Search Results

AFFINITY Proximal Tibia System is intended to treat fractures, nonunions of the proximal tibia including simple, comminuted, lateral wedge, depression, medial wedge, bicondylar combination of lateral wedge and depression, periprosthetic, and fractures with associated shaft fractures.

• · Simple metaphyseal fractures (Classification AO 41-A2)
• · Multifragmentary metaphyseal fractures (Classification AO 41-A3)
• · Simple bicondylar fractures (Classification AO41-C1, 41-C2)
• Multifragmentary bicondylar fractures (Classification AO 41-C3)
• · Simple joint, simple metaphyseal fractures (Classification AO 41-C1)
• · Diaphisary fractures (Classification AO 42A and 42B)

AFFINITY Proximal Tibia System consists of anatomical plates and screws for the placement of the proximal tibial condyles, improving the restoration of the original structure. Similarly, in combination with the variable angle technique, it allows for the placement of screws in different configurations providing appropriate support for the correct healing of fractures.
AFFINITY Proximal Tibia System consists of pre-contoured bone fixation plates and screws. The plates are made from biocompatible commercially pure titanium grade 4 according to ISO 5832-2 and ASTM F67 standard. The screws are made from biocompatible titanium alloy (Ti6Al4V) according to ISO 5832-3 and ASTM F136 standard.
The AFFINITY Proximal Tibia System plates can be fixed with variable angle technique.

The provided text is an FDA 510(k) summary for the AFFINITY Proximal Tibia System. This document describes a medical device (a bone plate and screw system for tibial fractures) and its claim of substantial equivalence to existing predicate devices.

Crucially, the document states that "Clinical testing was not necessary for the substantial equivalence determination." This means that the device's acceptance criteria and the proof it meets them do NOT involve human clinical studies or AI-driven performance metrics such as accuracy, sensitivity, specificity, or human-in-the-loop improvements.

Therefore, I cannot fulfill the request to describe the acceptance criteria and study that proves the device meets the acceptance criteria in the context of AI/machine learning performance. The provided text details non-clinical performance testing for a medical implant, focusing on mechanical, biocompatibility, and sterilization aspects.

Here's why I cannot provide the requested information based on the given text:

• No AI or algorithm present: There is no mention of any AI component, algorithm, or software in the device description or its testing.
• No clinical performance data (e.g., accuracy, sensitivity): The document explicitly states "Clinical testing was not necessary." The performance testing described is mechanical (bend, torsion, pullout strength), biocompatibility, and sterilization, which are relevant for physical implants, not AI diagnostic or assistive devices.
• No human reader studies (MRMC): Since no AI is involved, there are no studies assessing how human readers improve with AI assistance.
• No ground truth establishment for diagnostic performance: The "ground truth" mentioned in your prompt (expert consensus, pathology, outcomes data) is typically for validating diagnostic or classification algorithms. For a bone plate, ground truth relates to its mechanical integrity and biological safety, which were assessed through laboratory tests.

In summary, the provided document describes the regulatory approval of a physical medical device (a bone plate and screw system) through established non-clinical testing and comparison to predicates, not the validation of an AI/ML medical device.

If you have a document describing an AI/ML medical device's performance study, I would be happy to analyze it according to your detailed criteria.

Ask a specific question about this device

The Synthes 2.7/3.5mm Variable Angle LCP Ankle Trauma System is intended for fixation of the ankle in adults and adolescents (12-21) in which the growth plates have fused, and particularly in osteopenic bone. Specifically,

• Anterolateral Distal Tibia Plates are intended for fixation of osteotomies, fractures, nonunions, malunions, and replantations of bones and bone fragments of the diaphyseal and metaphyseal regions of the distal tibia.
• Medial and Anteromedial Distal Tibia Plates are intended for fixation of osteotomies, fractures, nonunions, malunions, and replantations of bones and bone fragments of the diaphyseal and metaphyseal regions of the distal tibia,
• Distal Tibia T Plates and Distal Tibia L Plates are intended to buttress partial articular fractures and bone fragments of the distal tibia, and
• Lateral Distal Fibula Plates are intended for fixation of osteotomies, fractures, nonunions, malunions, and replantations of bones and bone fragments of the diaphyseal and metaphyseal regions of the distal fibula.

The Synthes Anterolateral Distal Tibia Plates are intended to treat fractures of the distal tibia. These plates can be used with a new screw configuration, 3.5mm VA Locking Screws. The Anterolateral Distal Tibia Plates and 3.5mm VA Locking Screws will be offered in both stainless steel and titanium alloy (TAN), and in both sterile and non-sterile configurations. The Anterolateral Distal Tibia Plates will be offered in left and right configurations. The system accepts existing cortical screws, locking screws, dynamic locking screws, and metaphyseal screws (K100776, K063049, K112583, K000684, K111230, K120070, K110592, and K043185) as well as new 3.5mm VA Locking Screws, and allows for both dynamic compression and locking through Combi holes.

This is a 510(k) premarket notification for a medical device, specifically the Synthes 2.7/3.5mm Variable Angle LCP Ankle Trauma System - Anterolateral Distal Tibia Plates.

This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than providing clinical safety and efficacy data. Therefore, the information you're requesting regarding acceptance criteria, study details, expert review, and ground truth establishment, which are typical for studies validating AI/ML diagnostic devices, are not present in this document. This submission focuses on engineering analysis and comparison to existing, already approved devices.

Here's why your specific questions cannot be answered from this document:

• This is not an AI/ML device. The device is a physical bone fixation system (plates and screws). Therefore, concepts like "device performance" in terms of classification metrics (sensitivity, specificity), "test sets," "training sets," "ground truth" (in the context of expert consensus or pathology for diagnostic accuracy), or "MRMC studies" are not applicable.
• 510(k) is about substantial equivalence. The primary way this device met its acceptance criteria was by demonstrating that it is "at least as strong as" and has similar indications, design, materials, and performance characteristics as previously cleared predicate devices.

However, I can extract information related to the device and its "proof" of meeting requirements based on the document provided:

1. Table of Acceptance Criteria and Reported Device Performance:

Regarding the other points, as explained, they are not applicable or not provided in this 510(k) submission for a physical implantable device:

2. Sample size used for the test set and the data provenance: Not applicable. Performance was demonstrated through engineering analysis and fatigue testing, not a "test set" of clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No "ground truth" was established by experts for a diagnostic assessment.
4. Adjudication method for the test set: Not applicable.
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 not an AI-assisted device.
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: Not applicable. The "ground truth" equivalent here would be established engineering standards for strength and fatigue, against which the device was tested.
8. The sample size for the training set: Not applicable. No "training set" for an algorithm.
9. How the ground truth for the training set was established: Not applicable.

In summary, this 510(k) relied on demonstrating substantial equivalence through a comparison of indications, design, materials, and engineering performance (mechanical strength) to already approved predicate devices. It did not involve clinical studies or expert evaluations of diagnostic accuracy as would be the case for AI/ML diagnostic software.

Ask a specific question about this device

The Synthes Variable Angle LCP Ankle Trauma System is intended for fixation of the ankle in adults and adolescents (12-21) in which the growth plates have fused, and particularly in osteopenic bone. Specifically, Medial and Anteromedial Distal Tibia Plates are intended for fixation of osteotomies, fractures, nonunions, malunions, and replantations of bones and bone fragments of the diaphyseal and metaphyseal regions of the distal tibia Distal Tibia T Plates and Distal Tibia L Plates are intended to buttress partial articular fractures and bone fragments of the distal tibia, and Lateral Distal Fibula Plates are intended for fixation of osteotomies, fractures, nonunions, malunions, and replantations of bones and bone fragments of the diaphyseal and metaphyseal regions of the distal fibula.

The Synthes Variable Angle LCP Ankle Trauma System contains plates that are intended to treat fractures of the ankle, and includes multiple plate types to accommodate different fracture patterns and patient anatomy. Two new screw configurations are included in the Synthes Variable Angle LCP Ankle Trauma System; 2.7mm metaphyseal screws and 3.5mm VA Locking Screws. Specifically, the following plates and screws are included in the Synthes Variable Angle LCP Ankle Trauma System: • Medial and Anteromedial Distal Tibia Plates • Distal Tibia T Plates and Distal Tibia L Plates • Lateral Distal Fibula plate • 2.7mm Metaphyseal Screws • 3.5mm VA Locking Screws All of the plates will be offered in both stainless steel and titanium alloy (TAN), and in both sterile and non-sterile configurations. All of the plate configurations (with the exception of the Distal Tibia T plate, which is symmetrical), will be offered in left and right designs. The system accepts existing cortical and locking screws (i.e. K000684 and K043185) as well as new 3.5mm VA Locking Screws and 2.7mm Metaphyseal Screws, and allows for both dynamic compression and locking through Combi holes.

The provided text describes Synthes Variable Angle LCP Ankle Trauma System. This is a medical device and not an AI/ML algorithm. Therefore, many of the requested categories related to AI/ML performance and study design are not applicable.

Here's an analysis based on the available information:

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

For a medical implant like the Synthes Variable Angle LCP Ankle Trauma System, "acceptance criteria" are generally related to demonstrating substantial equivalence to predicate devices in terms of mechanical properties and biocompatibility. The summary details these as:

• New screws shown to be substantially equivalent to existing screws. |
  | Biocompatibility/Materials | - Plates offered in stainless steel and titanium alloy (materials commonly used and accepted for bone fixation). |
  | Design Characteristics | - Similar design characteristics to predicate Synthes Systems. |
  | Indications for Use | - Similar indications for use to predicate Synthes Systems (fixation of ankle fractures, osteotomies, nonunions, malunions, and replantations in adults and adolescents with fused growth plates, particularly in osteopenic bone). |

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

The information provided does not detail specific "test sets" in the context of clinical studies with human subjects for performance evaluation as would be done for an AI/ML device. The testing mentioned ("engineering analysis, static strength, and fatigue strength testing") refers to mechanical testing of the device components. The sample size for such mechanical tests would be the number of physical samples tested, but this is not provided in the 510(k) summary. The provenance would be the laboratory where the testing was conducted, but this is also not specified.

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)

This is not applicable as there is no "ground truth" derived from human experts for this type of mechanical device submission. The substantial equivalence is based on engineering and material science principles.

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

Not applicable. There is no clinical adjudication mentioned.

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 not an AI/ML device.

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

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

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

For this device, the "ground truth" for substantial equivalence is derived from:

• Established engineering principles (e.g., calculations of stress, strain).
• Material properties data for stainless steel and titanium alloys.
• Mechanical testing standards for orthopedic implants, which dictate how strength and fatigue are measured.
• Comparison to existing predicate devices and their known performance and safety profiles.

8. The sample size for the training set

Not applicable. This is not an AI/ML device, so there is no training set.

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

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

Ask a specific question about this device

The Synthes 3.5mm Low Profile Cortical Screws are intended for fixation of fractures, osteotomies, and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, tibia, calcaneous, femur, and fibula in adults, and in both 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 the screw fixation.

The 3.5mm Low Profile Cortical Screws are self-tapping, have either a stardrive or hexdrive recess, are manufactured from stainless steel and titanium and offered both sterile and non sterile. The self-tapping screws are available in lengths ranging from 10mm - 110mm and may be used independently or with any Synthes plate which accepts Synthes 3.5mm cortical screws. The low profile screw head is designed to minimize hardware prominence and the resultant potential for soft tissue irritation.

The Synthes 3.5mm Low Profile Cortical Screw is a bone fixation fastener. The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with acceptance criteria and results for the new device as an standalone product.

Therefore, the document does NOT contain information regarding:

• Acceptance criteria specified for the device's performance metrics.
• A formal study comparing the device's performance against defined acceptance criteria.
• Sample sizes for test sets, data provenance, number or qualifications of experts, or adjudication methods for ground truth.
• Multi-reader multi-case (MRMC) comparative effectiveness studies.
• Standalone algorithm performance.
• Ground truth types or how ground truth for training or test sets was established.

Instead, the submission addresses substantial equivalence based on design, intended use, fundamental product technology, materials, and geometric cross-sectional analysis comparing it to predicate devices.

Summary of Information directly from the document:

The provided document describes the Synthes 3.5mm Low Profile Cortical Screw and asserts its substantial equivalence to predicate devices (specifically, Synthes 3.5mm Cortex Screws, K043185).

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

This information is not provided in the document. The submission focuses on demonstrating substantial equivalence, not on acceptance criteria for novel performance metrics. The closest to "performance" mentioned is a "geometric cross sectional analysis" for comparison.

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

This information is not provided in the document. The submission does not describe a clinical performance study with a test set.

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):

This information is not provided in the document. The submission does not describe a clinical performance study involving ground truth established by experts.

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

This information is not provided in the document.

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 information is not applicable and not provided. This device is a bone fixation screw, not an AI-powered diagnostic tool.

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

This information is not applicable and not provided. This device is a bone fixation screw, not an algorithm.

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

This information is not provided in the document. The document refers to "geometric cross sectional analysis" for comparison, which does not involve a "ground truth" as typically defined for diagnostic device performance.

8. The sample size for the training set:

This information is not applicable and not provided. This device is a bone fixation screw, not a machine learning model.

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

This information is not applicable and not provided.

Substantial Equivalence Claim and Supporting Information:

The document states:
"Information presented supports substantial equivalence of the Synthes 3.5mm Low Profile Cortical Screw to the predicate devices. The proposed low profile screw has similar indications for use, is similar in design, incorporates the same fundamental product technology and is composed of the same materials."

Additionally, to support this claim:
"To additionally support substantial equivalence, geometric cross sectional analysis was conducted to compare the subject device to the predicate device with results supporting substantial equivalence."

Ask a specific question about this device

Cortical Screws are intended for fixation of fractures, osteotomies and nonunions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, tibia, calcaneous, femur and fibula.

Large Cannulated Screws (4.5mm diameter and larger) are intended for fracture fixation of large bones and large bone fragments. Diameters 6.5mm and larger are intended for large bones and large bone fragments such as femoral neck fractures; slipped capital femoral epiphyses; tibial plateau fractures; ankle arthrodeses; pediatric femoral neck fractures; intercondylar femur fractures; and subtalar arthrodeses.

Small Cannulated Screws (4.0mm diameter and smaller) are intended for fixation of fractures and non-unions of small bones and small bone arthrodeses. Examples include scaphoid and other carpal fractures, metacarpal and phalangeal fusions, osteotomies, and bunionectomies.

Cannulated screws are machined, metallic screws with a cannulation that are self drilling and self tapping, which can be guided into position by a guide wire.

Cortical and cancellous screws are machined, metallic screws and are self tapping.

All screws utilize a hex shaped recess that accepts a standard hex drive. Each type is offered in a variety of diameters and lengths, as well as short, medium, and fully threaded options.

Materials: The devices are manufactured from 316L Stainless Steel which meets ASTM F138 standards.

Function: Bone screws functions are to provide immediate stability and temporary fixation during the natural healing process.

The provided text is a 510(k) premarket notification for OrthoPediatrics Bone Screws. It primarily focuses on demonstrating substantial equivalence to previously marketed predicate devices rather than presenting a study against specific acceptance criteria for the new device's performance.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study that proves the device meets those criteria.

Key reasons for this include:

• 510(k) Premarket Notification Focus: A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective as a legally marketed device (predicate device) and does not require premarket approval (PMA). This is typically achieved by demonstrating "substantial equivalence," not by conducting new clinical studies or setting and meeting new performance acceptance criteria for the device itself.
• Lack of Performance Data: The document describes the device, its materials, function, and indications for use. It lists predicate devices. However, there is no mention of specific performance metrics (e.g., strength, durability, fatigue life, accuracy) for the OrthoPediatrics Bone Screws, nor any study data (sample sizes, ground truth, expert opinions) that would demonstrate the device meets such criteria.
• No Mention of AI/Algorithm: The context of "AI," "test set," "training set," "experts," "adjudication," "MRMC," and "standalone algorithm performance" strongly suggests a request related to an AI/Machine Learning device. The OrthoPediatrics Bone Screws are described as machined, metallic screws, which are physical hardware devices, not software or AI-driven systems.

In summary, this document is for a medical device (bone screws) seeking market clearance through substantial equivalence, and as such, it does not include performance studies with acceptance criteria in the manner described for software or AI-based diagnostic/assistive devices.

Ask a specific question about this device

The PERI-LOC Periarticular Locked Plating System can be used for adult and pediatric patients, as well as patients with osteopenic bone. PERI-LOC bones plates and screws are indicated for fixation of pelvic, small and long bone fractures, including those of the tibia, fibula, femur, pelvis, acetabulum, metacarpals, metatarsals, humerus, ulna, radius, calcaneus, and clavicle.

Components in the PERI-LOC™ Periarticular Locked Plating System are for single use only.

Hexalobular Bone Screws are line additions to the PERI-LOC™ Periarticular Locked Plating System cleared under K033669, K051735, K061352, and K993106. Like the predicate devices listed below, the subject components include various sizes of locking/non-locking Cortex and partially/fully threaded Cancellous bone screws made from stainless steel that are intended for use with locking bone plates for both the upper and lower extremity. The subject screws are designed for use with the PERI-LOC™ locking bone plates, which incorporate a screw-to-plate locking feature forming a locked, fixed angle construct to aid in holding fracture reduction.

This is a 510(k) premarket notification for a medical device called the PERI-LOC™ Periarticular Locked Plating System Hexalobular Bone Screws. These documents are generally used to demonstrate substantial equivalence to a predicate device, rather than to present a study demonstrating the device meets specific acceptance criteria in the way a clinical trial for a new drug or novel medical software would.

Therefore, the requested information about acceptance criteria and a study proving those criteria are met for this type of device submission is largely not applicable in the conventional sense of a clinical performance study. Instead, the "study" is a comparison to a predicate device and a demonstration that the new device shares similar technological characteristics, materials, and intended use as the legally marketed predicate.

Here's a breakdown based on the provided document:

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

• Acceptance Criteria: For this 510(k) submission, the "acceptance criteria" are primarily established by the features and performance of the predicate devices. The new device must demonstrate that its technological characteristics (design, materials, intended use) are substantially equivalent to these predicates and do not raise new questions of safety or effectiveness.
• Reported Device Performance: The document states that the PERI-LOC™ Hexalobular Bone Screws are "similar to legally marketed devices listed below in that they share similar indications for use, are manufactured from similar materials, and incorporate similar technological characteristics." This inherent similarity to the existing, cleared predicate devices is the "reported performance" for a 510(k) submission. Specific quantitative performance metrics (e.g., tensile strength, fatigue life) would have been part of the full submission, but are not detailed in this summary. However, the summary asserts that these characteristics are comparable.

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 in the context of a typical clinical trial. This submission relies on a comparison to existing predicate devices and likely includes in vitro mechanical testing data (which is not detailed in this summary). There is no mention of a "test set" of patients or data provenance in the way one would for an AI/software or drug trial. The "test" is the comparison to the predicate device's established performance and characteristics.

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. There is no "test set" requiring expert ground truth in the context of clinical interpretation for this orthopedic implant. The "ground truth" for showing substantial equivalence for this type of device largely comes from engineering specifications, material standards, and the known clinical performance and regulatory history of the predicate devices.

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

• Not applicable. No such adjudication method is mentioned or relevant for this type of medical device submission.

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 submission is for an orthopedic implant (bone screws), not an AI-assisted diagnostic device. Therefore, no MRMC study or evaluation of human reader improvement with AI assistance was performed or is relevant.

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

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

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

• For this device, the "ground truth" for demonstrating substantial equivalence includes:
  • Engineering specifications and material science: Demonstrating the new screws meet established standards for mechanical properties (e.g., strength, fatigue) comparable to the predicates.
  • Regulatory precedent: The predicate devices have already been deemed safe and effective by the FDA. The "ground truth" is that devices with similar characteristics have a history of safe and effective use.
  • Clinical experience with predicate devices: The established performance and safety profile of the predicate PERI-LOC systems.

8. The sample size for the training set

• Not applicable. This device submission does not involve a "training set" in the context of machine learning.

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

• Not applicable. As above, no training set for machine learning is involved.

Ask a specific question about this device