(143 days)
The In2Bones USA LLC, Fracture and Correction System plates and screws are intended to treat fractures and non-unions of the 5th metatarsal.
The Fracture and Correction System lag screws are intended to be used as screws, or in a plate-screw system for internal bone fraction for bone fractures, fusionies and non-unions of various bones, including humerus, radius, uha, tibia, calcaneus, fibula, and small bones (metacarpals, metatarsals, and phalanges).
The In2Bones Fracture and Correction System is a system of plates, screws and washers used to treat fracture and reconstruction of the bones of the extremities.
The provided text describes the regulatory clearance for the "In2Bones Fracture and Correction System," a medical device consisting of plates, screws, and washers used for bone fixation. However, the document does not contain information about acceptance criteria, device performance metrics, or study design details in the way requested by the prompt (e.g., sample size, expert qualifications, adjudication method, MRMC studies, standalone performance, ground truth establishment, or training set details).
This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices, primarily through performance data confirming the mechanical properties of the device rather than clinical or AI algorithm performance.
Here's what can be extracted from the document regarding "performance data," albeit not in the format of AI algorithm acceptance criteria:
1. Table of Acceptance Criteria and Reported Device Performance
As per the document, the device underwent various mechanical tests to demonstrate its substantial equivalence to predicate devices. The specific acceptance criteria (e.g., minimum torque values, maximum displacement under load) are not explicitly stated in this summary but are implied by the statement that the testing "demonstrate[s] that the device is substantially equivalent to the predicate devices identified."
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| (Not explicitly stated, but expected to meet or exceed predicate performance for mechanical properties) | * Pyrogenicity testing performed and successful |
| * Static driving torque testing performed and successful | |
| * Static pullout testing performed and successful | |
| * Static torsion testing performed and successful | |
| * Static bending testing performed and successful | |
| * Fatigue bending testing performed and successful | |
| Overall: Substantially equivalent to predicate devices based on these tests | Overall: Device demonstrated substantial equivalence to predicate devices K123241, K983495, K131920, and K160174 |
Missing Information (Regarding the original prompt's questions):
The document does not provide details for the following requested items as they are not relevant to a 510(k) submission for a mechanical bone fixation system:
- Sample size used for the test set and the data provenance: Not applicable in the context of mechanical testing. "Test set" here refers to physical device samples, not 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 mechanical properties is established by engineering standards and measurements, not medical expert consensus.
- Adjudication method: Not applicable.
- If a multi reader multi case (MRMC) comparative effectiveness study was done: No. This is not an AI-assisted diagnostic device, but a surgical implant.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No. This is not an AI algorithm.
- The type of ground truth used: For mechanical tests, the ground truth is derived from engineering measurements and established standards.
- The sample size for the training set: Not applicable. This is not an AI algorithm.
- How the ground truth for the training set was established: Not applicable. This is not an AI algorithm.
Summary from the provided text:
The In2Bones Fracture and Correction System demonstrated "substantial equivalence" to identified predicate devices (K123241, K983495, K131920, K160174) by undergoing mechanical performance testing, including pyrogenicity, static driving torque, static pullout, static torsion, static bending, and fatigue bending tests. The results of these tests (namely, that the device performed adequately to be deemed substantially equivalent) are reported, but the specific numerical acceptance criteria or detailed outcomes of each test are not provided in this 510(k) summary. The device's "acceptance criteria" were met by establishing that its technological characteristics and performance were comparable to legally marketed predicate devices, ensuring its safety and effectiveness.
§ 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.