(60 days)
The PRO-TOE® Hammertoe Fixation Systems are indicated for the fixation of ostectomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe, and mallet toe.
Cannulated Implants in the PRO-TOE® Hammertoe Fixation Systems, with the PRO-TOE® X-FLEX, can be used with Implantable K-wires for the delivery of implants or the temporary stabilization of outlying joints (e.g. MTP Joint),
The Implantable K-Wires are indicated for use in fixation of bone reconstructions, and as guide pins for insertion of other implants. Additionally, Implantable K-Wires are indicated for the fixation of osteotomies and reconstruction of the lesser toe following correction procedures for hammertoe, claw toe, mallet toe, and metatarsophalangeal joint instability.
The PRO-TOE® Hammertoe Fixation System is composed of implants and instruments intended for use in the fixation or reconstruction of the lesser toes. The implants within the PRO-TOE® Hammertoe System have proximal & distal fixation features and are offered in multiple sizes. The implants are manufactured from stainless steel and titanium alloy.
This FDA 510(k) summary describes a medical device, the PRO-TOE® Hammertoe Fixation System - C2 Implant Line Addition. It is a premarket notification for a new version of an existing device, adding new sizes and updating design. As such, the submission focuses on demonstrating substantial equivalence to previously cleared devices rather than providing a detailed study of its performance against acceptance criteria in the way a novel device might.
Here's an analysis of the provided text based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical Performance (Implicit): The device should be structurally sound and capable of performing its intended function without new worst-case scenarios related to mechanical failure. This is inferred from the type of device (bone fixation) and the tests mentioned. | "Analysis related to pullout and static bend testing has shown that the subject implants do not present a new worst case." This indicates that the new implants perform comparably to or better than the predicate devices in terms of pullout strength and resistance to bending. |
| Equivalence to Predicate Devices (Implicit): The new device should perform at least as well as, and not raise new questions of safety or effectiveness compared to, the predicate device. | "The design characteristics of the subject devices do not raise any new types of questions of safety or effectiveness. From the evidence submitted in this 510(k), the subject devices can be expected to perform at least as well as the predicate systems and are substantially equivalent." |
Explanation: In a 510(k) submission for a device modification, the "acceptance criteria" are often implicitly tied to demonstrating equivalence to an existing legally marketed device (the predicate). The primary acceptance criterion is that the new device is "substantially equivalent" to the predicate, meaning it performs as intended and does not raise new questions of safety or effectiveness. The reported performance here directly addresses this by stating that the mechanical testing (pullout and static bend) confirms the absence of a new worst-case scenario and that the device is expected to perform "at least as well" as the predicate.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated in terms of a specific number of implants or test repetitions for the pullout and static bend testing. The analysis refers to "the subject implants" generally.
- Data Provenance: The document (a 510(k) summary) does not specify the country of origin of the data. The testing described would typically be conducted in a laboratory setting, likely at the manufacturer's facility or a contracted testing lab. The study is non-clinical.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This information is not applicable to this type of submission. The "ground truth" for mechanical testing is based on engineered specifications and established test methods, not expert consensus on interpretations of data or images. The "experts" would be the engineers and technicians performing and interpreting the mechanical tests.
4. Adjudication Method for the Test Set
- Not applicable. Adjudication methods (like 2+1, 3+1) are used for situations involving human interpretation (e.g., medical imaging, clinical assessments) where there might be disagreement among reviewers. Mechanical test results are typically objective measurements.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
- No. An MRMC study is a clinical study involving multiple human readers assessing medical cases, often to compare diagnostic accuracy or treatment effectiveness. This submission for a bone fixation system modification relies on non-clinical (mechanical) testing and demonstration of substantial equivalence, not a clinical MRMC study.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. This device is a physical implant, not a software algorithm.
7. The Type of Ground Truth Used
- Engineering Specifications and Standardized Test Methods: The "ground truth" for the non-clinical testing (pullout and static bend) would be defined by established engineering principles, material science, and relevant ASTM/ISO standards for mechanical testing of medical implants. The performance is compared against the known performance of the predicate devices.
8. The Sample Size for the Training Set
- Not applicable. This refers to a physical medical device, not a machine learning algorithm.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. This refers to a physical medical device, not a machine learning algorithm.
Summary and Key Takeaways from the Document:
This 510(k) filing for the PRO-TOE® Hammertoe Fixation System - C2 Implant Line Addition is characteristic of a submission for a device modification rather than a completely novel device or an AI/software as a medical device (SaMD). The core of the submission is to demonstrate substantial equivalence to existing predicate devices (K132895 and K140148).
Therefore, the focus is on:
- Comparing the technological characteristics (materials, design, intended use).
- Presenting non-clinical evidence (mechanical testing like pullout and static bend) to show that the modified device performs at least as well as the predicate and does not introduce new safety concerns ("do not present a new worst case").
- Explicitly stating that no clinical evidence (human studies) was required for this demonstration of substantial equivalence.
The requested information about experts, adjudication, MRMC studies, standalone algorithm performance, and training/test set sample sizes (in the context of AI/ML) is generally not relevant to this type of device and 510(k) submission.
§ 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.