Search Results

The SBi Anatomic Ankle Athrodesis Interlocking Nail System is indicated for tibiotalocalcaneal arthrodesis of the ankle following:

• Post traumatic and degenerative arthritis involving both ankle and subtalar joints,
• Rheumatoid arthritis,
• Osteoarthritis,
• Pseudoarthrosis,
• Severe foot/ankle deformity, or
• Instability and skeletal defects after tumor resection.
  These include neuro-osteoarthroplasty (Charcot's foot), avascular necrosis of the talus, failed joint replacement, failed ankle fusion, and for distal tibia fracture non-unions when used concomitantly with tibiotalocalcaneal pathology.

The SBi Anatomic Ankle Arthrodesis Interlocking Nail System consists of implants, associated instruments, and trays. The implants are made of implantable grade titanium while the instrument components and trays are made of several materials: Aluminum, stainless steel, PEEK, POM, and composite materials. The implants are intended for single use only and will be offered sterile and non-sterile.

The provided text is a 510(k) Premarket Notification Summary for a medical device called the "SBi Anatomic Ankle Arthrodesis Interlocking Nail System." This documentation describes a surgical implant, not an AI/ML-based device or a diagnostic tool that would typically have acceptance criteria and a study proving its performance in the way your request outlines (e.g., accuracy, sensitivity, specificity, human reader improvement, standalone performance).

Therefore, I cannot extract the information you requested about acceptance criteria and studies demonstrating device performance related to AI or diagnostic metrics because this document does not contain such information.

Specifically, the document focuses on:

• Device Description: What the device is made of and how it functions.
• Intended Use: The medical conditions it is designed to treat (tibiotalocalcaneal arthrodesis of the ankle for various forms of arthritis, deformity, etc.).
• Substantial Equivalence: Comparing the device to already legally marketed predicate devices (Stryker T2 Ankle Arthrodesis Nail and Synthes Titanium Cannulated Hindfoot Arthrodesis Nail Expert System). This is the primary method of approval for 510(k) devices.
• Non-clinical data: Fatigue testing, cadaver implantation evaluations, literature search and evaluation, finite element analysis, and engineering/dimensional analysis. These are engineering and mechanical performance tests, not clinical studies in the diagnostic/AI sense.

There is no mention of:

• Acceptance criteria for diagnostic performance (e.g., sensitivity, specificity, AUC).
• A "study that proves the device meets the acceptance criteria" in the context of diagnostic accuracy.
• Sample sizes for test sets or training sets for an algorithm.
• Data provenance, experts establishing ground truth, adjudication methods.
• Multi-reader multi-case (MRMC) comparative effectiveness studies.
• Standalone algorithm performance.
• Any AI/ML components.

In summary, the request is not applicable to the provided document.

Ask a specific question about this device

The SBi Foot and Ankle Cannulated Screw System is indicated for fixation of small and long bones, such as femoral neck fractures; slipped capitol femoral epiphysis; tibial plateau fractures; ankle arthrodesis; pediatric femur fractures; intercondylar femur fractures; sacroiliac joint disruptions; and subtalar arthrodesis. The system is not intended for spinal use.

The SBi Foot and Ankle Cannulated Screw System consists of screws and washers that provide fixation of small and long bones. The devices are supplied non-sterile and are available in various sizes and configurations. There are several lengths and diameters of the cannulated screws washers appropriate to the screw diameter. There are fully threaded and partially threaded (16mm and 32mm of thread) configurations. The system also includes guide wires and instruments for use in implanting the screws.

I am sorry, but the provided text does not contain any information about acceptance criteria or a study proving that a device meets those criteria. The document is a 510(k) premarket notification summary for the SBi Foot and Ankle Cannulated Screw System, which focuses on demonstrating substantial equivalence to predicate devices rather than reporting on specific performance studies against acceptance criteria.

Therefore, I cannot provide the requested information, including:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for a test set.
3. Number and qualifications of experts for ground truth establishment.
4. Adjudication method for a test set.
5. Results of a multi-reader multi-case (MRMC) comparative effectiveness study.
6. Results of a standalone performance study.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

Ask a specific question about this device

The SBi SR MTP Toe Implant is intended for use as a hemi-arthroplasty implant for the metatarsophalangeal joint, for the treatment of degenerative and posttraumatic arthritis, hallux valgus, hallux rigidus, and an unstable or painful metatarsophalangeal (MTP) joint. The SBi SR MTP Toe Implant is intended for implantation with and without bone cement.

The SBi SR MTP Toe Implant is a one-piece, stemmed device intended to replace the articulating surface of the metatarsal at the MTP joint. The implant is available in a range of sizes to match the geometry of the metatarsal head. Design features include an articulating surface which extends posteriorly on the superior side of the implant and a gently barbed stem to improve fixation in the metatarsal. The implants are made from wrought CoCrMo alloy (ASTM F1587) with a plasma coating comprised of commercially pure titanium (ASTM F1580).

This device is a SBi SR MTP Toe Implant, a medical device, not an AI/ML device. Therefore, the concepts of "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of AI/ML performance metrics (such as sensitivity, specificity, F1-score, sample sizes for test/training sets, expert consensus for ground truth, MRMC studies) are not applicable.

Instead, for a medical device like this implant, the "acceptance criteria" and "proof" involve demonstrating substantial equivalence to a predicate device already legally marketed. This typically involves comparing characteristics such as:

• Intended Use: The purpose for which the device is used.
• Technological Characteristics: The materials, design, and other technical aspects of the device.
• Performance Data: This might include mechanical testing (e.g., strength, wear) to show the new device performs similarly or better than the predicate, or sometimes clinical data if there are significant differences in technological characteristics or intended use that raise new safety or effectiveness questions.

The provided document, a 510(k) summary and FDA clearance letter, explicitly states how this "acceptance" was met:

Substantial Equivalence:

• The document states: "Documentation was provided which demonstrated the SBi SR MTP Toe Implant is substantially equivalent to other legally marketed devices."
• The FDA's letter confirms: "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 (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified..."

Therefore, the "study" proving the device met "acceptance criteria" was a demonstration of substantial equivalence based on a comparison to a predicate device, as required for 510(k) clearance by the FDA. The document does not contain the specific performance data (e.g., mechanical testing results) that would have been submitted to demonstrate this equivalence, but rather the conclusion of the FDA's review.

Given this context, I cannot fill in the table or answer the subsequent questions as they pertain to AI/ML device evaluations, which are not relevant here.

Ask a specific question about this device

The SBi TwistoFIX is indicated for bone reconstruction, osteotomy, fracture repair, and fracture fixation of bones appropriate for the size of the device.

The SBi TwistoFIX System consists of a set of titanium bone screws for internal fixation. The screws are machined on the end of a drill shank which inserts into a driver. After insertion of the screw into the bone, the drill shank twists off and breaks cleanly from the screw head. The devices are supplied non-sterile and are available in various sizes diameters and lengths.

Based on the provided text, the SBi TwistoFIX is a medical device, specifically a bone fixation fastener. The 510(k) summary focuses on demonstrating "substantial equivalence" to existing legally marketed devices, rather than establishing performance against specific acceptance criteria through a formal study with a test set.

Therefore, many of the requested details, such as specific performance metrics, sample sizes, expert qualifications, ground truth establishment, and comparative effectiveness studies, are not applicable or not explicitly detailed in this type of regulatory submission for substantial equivalence.

Here's a breakdown of the information that can be extracted and what cannot:

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

• Acceptance Criteria: The primary acceptance criterion for a 510(k) submission is to demonstrate "substantial equivalence" to a predicate device. This means showing that the new device is as safe and effective as a legally marketed device that does not require PMA.
• Reported Device Performance: Instead of performance against specific acceptance criteria, the submission likely focused on comparing the SBi TwistoFIX's design, materials, and intended use as being similar to predicate devices. The document directly states: "Documentation is provided which demonstrated the SBi TwistoFIX to be substantially equivalent to other legally marketed devices."

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 Provided: In a substantial equivalence filing for a physical implant like this, there isn't typically a "test set" in the sense of a clinical trial or a dataset for an AI algorithm. The evaluation is based on engineering principles, material properties, and comparison to existing devices. Biomedical testing (e.g., mechanical strength, fatigue) would have been performed, but the sample sizes and specific provenance for such engineering tests are not detailed in this summary.

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 Provided: As there is no "test set" in the context of an AI or diagnostic device, there are no experts establishing ground truth for such a set. The "experts" involved would be regulatory reviewers at the FDA and engineers/scientists at Small Bone Innovations who would evaluate the technical aspects and equivalence claims.

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

• Not Applicable / Not Provided: This concept is relevant for clinical studies or AI model evaluation. It does not apply to a 510(k) submission demonstrating substantial equivalence for a bone screw.

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 physical bone screw, not an AI-assisted diagnostic tool. An MRMC study is not relevant here.

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

• No: This device is a physical implant, not an algorithm.

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

• Not Applicable / Not Provided: For substantial equivalence, the "ground truth" isn't outcomes data or expert consensus on diagnosis. Instead, it refers to established engineering standards (e.g., ISO 5832-3 for material properties), biomechanical testing acceptance criteria (which are not detailed here but would be part of the full submission), and the safe and effective history of the predicate devices.

8. The sample size for the training set

• Not Applicable / Not Provided: This device is a physical bone screw, not a machine learning model. There is no concept of a "training set" in this context.

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

• Not Applicable / Not Provided: See point 8.

Ask a specific question about this device

The SBi ArtFIX is intended for bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of bones appropriate for the size of the device.

The SBi ArtFIX System consists of compression screws that are used for internal fixation. ArtFIX is a cannulated, fully threaded, headless compression screw based on a conical design. The ArtFIX screw has a cutting tip and three thread configurations along its length.

This looks like an FDA 510(k) premarket notification for a medical device called "SBi ArtFIX," which is a bone fixation screw. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving performance against specific acceptance criteria through a clinical study as would be seen for a novel AI/software medical device.

Therefore, the provided text does not contain the information requested regarding acceptance criteria and the study that proves the device meets those criteria, as it's not a performance study report for an AI device.

Let's break down why the requested information isn't present in this document and what each point asks for:

1. A table of acceptance criteria and the reported device performance: This would typically be a table outlining specific metrics (e.g., sensitivity, specificity, accuracy for an AI device, or mechanical strength thresholds for a physical device) and the study results demonstrating the device met those pre-defined thresholds. The provided 510(k) summary for SBi ArtFIX focuses on substantial equivalence based on design, materials, and intended use, not performance against acceptance criteria.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): This refers to the characteristics of the dataset used to evaluate an AI model's performance. Since SBi ArtFIX is a physical bone screw and not an AI/software device, there is no "test set" in this context.

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): Ground truth is crucial for evaluating AI performance. For a physical device like a screw, there isn't "ground truth" established by experts in the same way as for diagnostic imaging.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: This describes how discrepancies in expert opinions were resolved when establishing ground truth for an AI device. Not applicable here.

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 specifically for evaluating the impact of AI assistance on human performance, a concept entirely unrelated to a bone fixation screw.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: This describes an AI device's performance without human interaction. Not applicable for a physical medical device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): As mentioned, "ground truth" for a physical screw isn't defined by these methods. Performance for such devices would be based on mechanical testing (e.g., fatigue, torsion, pull-out strength) and clinical outcomes in predicate device equivalency, not expert consensus on data.

8. The sample size for the training set: Refers to the dataset used to train an AI model. Not applicable for a physical device.

9. How the ground truth for the training set was established: Similar to point 8, not applicable for a physical device.

In summary, the provided document is a 510(k) clearance letter for a bone fixation screw, which establishes substantial equivalence to a predicate device based on design, materials, and intended use, not through a performance study that measures against specific acceptance criteria for an AI or software device.

Ask a specific question about this device

The SBi Titanium Threaded Pin is indicated for bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of bones appropriate for the size of the device.

The SBi Titanium Threaded Pin consists of a set of titanium threaded pins for internal fixation. Each threaded pin has a machined groove that provides a "break-away" capability. The devices are supplied non-sterile and are available in various sizes diameters and lengths.

The provided text is a 510(k) summary for the SBi Titanium Threaded Pin, seeking clearance from the FDA. This type of document focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a detailed study of device performance against specific acceptance criteria. Therefore, the information required to answer most of your questions is not typically found in this kind of regulatory submission.

Specifically, the document does not contain information about:

• A table of acceptance criteria and reported device performance.
• Sample sizes for a test set, data provenance, or details on retrospective/prospective studies.
• Number or qualifications of experts used to establish ground truth for a test set.
• Adjudication methods.
• Multi-reader multi-case (MRMC) comparative effectiveness studies or effect sizes.
• Standalone algorithm performance studies.
• The type of ground truth used (e.g., pathology, outcomes data).
• Sample size for a training set.
• How ground truth for a training set was established.

The 510(k) process primarily relies on demonstrating that a new device is as safe and effective as another legally marketed device (the predicate device) and that it has the same technological characteristics or has different technological characteristics but does not raise new questions of safety and effectiveness. This is typically achieved through comparisons of materials, design, indications for use, and often bench testing to confirm mechanical properties, rather than clinical studies with ground truth established by experts.

Summary of available information from the provided text:

• Device Name: SBi Titanium Threaded Pin
• Manufacturer: Small Bone Innovations International, SA
• Intended Use: The SBi Titanium Threaded Pin is indicated for bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of bones appropriate for the size of the device.
• Material: Ti-6Al-4V per ISO 5832-3
• Regulation Number: 21 CFR 888.3040 (Smooth or threaded metallic bone fixation fastener)
• Regulatory Class: Class II
• Product Code: JDW
• Substantial Equivalence: Documentation is provided which demonstrates the SBi Titanium Threaded Pin to be substantially equivalent to other legally marketed devices.

To answer your initial request directly, the document explicitly states: "Documentation is provided which demonstrates the SBi Titanium Threaded Pin to be substantially equivalent to other legally marketed devices." This statement is the "study" that proves the device meets the "acceptance criteria" of substantial equivalence required for 510(k) clearance. However, the details of that "documentation" (e.g., bench tests, materials safety data, design comparisons) are not provided in this summary. There is no performance data in the traditional sense of diagnostic accuracy or clinical outcomes presented here, as it's not a clinical trial summary.

Ask a specific question about this device

The SBi rHead Plating System is indicated for fractures of the proximal radius.

The SBi rHead Plating System consists of various plates and screws to treat fractures of the proximal radius. SBi plans to offer two plate designs: the rHead Neck Plate and the rHead Rim Plate. Both have a curved, T-shaped design to match the geometry of the proximal radius. Both will be available in a variety of neck widths, plate lengths, and hole geometries (threaded and non-threaded). Locking and non-locking screws will be included as part of the SBi rHead Plating System.

The provided document is a 510(k) summary for a medical device (SBi rHead Plating System). It is a regulatory submission for market clearance and does not contain information about acceptance criteria or a study proving that the device meets such criteria.

The document primarily focuses on:

• Device Description: The SBi rHead Plating System consists of plates and screws for proximal radius fractures.
• Intended Use: Fractures of the proximal radius.
• Material: Stainless steel.
• Substantial Equivalence: The manufacturer claims the device is substantially equivalent to other legally marketed devices, which is the basis for 510(k) clearance.

Therefore, I cannot provide the requested information from the given text as it is not present in the document. This type of submission relies on demonstrating similarity to existing devices, rather than presenting clinical or performance data against specific acceptance criteria.

Ask a specific question about this device

The SBi StaFIX is indicated for: . Fixation of fractures, osteotomies, and arthrodesis (fusion) in long and small bones. . Fixation of soft tissue to bone

The SBi StaFIX System consists of a set of stainless steel staples for internal fixation. The devices are supplied non-sterile and are available in several configurations and sizes.

The provided text is a 510(k) summary for the SBi StaFIX bone fixation system, a medical device. It describes the device, its intended use, and substantial equivalence to legally marketed predicate devices.

However, this document does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment relevant to the questions asked. It is a regulatory filing for market clearance based on substantial equivalence, not a detailed technical performance study report. Therefore, I cannot extract the requested information from the provided text.

Ask a specific question about this device

The RingFIXTM System is intended for:

1. fracture fixation (open and closed)
2. pseudarthrosis or nonunions of long bones
3. limb lengthening by epiphyseal or metaphyseal distraction
4. correction of bony or soft tissue deformities
5. correction of segmental bony or soft tissue defects

This Special 510(k) Submission is intended to add additional components to the RingFIX™ System

The provided text is a 510(k) Summary and an FDA clearance letter for the SBi RingFIX™ System. It focuses on establishing substantial equivalence to a predicate device and adding new components to an existing system.

Therefore, it does not contain the detailed information requested regarding acceptance criteria, specific device performance studies with sample sizes, expert involvement, ground truth establishment, or multi-reader multi-case studies typically associated with AI/software medical devices.

Medical devices like the SBi RingFIX™ System (a bone fixation appliance) are typically evaluated through different types of studies, such as:

• Mechanical Testing: To assess strength, fatigue, and other physical properties.
• Biocompatibility Testing: To ensure the materials are safe for use in the body.
• Sterilization Validation: To confirm the device can be effectively sterilized.
• Pre-clinical (animal) studies: In some cases, to assess performance in a living system.
• Clinical studies (human trials): For new or high-risk devices, to demonstrate safety and effectiveness in patients.

The 510(k) Summary states: "The Design Control Activities Summary demonstrates that the modified device met all of the pre-determined acceptance criteria. The modified RingFIX™ System will achieve the same stability as afforded by the currently available RingFIX™ System." This indicates that performance data exists, but the specifics are not included in this summary document.

Based on the provided text, I cannot complete the requested tables and sections as the information is not present. The document describes a "Special 510(k) Submission" intended to add additional components to an existing system, rather than a clinical trial for a novel device or an AI-powered one.

Ask a specific question about this device

The SBi Distal Radius Volar Plating System is intended for use in fixation of distal radial fractures. The implants are intended for one time use only

The SBi Distal Radius (DR) Plating System consists of plates and screws that provide internal fixation of the distal radius. The devices are supplied non-sterile and are available in various sizes and configurations. There are several plate configurations in right and left hand orientations. The System also includes an assortment of cortical and cancellous screws some of which can be locked into the plates at varying angles.

The provided text is related to a 510(k) premarket notification for a medical device: the SBi Distal Radius Volar Plating System. This document focuses on demonstrating substantial equivalence to a predicate device, which is a regulatory pathway for medium-risk medical devices in the US.

In the context of 510(k) submissions for such traditional devices, "acceptance criteria" and "device performance" are typically proven through bench testing (mechanical and material properties) and sometimes biocompatibility testing, rather than clinical studies involving human patients or complex AI algorithm evaluations. The "study" proving acceptance criteria here refers to these engineering tests.

Therefore, many of the requested points related to AI modeling, ground truth establishment, expert adjudication, and MRMC studies are not applicable to this type of device and submission.

Here's an breakdown based on the provided text:

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

The document broadly states "Documentation is provided which demonstrated the SBi Distal Radius Volar Plating System to be substantially equivalent to other legally marketed devices." This implies that the device's material properties, mechanical strength, and design features were tested and compared against established standards for existing legally marketed devices (predicates). Specific numerical acceptance criteria and performance results are not detailed in this summary document, as they would typically be in the full submission referenced.

However, given the nature of bone fixation systems, the acceptance criteria would generally fall into categories like:

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

• Test Set Sample Size: For mechanical testing (e.g., fatigue, static strength), samples typically involve a statistically significant number of devices, often 3-6 or more specimens for each test condition, to demonstrate statistical equivalence or compliance with standards. The exact number is not specified in this summary.
• Data Provenance: The tests would have been performed in a laboratory setting (e.g., by the manufacturer or a third-party testing facility). This is not human clinical data, so country of origin of data and retrospective/prospective distinctions are not applicable.

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

• Not Applicable. For mechanical testing, the "ground truth" is established by direct physical measurement according to validated test methods and standards (e.g., ASTM standards). It does not involve expert consensus in the way a clinical image interpretation would. Engineering and materials science experts would design and conduct the tests, but not "establish ground truth" in the clinical sense.

4. Adjudication method for the test set:

• Not Applicable. Adjudication relates to resolving discrepancies in expert opinions on clinical data. For bench testing, test results are objective measurements evaluated against pre-defined engineering specifications and standards.

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 traditional medical device (bone plate system), not an AI/CADe/CADx device. Therefore, no MRMC study involving human readers or AI assistance would have been performed.

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

• Not Applicable. This is a physical implant, not a software algorithm.

7. The type of ground truth used:

• For this device, the "ground truth" for proving acceptance criteria is based on established engineering standards, material specifications, and validated mechanical test methods. The direct measurement of physical and mechanical properties against these standards constitutes the ground truth. There is no clinical "ground truth" in the sense of pathology, expert consensus on imaging, or outcomes data used to establish the performance of the device itself (beyond clinical outcomes of the procedure the device is used in, which are generally not part of a 510(k) for devices like this).

8. The sample size for the training set:

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

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

• Not Applicable. As there is no training set.

Ask a specific question about this device