(109 days)
- Fracture and osteotomy fixation and joint arthrodesis of the hand and foot.
- Fixation of proximal tibial metaphysis osteotomy
- Hand and foot bone fragment and osteotomy fixation and joint arthrodesis
- Fixation of small bone fragments (i.e. small fragments of bone which are not comminuted to the extent to preclude staple placement). These fragments may be located in long bones such as the femur, fibula, and tibia in the lower extremities; the humerus, ulna or radius in the upper extremities; the clavicle and in flat bone such as the pelvis, scapula and sternum.
The TiTHON Staples with OsseoTi Technology are long-term fixation staple implants. TiTHON Staples are available in widths of 15, 20 and 25mm, with leg lengths of 7, 10, 15, 20and 20mm. OsseoTi is a porous metal construct made of a Ti-6Al-4V alloy. The porous architecture mimics the porous structure of human cancellous bone.
This document is a 510(k) premarket notification for a medical device called the "TiTHON Staple with OsseoTi Technology." This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing extensive clinical efficacy studies typically seen for novel devices.
Therefore, many of the requested categories related to clinical study design, acceptance criteria for performance, and ground truth establishment will not be directly available or applicable in the way they would be for an AI/algorithm-based device.
Here's the information extracted and interpreted based on the provided text:
1. A table of acceptance criteria and the reported device performance
For a 510(k) submission for a bone staple, acceptance criteria and performance are typically evaluated through non-clinical mechanical testing, demonstrating that the device meets established regulatory standards and performs comparably to the predicate device.
| Acceptance Criteria (Expected Performance) | Reported Device Performance |
|---|---|
| Meet ASTM F564 Standard Specification and Test Methods for Metallic Bone Staples (mechanical properties) | Mechanical testing performed in keeping with ASTM F564. |
| Biocompatibility (implied requirement for implantable devices) | Materials: Manufactured from titanium alloy (Ti-6Al-4V) - generally considered biocompatible for implantable devices. |
| Sterility (expected for implantable devices) | Provided sterile by gamma irradiation. |
Note: The document states "No clinical testing was provided to establish substantial equivalence." Therefore, there are no reported clinical performance metrics like sensitivity, specificity, accuracy, or similar for this type of device.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable. The submission relies on non-clinical mechanical testing and comparison of technological characteristics to a predicate device, rather than clinical data from human subjects. Therefore, there is no "test set" in the context of clinical data, no country of origin of data, and no retrospective or prospective study design.
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 information is not applicable. Ground truth, in the context of expert consensus, is typically for evaluating diagnostic or predictive algorithms. For a bone staple, "ground truth" relates to its material properties and mechanical performance, which are evaluated through standardized laboratory tests, not expert consensus on clinical cases.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable. There is no clinical test set requiring adjudication. Mechanical testing results are objective measurements against a standard.
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 information is not applicable. This is a medical device (bone staple), not an AI algorithm. Therefore, no MRMC study, human readers, or AI assistance is involved.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable. This is a medical device (bone staple), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For this device, the "ground truth" for demonstrating safety and effectiveness relies on:
- Mechanical testing standards (ASTM F564): The properties and performance characteristics of the staple are compared to the requirements and established performance norms defined in this standard.
- Material specifications: The composition (Ti-6Al-4V alloy) and structure (porous metal construct mimicking cancellous bone) are characterized and assessed against established knowledge for implantable materials.
- Predicate device characteristics: The technological characteristics (intended use, indications, materials, design, sterilization) are directly compared to a legally marketed predicate device (Speed™, Speed Shift™, Speed Titan™, Speed Arc™ - Biomedical Enterprises, Inc. -K142292), implying that if the new device is functionally identical or superior without raising new safety concerns, it is "proven" to be safe and effective.
8. The sample size for the training set
This information is not applicable. This is a medical device (bone staple), not an AI algorithm. There is no "training set."
9. How the ground truth for the training set was established
This information is not applicable. There is no "training set" or need for ground truth establishment in that context for this device.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.