(15 days)
The bone plate and screw system is intended for use in providing fixation during fractures, fusions and osteotomies. The system consists of plates and screws for treatment of the phalanges, and metatarsals.
The Nexa Orthopedics bone plate and screw system of plates and screws made of Stainless Steel (316L) and Titanium (6AL-4V ELI) intended to be implanted into the bones of the foot, ankle, hand, wrist, ulna and radius. The plates are provided in 4 sizes, right and left configuration. The screws are provided in 2 diameters 2.7 and 3.2 and lengths from 12-28 mm. The plates and screws are used for fracture fixation, fusion, and osteotomy of the bones of the foot.
This document is a 510(k) premarket notification for the Nexa bone plate and screw system, dated December 22, 2005. It focuses on establishing substantial equivalence to a predicate device rather than detailing specific performance criteria or a comprehensive clinical study report. Therefore, much of the requested information regarding acceptance criteria and a study proving those criteria cannot be directly extracted from this document in the typical sense of a modern medical device clinical study report.
However, I can extract and infer information relevant to the context of a 510(k) submission at that time, focusing on how the device demonstrates substantial equivalence rather than meeting specific quantifiable performance targets like sensitivity/specificity for an AI algorithm.
1. A table of acceptance criteria and the reported device performance
In the context of the 2005 510(k) for this device, "acceptance criteria" and "reported device performance" are primarily about demonstrating substantial equivalence to the predicate device. The performance is assessed by comparing design characteristics, material, and intended use. The "acceptance criteria" are implied to be that the new device is as safe and effective as the predicate based on these comparisons.
| Item | Acceptance Criteria (Implied for Substantial Equivalence) | Reported Device Performance (Nexa Orthopedics System) |
|---|---|---|
| Product Name | Must function as a bone plate and screw system. | Nexa bone plate and screw system |
| Use | Single use. | Single use. |
| Fixation | Method of fixation should be screw-based. | Screw. |
| Material | Industry standard materials used for bone plates and screws (e.g., Stainless Steel, Titanium). No new materials introduced. | Stainless Steel (316L) and Titanium (6AL-4V ELI). Acknowledged as "industry standard materials." |
| Sizes | Must be available in appropriate sizes for intended application (phalanges, metatarsals). Sizes within the expected range for predicate devices or with justification. | Plates: 4 sizes, right and left. Screws: dia 2.7mm, 3.2mm, length 12-28mm. (Predicate: Plates 2 sizes, Screws length 8-24mm - Nexa offers more sizes, which is noted but not considered a deviation from equivalence for this type of device). |
| Indications for Use | Intended for fixation during fractures, fusions, and osteotomies of the phalanges and metatarsals, similar to predicate. The scope of indications must be substantially equivalent. | "The bone plate and screw system is intended for use in providing fixation during fractures, fusions and osteotomies. The system consists of plates and screws for treatment of the phalanges, and metatarsals." (This aligns with the predicate's general intent for foot bones). |
| Biocompatibility (Implied) | Must be biocompatible, as expected for implantable devices made of standard materials. | Not explicitly stated in this summary, but implied by the use of "industry standard materials" (316L Stainless Steel and Ti 6AL-4V ELI), which are well-established for biocompatibility in implantable devices. |
| Mechanical Strength (Implied for Fixation) | Must provide adequate mechanical strength for fracture fixation, fusions, and osteotomies, comparable to predicate devices. | Not explicitly detailed in this summary, but "similar design characteristics" and "fixation" suggest comparable mechanical properties derived from similar materials and design principles to the predicate. |
Study that proves the device meets the acceptance criteria:
The document describes a comparison to a predicate device as the "study" demonstrating that the device meets the implied acceptance criteria for substantial equivalence.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not applicable in the context of this 510(k) submission. This is not a study assessing clinical performance with a "test set" of patient data or images in the way an AI/software device would. The "test" here is the comparison of device specifications and intended use against a legally marketed predicate device.
- Data Provenance: Not applicable. The "data" consists of device specifications, materials, and intended use as described by the manufacturer in comparison to public information about the predicate device.
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)
- Number of Experts: Not applicable. There is no "ground truth" establishment by external experts for a test set in this type of submission. The "ground truth" for substantial equivalence is the information presented by the applicant and evaluated by the FDA reviewer.
- Qualifications of Experts: FDA reviewers (e.g., in the Orthopedic Reviewing Panel, Office of Device Evaluation) would analyze the information, but they are not establishing a clinical "ground truth" for a dataset.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable. There is no test set requiring expert adjudication.
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
- MRMC Study: No, absolutely not. This is a 510(k) for a physical orthopedic implant (bone plate and screw system), filed in 2005. MRMC studies, especially those involving AI assistance, are relevant to diagnostic imaging algorithms or CAD systems, which are completely different device types.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance Study: No. This is a physical implant. There is no "algorithm" to evaluate.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: The "ground truth" in this context is the established safety and effectiveness of the legally marketed predicate device (Wright Medical Charlotte Small MTP Fusion Plate), and the demonstration that the new device is substantially equivalent to it based on shared technological characteristics, materials, and intended use. There is no clinical "ground truth" dataset in the sense of patient outcomes or pathology.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. This is not a machine learning or AI device.
9. How the ground truth for the training set was established
- Ground Truth for Training Set Establishment: Not applicable.
Summary for the context of this 2005 510(k) for an orthopedic implant:
The "acceptance criteria" here implicitly revolve around demonstrating that the Nexa bone plate and screw system is substantially equivalent to its predicate device (Wright Medical Charlotte Small MTP Fusion Plate) in terms of:
- Intended use
- Device materials
- Design characteristics
- Principles of operation
The "study" that proves the device meets these acceptance criteria is the comparative analysis presented in the 510(k) submission, specifically the "Comparison to Predicate Device" section. This comparison highlights similarities in all critical aspects (use, fixation, material, general indications for use, and manufacturing standards) between the proposed device and the predicate. The FDA's issuance of the 510(k) clearance (DEC 22 2005) serves as the "proof" that the device met these implicit acceptance criteria for substantial equivalence.
§ 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.