Search Results

The proposed indications for use for the Integra® CAPTURE™ Screw System are as follows:
"The CAPTURE™ Screw System implants (screws) are intended for fixation of fractures, and osteotomies of the small bones in the hand and foot. The implants are intended for single use only.

The proposed indications for use for the Integra® Ti6® Internal Fixation System are as follows: "The Ti6@ Internal Fixation System implants (screws) are intended for fixation of fractures, non-unions, arthrodeses and osteotomies of the small bones in the hand and foot. The implants are intended for single use only.

The Integra® CAPTURETM Screw System and Integra® Ti6® Internal Fixation System consists of bone screws of various designs and sizes intended to fixate bones in cases of fractures, osteotomies, or fusions. The screws are self- drilling and self-tapping, and are manufactured from Ti-6Al-4V titanium alloy. This submission presents new cannulated (Digital Fusion) and non-cannulated (QuickSnap) screw designs that are line extensions to the current Integra® CAPTURE™ Screw System and Integra® Ti6® Internal Fixation System.

This document is a 510(k) premarket notification for the Integra® CAPTURE™ Screw System & Integra® Ti6® Internal Fixation System. It describes the device, its intended use, and the basis for substantial equivalence to predicate devices. Crucially, as a 510(k) submission, it focuses on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than proving novel effectiveness through clinical trials.

The document states:
"Clinical Performance Data: Clinical performance data was not necessary to demonstrate substantial equivalence."

Therefore, the specific information requested about acceptance criteria for device performance studies, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone algorithm performance, and training set details will not be available in this document as it explicitly states clinical performance data was not required or provided.

However, I can provide the non-clinical performance data and its findings, which were used to establish substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: Not specified in the document for the non-clinical tests.
• Data Provenance: The tests were conducted "per ASTM F543," which is a standard for metallic bone screws. This indicates laboratory testing, not human patient data.

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

• Not applicable. The ground truth for mechanical testing is based on established engineering standards (ASTM F543) and physical measurements, not expert human interpretation.

4. Adjudication method for the test set:

• Not applicable as the testing involves direct physical measurements against engineering standards rather than 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:

• No. A MRMC comparative effectiveness study was not done. This device is a bone fixation screw system, not an AI or imaging diagnostic device that would involve human readers or AI assistance in interpretation.

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

• No. This device is a physical medical device (screws), not an algorithm or software. Standalone performance as an algorithm is not applicable.

7. The type of ground truth used:

• Non-clinical performance data: Ground truth was established by adherence to ASTM F543 standards for mechanical properties (Torsional Strength, Driving Torque, Axial Pullout Strength) and comparison to predicate devices.

8. The sample size for the training set:

• Not applicable. This device is a physical medical implant, not an AI or machine learning model that requires a training set. The "training" for the device's design and manufacturing would come from engineering principles and standards.

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

• Not applicable. See point 8.

Ask a specific question about this device

ALLY™ Bone Screws are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation, appropriate for the size of the device.

The ALL Y™ Bone Screws are fully threaded cortical screws offered in various diameters and lengths. All screws are manufactured from titanium alloy. The implants are single use only.

The provided text describes the 510(k) submission for the ALLY™ Bone Screws, a Class II medical device. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study of its performance in a clinical setting against specific acceptance criteria in the way an AI/ML device would.

Therefore, many of the requested categories are not applicable to this submission. This device is a bone screw, not an AI/ML algorithm or software device.

Here's a breakdown of the available information based on your request:

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

For a traditional medical device like a bone screw, acceptance criteria typically refer to engineering specifications and performance testing results against established industry standards.

2. Sample size 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. For engineering tests of a medical device, the sample size would typically refer to the number of screws tested for each mechanical property. The data provenance would be that the tests were conducted in a lab setting, not from clinical 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. For a bone screw, "ground truth" is established through standardized mechanical testing and engineering analysis rather than expert consensus on clinical data.

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

Not applicable. Adjudication methods are relevant for studies involving human interpretation (e.g., image reading) to establish ground truth, not for mechanical testing of a device.

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 a bone screw, not an AI/ML diagnostic tool requiring MRMC studies.

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

Not applicable. This device is a bone screw, not an AI/ML algorithm.

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

The "ground truth" for this device's performance is established by objective mechanical testing against ASTM F543 standards and engineering analysis. It is not based on expert consensus, pathology, or outcomes data in the traditional sense.

8. The sample size for the training set

Not applicable. This device is a bone screw, not an AI/ML algorithm that requires a training set.

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

Not applicable. This device is a bone screw, not an AI/ML algorithm.

Ask a specific question about this device

The HV Screw is indicated for fixation of bone fractures or for bone reconstruction. Examples include:

• · Mono or Bi-Cortical osteotomies in the foot or hand
• · Distal or Proximal metatarsal or metacarpal osteotomies
• · Fusion of the first metatarsophalangeal joint and interphalangeal joint
• · Fixation of osteotomies for Hallux Valgus treatment (such as Scarf, Chevron, etc.)
• Akin type osteotomy
• · Arthrodesis base first metatarsal cuneiform joint to reposition and stabilize metatarsus varus primus
• · Talar/navicular arthrodesis

The HV Screws are cannulated screws offered in 3.0mm diameter, various lengths, and have self-tapping features on both distal and proximal threads. All screws are manufactured from titanium alloy.

The provided document is a 510(k) Premarket Notification from the FDA regarding the HV Screw System by Wright Medical Technology, Inc. This document is a regulatory approval for a medical device (a bone fixation fastener), not a clinical study on an AI/machine learning diagnostic device.

Therefore, the input does not contain the information required to answer the questions about acceptance criteria, study design, ground truth establishment, or human reader performance for an AI/ML device.

Here's why the provided text does not contain the requested information:

• Type of Device: The HV Screw System is a physical medical implant (a screw for bone fixation), not an AI/machine learning software or diagnostic device. As such, the performance criteria and study methodologies described are for a mechanical implant, not an AI algorithm.
• Performance Metrics: The "Validation and/or Verification Method" in the document focuses on mechanical properties like torsional testing, axial pullout force, and bending strength, which are relevant to a screw's physical performance, not diagnostic accuracy (e.g., sensitivity, specificity, AUC).
• Clinical Evidence: The document explicitly states "8. Substantial Equivalence- Clinical Evidence: N/A". This indicates that no human clinical study was conducted for this submission, as is often the case for medical devices that demonstrate substantial equivalence to a predicate device through non-clinical (e.g., benchtop) testing.
• AI/ML Specifics: There is no mention of algorithms, machine learning, human readers, experts establishing ground truth for diagnostic images, test sets, training sets, or adjudication methods, as these concepts are not applicable to the HV Screw System.

Based on the provided text, I cannot fill in the requested table or answer the specific questions related to an AI/machine learning device.

The document describes the regulatory process for a physical medical device (HV Screw System) and its substantial equivalence to a predicate device based primarily on non-clinical (mechanical) testing. It does not provide any details about an AI/ML study.

Ask a specific question about this device

The MICA™ Screw is indicated for fixation of bone fractures or for bone reconstruction. Examples include:

• · Mono or Bi-Cortical osteotomies in the foot or hand
• · Distal or Proximal metatarsal or metacarpal osteotomies
• · Weil osteotomy
• · Fusion of the first metatarsophalangeal joint and interphalangeal joint
• · Fixation of osteotomies for Hallux Valgus treatment (such as Scarf, Chevron, etc.)
• · Akin type osteotomy
• · Arthrodesis base first metatarsal cuneiform joint to reposition and stabilize metatarsus varus primus
• Calcaneus/cuboid arthrodesis
• · Talar/navicular arthrodesis

The MICA™ Screws are intended for use in bone reconstruction, osteotomy, arthrodesis, fracture repair, and fracture fixation of bones appropriate for the size of the device. All MICA™ Screws are fully threaded, cannulated screws made from titanium alloy.

The provided document describes the MICA™ Screw System, a medical device for bone fixation, and its substantial equivalence to a predicate device, rather than an AI/ML powered device. Therefore, many of the requested details about acceptance criteria for AI performance and study design for AI models (e.g., sample size for test/training sets, expert ground truth, MRMC studies, standalone performance) are not applicable to this document.

However, I can extract the acceptance criteria and performance data for the non-clinical testing performed on the MICA™ Screw System.

1. 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)

This information is not provided in the document. The testing described is non-clinical, involving mechanical and material properties of the device, not patient data.

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

This information is not applicable as the testing is non-clinical and does not involve human experts establishing ground truth for diagnostic or prognostic purposes.

4. Adjudication method for the test set

This information is not applicable as the testing is non-clinical.

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 is not applicable as the document describes a mechanical bone screw system, not an AI/ML powered device.

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

This is not applicable as the document describes a mechanical bone screw system, not an AI/ML powered device.

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

For the non-clinical tests, the "ground truth" or reference standards are engineering specifications, established mechanical test methods, and predefined thresholds for material properties (e.g., specific torque values, force limits, endotoxin levels).

8. The sample size for the training set

This is not applicable as the document describes a mechanical bone screw system, not an AI/ML powered device.

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

This is not applicable as the document describes a mechanical bone screw system, not an AI/ML powered device.

Ask a specific question about this device

1. Fixation of small bones, including those in the foot, patella, ankle, wrist and elbow.
2. Arthrodesis of the foot, wrist and elbow.
3. Small and long bone osteotomies.
4. Fracture fixation of small bones, small bone fragments and long bones.

The 3.0mm Biomet Cannulated Screw System consists of bone screws of various lengths and are Ti alloy partially threaded screws with the associated 3.0mm washer. They are offered in both a sterile and non-sterile configuration. The 3.0mm Biomet Cannulated Screw System also contains dimensionally optimized corresponding instruments which are used with the 3.0mm Biomet Cannulated Screws and washers to aid in the alignment and stabilization of fractures to the skeletal system.

This document is a 510(k) premarket notification for a medical device called the "3.0mm Biomet Cannulated Screw System." It seeks to demonstrate substantial equivalence to legally marketed predicate devices, not necessarily to prove specific performance criteria against predefined thresholds.

Therefore, the requested information elements related to acceptance criteria and a study proving those criteria are not directly applicable or available in this specific type of regulatory submission document. This document focuses on demonstrating that the new device is as safe and effective as a previously cleared device.

However, I can extract the relevant information from the document as it pertains to the basis for substantial equivalence, which includes some performance data.

Here's a breakdown based on your request, as much as can be derived from the provided text:

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

This document does not specify formal "acceptance criteria" for clinical performance that would typically be seen in a clinical trial. Instead, the performance is compared against predicate devices to demonstrate substantial equivalence. The non-clinical tests indicate that the new device's performance is "equal to or better than the predicate devices."

2. Sample size 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 specified. The non-clinical tests were conducted per ASTM F543, which specifies testing methodologies, but the sample size used for these specific tests is not provided in this summary.
• Data Provenance: Not specified, but generally, bench testing (non-clinical) occurs in a lab setting, not tied to patient data. Since no clinical studies were performed, there is no patient data provenance to report.

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. This device underwent non-clinical (bench) testing, not clinical studies requiring expert ground truth establishment.

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

• Not applicable. This was bench testing, not a clinical study involving human judgment or 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. This is a bone fixation screw system, not an AI/imaging device. Therefore, no MRMC study or AI assistance evaluation was performed.

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

• Not applicable. This is a physical medical device (bone screw), not an algorithm or software.

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

• For the non-clinical tests, the "ground truth" or reference for performance was established by standardized mechanical testing methodologies (ASTM F543) and comparison to the performance of legally marketed predicate devices. There is no clinical ground truth (like pathology or outcomes data) mentioned because no clinical studies were performed.

8. The sample size for the training set

• Not applicable. This is a physical medical device, not a machine learning algorithm that requires a training set.

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

• Not applicable. As above, this is not a machine learning algorithm.

Ask a specific question about this device

The Biomet Headless Compression Screws and Twist-Off Screws are indicated for fixation of a joint (arthrodesis) or bone reconstruction (osteotomy) of the mid-foot bones, metatarsal and phalanges of the foot or the phalanges, metacarpals and carpals of the hand. In the foot, these include procedures to correct Hallux Valgus (bunions), Hallux Varus and Hallux Rigidus, Hammer toe, Claw toe and Mallet toe.

The Biomet Headless Compression and Twist-Off Screws consist of bone screws of various lengths and diameters. The Biomet Headless Compression and Twist-Off Screws are also accompanied by dimensionally optimized corresponding instruments which are used to aid in the alignment and stabilization of fractures to the skeletal system. The Biomet Headless Compression Screws are a cannulated headless screw, which is inserted below the bone surface. The Biomet Headless Compression Screw is designed to minimize soft tissue irritation and provides compression due to a dual thread design. The Biomet Twist-Off Screw is a solid one piece screw that has a direct connection to a drill or large diameter pin driver, this allows the screw to break-off cleanly upon contact. The Biomet Twist-Off Screw also has compression capabilities with a thread-free segment that achieves compression at the osteotomy site.

This document does not describe a study that proves the device meets specific acceptance criteria in the way you've outlined for an AI/algorithm-based device.

The provided text is a 510(k) premarket notification summary for Biomet Headless Compression and Twist-Off Screws, which are physical medical devices (bone screws), not an AI algorithm or software. Therefore, many of the requested categories (like MRMC studies, ground truth for training/test sets, expert adjudication, AI improvement effect size) are not applicable to this type of device submission.

However, I can extract the relevant information from the document regarding the device's performance assessment:

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

Note: The document states "Results indicate that the subject screws are substantially equivalent to legally marketed devices offering a reasonable assurance of safety and effectiveness." It does not provide specific numerical values for the performance criteria, only that they met the standards of ASTM F543 and were comparable to predicate devices.

The following questions are NOT APPLICABLE to this document as it pertains to a physical medical device (bone screws) and not an AI or algorithm-based device:

• 2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective) - N/A (mechanical testing on screws themselves)
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts - N/A
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set - N/A
• 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 - N/A
• 6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done - N/A
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc) - N/A (Ground truth for mechanical testing is typically the physical measurement itself against established standards).
• 8. The sample size for the training set - N/A
• 9. How the ground truth for the training set was established - N/A

Ask a specific question about this device

Wright's ORTHOLOC® 3Di Ankle Plating System is intended for fixation of fractures, osteotomies, and non-unions of the distal tibia and fibula such as:

• Lateral Malleolar Fractures
• Syndesmosis injuries
• Medial Malleolar Fractures
• Bi-Malleolar Fractures
• Tri-Malleolar Fractures
• Posterior Malleolar Fractures
• Distal Anterior Tibia Fractures
• Vertical Shear Fractures of the Medial Malleolous
• Pilon Fractures
• Distal Tibia Shaft Fractures
• Distal Fibula Shaft Fractures
• Distal Tibia Periarticular Fractures
• Medial Malleolar Avulsion Fractures
• Lateral Malleolar Avulsion Fractures

ORTHOLOC® 3Di Locking Screws:
The ORTHOLOC® 3Di locking screws are intended for use with Wright's ORTHOLOC® 3Di Plating Systems of the same base material.

ORTHOLOC® Bone Screws:
ORTHOLOC® Screws are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation, appropriate for the size of the device.

Washer
Wright's washers are intended to prevent a screw head from breaking through the cortex of the bone by distributing the forces/load over a large area when used for fracture fixation of bone fragments.

The ORTHOLOC® 3Di .Ankle Plating System contains plates belonging to 1 of 2 general categories-distal tibia and fibula-based on the contouring of each plate: All plates feature polyaxial locking screw holes. Some plates have k-wire holes, compression slots, or syndesmosis slots. The plates are made from titanium alloy and accept 2.7mm ORTHOLOC® 3Di locking screws. 2.7mm. 3.5mm and 4.0mm ORTHOLOC® Bone Screws, and 4.0mm Wright™ Compression Screws (cleared under K082320, now branded DART-FIRE®). Washers are also available for use with the ORTHOLOC® Bone Screws.

Here's an analysis of the provided text regarding the Ortholoc® 3Di Ankle Plating System, focusing on acceptance criteria and study details:

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

The provided document (K131093) is a 510(k) summary for a medical device. For a 510(k) submission, the primary acceptance criteria for a new device are typically Substantial Equivalence to a legally marketed predicate device. This means the new device must be as safe and effective as the predicate.

The document does not outline specific, quantitative acceptance criteria in terms of performance metrics (e.g., bone healing rates, complication rates, specific mechanical load tolerances against a statistically defined threshold). Instead, it relies on a comparison to the predicate device.

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

The document explicitly states: "(b)(2). Substantial Equivalence - Clinical Evidence N/A". This indicates that no clinical test set (human patient data) was used in this 510(k) submission. The comparison for substantial equivalence was based on non-clinical evidence (mechanical analysis and comparison of design/materials/indications to the predicate). Therefore, there is no sample size for a clinical test set, no data provenance (country, retrospective/prospective) to report for human studies.

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)

Since no clinical test set was used, and specifically no human data requiring expert assessment for ground truth, this information is not applicable to this submission. The "ground truth" for the submission was established by comparing the device's design and mechanical properties to those of the predicate device, likely by Wright Medical Technology's internal engineering and regulatory teams, and subsequently reviewed by the FDA.

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

As no clinical test set was utilized requiring expert adjudication, this information is 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

No MRMC study was done. This device is a bone plating system, not an imaging or diagnostic device that would typically involve human readers or AI assistance in interpretation. The nature of the device (implantable hardware) means this type of study is irrelevant.

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

This question is not applicable as the device is a bone plating system and does not involve algorithms or AI for diagnostic or interpretive purposes. Performance is related to its mechanical properties and biocompatibility as an implant.

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

For this 510(k) submission, the "ground truth" for the device's safety and effectiveness was established by:

• Comparison to the Predicate Device: The predicate device, ORTHOLOC® 3Di Ankle Plating System (K102429), serves as the primary "ground truth" reference. The new device must demonstrate it is as safe and effective as this previously cleared device.
• Non-Clinical Mechanical Analysis: This involves engineering evaluations (e.g., stress testing, fatigue testing) to ensure the new plates do not represent a "new worst-case" scenario compared to the predicate. The "ground truth" for these tests would be established by validated engineering standards and methods.

8. The sample size for the training set

Since no clinical studies were performed, and no AI/algorithm components are part of this device, there is no training set in the context of machine learning or clinical trials. The "development" of the device would involve engineering design and validation, not a training set of data.

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

As there is no training set for this device type within the context of the 510(k) submission, this question is not applicable.

Ask a specific question about this device