(87 days)
Properly used, in the presence of adequate immobilization, absorbable SmartNail™ is intended for use in the fixation of fragments of fractured non-load bearing bones, osteotomies and arthrodeses, for example in the fixation of apical fragments, osteochondral fragments and cancellous/non-load bearing fragments. The SmartNail™ includes an arthroscopic applicator set. The arthroscopic applicator set consists of Handle, Tip, Piston, House, Wrench, Drill bit and K-wires.
The SmartNail™ is not intended for use in and is contraindicated for: 1) Fractures and osteotomies of cortical bone (except cortical bones of the foot and the hand), 2) Fractures and osteotomies in weight bearing cancellous bone, 3) Situations where internal fixation is otherwise contraindicated, e.g., active or potential infection and where patient co-operation cannot be guaranteed (e.g. alcoholism), 4) Treatment of physeal fractures in children, because the effect of SmartNail™ upon the healing of growth plate has not been tested clinically.
The SmartNail™ is provided with a diameter of 1.5 mm and lengths of 16, 20 and 25 mm. 5 barbs, placed at intervals of 1.5 mm on two sides of the SmartNail™, prevent the implanted SmartNail™ from slipping out. The SmartNail™ is made of polylactide homopolymer and polylactide copolymer materials with strength retention time 20-50 weeks.
This 510(k) summary (K993074) for the Bionx Implants Inc. SmartNail™ does not contain information about acceptance criteria or a study demonstrating device performance against such criteria.
The provided document is a 510(k) premarket notification for a medical device. This type of submission focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving a device meets specific performance acceptance criteria through clinical or analytical studies in the way an AI/ML device submission would.
Here's why the requested information is not present and what the document does provide:
- Type of Device: The SmartNail™ is an "Absorbable Bone Fixation Nail," a physical implant, not a software-as-a-medical-device (SaMD) or an AI/ML diagnostic tool. Therefore, the usual metrics like sensitivity, specificity, AUC, or reader studies are not applicable.
- Purpose of 510(k): The primary goal of a 510(k) is to show that a new device is as safe and effective as a predicate device, as stated in the "Substantial Equivalence" section. This is typically achieved by comparing design, materials, manufacturing processes, intended use, and sometimes non-clinical performance data (e.g., mechanical strength, degradation properties) to the predicate.
- "Study that proves the device meets the acceptance criteria": For a physical implant like the SmartNail™, this would typically involve biocompatibility testing, mechanical testing (e.g., tensile strength, bending strength), and potentially animal studies or limited human clinical data to support safety and performance. However, these are generally presented as justification for substantial equivalence, not as a direct "performance study" with a defined acceptance criterion table in the summary. The summary mentions "strength retention time 20-50 weeks," which relates to performance, but no comparative data or acceptance criteria are provided in this specific document excerpt.
Therefore, I cannot populate the table or answer the specific questions related to acceptance criteria, sample sizes, experts, adjudication, MRMC studies, or ground truth as these concepts are not addressed in this 510(k) summary for a physical implant.
The provided document details the following:
- Device Name: SmartNail™
- Submitter Information: Bionx Implants Inc.
- Date Prepared: September 2nd, 1999
- Classification Name: Bone Fixation Nail
- Product Code: IDS
- Predicate Devices:
- Intended Use: Fixation of fragments of fractured non-load bearing bones, osteotomies, and arthrodeses (e.g., apical fragments, osteochondral fragments, cancellous/non-load bearing fragments). Includes an arthroscopic applicator set.
- Contraindications: Fractures/osteotomies of cortical bone (except foot/hand), fractures/osteotomies in weight-bearing cancellous bone, situations where internal fixation is contraindicated (e.g., infection, patient non-cooperation), and physeal fractures in children.
- Device Description:
- Diameter: 1.5 mm
- Lengths: 16, 20, 25 mm
- Features: 5 barbs placed at 1.5 mm intervals on two sides to prevent slipping.
- Material: Polylactide homopolymer and polylactide copolymer materials.
- Strength Retention Time: 20-50 weeks.
- Substantial Equivalence Rationale: Stated to be substantially equivalent to predicate devices due to same intended use, principles of operation, and very similar technological characteristics. Minor technological differences do not raise new safety or effectiveness issues.
- FDA Decision: The FDA found the device "substantially equivalent" and permitted it to be marketed (dated December 10, 1999).
§ 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.