(207 days)
The Arrowhead 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 Arrowhead Fixation Device implant features a three dimensional arrow shape. The implants are available in multiple lengths and in 2 different angles. The implant is manufactured from stainless steel and is designed for single use only.
The provided text describes a medical device called the "Arrowhead Fixation Device" and its 510(k) summary for premarket notification. This document focuses on demonstrating substantial equivalence to predicate devices through mechanical testing rather than a clinical study with human patients, AI algorithms, or expert consensus on images. Therefore, many of the requested categories related to such studies will not be applicable.
Here's an analysis based on the provided information:
Acceptance Criteria and Device Performance
| Acceptance Criteria Category | Acceptance Criteria (What was measured/compared to) | Reported Device Performance |
|---|---|---|
| Technological Characteristics | Similar to predicate devices: newdeal K-wire, Arthrex K-wire, Nexfix Compression Pin, BioPro DCS, PRO-TOE VO Hammertoe, and PRO TOE Endosorb Small Hammer Toe Pin. | The Arrowhead Fixation Device has similar technological characteristics to the predicate devices. |
| Mechanical Strength (Rotational Forces) | At least equivalent to the newdeal K-wire. | Testing confirmed that the Arrowhead Fixation Device is at least equivalent to the newdeal K-wire in rotational forces. |
| Mechanical Strength (Pull-out Testing) | At least equivalent to the newdeal K-wire. | Testing confirmed that the Arrowhead Fixation Device is at least equivalent to the newdeal K-wire in pull-out strength. |
| Mechanical Strength (Four-Point Bend Testing) | At least equivalent to the newdeal K-wire. | Testing confirmed that the Arrowhead Fixation Device is at least equivalent to the newdeal K-wire in four-point bending. |
| Indications for Use | Similar to legally marketed predicate devices. | The Arrowhead Fixation Device has similar indications for use: fixation of osteotomies, arthrodeses and reconstruction in the lesser toes following corrective procedures (not for use in the spine). |
| Single Use Only | Device design for single use only. | The implant is manufactured from stainless steel and is designed for single use only. (This is a design specification, not a performance metric in the same way as mechanical testing, but it's an important characteristic mentioned.) |
Study Proving Acceptance Criteria:
The study that proves the device meets the acceptance criteria is a mechanical testing study. This study was performed to demonstrate that the Arrowhead Fixation Device is at least equivalent to the identified predicate devices in key mechanical properties.
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Sample size used for the test set and the data provenance:
- The document does not specify the exact sample size (number of devices tested) for the mechanical tests (Rotational Forces Testing, Pull-out Testing, Four-Point Bend Testing).
- The data provenance is not explicitly stated as "country of origin," but the submission is from a U.S. company (Arrowhead Products LLC, Hampton, GA). The testing would have been conducted as part of the premarket submission process. This is a prospective set of tests conducted specifically for this submission.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This was a mechanical testing study, not a study requiring expert clinical or image-based ground truth. The "ground truth" for mechanical testing is the physical load/force applied and the resulting deformation/failure, which is objectively measured by testing equipment. Comparative performance was against a predicate device.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods like 2+1 or 3+1 are used in studies involving human interpretation (e.g., radiologists reviewing images) to establish a consensus ground truth. This was a mechanical testing study.
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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 document describes a medical implant (bone fixation device) and its premarket mechanical testing. It does not involve AI, image analysis, or human readers.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This document does not describe an algorithm or AI device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this study was the objective mechanical performance of the predicate device (newdeal K-wire) under specific test conditions (Rotational Forces, Pull-out, Four-Point Bend). The Arrowhead Fixation Device's performance was then compared to this established baseline.
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The sample size for the training set:
- Not applicable. There is no "training set" in the context of mechanical equivalence testing for an implantable device. Training sets are relevant for machine learning algorithms.
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How the ground truth for the training set was established:
- Not applicable. As there is no training set, there's no ground truth for it.
§ 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.