(101 days)
The OSTEOMED ExtremiFuse System is indicated for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe, and mallet toe.
The OSTEOMED ExtremiFuse System is indicated for small bone reconstruction limited to interdigital repair and fusion of the phalanges. The ExtremiFuse implant is a one piece implant with a threaded portion and a barbed portion that holds the resected faces of the two phalanges together. The implant is offered in 3 diameter sizes of 2.4mm, 3.0mm and 4.0mm. For each size, the implant is available in angle configurations of 0° and 10°. The system instruments include wires, broaches, cannulated drills, and implant drivers to facilitate the placement of the implants. The ExtremiFuse implants are made from implant grade titanium alloy (Ti6Al4V) per ASTM F136. The instrumentation is made from various grades of surgical grade stainless steel, anodized aluminum, and/or medical grade plastic.
The provided text describes a 510(k) submission for the OsteoMed ExtremiFuse System, a medical device for foot surgery. It focuses on demonstrating substantial equivalence to existing predicate devices rather than proving performance against specific acceptance criteria through a standalone study. Therefore, much of the requested information regarding a study proving acceptance criteria is not present in the provided text.
However, I can extract the available information and highlight what is missing.
Here's a breakdown based on the provided text, addressing the requested points:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical acceptance criteria in a table format that the device was tested against. Instead, it states that the device "underwent verification evaluation to ensure that the design features met the required mechanical strength criteria for their intended use." The performance is reported in terms of "substantial equivalence" to predicate devices based on specific mechanical tests.
| Acceptance Criteria (Explicitly Stated) | Reported Device Performance |
|---|---|
| Mechanical strength criteria for intended use (not quantified) | Demonstrated substantial equivalence in "pullout test, torque test, and bending test" compared to predicate devices. The device "perform[s] as well or better when compared to the predicate devices for the intended use." |
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the text. The document refers to "verification evaluation" and "pullout test, torque test, and bending test," but does not specify the sample sizes (number of implants tested) for these mechanical tests. There is no mention of human subject data, and therefore no information on data provenance (country of origin, retrospective/prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the text. As this was a mechanical device rather than, for example, an AI diagnostic tool, "ground truth" as typically understood in AI/medical imaging studies (e.g., expert consensus on pathology) is not applicable here. The "truth" in this context would be engineering specifications and mechanical test results, which do not involve expert interpretation in the same way.
4. Adjudication Method for the Test Set
This information is not provided in the text. Adjudication methods (like 2+1 or 3+1) are typically used for clinical endpoints or expert interpretation, which are not detailed in this mechanical equivalence submission.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic tools or systems where human readers interpret medical images or data. The OsteoMed ExtremiFuse System is a physical surgical implant, not an AI or diagnostic device.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
A standalone performance study, as typically understood for algorithms without human-in-the-loop, was not done. The "performance" assessment was based on physical mechanical testing of the implant itself, and its comparison to predicate devices, not on an algorithm's output.
7. The Type of Ground Truth Used
For this mechanical device, the "ground truth" used for performance assessment would inherently be the results of established engineering and biocompatibility tests (e.g., precise measurements of pullout strength, torque resistance, bending deflection as per industry standards like ASTM F136 for material or specific test methods for mechanical properties). The text refers to "mechanical strength criteria" and confirms the material (Ti6Al4V) is "biocompatible."
8. The Sample Size for the Training Set
This information is not applicable and therefore not provided. The OsteoMed ExtremiFuse System is a physical surgical implant, not a data-driven model or algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not applicable and therefore not provided, as there is no training set for this type of medical device.
Summary of Device Performance and Study:
The OsteoMed ExtremiFuse System's performance was assessed through mechanical testing (pullout, torque, and bending tests) to demonstrate substantial equivalence to legally marketed predicate devices (Pro-Toe VO HammerToe Implant System, OsteoMed Cannulated Screw System, OsteoMed Foot Plating System, K-Wires). The submission states that the device "meets the required mechanical strength criteria for their intended use" and "performs as well or better" than the predicate devices. Clinical testing was explicitly stated as "not required to support substantial equivalence." This means that the assessment relies entirely on engineering principles and comparative mechanical data, rather than clinical efficacy studies or deep statistical analysis of AI model performance.
§ 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.