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.
This Premarket Notification is to add 5.0mm Tibial Locking Screws in 20 to 24mm lengths, 5.0 mm Talar Screws with Threaded Head in 40 to 44mm lengths, and 6.0mm Calcaneal Locking Screws with Threaded Head in 50 to 68mm lengths to the system.

This 510(k) premarket notification is for a modification to an existing device, the SBi Anatomic Ankle Arthrodesis Interlocking Nail System. The submission is to add shorter lengths of existing screw types (5.0mm Tibial Locking Screws, 5.0 mm Talar Screws with Threaded Head, and 6.0mm Calcaneal Locking Screws with Threaded Head) to the system.

Given that this is a "Special 510(k)" submission for a modification to existing, substantially equivalent devices, the nature of the "acceptance criteria" and "study" described in the provided text focuses on demonstrating that the modified devices maintain substantial equivalence to the predicate devices. It's not a performance study of a novel AI device with specific accuracy or sensitivity metrics.

Here's an analysis based on the provided text, addressing your questions where applicable:

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

For a Special 510(k) seeking to modify an existing device, the "acceptance criteria" revolve around demonstrating that the modification does not negatively impact the safety and effectiveness of the device compared to its predicate. The "reported device performance" reflects that these criteria were met.

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

This submission does not involve clinical studies with human test sets or data provenance in the way an AI diagnostic device would. The "study" here is a bench testing and engineering rationale.

• Test Set Sample Size: Not applicable in the traditional sense. The "test set" would be the modified screw components themselves, which are physically tested or analyzed through engineering principles. The document doesn't specify a number of screws fabricated and tested, but rather refers to an "Engineering Rationale" which implies calculations and potentially physical testing of representative samples.
• Data Provenance: Not applicable. The "data" comes from engineering analysis, material properties, and potentially physical bench testing conducted by the manufacturer.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. "Ground truth" for this type of modification is established by engineering principles, accepted material standards (ASTM F136), and regulatory requirements for medical devices. There are no radiologists or clinical experts involved in establishing "ground truth" for the mechanical properties or sterilization validity of the screws.

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

Not applicable. This is not a clinical study involving human interpretation or consensus. The "adjudication" is implicitly the regulatory review process by the FDA, where their experts evaluate the provided engineering rationale and bench test results against established standards to determine substantial equivalence.

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

Not applicable. This is not an AI device, and no MRMC study was conducted.

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

Not applicable. This is not an algorithm or AI device.

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

The "ground truth" for this modification is based on:

• Engineering mechanics (e.g., bending load calculations)
• Materials science (e.g., ASTM F136 standard for TiAl6V4 titanium)
• Sterilization validation principles (e.g., impact of mass on sterilization parameters)
• Regulatory requirements for demonstrating substantial equivalence to a predicate device.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that requires a training set.

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

Not applicable. There is no training set for this device.

Summary of the Study:

The "study" in this context is an Engineering Rationale and Bench Testing (or analysis), rather than a clinical trial. The manufacturer submitted documentation demonstrating that the modified screws (shorter versions of existing screws) maintain or improve upon the safety and effectiveness of the predicate screws. This was achieved by providing:

• Material equivalence: Showing the new screws use the identical, implantable grade titanium as the predicate.
• Design equivalence: Confirming that the critical design features (head, diameters, thread) are identical, with only length being varied.
• Mechanical assessment: An engineering rationale that concluded shorter screws would experience lower bending loads (an improvement) compared to longer ones of the same minor diameter.
• Sterilization assessment: An engineering rationale that concluded the reduced total mass of the modified configuration ensured existing sterilization parameters remained valid.

Based on this engineering rationale and bench testing, the FDA determined the modified device (SBi Anatomic Ankle Arthrodesis Interlocking Nail System with the added shorter screws) was substantially equivalent to the predicate device (K112982).

Ask a specific question about this device

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

Indications for use when used with a hemi-elbow implant:

The SBi rHead Radial Head is indicated for use in replacement of the radial head for degenerative, or post-traumatic disabilities presenting pain, crepitation and decreased motion at the radiohumeral and or proximal radio-ulnar joint with:

• . Joint destruction or subluxation visible on x-ray
• Resistance to conservative treatment .

Primary replacement after fracture of the radial head

• . Symptomatic sequelae after radial head resection
• Revision following failed radial head arthroplasty .

Indications for use when used with a uni-elbow implant:

The SBi Radial-Capitellar Implant is indicated for use in the elbow for reduction or relief of pain and/or improved elbow function in skeletally mature patients with the following conditions:

• Non-inflammatory degenerative joint disease including osteo-arthritis or traumatic arthritis
• . Inflammatory degenerative joint disease including rheumatoid arthritis
• Correction of functional deformity .
• Revision procedures where other treatments and devices have failed and .
• . Treatment of fractures that are unmanageable using other technologies

The SBirHead, tHead Lateral, and rHead Recon prostheses are implants that are intended to replace the proximal end of the radius. The implants consist of two (2) parts, the head and a stem, which fit together. The rHead™ Standard is designed with a Morse taper coupling mechanism to firmly attach the head onto the stem. The rHead™ RECON is designed with a "ball/socket" (bipolar) coupling mechanism between the head and stem which adds an element of alignment flexibility. The rHead™ Lateral is designed using a dovetail coupling mechanism.

The stem is made from a Cobalt Chrome alloy (CoCrMo) with or without a powder titanium (Ti) coating. The radial stem geometry is designed to anatomically fit within the intramedullary canal. The intramedullary surfaces of the stem are roughened to assist in optimal fixation. A version of the stem may be plasma sprayed with a powder titanium coating to further assist in optimal fixation. The extended stem provides additional fixations where excess bone loss due to trauma has occurred. Stems are for cemented or uncemented use when used with the rHead heads.

Each component is supplied in various sizes to support the differences in human anatomies. Each implant can be used in either the right or left arm and the heads and stems are modular.

rHead Radial Head Extended Stems are made from a Cobalt Chrome alloy (CoCrMo) with or without a powder titanium (Ti) coating. rHead Radial Head Extended Stems are configured to fit the rHead, rHead Recon, and rHead Lateral heads as well as rHead, rHead Recon, and rHead Lateral heads that fit the Radial Capitellum radial head implants.

The rHead, rHead Lateral, and rHead Recon prostheses are used with trials and surgical instruments including a sterilization tray.

The implants are intended for single use only.

The provided text is a 510(k) Premarket Notification Summary for the SBi rHead™ Radial Head Extended Stems. It primarily focuses on demonstrating substantial equivalence to predicate devices and detailing the device's description, intended use, and materials.

However, this document does NOT contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.

Therefore, I cannot provide the requested table and study details. The document states that "Documentation is provided which demonstrated the SBi rHead™ Radial Head Extended Stems to be substantially equivalent to other legally marketed SBi devices," but it does not elaborate on what that documentation entails in terms of performance studies.

Based on the provided text, the answer to your request is that the document does not contain the information needed to describe acceptance criteria and associated performance study details.

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 Mini Rail External Fixation System is intended for fixation, compression, and distraction osteo-genesis of small bones, such as metacarpal and metatarsal. The system also includes the instruments with which to place the pins and assemble the construct. A tray is available for conveying and storing the system. The system is not intended for spinal use.

The SBi Mini Rail External Fixation System is indicated for use in external fixation of fractures and/or reconstruction of small bones, including metacarpal and metatarsal.

The SBi Mini Rail External Fixation System consists of pins of various diameters and lengths as well as the rails and accessories with which to connect and stabilize them. The system also includes instruments to implant the pins and connect the external components. A tray is included to store and transport the set. The devices are supplied non-sterile.

This document, K093550, is a 510(k) premarket notification for the "SBi Mini Rail External Fixation System". It primarily focuses on demonstrating substantial equivalence to a predicate device and obtaining FDA clearance for marketing.

Therefore, the document does not contain the detailed clinical study information typically associated with establishing acceptance criteria and proving device performance through a study, especially for AI/algorithm-based devices.

The provided text describes a medical device (an external fixator) and its intended use, materials, and substantial equivalence to a prior device. It's a regulatory submission for product clearance, not a study report or a document detailing performance metrics.

Based on the provided text, I cannot extract the requested information regarding acceptance criteria and the study proving the device meets them because such information is not present in this type of FDA submission.

Here's a breakdown of why each specific point cannot be addressed from the given document:

1. A table of acceptance criteria and the reported device performance: This document does not describe performance metrics or acceptance criteria for the device in the way you would expect for an AI algorithm study. It describes the physical device, its components, and its intended use, rather than quantifiable performance outcomes from a study.
2. Sample size used for the test set and the data provenance: No clinical or performance study data (test set, training set) is presented. The document states a modified device is equivalent to a cleared predicate (K964094), implying the basis for clearance is engineering and material equivalence, not clinical performance study data in the typical sense for AI.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as there is no test set or ground truth described for an AI/algorithm.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable, as there is no test set or ground truth described for an AI/algorithm.
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 describes a physical medical device (external fixator), not an AI diagnostic or aid.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable, as there is no ground truth described for an AI/algorithm.
8. The sample size for the training set: Not applicable, as there is no training set mentioned.
9. How the ground truth for the training set was established: Not applicable, as there is no training set mentioned.

In summary, the provided document is a regulatory submission for a physical medical device based on substantial equivalence, and it does not contain the information required to answer your questions regarding acceptance criteria and study data for an AI or imaging diagnostic tool.

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 Forefoot Set is indicated for bone fixation of the hand and foot following trauma or osteotomy.

The SBi Forefoot Set consists of screws and washers that provide internal fixation of bones. The devices are supplied non-sterile and are available in various sizes and configurations.

I am sorry, but the provided text is a 510(k) summary for a medical device (SBi Forefoot Set), which is a regulatory document submitted to the FDA to demonstrate substantial equivalence to a legally marketed predicate device. This type of document does not typically contain information about specific acceptance criteria and the detailed study results you've requested regarding device performance, sample sizes, ground truth establishment, or clinical comparative effectiveness studies.

The document primarily focuses on:

• Identifying the manufacturer and device.
• Classifying the device and its product code.
• Stating its intended use and materials.
• Asserting its substantial equivalence to other legally marketed devices.

Therefore, I cannot extract the following information from the provided text:

1. A table of acceptance criteria and the reported device performance: This information is not present. The document declares substantial equivalence, implying the device meets performance standards similar to predicates, but doesn't detail those standards or specific performance metrics.
2. Sample size used for the test set and the data provenance: Not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
4. Adjudication method for the test set: Not mentioned.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: Not mentioned.
6. If a standalone performance study was done: Not mentioned.
7. The type of ground truth used: Not mentioned.
8. The sample size for the training set: Not applicable, as this is a physical medical device (screws and washers for bone fixation), not an AI/software device that would have a "training set."
9. How the ground truth for the training set was established: Not applicable for the same reason as above.

The 510(k) process for devices like the SBi Forefoot Set typically relies on mechanical testing, material specifications, and comparison to predicate devices, rather than clinical efficacy studies involving "test sets" with "ground truth" established by experts in the context of an AI/software device.

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