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510(k) Data Aggregation
(48 days)
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.
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. 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 decradation 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, and nonpyrogenic. The additional devices included in this submission are: 9 x 10mm, and 11 x 10 mm.
The OSSIOfiber® Compression Staples are designed to be used with commonly available orthopedic surgical tools such as ISO 9714 compatible instrumentations.
The provided document is a 510(k) Premarket Notification summary for the OSSIOfiber® Compression Staple. It describes the device, its intended use, and the non-clinical data used to demonstrate substantial equivalence to predicate devices. However, this document does not contain information related to an AI/ML-driven medical device, digital health software, or any study involving human readers or ground truth established by experts.
The primary focus of this submission is on the physical and mechanical properties of a medical implant (a compression staple) and its biocompatibility. The acceptance criteria discussed are related to the mechanical performance of the staple and its degradation profile.
Therefore, I cannot provide the requested information regarding:
- A table of acceptance criteria and reported device performance for an AI/ML device.
- Sample size used for a test set or data provenance for an AI/ML device.
- Number of experts used to establish ground truth or their qualifications.
- Adjudication method for a test set.
- Multi Reader Multi Case (MRMC) comparative effectiveness study or effect size.
- Standalone (algorithm only) performance.
- Type of ground truth used (expert consensus, pathology, outcomes data, etc.) for an AI/ML device.
- Sample size for the training set or how ground truth was established for a training set (as this is not an AI/ML device).
The document specifically mentions:
- Non-Clinical Data: "Static bending, bending fatique and pull-out testing were performed to verify the strength and fixation properties of the OSSIOfiber® Compression Staple, and to compare them to those of the primary predicate device, the OS2®-VP Varisation Staple (K153770). Testing on the subject device were done initially and following in-vitro degradation. The in-vitro degradation profile was characterized."
- Biocompatibility: "Biocompatibility for the implants was established primarily based on the referenced ISO 10993 data from the previously cleared predicate and reference devices (K212594, K203465) as well as a rationale."
These are standard engineering and biocompatibility tests for physical medical devices, not performance metrics for AI/ML algorithms.
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(242 days)
OSSIOfiber® Compression Screws are indicated for maintenance of alignment and fixation of bone fractures, comminuted fractures, fragments, osteotomies, 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. The screws are partially threaded and have a cannulated design. The additional devices included in this submission are: 65 - 100 mm long, and 6.5 mm diameter.
The OSSIOfiber® Compression Screws are designed to be used with commonly available orthopedic surgical tools such as ISO 5835/ISO 9714 compatible instrumentations.
This document describes a 510(k) premarket notification for the OSSIOfiber® Compression Screw, 6.5mm, which is a line extension (longer lengths) of a previously cleared device. The submission focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a study for a new diagnostic or AI-powered medical device. Therefore, many of the requested categories for AI/diagnostic device studies are not applicable to this submission.
Here's an analysis based on the provided text, indicating where information is not applicable (N/A) for this type of submission:
1. Table of acceptance criteria and the reported device performance:
Since this is a submission for a medical device (bone screw) based on substantial equivalence, the "acceptance criteria" are typically met by demonstrating that the new device has similar technological characteristics (material, design, intended use, etc.) to a legally marketed predicate and that any differences do not raise new questions of safety or effectiveness. Performance is typically established through non-clinical testing.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Intended Use | Same as predicate (K193660): Maintenance of alignment and fixation of bone fractures, comminuted fractures, fragments, osteotomies, and bone grafts, of the upper extremity, fibula, knee, ankle and foot in the presence of appropriate brace and/or immobilization. |
| Indications for Use | Same as predicate (K193660): Maintenance of alignment and fixation of bone fractures, comminuted fractures, fragments, osteotomies, and bone grafts, of the upper extremity, fibula, knee, ankle and foot in the presence of appropriate brace and/or immobilization. |
| Material Composition | Same as predicate (K193660): Degradable poly (L-lactide-co-D,L-lactide) (PLDLA) reinforced with continuous mineral fibers. |
| Design Characteristics | Same as predicate (K193660): Cannulated bone screws, partially threaded. New lengths: 65 - 100 mm long, 6.5 mm diameter (longer than previous cleared range). |
| Manufacturing and Sterilization Methods | Same as predicate (K193660). |
| Principles of Operation | Same as predicate (K193660). |
| New Performance Worst-Case | The additional lengths of the OSSIOfiber® Compression Screws, 6.5mm do not introduce a new performance worst-case relative to the cleared primary predicate. |
| Chemical Characterization | Completed; supports additional longer screw lengths. |
| Toxicological Risk Assessment | Completed; supports additional longer screw lengths. |
| Mechanical Performance Testing | Not performed for the subject lengths, as they "do not present a new worst case for the OSSIOfiber® Compression Screw family." The implication is that the performance of the predicate device is considered sufficiently representative or conservative for these longer lengths within the same family, or previous testing for the predicate already covered these mechanical aspects sufficiently. Previous testing likely included fatigue, torsional strength, bending strength, etc. |
| Similarities to Reference Device (K203105) | Additional longer lengths are similar to those of the Inion CompressOn™ Screw (K203105), which is cleared for similar indications and principles of operation/technological characteristics. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not applicable. This submission relies on non-clinical testing (chemical characterization, toxicological assessment) and comparison to a predicate device, not a test set for diagnostic accuracy with a specific sample size of patients.
- Data Provenance: The non-clinical data would typically originate from testing conducted by or for the manufacturer (Ossio Ltd. in Israel, per the address). The submission states "pre-clinical studies" for degradation, but details are not provided for the specific 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)
- Not applicable. There is no "ground truth" establishment in the context of an AI/diagnostic algorithm test set for this bone screw submission. The assessment is based on engineering principles, materials science, and regulatory comparison.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No diagnostic test set or adjudication process is mentioned.
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 for a physical medical device (bone screw), not an AI algorithm.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This is for a physical medical device (bone screw), not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable in the context of AI/diagnostic device ground truth. For this type of device, "ground truth" aligns with the established understanding of materials science, biomechanics, and the regulatory requirements for demonstrating safety and effectiveness of bone fixation devices, primarily through non-clinical testing and comparison to existing devices.
8. The sample size for the training set
- Not applicable. This is for a physical medical device (bone screw), not an AI algorithm.
9. How the ground truth for the training set was established
- Not applicable. This is for a physical medical device (bone screw), not an AI algorithm.
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