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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).

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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.

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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.

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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.

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The SBI Radio-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: 1) non-inflammatory degenerative joint disease including osteo-arthritis or traumatic arthritis; 2) inflammatory degenerative joint disease including rheumatoid arthritis; 3) correction of functional deformity; 4) revision procedures where other treatments and devices have failed; and 5) treatment of fractures that are unmanageable using other techniques. The SBI Lateral Assembly Radio-Capitellar implant is intended for cemented use only.

The SBI Lateral Radio Capitellar Implant provides an alternative to hemi-arthroplasty of the proximal radial head. The implant is used for the treatment of degenerative joint disorders of the radio-capitellar joint allowing activities of daily living to be performed with no or significantly reduced pain. The radio-capitellar implant is designed to be used with the radial stem components of the rHead and rHead Recon stem implants cleared for market under 510(k) K011819 and K023604 respectively.

This document is a 510(k) summary for the SBI Lateral Radio Capitellum, an elbow joint prosthesis. It outlines the device's description, intended use, materials, and its substantial equivalence to previously marketed devices. However, it does not contain the information required to answer the questions about acceptance criteria and study details.

The provided text does not include any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert adjudication, or comparative effectiveness studies (MRMC or standalone). This document is a regulatory submission for premarket notification (510(k)), which focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance study results against specific acceptance criteria.

Therefore, I cannot provide the requested table and study details based solely on the input given.

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