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The MAC External Fixation System is a unilateral external fixation device intended for use in children and adults in the treatment of bone conditions including leg lengthening, osteotomies, arthrodesis, fracture fixation, and other bone conditions amenable to treatment by use of the external fixation modality. The addition of the MAC Male Adapter does not change the indications for use for the MAC External Fixation System.

The purpose of this submission is to add a Male Adapter Assembly to the previously cleared MAC External Fixation System. The subject MAC Male Adapter Assembly is intended to attach to the existing MAC Module), and allows the MAC to connect to other external fixation components, including: Construx Female Telescoping Arm, Carbon T-clamp, the DFS Angular Hinge and the Carbon Ankle component. These connections allow the surgeon to treat a variety of bone conditions amenable to treatment by use of the external fixation modality.

The provided text describes a 510(k) summary for the "MAC External Fixation System," specifically regarding the addition of a "Male Adapter Assembly." The acceptance criteria and supporting evidence are related to the mechanical performance of this new component.

Here's a breakdown of the requested information based on the provided text:

Acceptance Criteria and Device Performance

Study Details

The study described is a mechanical testing study to demonstrate substantial equivalence, not a clinical study involving human patients or complex AI algorithms. Therefore, many of the requested fields are not applicable (N/A) in this context.

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

   • Sample Size: Not explicitly stated in terms of number of constructs tested, but it refers to "assemblies" of the MAC Male Adapter with aluminum and carbon components.
   • Data Provenance: N/A (Mechanical testing, not human data). The testing was conducted internally or by a testing facility as part of the regulatory submission.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A. Ground truth here refers to engineering specifications and performance benchmarks derived from predicate devices, not expert human interpretation.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: N/A. Mechanical testing results are objective measurements against defined criteria, not subjective interpretations requiring adjudication.

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: N/A. This is a mechanical device, not an AI-powered diagnostic tool.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: N/A. This is a hardware device; there is no algorithm involved.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The ground truth for performance was established by "pre-established acceptance criteria established by the predicate devices." This implies engineering specifications and performance benchmarks derived from similar, already approved external fixation systems.

7. The sample size for the training set: N/A. This refers to mechanical testing, not a machine learning model.

8. How the ground truth for the training set was established: N/A. No training set is applicable here. The "ground truth" for the mechanical tests was based on performance criteria derived from predicate devices.

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The Biomet Forerunner™ Plating System is used for adult or pediatric patients as indicated for pelvic, small and long bone fracture fixation of bones that have been surgically prepared (osteotomy) for correction of deformity or arthrodesis. Indications for use include internal fixation of the tibia, fibula, femur, metacarpals, metatarsals, humerus, ulna, radius, middle hand, and middle foot bones. This 510(k) expands the indications for use to the forefoot, and adds specific indications for midfoot/forefoot procedures:

1. Treatment of fractures and fracture-dislocations of the midfoot/forefoot
2. Malunions
3. Non-unions
4. Joint fusions/arthrodesis
5. Corrective osteotomies for deformities
   These procedures in the midfoot/forefoot may be indicated as a result of trauma, deformity, osteoarthritis, and rheumatoid arthritis.

The Biomet Forerunner" Plating System is an internal fixation system consisting of various sized plates and screws. The plates and screws are fabricated from Ti-6Al-4V.

The provided text describes a 510(k) premarket notification for the Biomet Forerunner Plating System, which is a metallic bone fixation device. This specific submission expands the indications for use of the system to include the forefoot and adds specific midfoot/forefoot procedures.

However, the document is a regulatory submission describing a device and its intended use, rather than a study evaluating its performance against specific acceptance criteria. The FDA's review concludes that the device is "substantially equivalent" to predicate devices, meaning it does not raise new issues of safety or effectiveness compared to existing, legally marketed devices.

Therefore, the requested information regarding acceptance criteria, reported device performance, study details (sample sizes, data provenance, ground truth, experts, adjudication, MRMC, standalone performance), and training set information is not present in this document.

The "Summary of Technologies" section states: "The technological characteristics of the Forerunner" Plating System are the same as, or similar to, the predicate devices." This implies that the device's performance would be considered similar to the predicate devices, which have already been deemed safe and effective.

In summary, this document does not contain the information required to populate the table or answer the specific questions about acceptance criteria and a study proving device performance, as it is a substantial equivalence claim for a physical medical device, not an AI/software performance study.

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The SMPle™ Pediatric Submuscular Plating System is intended for adult or pediatric patients as indicated for long bone fracture fixation of bones that have been surgically prepared (osteotomy) for correction of deformity, malunions, non-union or arthrodesis. Indications for use include internal fixation of the tibia, fibula, femur, humerus, ulna, and radius.

In pediatric femoral applications, the SMPle™ Pediatric Submuscular Plating System is intended for use in the treatment of femoral fractures, malunions or non-unions, femoral osteotomies required for the correction of deformity, and arthrodesis. Indications for buttressing multi-fragmentary distal femoral fractures include: supracondylar, intra-articular and extra-articular condylar, periprosthetic fractures and fractures in normal or osteopenic bone, non-unions and mal-unions, and osteotomies of the femur.

Single/multiple metallic bone fixation appliances and accessories (21 CFR 888.3030)

The provided text is a 510(k) Summary for the Biomet Trauma SMPLe™ Pediatric Submuscular Plating System. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific acceptance criteria through a clinical study with performance metrics.

Therefore, the following information is not available in the provided text:

• A table of acceptance criteria and reported device performance.
• Details about a specific study, including sample sizes, data provenance, number or qualifications of experts, ground truth establishment, or adjudication methods for any test or training sets.
• Information on Multi-Reader Multi-Case (MRMC) comparative effectiveness studies or standalone algorithm performance.

Explanation Based on the Provided Text:

The 510(k) Summary states the following as its primary method for regulatory approval:

• Substantial Equivalence: "The SMPle™ Pediatric Submuscular Plating System is substantially equivalent to its predicate devices with respect to intended use and indications, technological characteristics, and principles of operation and does not present any new issues of safety or effectiveness."

Instead of presenting performance data against defined acceptance criteria, the submission relies on demonstrating that the new device is as safe and effective as pre-existing, legally marketed devices (predicates). The "study" referenced here is likely a combination of engineering analysis and comparison to predicate device characteristics, which doesn't typically involve a clinical trial with specific performance metrics as would be seen for AI/diagnostic devices.

Predicates mentioned are:

• Synthes 3.5 and 4.5 Locking Compression Plates for expanded indications (K082807)
• Orthopediatrics PediLoc™ Plating Systems (K083286)
• Biomet IQL Plating System (K020221)
• Biomet OptiLock® Periarticular Plating System (K061098)

In summary, this document is a regulatory submission for a medical device (bone plating system) using the 510(k) pathway, which primarily seeks to establish substantial equivalence to predicate devices, not to present a clinical study with detailed performance acceptance criteria and results as might be expected for software-as-a-medical-device or diagnostic tools.

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The OptiLock® VL Distal Radius Plating System consists of a series of plates, screws and locking pegs that are intended for the fixation of intra-articular and extra-articular fractures involving the distal radius, ulna (and other small bones). This system is also intended for use in osteopenic bone. Specific indications include:

1. Fixation of intra-articular and extra-articular fractures
2. Treatment of mal-unions
3. Treatment of non-unions
4. Osteotomies
5. Wrist arthrodesis

The OptiLock® VL Distal Radius Plating System is comprised of a series of anatomically contoured plates, and locking, variable angle locking and non-locking screws, as well as locking pegs intended to be used in the distal radius, ulna (and other small bones). This system may also be used in osteopenic bone. The plates are available in several styles to address the anatomy of the distal radius/ulna. The screws are available in two diameters, in locking, non-locking and variable angle locking styles. Locking pegs are also available as an option for stabilizing the plate to the bone.

The plates and screws of the OptiLock® VL Distal Radius Plating System are fabricated from titanium alloy (Ti-6Al-4V), which conforms to ASTM specification F-136, or stainless steel alloy which conforms to ASTM specification F-138 or F-139. Plates and screws fabricated from titanium alloy are anodized to color-code the different sizes to assist the surgeon with size selection.

The provided text is a 510(k) Summary for the Biomet Trauma OptiLock® VL Distal Radius Plating System. This type of submission is for medical devices, specifically orthopedic implants, which are typically evaluated based on substantial equivalence to existing legally marketed predicate devices, rather than through studies involving AI or diagnostic performance metrics.

Therefore, the document does not contain the information requested in the prompt, such as acceptance criteria based on device performance metrics (like accuracy, sensitivity, specificity), details of a study proving such performance, sample sizes for test or training sets, data provenance, expert ground truthing, adjudication methods, or MRMC studies.

Instead, the document focuses on:

• Device Description: What the device is made of and its components.
• Indications for Use: What the device is intended to treat.
• Summary of Technologies: Stating that the technology is similar to other legally marketed devices.
• Substantial Equivalence: Arguing that the device is as safe and effective as predicate devices already on the market, primarily based on engineering analysis rather than clinical performance studies against specific criteria.

Therefore, I cannot fulfill the request as the essential information related to performance criteria and a study proving device performance (as would be applicable for diagnostic or AI-driven devices) is not present in the provided text.

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The Biomet BioDrive Screw System is indicated for alignment and stabilization of small bone fractures.

Specifically:

• Fixation of small bones, such as those in the foot, ankle, wrist, elbow and hand for . treatment of fractures, non-unions, or mal-unions
• Ligament reconstruction
• Osteochondritis dissecans
• Arthrodesis of the foot, ankle, wrist, elbow and hand
• Small bone osteotomies, including first metatarsal head osteotomy, metatarsal . osteotomies, phalangeal osteotomies, and carpal/metacarpal osteotomies

These procedures may be indicated as a result of trauma, deformity, osteoarthritis, and rheumatoid arthritis.

The Biomet BioDrive Micro Screw System consists of screws, a micro nail plate and ancillary instruments intended for surgery to aid in alignment and stabilization of fractures of small bones such as those in the foot, elbow, ankle, and hand.

The provided document is a 510(k) Premarket Notification for the Biomet BioDrive Micro Screw System. This type of notification is for medical devices that are substantially equivalent to a legally marketed predicate device, and it does not typically include detailed performance studies with acceptance criteria, sample sizes, expert ground truth, or AI-specific metrics like those requested.

The document focuses on demonstrating substantial equivalence to predicate devices based on intended use, indications, technological characteristics (material, design, sizing), and principles of operation. It explicitly states: "The technological characteristics (material, design, and sizing) of the implants and instruments comprising the BioDrive Micro Screw System are the same as or similar to the predicate devices."

Therefore, most of the requested information regarding acceptance criteria, specific device performance studies, and AI-related metrics cannot be found in this document.

Here's a breakdown of what can be extracted and what is not available based on the provided text:

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

• Not available. The document does not describe specific performance criteria or a study with measured performance outcomes against those criteria. The 510(k) pathway for this device relies on substantial equivalence to predicate devices, not on de novo performance testing against acceptance criteria in the way a novel AI device might.

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

• Not applicable/Not available. No clinical test set or data provenance is detailed in this 510(k) summary. Performance is inferred through equivalence to existing predicate devices, which would have undergone their own testing in the past.

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/Not available. As there is no specified test set described for this 510(k), there is no mention of experts establishing ground truth for performance.

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

• Not applicable/Not available. Similar to above, this information is not relevant to the content of this 510(k) document, which does not describe a performance study with a test set 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

• Not applicable/Not available. This device is a bone screw system, not an AI image analysis or diagnostic tool. Therefore, an MRMC study or AI assistance is not relevant to its regulatory submission.

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

• Not applicable/Not available. This device is a physical medical implant (screws and plates), not an algorithm or software.

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

• Not applicable/Not available. No ground truth is described as part of this 510(k) submission for performance evaluation, as it relies on substantial equivalence.

8. The sample size for the training set

• Not applicable/Not available. This device is not an AI/ML model, so there is no concept of a training set.

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

• Not applicable/Not available. This device is not an AI/ML model, so there is no concept of a training set or its ground truth establishment.

In summary, the provided document is a regulatory submission focused on substantial equivalence for a physical medical device, not a performance study for an AI/ML medical device. Therefore, the specific details requested regarding detailed performance evaluations, test sets, expert annotations, and AI-related metrics are not present.

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The Biomet Phoenix™ Ankle Nail System and the Biomet® Ankle Arthrodesis Nail are indicated for tibiotalocalcaneal arthrodesis (fusion).

Specific indications include:

1. Avascular necrosis of the talus
2. Failed total ankle arthroplasty
3. Trauma (malunited tibial pilon fracture)
4. Severe deformity or instability as a result of talipes equinovarus, cerebral vascular accident, paralysis or other neuromuscular disease
5. Revision ankle arthrodesis
6. Neuroarthropathy
7. Rheumatoid arthritis
8. Osteoarthritis
9. Pseudoarthrosis
10. Post-traumatic arthrosis
11. Previously infected arthrosis
12. Charcot foot
13. Severe endstage degenerative arthritis
14. Severe defects after tumor resection
15. Pantalar arthrodesis

The Biomet Phoenix™ Ankle Nail System is an intramedullary nail system (nails and screws) comprised of Ti-6Al-4V and UHMWPE. The Biomet® Ankle Arthrodesis Nail System is an intramedullary nail system (nails and screws) comprised of T-6Al-4V.

This is a 510(k) premarket notification for a medical device (intramedullary fixation rod), not a study evaluating device performance against acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, study design, ground truth, and expert involvement is not present in this document.

Here's what can be inferred from the provided text:

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

• This document is a 510(k) submission, indicating a review by the FDA for substantial equivalence to a predicate device, not a clinical study with predefined acceptance criteria and performance reporting in the typical sense.
• The letter states, "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent...". This implies that the device met the regulatory acceptance criterion of being substantially equivalent to a predicate device.
• No specific performance metrics are reported in this document.

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

• Not applicable. This is not a clinical study involving a test set of data.

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. The document refers to "input from surgeons who have reviewed the surgical technique" for contraindications, but this is not related to establishing ground truth for a test set in a clinical performance study.

4. Adjudication method (e.g. 2+1, 3+1, none) 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 document does not describe such a study and the device is an intramedullary fixation rod, not an AI diagnostic tool.

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

• Not applicable.

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

• Not applicable.

8. The sample size for the training set

• Not applicable.

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

• Not applicable.

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The EBI OptiLock Periarticular Plating System (The System) is indicated for fixation of fractures and osteotomies involving the femur or tibia.

The System is intended for buttressing multifragment distal femur fractures including: supracondylar, intra-articular and extra-articular condylar fractures, fractures in normal or osteopenic bone and nonunions and malunions.

The System is intended for the treatment of non-unions, malunions and fractures of the proximal tibia, including simple, comminuted lateral wedge, depression, medial wedge, bicondylar, combinations of lateral wedge and depression and fractures with associated shaft fractures.

The System is intended to buttress Metaphyseal fractures of the medial tibial plateau, split-type fractures of the medial tibial plateau, medial split fractures with associated depressions and split of depression fractures of the medial tibia plateau. Also, for use in the fixation of osteopenic bone and fixation of nonunions and malunions for the medial proximal tibia and tibial shaft.

The System is indicated for the fixation of fractures of the distal tibia including, but not limited to, ankle fractures, periarticular, intraarticular and distal tibia fractures with a shaft extension, malleolar and distal fibular fractures.

This submission is being made for sterile packaging of plates and screws that comprise the OptiLock Periarticular Plating System.

The provided text is a 510(k) summary for a medical device (EBI OptiLock Periarticular Plating System). It primarily focuses on demonstrating substantial equivalence to predicate devices and detailing the indications for use. It does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria through testing with a defined dataset, ground truth, or expert review.

Therefore, I cannot populate the requested table and sections based on the provided text. The document states:

• "The technological characteristics of the OptiLock Periarticular Plating System are the same as, or similar to the predicate devices."
• "The OptiLock Periarticular Plating System is substantially equivalent to its predicate devices with respect to intended use and indications, technological characteristics and principles of operation and do not present any new issues of safety or effectiveness."

This indicates that the submission relies on the similarity of its design and intended use to previously cleared devices, rather than presenting a performance study with acceptance criteria.

Response:

Based on the provided 510(k) Summary for the EBI OptiLock Periarticular Plating System, there is no information regarding specific acceptance criteria or a study that proves the device meets such criteria in terms of analytical or clinical performance.

The document is a 510(k) premarket notification that demonstrates substantial equivalence to predicate devices based on intended use, indications, technological characteristics, and principles of operation. It does not present data from a performance study with a test set, ground truth, or expert review.

Therefore, the requested information cannot be extracted from this document, and the table and sections below cannot be filled.

1. Table of acceptance criteria and the reported device performance

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

• Sample Size for Test Set: Not applicable, no performance study data provided.
• Data Provenance: Not applicable, no performance study data provided.

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, no ground truth establishment for a test set is described.

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

• Not applicable, no test set or adjudication method 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, this is a medical device for internal fixation (plates and screws), not an AI/software device. No MRMC study was performed or described.

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

• Not applicable, this is a medical device for internal fixation (plates and screws), not an algorithm or AI device.

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

• Not applicable, no ground truth for a performance study is described.

8. The sample size for the training set

• Not applicable, this is a physical medical device, not a software/AI device that requires a training set.

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

• Not applicable, this is a physical medical device.

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The BioDrive® Cannulated Screw System is indicated for the following:

• Fixation of fractures in long bones
• Fixation of small bones, including those in the foot, patella, ankle, wrist & elbow
• Arthrodesis of the foot, wrist and elbow
• Small and long bone osteotomies
• Fixation of pelvis and the illiosacral joint

The Biodrive® Cannulated Screw System consists of cannulated screws of various diameters and lengths with four threaded configurations. The system includes 3 different size washers, the use of which are optional, as well as guide wire and complete instruments. They are made from made Titanium alloy (Ti-6AL-4V) in conformance with ASTM F136 standard. The Titanium screws are also available acid etched (Osseotite™).

The provided document K082874 is a 510(k) summary for the BioDrive® Cannulated Screw System. Based on the content of this document, here's an analysis of the acceptance criteria and study information:

Description of Acceptance Criteria and Study to Prove Device Meets Criteria

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document explicitly states "Clinical Testing: None provided as a basis for substantial equivalence." This implies that the acceptance criteria are not based on specific clinical performance metrics (e.g., success rates, complication rates) but rather on demonstrating substantial equivalence to predicate devices through non-clinical means.

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

• Sample Size: Not applicable. No clinical test set was used for this 510(k) submission.
• Data Provenance: Not applicable. The submission relies on an "engineering rationale" and equivalence to existing devices rather than new clinical data from a test set.

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

• Not applicable. No clinical test set was used, and thus no ground truth was established by experts for human performance evaluation.

4. Adjudication Method for the Test Set

• Not applicable. No clinical test set requiring adjudication was performed.

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

• No. The document explicitly states "Clinical Testing: None provided as a basis for substantial equivalence." Therefore, no MRMC study, which typically involves human readers assessing cases with and without AI, was conducted or reported.

6. Standalone (Algorithm Only) Performance Study

• Not applicable. This device is a medical implant (cannulated screw system), not an algorithm or AI software. Therefore, a standalone algorithm performance study is not relevant. The substantial equivalence is based on the physical properties and intended use.

7. Type of Ground Truth Used

• Engineering Rationale and Predicate Device Performance: The "ground truth" for this submission is implicitly the established safety and effectiveness of the identified predicate devices, as well as the mechanical and material specifications (ASTM F136 standard for Titanium alloy) which form the basis of the engineering rationale. There is no biological or diagnostic "ground truth" in the traditional sense, as it's a structural medical device.

8. Sample Size for the Training Set

• Not applicable. This is a physical medical device, not an AI/ML algorithm. There is no concept of a "training set" in this context.

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

• Not applicable, as there is no training set for a physical medical device. The "ground truth" for its design and manufacturing is derived from established engineering principles, material standards (ASTM F136), and the performance history of similar predicate devices.

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Unilateral external fixation device intended for use in children and adults in the treatment of bone conditions including leg lengthening, osteotomies, arthrodesis, fracture fixation, and other bone conditions amendable to treatment by use of the external fixation modality. For the XFIX® DFS® Rail System the indications are unilateral external fixation device intended for use in children and adults in the treatment of bone conditions including leg lengthening, osteotomies, arthrodesis, fracture fixation, acute or gradual correction and other bone conditions amendable to treatment by use of the external fixation modality.

The Systems consist of external fixation components and implantable bone screws. The system is utilized in the following manner: bone screws are inserted through the patients skin and soft tissue into bone. The fixator frame of the system is attached the shanks of the bone screws.

The provided text is a 510(k) summary for a medical device (Lower Extremity External Fixation) and the associated FDA clearance letter. It explicitly states that no clinical testing was performed as a basis for substantial equivalence.

Therefore, the requested information regarding acceptance criteria and a study proving the device meets those criteria cannot be found in this document. The device's clearance was based on its similarity to legally marketed predicate devices, and non-clinical laboratory testing.

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The Biomet Phoenix™ Ankle Nail System is indicated for tibiotalocalcaneal arthrodesis (fusion).

Specific indications include:

1. Avascular necrosis of the talus
2. Failed total ankle arthroplasty
3. Trauma (malunited tibial pilon fracture)
4. Severe deformity or instability as a result of talipes equinovarus, cerebral vascular accident, paralysis or other neuromuscular disease
5. Revision ankle arthrodesis
6. Neuroarthropathy
7. Rheumatoid arthritis
8. Osteoarthritis
9. Pseudoarthrosis

The Biomet Phoenix™ Nail System is an intramedullary nail system comprised of Ti-6Al-4V and UHMWPE.

This document describes the Biomet Phoenix™ Ankle Nail System, an intramedullary nail system for tibiotalocalcaneal arthrodesis (ankle fusion). The 510(k) summary indicates that the device's substantial equivalence was established through non-clinical testing.

Here's an analysis of the provided information, focusing on acceptance criteria and the study:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: Not applicable. The primary evidence for substantial equivalence came from engineering analyses and comparisons to predicate devices, not studies with a "test set" of patient data.
• Data Provenance: Not applicable for patient data. The non-clinical testing involved engineering analyses.

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

• Not applicable. No clinical test set requiring expert ground truth establishment was conducted. The evaluation was based on engineering principles and comparison to predicate devices.

4. Adjudication Method for the Test Set:

• Not applicable. There was no clinical test set requiring adjudication.

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

• No MRMC comparative effectiveness study was done. The submission explicitly states: "Clinical Testing: None provided as a basis for substantial equivalence."

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance):

• Not applicable. This device is a medical implant (intramedullary nail), not an AI algorithm or diagnostic tool. Its performance is related to its mechanical properties and design, not an algorithm's output.

7. Type of Ground Truth Used:

• Engineering Principles and Predicate Device Characteristics: The "ground truth" for demonstrating the device's functionality and substantial equivalence was based on established engineering principles applied during the non-clinical tests and direct comparison of the device's characteristics (materials, design, sizing) to those of legally marketed predicate devices.

8. Sample Size for the Training Set:

• Not applicable. There was no training set in the context of an AI/ML algorithm. The evaluation was based on non-clinical testing and comparison to predicate devices.

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

• Not applicable. There was no training set. The "ground truth" for the non-clinical testing would have been derived from established biomechanical testing standards and expected performance based on the predicate devices.

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