic or AI-driven imaging device. Therefore, MRMC studies involving human readers and AI assistance are irrelevant to this device.

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

This section is not applicable. The device is a physical medical implant, not an algorithm or software. Therefore, the concept of "standalone algorithm performance" does not apply.

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

The "ground truth" for this non-clinical study is defined by:

• Established engineering standards: Specifically ASTM F1264 (for intramedullary fixation devices) and ASTM F543 (for metallic bone screws). The device's performance is compared against the performance of predicate devices which are presumed to meet these standards.
• Predicate device characteristics: The critical "truth" is that the Intramedullary Nail and Screws - NEONAIL performs sufficiently similarly to and is materially and structurally equivalent to the identified predicate devices (Howmedica Osteonics Corp. T2 Femoral Nail, Stryker T2 Femoral Nail, Stryker Trauma AG T2 Tibial Nailing System, Howmedica Osteonics Corp. T2 Proximal Humeral Nail, Howmedica Osteonics Corp. T2 Nailing System) to be considered substantially equivalent by the FDA.

8. The sample size for the training set

This section is not applicable. Since this involves mechanical testing and not machine learning or AI, there is no "training set."

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

This section is not applicable as there is no "training set."

Ask a specific question about this device

The PEEK Cage for the Vertebral Spine NeoSpace PLIF, TLIF, and ALIF devices are indicated for spinal fusion procedures at one or two contiguous levels from L2-S1, in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have Grade 1 Spondylolisthesis at involved levels. Patients must have undergone a regimen of six months of non-operative treatment prior to treatment in the lumbar spine. The PLIF devices may be used singularly or in pairs. All lumbar devices are to be used with supplemental fixation cleared for use in the lumbar spine.

The Cervical devices are indicated for spinal fusion procedures at one level in the cervical spine from C3 to T1 for the treatment of cervical disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). Patients must have undergone a regimen of six weeks of non-operative treatment prior to treatment in the cervical spine. One cervical device is used per intervertebral space. All cervical devices are to be used with supplemental fixation cleared for use in the cervical spine.

All lumbar and cervical devices are intended for use with autogenous bone graft.

The PEEK CAGE FOR THE VERTEBRAL SPINE NEOSPACE is an intervertebral body fusion device that is implanted into the vertebral body space to improve stability of the spine while supporting fusion. Components are offered in a variety of shapes and sizes to meet the requirements of the individual patient anatomy. Components are manufactured from PEEK -Optima (per ASTM F2026).

The provided document describes a medical device called the "PEEK CAGE FOR THE VERTEBRAL SPINE NEOSPACE," an intervertebral body fusion device. The document focuses on establishing substantial equivalence for this device to legally marketed predicate devices, primarily through performance testing.

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

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document states that testing was performed on "worst case subject devices." However, it does not specify the exact number (sample size) of devices tested for each performance test.
• Data Provenance: The document does not specify the country of origin of the data or whether the tests were retrospective or prospective. It only mentions the submitter is from Brazil.

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

This information is not applicable as the study described is a mechanical performance study of a device, not an AI or diagnostic study requiring expert ground truth for interpretation of outcomes. The 'ground truth' for this type of study is the physical measurement against established ASTM standards and comparison to predicate devices.

4. Adjudication Method for the Test Set

This information is not applicable for a mechanical performance study. Adjudication methods are typically used in clinical or diagnostic studies to resolve discrepancies in expert interpretations or assessments.

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

• No, an MRMC comparative effectiveness study was not mentioned or conducted. This type of study is relevant for evaluating the impact of AI on human reader performance in diagnostic tasks, which is not the nature of this submission.
• Effect Size: Not applicable.

6. Standalone (Algorithm Only) Performance Study

• No, a standalone performance study (algorithm only without human-in-the-loop performance) was not done. This submission is for a physical medical implant, not an algorithm or AI system.

7. Type of Ground Truth Used

The ground truth for this mechanical performance testing is based on established engineering standards (ASTM F2077 and ASTM F2267) and comparison to the performance of legally marketed predicate devices. It is not expert consensus, pathology, or outcomes data in the typical sense for a diagnostic device.

8. Sample Size for the Training Set

This information is not applicable. The study is a mechanical performance test for a physical medical device, not an AI algorithm that requires a training set.

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

This information is not applicable as there is no training set mentioned or required for this type of device submission.

Ask a specific question about this device

Small and Large Fragments Osteosynthesis System NEOFIX is intended for small and large bone fracture fixation, arthrodesis and osteotomy fixation. Examples include: fractures of the clavicle, scapula, humerus, olecranon, radius, ulna, carpals, metacarpals, distal femur, proximal tibia, tibial pilon, fibula, calcaneus, tarsals and metatarsals; small fragments of the hand and wrist; pelvis and acetabulum fractures; periprosthetic fractures; metatarsal and phalangeal osteotomies; and carpal, metacarpal, wrist and ankle arthrodesis. The use of locking plate/screw systems is suited for treatment of fractures in osteopenic bone. This system is not indicated for use in the spine.

NEOFIX consists of plates and screws in a variety of designs and sizes and made from commercially pure titanium or Ti-6Al-4V alloy. Plates are provided in straight designs and in various geometric configurations that are commonly used in trauma and reconstructive surgery. Plates are provided with screw holes to accommodate non-locking and locking screws designs. Screws are provided in cortical (locking and non-locking) and cancellous thread designs in various diameters and lengths.

The provided text describes a 510(k) summary for a medical device called "Small and Large Fragments Osteosynthesis System NEOFIX". This type of submission focuses on demonstrating substantial equivalence to pre-existing devices rather than independent performance validation against pre-defined acceptance criteria in a clinical study. Therefore, most of the requested information about acceptance criteria, study design, and ground truth establishment is not applicable in this context.

Here's a breakdown of the available information:

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

• Acceptance Criteria: Not explicitly stated as performance metrics in a clinical study. The acceptance criteria for a 510(k) submission are primarily to demonstrate substantial equivalence to predicate devices. This is achieved through comparisons of intended use, technological characteristics, materials, design, packaging, and sterilization methods.
• Reported Device Performance:
  • Demonstrated through engineering analysis and mechanical testing.
  • Standards referenced: ASTM F382 (Standard Specification for Osteosynthesis Plates) and ASTM F543 (Standard Specification for Metallic Medical Bone Screws).
  • Conclusion from testing: "Any differences in the technological characteristics do not raise new issues of safety or efficacy."
  • Overall similarities to predicates: Same intended use, operating principle, basic design, similar materials, similar packaging and sterilization.

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

• Not applicable. This was not a clinical study involving a test set of patient data. Performance was evaluated through mechanical testing of the device components.

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

• Not applicable. There was no ground truth derived from expert consensus on patient data.

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

• Not applicable. There was no adjudication of clinical outcomes or expert readings.

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

• Not applicable. This device is an orthopedic implant (plates and screws), not an AI-assisted diagnostic tool.

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

• Not applicable. This device is a physical implant, not an algorithm.

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

• Not applicable. The "ground truth" equivalent for this type of submission is adherence to established engineering standards (ASTM F382, ASTM F543) and demonstrable equivalence to predicate devices, rather than clinical outcomes or diagnostic accuracy.

8. The sample size for the training set:

• Not applicable. This device does not involve a training set as it is not an AI/machine learning product.

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

• Not applicable. As above, no training set was used.

Ask a specific question about this device

Mini and Micro Fragments Reconstruction System – NEOFACE is intended for use in selective trauma of the midface, maxillofacial surgery, reconstructive procedures, and selective orthognathic surgery of the maxilla, mandible and chin.

Mini and Micro Fragments Reconstruction System – NEOFACE is a fixation system for use in selective trauma of the midface, maxillofacial surgery, reconstructive procedures, and selective orthognathic surgery of the maxilla, mandible and chin. It consists of implant plates and implant screws. The plates of the subject system include mini and micro fragment reconstruction plates. Plates are made of commercially pure titanium and screws are made of titanium alloy.

The provided text describes a medical device, the "Mini and Micro Fragments Reconstruction System - NEOFACE," and its 510(k) summary for FDA clearance. However, it does not contain information about acceptance criteria or a specific study proving the device meets those criteria in the context of an AI/algorithm-based system.

The document is a traditional 510(k) submission for a physical medical implant system (plates and screws) and primarily focuses on demonstrating substantial equivalence to predicate devices through design principles, materials, technological characteristics, and mechanical testing.

Therefore, many of the requested bullet points, particularly those related to AI/algorithm performance (e.g., sample sizes for test/training sets, ground truth establishment, MRMC studies, standalone performance), cannot be extracted from this document as they are not applicable to the type of device described.

Here's what can be extracted based on the provided text, with explanations where information is missing or not applicable:

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

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

• Not Applicable. This document describes mechanical testing of physical implants, not a "test set" in the context of an AI/algorithm. Mechanical testing generally involves predefined samples of the manufactured devices. The provenance of the testing (e.g., where the tests were conducted) is not specified beyond "NEOORTHO PRODUTOS ORTOPÉDICOS S/A" being located in Brazil.

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" in the context of expert consensus or pathology is relevant for diagnostic algorithms. For mechanical testing, the "ground truth" is established by the standardized test methods (ASTM F382 and F543) and the physical properties of the materials and device design. The "experts" involved would be engineers or technicians performing the tests, but their specific number or qualifications are not detailed here, as it's typically understood to be standard practice for such testing.

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

• Not Applicable. Adjudication methods are used in studies involving human interpretation or subjective assessment. Mechanical testing relies on objective measurements according to standardized protocols, not 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. An MRMC study is not mentioned as this is a physical medical device, not an AI or imaging diagnostic tool.

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

• No. This is not an algorithm-based device.

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

• The "ground truth" for this device revolves around the physical and mechanical properties of the materials and the manufactured implants, as evaluated against established ASTM standards (F382 for plate bending, F543 for screw torsional strength, breaking angle, and axial pullout strength).

8. The sample size for the training set

• Not Applicable. There is no "training set" as this is not an AI/algorithm device.

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

• Not Applicable. There is no "training set" and therefore no ground truth to be established for it.

Ask a specific question about this device