(89 days)
The ARROW-LOK Digital Fusion System is indicated for fixation of osteotomies, arthrodeses and reconstruction in the lesser toes following corrective procedures. It is not intended for use in the spine.
The ARROW-LOK Digital Fusion device features a three dimensional arrow shape. The implants are available in multiple lengths with arrowheads of various diameters and in 2 different angles. The implant is manufactured from stainless steel and is designed for single use only.
This document describes a 510(k) submission for the ARROW-LOK Digital Fusion System, which includes additions of a 2.5mm Diameter ARROW-LOK Implant and ARROW-LOK Hybrid Implant. This is a medical device submission, and therefore the "study" referred to in the prompt is actually the performance evaluations conducted to demonstrate substantial equivalence to predicate devices. The concept of "acceptance criteria" and "device performance" in this context refers to showing that the new device performs at least as well as, or equivalently to, the predicate devices based on specific mechanical tests.
Here's a breakdown of the requested information based on the provided text:
1. Table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in a tabular format with numerical targets. Instead, it describes performance evaluations that demonstrated the new device to be "at least equivalent to the predicate devices." The performance is reported in terms of achieving this equivalence.
| Performance Evaluation Type | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Rotational Forces Testing | Performance equivalent to or better than predicate devices (Arrowhead Fixation Device (K100926) and NEWDEAL, S.A. K-wire (K022599)). | Equivalence to predicate devices confirmed. |
| Pull-out Testing | Performance equivalent to or better than predicate devices (Arrowhead Fixation Device (K100926) and NEWDEAL, S.A. K-wire (K022599)). | Equivalence to predicate devices confirmed. |
| Four-Point Bend evaluations | Performance equivalent to or better than predicate devices (Arrowhead Fixation Device (K100926) and NEWDEAL, S.A. K-wire (K022599)). | Equivalence to predicate devices confirmed. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample size for the mechanical tests. The data provenance is not mentioned, but as this is a 510(k) submission to the FDA, it is expected that the tests were conducted under controlled conditions as part of a prospective evaluation for regulatory approval.
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)
This is a submission for a mechanical implant. The "ground truth" here is established by engineering and biomechanical testing standards and methodology, not clinical expert consensus in the same way an AI diagnostic tool would. Therefore, the concept of "experts" in the context of clinical ground truth establishment is not applicable. The evaluations were likely performed by engineers or technicians skilled in biomechanical testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. As this involves objective mechanical testing, there is no "adjudication method" in the sense of reconciling divergent human assessments. The results are quantitative and directly measurable according to established test protocols.
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
Not applicable. This is a physical medical device (implant), not an AI algorithm for clinical image interpretation or diagnosis. Therefore, MRMC studies involving human readers and AI assistance are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a physical medical device, not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the performance evaluations (Rotational Forces, Pull-out, Four-Point Bend) is established by engineering specifications, industry standards for mechanical testing of orthopedic implants, and direct comparative measurements against predicate devices. It is not expert consensus, pathology, or outcomes data in a clinical sense.
8. The sample size for the training set
Not applicable. This is a physical medical device. There is no concept of a "training set" as found in machine learning or AI development.
9. How the ground truth for the training set was established
Not applicable. There is no "training set" for a physical medical device.
§ 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.