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OSSIOfiber® Threaded Trimmable Fixation Nails are indicated for maintenance of alignment and fixation of bone fractures, comminuted fractures, fragments, osteotomies, arthrodesis, and bone grafts, of the upper extremity, fibula, knee, ankle and foot in the presence of appropriate brace and/or immobilization in adults and children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by fixation.

The OSSIOfiber® Threaded Trimmable Fixation Nails are threaded cannulated bone implants made of degradable poly (L-lactide-co-D, L-lactide) (PLDLA) reinforced with continuous mineral fibers. The polymer content degrades by hydrolysis into alpha-hydroxy acids that are metabolized by the body. The fibers are made of minerals that are found in natural bone. As the OSSIOTiber® implants degrade, the load transfers to the surrounding anatomy throughout the healing period of the osteotomy, fusion, or fracture. Substantial degradation takes place within approximately 18 months as shown in pre-clinical studies, thus eliminating the requirement for future hardware removal surgery.

The OSSIOfiber® Threaded Trimmable Fixation Nails are supplied sterile, for single patient use only. The implants are available in several sizes and designs.

The OSSIOfiber® Threaded Trimmable Fixation Nails are designed to be used with commonly available orthopedic surqical tools such as ISO 9714 compatible instruments.

This document is a 510(k) premarket notification decision letter from the FDA regarding a medical device, the OSSIOfiber® Threaded Trimmable Fixation Nail. This type of document does not contain information about AI/ML device performance or the study designs for evaluating such performance.

The content focuses on:

• Device Classification: Class II, regulated under 21 CFR 888.3040 (Smooth or threaded metallic bone fixation fastener).
• Predicate Devices: Identifying previously cleared devices (Inion FreedomScrew™, OSSIOfiber® Compression Screw, etc.) for comparison.
• Device Description: Material composition (degradable poly (L-lactide-co-D, L-lactide) reinforced with continuous mineral fibers), degradation properties, and sterile single-use nature.
• Indications for Use: Maintenance of alignment and fixation of bone fractures, comminuted fractures, fragments, osteotomies, arthrodesis, and bone grafts in upper extremity, fibula, knee, ankle, and foot for adults and children/adolescents.
• Non-Clinical Data: Mentions mechanical testing (pull-out, flexural bending, torsional strength, driving torque) and biocompatibility studies (based on ISO 10993) to demonstrate equivalence to predicate devices, especially regarding initial performance and after in-vitro degradation. It also mentions chemical characterization and toxicological risk assessment for pediatric use.
• Conclusion: The FDA determined the device is substantially equivalent to its predicate devices based on non-clinical testing.

Therefore, I cannot provide the requested information regarding acceptance criteria, AI/ML study design, sample sizes, expert ground truth, MRMC studies, or standalone algorithm performance, as these details are not present in the provided text. This document is a regulatory approval letter, not a clinical or technical study report.

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OSSIOfiber® Cannulated Trimmable Fixation Nails are indicated for maintenance of alignment and fixation of bone fractures, osteotomies, arthrodesis, and bone grafts in the presence of appropriate additional immobilization (e.g. rigid fixation implants, cast, brace).

The OSSIOfiber® Cannulated Trimmable Fixation Nails are fixation devices made of degradable poly (L-lactide-co-D,L-lactide) (PLDLA) reinforced with continuous mineral fibers. The polymer content degrades by hydrolysis into alpha-hydroxy acids that are metabolized by the fibers are made from materials that are found in natural bone. As the OSSIOfiber® implants degrade, the load transfers to the surrounding anatomy throughout the healing period of the osteotomy, fusion, or fracture. Substantial degradation takes place within approximately 18 months as shown in pre-clinical studies, thus eliminating the requirement for future hardware removal surgery.

The OSSIOfiber® Cannulated Trimmable Fixation Nails are cannulated, supplied sterile, for single patient use only, and non-pyrogenic. The additional device included in this submission is 100 mm long and 3.5mm core diameter (4.0 mm outer diameter).

The OSSIOfiber® Cannulated Trimmable Fixation Nails are designed to be used with commonly available orthopedic surqical tools such as ISO 9714 compatible instrumentations.

This document does not describe acceptance criteria or a study proving that the device meets those criteria. Instead, it is an FDA 510(k) clearance letter for a medical device called the OSSIOfiber® Cannulated Trimmable Fixation Nail.

The core of this submission is to demonstrate substantial equivalence to a previously cleared predicate device (K203465), rather than proving performance against specific acceptance criteria through new clinical or non-clinical studies.

Here's why the requested information cannot be extracted from the provided text:

• No Acceptance Criteria or Performance Data: The document explicitly states: "Non-clinical performance testing was not performed as the subject device does not represent a new mechanical performance worst-case for the OSSIOfiber® Cannulated Trimmable Fixation Nail cleared family." This means the submission did not include new studies to generate performance data for this particular longer nail length against new acceptance criteria.
• Focus on Substantial Equivalence: The entire submission hinges on the claim that the new device (a longer version of an existing nail) has "the same intended use, indications for use, material composition, design characteristics, manufacturing and sterilization methods and principles of operation as the predicate device (K203465)." Because of this, new performance studies were deemed unnecessary by the manufacturer and accepted by the FDA for this specific 510(k) submission.
• No AI Component: The device described is a physical medical implant (a bone fixation nail), not an AI/ML-driven diagnostic or therapeutic device. Therefore, concepts like acceptance criteria for AI performance, training/test sets, expert ground truth establishment, MRMC studies, or standalone algorithm performance are not relevant to this submission.

In summary, the provided text does not contain the information required to answer your prompt because the 510(k) submission for this device did not involve new performance studies with acceptance criteria, as it was based on demonstrating substantial equivalence to a predicate device.

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The OSSIOfiber® Suture Anchors are indicated for fixation of suture (soft tissue) to bone in the shoulder, footlankle, knee, hand/wrist, and elbow in the following procedures:

• Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction.
• I Foot/Ankle: Lateral Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair and Bunionectomy.
• I Knee: Anterior Cruciate Ligament Repair (4.75-5.5 Anchors Only), Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Illiotibial Band Tenodesis and Quadriceps Tendon Repair. Secondary or adjunct fixation of ACL/PCL reconstruction or repair (4.75 - 5.5 Anchors only).
• . Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction.
• . Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondylitis repair (Tennis Elbow).

The OSSIOfiber® Suture Anchor consists of an eyelet and anchor body preloaded on an inserter. The anchor body and eyelet are made from poly (L-lactide-co-D,L-lactide) (PLDLA) reinforced with continuous mineral fibers. OSSIOfiber® implants have been shown to be biocompatible. The polymer content degrades by hydrolysis into alpha-hydroxy acids that are metabolized by the fibers are made from minerals that are found in natural bone. As the OSSIOfiber® implants degrade, the load transfers to the surrounding anatomy throughout the healing period of the bone. Substantial degradation takes place within approximately 18 months as shown in pre-clinical studies, thus eliminating the requirement for future hardware removal surgery. Sutures, needles and suture snare may also be provided with the device depending on configuration.

The OSSIOfiber® Suture Anchors are sterile, single-use, and non-pyrogenic.

The provided text is a 510(k) summary for the OSSIOfiber® Suture Anchor, a medical device. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving a device (like an AI model) meets acceptance criteria based on performance metrics such as sensitivity, specificity, or reader improvement.

Therefore, I cannot provide the information requested in your prompt based on the provided text, as the document describes a mechanical medical device (suture anchor) and its non-clinical testing for substantial equivalence, not a study involving AI or human reader performance.

The request asks for details like:

• A table of acceptance criteria and reported device performance (in terms of AI metrics)
• Sample size and data provenance for a test set
• Number and qualifications of experts for ground truth
• Adjudication methods
• MRMC comparative effectiveness study results (AI vs. human)
• Standalone algorithm performance
• Type of ground truth used (e.g., pathology, outcomes)
• Training set sample size and ground truth establishment

None of this information is present in the provided 510(k) summary for the OSSIOfiber® Suture Anchor, which is a physical implant, not a diagnostic AI device. The "non-clinical data" section pertains to mechanical tests (static pull-out, cyclic pull-out, torsional strength, driving torque, insertion testing) and biocompatibility, which are relevant for a suture anchor but not for the type of AI-driven diagnostic device your prompt describes.

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The OSSIOfiber® Staple is indicated for fixation of arthrodesis, osteotomies in hand or foot surgery in the presence of appropriate brace and/or immobilization.

The number and size of the OSSIOfiber® Staples must be adapted to the indication.

The OSSIOfiber® Staple is a fixation implant made of degradable poly (L-lactide) (PLDLA) reinforced with continuous mineral fibers. OSSIOfiber® implants have been shown to be biocompatible. The polymer content degrades by hydrolysis into alpha-hydroxy acids that are metabolized by the body. The fibers are made of minerals that are found in natural bone. As the OSSIOfiber® implants degrade, the load transfers to the surrounding anatomy throughout the healing period of the osteotomy, fusion, or fracture. Substantial degradation takes place within approximately 18 months as shown in pre-clinical studies, thus eliminating the requirement for future hardware removal surgery.

The OSSIOfiber® Staples are supplied sterile, for single patient use only, and non-pyrogenic. They are available in several sizes: 11-25 mm bridge lengths, and 15-22 mm leg lengths.

The OSSIOfiber® Staples are designed to be used with commonly available orthopedic surgical tools such as ISO 9714 compatible instrumentations.

This document, K212594, is a 510(k) Premarket Notification for the OSSIOfiber® Staple. It outlines the FDA's determination of substantial equivalence to a legally marketed predicate device. This document focuses on the mechanical and material properties of the absorbable staple, not on an AI/ML-driven device or study involving human readers analyzing images. Therefore, many of the requested points regarding AI/ML study design, reader performance, ground truth establishment for AI training sets, etc., are not applicable to the content of this document.

However, I can extract information related to the device's performance based on non-clinical data and the rationale for its acceptance.

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

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

The document does not provide a direct table of numerical "acceptance criteria" against "reported performance" for the device in the typical AI/ML context (e.g., sensitivity, specificity thresholds). Instead, it states that the device's performance was evaluated through non-clinical mechanical testing and compared to a predicate device. The acceptance criterion is "at least equivalent performance" to the predicate.

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

This document details non-clinical laboratory testing of mechanical properties, not a clinical study on human subjects or an AI/ML test set. Therefore, concepts like "test set sample size" (in terms of patient data) and "data provenance" (country of origin, retrospective/prospective) are not applicable. The testing was conducted in a laboratory setting. The specific number of samples for each mechanical test (e.g., number of staples tested for bending) is not detailed in this summary, but standards like ASTM F564-17 typically specify minimum sample sizes for such tests.

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)

This is not applicable as the device is an implant, and the testing involves mechanical and material properties, not interpretation of medical images or data by experts to establish a "ground truth" for an AI model. "Ground truth" here refers to the measured physical properties of the device.

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

Not applicable. This is not an AI/ML study involving human readers and adjudicated interpretations. Mechanical tests have objective outputs (e.g., force, displacement, cycles to failure).

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 medical device (an absorbable staple), not an AI-driven diagnostic or assistive tool, and therefore 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 AI algorithm. The "standalone performance" refers to the intrinsic mechanical properties of the device itself.

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

For the mechanical testing, the "ground truth" is defined by the measured physical properties (e.g., ultimate bending strength, fatigue life, pull-out force) determined through standardized laboratory tests (e.g., ASTM F564-17). For biocompatibility, the ground truth is established by compliance with ISO 10993 standards and a rationale.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires training data.

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

Not applicable. As above, this is not an AI/ML device.

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OSSIOfiber™ Compression Screws are indicated for maintenance of alignment and fixation of bone fractures, comminuted fractures, fragments, arthrodesis, and bone grafts, of the upper extremity, fibula, knee, ankle and foot in the presence of appropriate brace and/or immobilization.

The OSSIOfiber™ Compression Screws are cannulated bone screws made of degradable poly (Llactide-co-D. L-lactide) (PLDLA) reinforced with continuous mineral fibers. The polymer content degrades by hydrolysis into alpha-hydroxy acids that are metabolized by the fibers are made from minerals that are found in natural bone. As the OSSIOfiber™ implants degrade, the load transfers to the surrounding anatomy throughout the healing period of the osteotomy, fusion, or fracture. Substantial degradation takes place within approximately 18 months as shown in pre-clinical studies, thus eliminating the requirement for future hardware removal surgery.

The OSSIOfiber™ Compression Screws are supplied sterile, for single patient use only, and are available in several sizes: 26-60 mm long, and 3.5-6.5 mm diameter. The screws are partially threaded, cannulated design.

The OSSIOfiber™ Compression Screws are designed to be used with commonly available orthopedic surgical tools such as ISO 5853/ISO 9714 compatible instrumentations.

The provided text describes the OSSIOfiber™ Compression Screw and its substantial equivalence to a predicate device, focusing on non-clinical testing for mechanical properties and biocompatibility. It does not contain information about a study involving acceptance criteria related to device performance in an AI/software context.

Therefore, I cannot fulfill the request as it pertains to acceptance criteria, a study proving device meets acceptance criteria, sample sizes for test/training sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance, as these details are not present in the provided document for this medical device.

The document focuses on the regulatory clearance process for a physical medical device (bone screw) based on demonstrating substantial equivalence through mechanical testing and biocompatibility assessment, not on a software or AI-driven device requiring performance metrics like sensitivity, specificity, or reader studies.

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