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The OSSIOfiber® Interference Screws, are indicated for fixation of tissue, including ligament or tendon to bone, or a bone/tendon to bone 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. Interference fixation is appropriate for surgeries of the knee, shoulder, elbow, ankle, foot, and hand/wrist where the sizes offered are patient appropriate; Specifically:

• Shoulder: Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
• Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair, Flexor Hallucis Longus for Achilles Tendon reconstruction, tendon transfers in the foot and ankle
• Knee: Repair/Reconstruction of the Anterior Cruciate Ligament, Posterior Cruciate Ligament, Medial Collateral Ligament, Lateral Collateral Ligament, Patellar Tendon, Posterior Oblique Ligament, Iliotibial Band Tenodesis, MPFL
• Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collament Reconstruction
• Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction, Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty), Carpal Ligament Reconstructions and repairs, tendon transfer in the hand/wrist

The OSSIOfiber® Interference Screw is an orthopedic implant made of poly (L-lactide-co-D,L-lactide) (PLDLA) reinforced with continuous mineral fibers. The OSSIOfiber® Interference Screws are cannulated and fully threaded, available in diameters ranging from 6 to 12 mm and lengths from 23 to 28 mm. The polymer content degrades by hydrolysis into alpha-hydroxy acids that are metabolized by the body. 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 implantation site. 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® Interference Screw is supplied sterile, for single patient use only.

The OSSIOfiber® Interference Screw is designed to be used with commonly available orthopedic surgical tools such as ISO 9714 compatible instrumentation such as ISO 9714 compatible instrumentations.

This document does not describe a study that uses AI or machine learning. It describes a medical device called the OSSIOfiber® Interference Screw and its clearance through the FDA 510(k) process. This process focuses on demonstrating substantial equivalence to a legally marketed predicate device, primarily through non-clinical (laboratory/mechanical) testing rather than clinical studies with human subjects or AI performance evaluations.

Therefore, many of the requested categories for AI/ML study acceptance criteria and performance data cannot be filled from the provided text.

Here's an analysis of what information can be extracted or inferred from the text related to the device's acceptance criteria and study, with explanations for the missing AI/ML specific data:

Device: OSSIOfiber® Interference Screw

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) clearance letter does not specify explicit numerical acceptance criteria in the typical format (e.g., "pull-out strength > X N"). Instead, it states that the device was found to be "at least as safe and effective" and demonstrated "at least equivalent performance" to the predicate devices. The performance is assessed comparatively.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not explicitly stated. The document mentions "Pull-out testing," "Torsional strength," and "driving torque testing" but does not provide the number of samples tested for each.
• Data Provenance: The studies are "non-clinical data" and "in-vitro degradation." This implies laboratory testing rather than human clinical data. The country of origin of the data is not specified, but the submitter is "Ossio Ltd." in Caesarea, Israel. The studies are prospective in the sense that they were conducted for the purpose of this 510(k) submission, not gathered retrospectively from patient treatments.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

Not applicable. This information is relevant for studies involving human interpretation (e.g., image analysis by radiologists). The described studies are non-clinical (mechanical and biocompatibility testing). Ground truth in this context would be defined by standard engineering and biocompatibility testing protocols, not expert consensus.

4. Adjudication Method for the Test Set

Not applicable. No adjudication method is described because the studies are non-clinical engineering tests.

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 medical device clearance based on non-clinical performance and substantial equivalence, not an AI/ML diagnostic or assistive software. There is no AI component described.

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

Not applicable. This section is for AI/ML algorithms. No such algorithm is described.

7. The Type of Ground Truth Used

For mechanical testing (pull-out, torsional strength, driving torque): The "ground truth" is established by direct physical measurement according to validated test methods and engineering standards. The performance of the predicate device serves as the benchmark for comparison.

For biocompatibility: Ground truth is established by the results of ISO 10993 testing, which uses established biological endpoints and criteria.

8. The Sample Size for the Training Set

Not applicable. This is for AI/ML studies. No training set is mentioned as there is no AI/ML component.

9. How the Ground Truth for the Training Set Was Established

Not applicable. This is for AI/ML studies.

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The OSSIOfiber® Suture Anchors 2.5-3.5 mm, are intended to be used for suture or tissue fixation in the foot, ankle, knee, hand, wrist, elbow, and shoulder, 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. Specific indications are listed below:

• Shoulder: Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, AcromioClavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction

• Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus reconstruction, Digital Tendon Transfers, Mid-foot Reconstruction

• Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis, Joint Capsule Closure

• Hand/Wrist: Scapholunate Ligament Reconstruction, Carpal Ligament Reconstructions, Repair/Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP, and MCP joints for all digits, Digital Tendon Transfers

• Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondylitis Repair (Tennis Elbow)

The OSSIOfiber® Suture Anchor 2.5-3.5 mm, consists of an anchor preloaded on an inserter. The anchor is made from 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 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 2.5-3.5mm are supplied sterile, for single patient use only.

The OSSIOfiber® Suture Anchors 2.5-3.5mm are designed to be used with commonly available orthopedic surgical tools such as ISO 9714 compatible instrumentations.

The provided text is an FDA 510(k) clearance letter and its associated 510(k) Summary. It describes a medical device, the OSSIOfiber® Suture Anchor 2.5-3.5 mm, and its substantial equivalence to predicate devices, rather than a study proving the device meets specific acceptance criteria based on performance metrics that would typically apply to AI/ML or diagnostic devices.

The document focuses on demonstrating substantial equivalence for a physical implantable device, which relies on comparing its technological characteristics (intended use, materials, design, principles of operation, manufacturing, sterilization) and performance (mechanical testing, biocompatibility) to already cleared devices. It does not involve a diagnostic or predictive algorithm, thus many of the criteria requested (e.g., test set sample size, expert ground truth, MRMC study, standalone performance) are not applicable.

Here's an analysis based on the information provided, highlighting the differences in context:

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

Since this is a physical medical device clearance, the "acceptance criteria" are not reported as specific numerical benchmarks for diagnostic performance (like sensitivity or specificity). Instead, they relate to demonstrating comparable safety and effectiveness through a combination of:

• Technological Characteristics: The device must have substantially similar or identical intended use, principles of operation, material composition, design, manufacturing, and sterilization methods as predicate devices.
• Performance (Non-Clinical): Mechanical properties (strength, fixation) and biological response (biocompatibility) must be at least equivalent to the predicate device.

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

• Test Set Sample Size: The document does not specify a "test set sample size" in the context of diagnostic performance. For mechanical testing, the number of devices or constructs tested for static and cyclic pull-out is not explicitly stated. The "in-vitro degradation profile" was characterized, but the sample size for this is also not given.
• Data Provenance: The mechanical testing and degradation characterization were performed "in-vitro." Biocompatibility was established based on ISO 10993 data from previously cleared devices and rationales. This suggests laboratory-based testing and references to existing, accepted data.

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

This question is not applicable. The device is a surgical implant, not a diagnostic tool requiring expert interpretation of images or data to establish a "ground truth" for a test set. The "ground truth" for a device like this would be established through established engineering and biological standards and clinical experience with predicate devices.

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

This is not applicable as there is no diagnostic or interpretive test set requiring adjudication in this context.

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

This is not applicable. This is not an AI-assisted diagnostic device, and therefore, no MRMC study or AI assistance effect size is relevant or mentioned.

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

This is not applicable. This is a physical implantable device, not an algorithm.

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

For this type of device, the "ground truth" is typically defined by:

• Established engineering standards: Performance metrics like pull-out strength, cyclic fatigue, and degradation rates are measured against accepted industry standards or the performance of legally marketed predicate devices, which are deemed safe and effective.
• Biocompatibility standards: Compliance with ISO 10993 series for biological evaluation of medical devices, which typically involves in-vitro and/or in-vivo testing, leading to a conclusion of acceptable biological risk.
• Clinical history of predicate devices: The "ground truth" for safety and effectiveness is largely based on the long-term clinical use and acceptance of the predicate technologies (similar design, materials, surgical indications).

8. The sample size for the training set:

This is not applicable. There is no concept of a "training set" for this type of physical medical device in the context of this 510(k) submission.

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

This is not applicable, as there is no training set.

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The OSSIOfiber® Compression Staple is indicated for fixation of arthrodesis, osteotomies and fractures in hand or foot surgery 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 number and size of the OSSIOfiber® Compression Staples must be adapted to the indication.

The OSSIOfiber® Compression Staple is a fixation implant made of degradable poly (L-lactide-co-D, Llactide) (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 Staples are supplied sterile, for single patient use only. They are available in several sizes: 9-25 mm bridge lengths, and 10-22 mm leg lengths. The OSSIOfiber® Compression Staples are designed to be used with commonly available orthopedic surgical tools such as ISO 9714 compatible instrumentations.

The provided text is a 510(k) summary for a medical device (OSSIOfiber® Compression Staple) and does not describe a study involving an AI/Machine Learning device or a diagnostic algorithm. It is a submission for a physical orthopedic implant seeking to expand its indications for use to include pediatric patients, based on substantial equivalence to previously cleared devices.

Therefore, I cannot extract the information requested regarding acceptance criteria, device performance, sample sizes, expert ground truth, MRMC studies, or standalone algorithm performance, as these concepts are not relevant to this type of device submission.

The document discusses:

• Device: OSSIOfiber® Compression Staple (an orthopedic implant)
• Purpose of Submission: To add pediatric patient populations (children 2-12 years and adolescents 12-21 years) to the indications for use.
• Basis for Clearance: Substantial equivalence to previously cleared predicate devices (K212594, K233302) and an additional predicate (K210582), as well as reference devices (K231272).
• Non-Clinical Data: Biocompatibility was established in prior clearances and referenced from other devices. No additional mechanical performance testing was deemed necessary because the expanded indication did not present a "new worst case" compared to already cleared predicates.

In summary, the information requested is not present in the provided text because the device and its submission type do not involve an AI/ML component or diagnostic testing that would require such performance evaluation metrics.

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OSSIOfiber® Threaded Trimmable Fixation Nails 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 in adults and children (2-12 vears) 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 fixation implants made of degradable poly (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 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® 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 surgical tools such as ISO 9714 compatible instruments.

Based on the provided text, the device in question is the OSSIOfiber® Threaded Trimmable Fixation Nail, which is a bone fixation implant. The 510(k) submission primarily focuses on adding compatible instrumentation and demonstrating substantial equivalence to predicate devices, rather than presenting a study proving a software-based device meets specific acceptance criteria related to diagnostic performance (e.g., sensitivity, specificity, or human-in-the-loop performance with AI).

The document details physical and mechanical properties of a medical implant and its equivalence to previously cleared devices. Therefore, many of the requested criteria for a study proving device performance (especially those related to AI/software, expert readers, ground truth establishment, training sets, etc.) are not applicable to this type of device and submission.

However, I can extract the relevant information regarding the device's "performance" in the context of this submission, which primarily involves mechanical testing and biocompatibility.

Here's a breakdown based on the information provided, reinterpreting "acceptance criteria" and "study" in the context of a bone fixation implant and a 510(k) submission for an instrument change:

Device: OSSIOfiber® Threaded Trimmable Fixation Nail

Type of Submission: Traditional 510(k) premarket notification for additional compatible instrumentation.

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

For this type of device, "acceptance criteria" relates to mechanical and material performance rather than diagnostic accuracy. The document states:

"Although there are differences between the subject device and the additional predicate device in regards to design, mechanical pull-out testing demonstrated at least equivalent performance both initially and after in vitro degradation." |
| Biocompatibility | "Biocompatibility and magnetic resonance (MR) safety compatibility was established within the primary predicate submission (K233198)." (Implies, and met, the criteria from the predicate device). |
| Substantial Equivalence to Predicate Devices (Overall Safety & Effectiveness) | "The OSSIOfibe® Threaded Trimmable Fixation Nails are as safe and effective as their predicate devices."

"Non-clinical testing data demonstrate that the OSSIOfiber® Threaded Trimmable Fixation Nails are at least as safe and effective as their predicate devices (K233198, K203465, K231272). Thus, the OSSIOfiber® Threaded Trimmable Fixation Nails are substantially equivalent to it's predicate devices." |

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

• Sample Size: The document does not specify the exact number of samples (nails/implants) used for the mechanical pull-out testing. It only states "Mechanical pull-out testing was performed."
• Data Provenance: The testing appears to be non-clinical (laboratory-based) as it refers to "in-vitro degradation." There is no mention of human or animal study data provenance (e.g., country of origin, retrospective/prospective). This is typical for mechanical testing of implants.

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

• Not Applicable. This is a mechanical/biocompatibility study of an implant, not a study involving human interpretation of medical images or data. Therefore, no experts (e.g., radiologists) were used to establish ground truth for a test set in the diagnostic sense.

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

• Not Applicable. See point 3. This concept applies to human interpretation of data, not to mechanical testing.

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 a software/AI-assisted diagnostic device. No comparative effectiveness study with human readers was performed.

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

• Not Applicable. This is not an algorithm-based device. No standalone algorithm performance was assessed.

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

• For mechanical testing, the "ground truth" is typically the measured physical properties of the materials and devices under controlled conditions, compared against established engineering standards or predicate device performance.
• For biocompatibility, the "ground truth" is established through testing against relevant ISO standards (e.g., ISO 10993) which define acceptable biological responses. The document states biocompatibility was "established within the primary predicate submission (K233198)," implying it met the required standards.

8. The sample size for the training set

• Not Applicable. This is not a machine learning/AI device, so there is no concept of a "training set" in this context.

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

• Not Applicable. See point 8.

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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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