(84 days)
The Osteo 4.0mm Cannulated Screw System is indicated for osteochrondritis dissecans, ligament fixation, and long and small bone fracture fixation, which may include the following:
- Fractures of the olecranon, distal humerus .
- Fractures of the ulna and radius .
- Patellar fractures .
- . Distal tibia and pilon fractures
- Fractures of the tarsals and metatarsals .
- Tarso-metatarsal and metatarso-phalangeal arthrodeses .
- . Metatarsal and phalangeal osteotomies
- Fractures of the posterior wall of the acetabulum and other fractures of the pelvic ring .
- Fractures of the fibula, medial malleolus, and os calcis .
- Other small fragment, cancellous bone fractures .
The Osteo 4.0mm Cannulated Screw System consists of 4.0mm thread diameter self-tapping cannulated screws of varying lengths and one washer, the use of which is optional. All components of the system are provided sterile and non-sterile. The screw and washer are manufactured from Titanium 6Al-4V ELI alloy. The screw has a thread diameter of 4.0mm. The washer has an outer diameter of 7.0mm and an inner diameter of 4.0mm. The surfaces of the screws and washers are anodized with a Type II coating.
This 510(k) premarket notification for the "Osteo 4.0mm Cannulated Screw System - Expanded Indications" primarily focuses on establishing substantial equivalence to previously marketed devices. It does not contain information typically found in studies designed to prove a device meets specific acceptance criteria through performance evaluation.
Therefore, many of the requested sections (Table of Acceptance Criteria, Sample sizes, Number of experts, Adjudication method, MRMC study, Standalone performance study, Ground truth type, Training set sample size, Training set ground truth) cannot be extracted from the provided text because the document describes a regulatory submission based on equivalence, not a direct performance study.
Here's a breakdown of what can be inferred and what is explicitly missing:
Acceptance Criteria and Device Performance
This document does not present specific acceptance criteria or performance data for the Osteo 4.0mm Cannulated Screw System in the way a clinical or technical study would. Instead, its "acceptance" is based on substantial equivalence to predicate devices already on the market.
Implicit "Acceptance Criteria": The device is considered "accepted" by the FDA if it is substantially equivalent to legally marketed predicate devices, meaning it holds the same intended use and technological characteristics, and raises no new questions of safety or effectiveness.
Reported Device "Performance": The document lists the intended uses (indications) for the device, which are presented as being equivalent to those of the predicate devices. No specific quantitative performance metrics (e.g., strength, durability, clinical success rates) are reported as part of a study in this document.
Missing Information (Not present in the provided text):
-
A table of acceptance criteria and the reported device performance: This document does not define explicit acceptance criteria or report performance against such criteria. Its entire premise is substantial equivalence.
-
Sample size used for the test set and the data provenance: No test set is described for performance evaluation. The equivalence is based on comparing the device's design and intended use to predicate devices.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth establishment related to a test set is discussed.
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable as no test set for performance evaluation is described.
-
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 a physical medical device (screws), not an AI-powered diagnostic tool. Therefore, an MRMC study is not relevant and not discussed.
-
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable as this is a physical medical device.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): No ground truth for performance evaluation is established or mentioned.
-
The sample size for the training set: Not applicable as this is a physical medical device, not a machine learning model.
-
How the ground truth for the training set was established: Not applicable.
What the document does provide regarding the regulatory "study" (review process):
- Basis for "Proof": The document argues for substantial equivalence by comparing the "Osteo 4.0mm Cannulated Screw System" to the "Richards 4.0mm Cannulated Screw" and the "4.0mm cannulated screws in the ACE Medical Titanium 3.5/4.0mm Small Fragment System." This comparison forms the "study" equivalent for a 510(k) submission seeking regulatory clearance.
- Key Comparison Points:
- Device Description: Both the subject device and predicate devices are 4.0mm thread diameter cannulated screws of varying lengths. The subject device also includes an optional washer.
- Material: Both are manufactured from Titanium 6Al-4V ELI alloy.
- Intended Use/Indications: The subject device's indications for use are expanded but are presented as being in keeping with those of other legally marketed cannulated screws, including the specific indications for the predicate devices (e.g., fractures of the fibula, os calcis, medial malleolus). The expanded indications are also for long and small bone fracture fixation, osteochrondritis dissecans, and ligament fixation, covering various anatomical sites.
- Technological Characteristics: The submission explicitly states the subject components "are substantially equivalent in design and intended use to the predicate devices offered by Richards and ACE Medical."
In essence, the "study" described is a regulatory comparison demonstrating substantial equivalence rather than a scientific performance study with defined acceptance criteria and experimental results.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.