(160 days)
The Eidosmed EDG is a depth gauge measuring device intended for various medical purposes including but not limited to, measuring the depth of a passageway in a bone or other tissue to enable insertion of properly sized screws and implants.
The Eidosmed Electronic Depth Gauge (“EDG”) is a depth gauge measuring device intended for various medical purposes, including but not limited to, measuring the depth of a passageway in a bone or other tissue to enable insertion of properly sized screws and implants. In addition to mechanically measuring and displaying depth using an analog scale, the EDG displays this information using a digital readout. The EDG, referred to as the EDG 4.0 version, is a completely disposable device. It is intended to be used on one patient, over the course of one surgical procedure.
The information provided describes the Eidosmed Electronic Depth Gauge (EDG) and its performance relative to a predicate device. While it mentions "acceptance criteria" through the lens of equivalence to the predicate device and specific performance metrics, it does not explicitly state a pre-defined set of acceptance criteria in the typical sense (e.g., "device must achieve X accuracy"). Instead, the study's goal was to demonstrate substantial equivalence and superior performance in certain aspects.
Here's an organized breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not specify explicit, pre-defined acceptance criteria with pass/fail thresholds. Instead, it demonstrates the device's performance through comparison to a predicate device and established benchmarks. The acceptance is implied by demonstrating substantial equivalence and superior performance in the stated metrics.
| Performance Metric | Implied Acceptance Criteria (via comparison/benchmark) | Reported Device Performance (EDG) |
|---|---|---|
| Gauge R & R (Repeatability & Reproducibility) | Below 10% industry benchmark and comparable to predicate. | 2.48% (signifies excellent precision) |
| Accuracy | Outperform the analog predicate device. | Outperformed the accuracy of the analog predicate device (with an alpha = .0005) |
| Substantial Equivalence | Equivalent with respect to intended use, design, risks, device characteristics, and performance aspects to the predicate device (Acromed Interbody Depth Gauges, K873191). | Demonstrated as substantially equivalent in various aspects. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the Gauge R & R (GR&R) testing or the accuracy comparison.
The data provenance is not specified (e.g., country of origin, retrospective/prospective). This appears to be a laboratory/bench test rather than a clinical study involving patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the document. Given that the testing involved GR&R and accuracy of measuring depth against a predicate device, it's more likely to be a bench test where the "ground truth" would be established by precise measurement tools or calibrated standards, rather than expert judgment.
4. Adjudication Method for the Test Set
The document does not specify any adjudication method. As mentioned above, the nature of the tests (GR&R, accuracy comparison of a depth gauge) suggests objective measurements rather than subjective assessments requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The study described focuses on the performance of a measuring device (depth gauge) itself, not on human interpretation of images or data, nor on the effect of AI assistance on human readers.
6. Standalone Performance Study (Algorithm Only)
Yes, a standalone performance study was done in the sense that the device's performance (EDG) was evaluated independently and then compared to the predicate device. The EDG itself is a standalone measuring device, and its GR&R and accuracy were measured directly. The document states: "Tests were performed on the device which demonstrated that the device is safe and effective, performs comparably to and is substantially equivalent to the predicate device."
7. Type of Ground Truth Used
The type of ground truth used was likely measurement against calibrated standards or highly precise mechanical references for depth. For the Gauge R & R (Repeatability & Reproducibility) testing and accuracy comparison, the "ground truth" would originate from the known, true depths being measured by the device and the predicate. It is not an expert consensus, pathology, or outcomes data, as this is a physical measuring device.
8. Sample Size for the Training Set
The concept of a "training set" is not applicable here as the EDG is a mechanical/electronic measuring device, not an AI/machine learning algorithm that requires training data.
9. How the Ground Truth for the Training Set Was Established
As noted above, a "training set" and its associated ground truth establishment are not applicable to this device.
§ 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.