(23 days)
The Extremity Medical Calcaneal Osteotomy Device is intended for fixation of osteotomies of the calcaneus.
The Calcaneal Osteotomy Device is a bone fixation device consisting of a bracket and lag screws and a set of instruments used for implant site preparation and delivery. The bracket is offered in height sizes of 6mm to 13mm. The modified device allows for placement of the implant with 3 lag screws. The Calcaneal Osteotomy Device is intended for fixation of osteotomies of the calcaneus.
Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the Extremity Medical Calcaneal Osteotomy Device.
This document describes a 510(k) premarket notification for a medical device. For such submissions, the acceptance criteria and study data are primarily focused on demonstrating substantial equivalence to a previously legally marketed predicate device, rather than proving absolute safety and effectiveness through extensive clinical trials as might be required for a PMA (Premarket Approval).
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (What was tested for "equivalence") | Reported Device Performance |
|---|---|
| Pull-out strength (mechanical property) | Tested and demonstrated equivalence to the predicate device. |
| Torque strength (mechanical property) | Tested and demonstrated equivalence to the predicate device. |
| Bending strength (mechanical property) | Tested and demonstrated equivalence to the predicate device. |
| Material composition | Equivalent to the predicate device. |
| Design (bracket, lag screws, instruments) | Equivalent to the predicate device, with a modification allowing 3 lag screws. |
| Indications for Use | The same as the predicate device: "fixation of osteotomies of the calcaneus." |
| Principles of Operation | Equivalent to the predicate device. |
2. Sample Size Used for the Test Set and Data Provenance
The document states: "Pull-out, torque and bending strength was assessed compared to the predicate device and worse case constructs have been tested to demonstrate equivalence."
- Sample Size: The exact number of samples tested for pull-out, torque, and bending strength is not specified in this document. It mentions "worse case constructs," implying a targeted selection of samples that represent the most challenging scenarios for the device's mechanical integrity.
- Data Provenance: The testing appears to be retrospective (or in-vitro testing for regulatory submission) and conducted by the manufacturer, Extremity Medical, LLC. The country of origin for the data is not explicitly stated but can be inferred as the United States, where the company is located and where the submission was made to the FDA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not applicable to this submission. The "ground truth" for demonstrating substantial equivalence here is based on engineering and mechanical testing standards, not expert clinical consensus or interpretation of patient data. The mechanical tests compare the new device's performance to the known performance of the predicate device.
4. Adjudication Method for the Test Set
This is not applicable. The "adjudication method" primarily applies to human interpretation tasks, such as in clinical trials or diagnostic image readings where multiple experts might disagree. For mechanical testing, the results are typically quantitative and assessed against predefined engineering specifications or direct comparison to predicate device performance.
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
This is not applicable. An MRMC study is relevant to diagnostic or screening devices, often involving AI, to assess the impact on human reader performance. This device is a surgical implant (bone fixation fastener) and does not involve human readers or AI in its direct application or evaluation for this submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not applicable. This device is a physical surgical implant, not an algorithm or an AI system. Therefore, standalone algorithm performance is not a relevant concept here.
7. The Type of Ground Truth Used
The "ground truth" for this regulatory submission is established through:
- Mechanical Testing Results: Data from pull-out, torque, and bending strength tests.
- Engineering Specifications and Benchmarking: Comparison of the device's performance against the predicate device and relevant industry standards for mechanical properties.
- Material Characterization: Verification of the material properties to be equivalent to the predicate device.
- Design Review: Comparison of the design features to the predicate device.
8. The Sample Size for the Training Set
This is not applicable. This device does not use an algorithm that requires a "training set" in the context of machine learning. The "training" for the device's development would involve engineering design, prototyping, and iterative mechanical testing.
9. How the Ground Truth for the Training Set was Established
This is not applicable for the same reason as point 8. No "training set" in the AI sense exists for this device. The development process relies on engineering principles and verification against established mechanical and material standards.
§ 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.