(79 days)
The Reconstruction Locking Plate and 3.5mm Locking Screw are used together and intended to treat fractures of various bones, including the clavicle and pelvis.
The proposed devices of Reconstruction Locking Plate and 3.5mm Locking Screw are intended to treat fractures of various bones, including the clavicle and pelvis. They are made of Titanium Alloy (Ti-6AL-4V), which meet ASTM F136, Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications, which are widely used for surgical implants with well known biocompatibility. The plates vary essentially through different lengths and number of plate holes. The screws are self-tapping with 3.5mm major diameter, which are applied with the reconstruction locking plates together. The proposed devices are not provided sterile. It is required to be sterilized via autoclave method to reach a SAL of 10 by the hospital prior to surgery. The sterilization method is presented in the user manual, which was validated per ISO 17665-1: 2006 Sterilization of health care products -- Moist heat -- Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices.
The provided text describes a 510(k) summary for a medical device called "Reconstruction Locking Plate and 3.5mm Locking Screw." This summary focuses on establishing substantial equivalence to a predicate device rather than detailing specific acceptance criteria and a study proving the device meets those criteria from an AI/algorithm performance perspective.
Here's an analysis based on the provided text:
Acceptance Criteria and Device Performance (as inferable from the document):
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Material Compliance: Meets ASTM F136 (Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications) | The proposed devices are made of Titanium Alloy (Ti-6AL-4V), which meets ASTM F136. |
| Biocompatibility: Demonstrated for surgical implants. | Titanium Alloy (Ti-6AL-4V) is widely used for surgical implants with well-known biocompatibility. |
| Sterilization: Achieves a Sterility Assurance Level (SAL) of $10^{-6}$ via autoclave method. | Sterilization method is presented in the user manual and validated per ISO 17665-1:2006. |
| Bench Test Performance: Meets design specifications and is Substantially Equivalent (SE) to the predicate device. | Bench tests were conducted to verify that the proposed device met all design specifications and was SE to the predicate device. |
| Standard Compliance (Metallic Bone Plates): Conforms to ASTM F382-99. | Test results demonstrated compliance with ASTM F382-99. |
| Standard Compliance (Metallic Medical Bone Screws): Conforms to ASTM F543-07. | Test results demonstrated compliance with ASTM F543-07. |
Study Information (Based on the document):
The document describes non-clinical (bench) testing, not a clinical study involving human subjects or AI performance. Therefore, many of your requested points are not applicable to this type of submission.
- Sample size used for the test set and the data provenance: Not applicable. The "test set" in this context refers to the physical devices undergoing bench tests. The document doesn't specify the number of plates/screws tested for each bench test, nor does it refer to data provenance in the sense of patient data.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for material and mechanical properties is typically established by laboratory measurements and adherence to engineering standards, not expert consensus in the medical image interpretation sense.
- Adjudication method for the test set: Not applicable. Bench tests follow standardized protocols.
- 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/algorithm device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/algorithm device.
- The type of ground truth used: For the bench tests, the ground truth is the specified mechanical properties, material composition, and sterilization efficacy as defined by the referenced ASTM and ISO standards. These are objectively measurable physical properties.
- The sample size for the training set: Not applicable. This is not an AI/algorithm device.
- How the ground truth for the training set was established: Not applicable. This is not an AI/algorithm device.
Summary of the Study described in the document:
The study was a series of non-clinical bench tests conducted to demonstrate that the "Reconstruction Locking Plate and 3.5mm Locking Screw" met its design specifications and was substantially equivalent to a predicate device (Syntec Osteo - plate and screw Fixation).
- Tests Performed: The document explicitly mentions tests verifying compliance with:
- ASTM F382-99 (Standard Specification and Test Method for Metallic Bone Plates)
- ASTM F543-07 (Standard Specification and Test Methods for Metallic Medical Bone Screws)
- Material Verification: The device's material (Ti-6AL-4V) was confirmed to meet ASTM F136, indicating biocompatibility.
- Sterilization Validation: The sterilization method (autoclave) was validated per ISO 17665-1:2006 to ensure a SAL of $10^{-6}$.
The purpose of these tests was to show that the new device performs similarly and safely to a legally marketed predicate device, thereby supporting the 510(k) clearance process based on "Substantial Equivalence." There is no mention of AI, human readers, or clinical data in this submission summary.
§ 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.