(119 days)
Indicated for small bone fusion, fractures and inter-digital fusion of the fingers, toes and small bones.
The Arthrosurface Inc's Hammertoe Correction System consists of two intramedullary bone screws, a taper lock pin and a set of instruments used for implant site preparation and delivery. The taper lock pin provides a press fit connection between the two screws with light contact pressure. The implant components are manufactured using implant grade titanium alloy and cobaltchrome alloy.
The provided text is a 510(k) summary for the Arthrosurface Inc's Hammertoe Correction System. This document focuses on demonstrating substantial equivalence to existing devices through comparative mechanical testing and cadaveric testing, rather than an independent study proving device performance against acceptance criteria with a focus on AI or algorithmic performance.
Therefore, many of the requested categories (especially those related to AI algorithm performance, ground truth, experts, and training/test sets) are not applicable to this type of regulatory submission as they are for a surgical implant, not an AI software medical device.
I will provide information relevant to the acceptance criteria and supporting studies as much as possible from the given text.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred) | Reported Device Performance (Inferred) |
|---|---|
| Mechanical Equivalence: | |
| - Comparable static cantilever bending strength | "Results from static and dynamic cantilever bending, torque to failure, pull-out force, insertion-removal torque and axial disassembly force tests along with comparative dimensional analyses were used to support equivalence to predicate devices." The implication is that the device performed comparably to the predicate devices in these mechanical tests. |
| - Comparable dynamic cantilever bending strength | |
| - Comparable torque to failure | |
| - Comparable pull-out force | |
| - Comparable insertion-removal torque | |
| - Comparable axial disassembly force | |
| Functional Equivalence: | |
| - Performance in anatomical simulation (cadaveric testing) | "Data from cadaveric testing were also reported." The implication is that the device performed acceptably in a simulated clinical setting, comparable to its predicates. |
| Material Equivalence: | |
| - Use of implant-grade materials | "The implant components are manufactured using implant grade titanium alloy and cobalt-chrome alloy." (This is a design specification, aligning with predicate devices). |
| Design/Intended Use Equivalence: | |
| - Substantially similar intended use, design features, materials, and application to predicate devices. | The FDA determined the device is "substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices." The text explicitly states: "The intended use, materials, design features and application of the Proposed Device are substantially equivalent to the following previously cleared and commercially marketed devices." |
Study Proving Device Meets Acceptance Criteria:
The study proving the device meets the acceptance criteria is a Comparative Mechanical Testing study and Cadaveric Testing. The primary goal of these studies, in the context of a 510(k) submission, is to demonstrate substantial equivalence to predicate devices already on the market, not necessarily to meet pre-defined standalone performance metrics against an absolute standard.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated for specific tests. The text mentions "Comparative Mechanical Testing was performed per relevant recognized standards" and "Data from cadaveric testing were also reported." The sample sizes for these tests are generally dictated by the chosen standards (e.g., ISO, ASTM) or internal protocols for cadaveric work, but the exact numbers are not provided in this summary.
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). However, given that this is a 510(k) submission to the FDA for a US market, it is reasonable to infer the testing was conducted in facilities compliant with US regulatory requirements (e.g., GLP for non-clinical testing). The studies would be considered prospective as they were conducted specifically to support this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This section is Not Applicable in this context. The "ground truth" for a mechanical implant device is primarily established through objective physical measurements and material science standards, not by expert consensus in a diagnostic sense. For cadaveric testing, the "ground truth" would be the observed biomechanical performance or failure modes. There is no mention of human interpretation being the primary ground truth.
4. Adjudication Method for the Test Set
This section is Not Applicable. Adjudication methods like 2+1 or 3+1 refer to how discrepant expert opinions are resolved, which is relevant for diagnostic or AI performance evaluations, not for mechanical testing of an implant.
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 section is Not Applicable. This request pertains to AI software performance evaluation. The submitted device is a physical surgical implant, not an AI or diagnostic imaging device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This section is Not Applicable. The device is a surgical implant, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this device's evaluation is primarily:
- Mechanical Performance Data: Objective measurements obtained from standardized mechanical tests (static and dynamic cantilever bending, torque to failure, pull-out force, insertion-removal torque, axial disassembly force).
- Material Specifications: Adherence to implant-grade material standards (titanium alloy, cobalt-chrome alloy).
- Biomechanical Observation/Data: Observations and measurements from cadaveric testing that simulate in-vivo conditions.
- Comparative Dimensional Analysis: Measurement and comparison of device dimensions to predicate devices.
8. The Sample Size for the Training Set
This section is Not Applicable. There is no "training set" in the context of mechanical testing for a physical implant. The device design and materials are based on established engineering principles and prior knowledge.
9. How the Ground Truth for the Training Set Was Established
This section is Not Applicable. As there is no training set for a mechanical implant, there is no ground truth to establish 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.