(256 days)
The PROstep™ MIS 5mm Chamfer Screw is indicated for fixation of bone reconstruction. Examples include:
- Arthrodesis of the first metatarsal cuneiform joint to reposition and stabilize metatarsus primus varus
- Calcaneus/cuboid arthrodesis
- Talar/navicular arthrodesis
The PROstep™ MIS 5mm Chamfered Screw is designed to facilitate internal fixation for minimally invasive reduction of hallux valgus deformity and subsequent fusion of the first metatarsal cuneiform joint. The subject cannulated screw is made from titanium alloy (ASTM F136 Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401) and features multiple lengths. The subject screw is sterile and provided with both sterile and non-sterile instrumentation.
This FDA 510(k) summary describes a medical device, the PROstep™ MIS 5mm Chamfer Screw System, and its substantial equivalence to a predicate device. However, it does not contain information typically associated with acceptance criteria and a study proving device performance as would be found for a diagnostic AI/ML device.
The document is for a metallic bone fixation fastener, which is an orthopedic implant. For such a device, "acceptance criteria" and "study proving device meets acceptance criteria" are generally evaluated through non-clinical mechanical, material, and biocompatibility testing, rather than studies involving extensive data sets, ground truth establishment, or human reader performance as seen in AI/ML or diagnostic imaging device submissions.
Here's a breakdown of the requested information based on the provided text, highlighting what is (and isn't) present:
A. Table of Acceptance Criteria and Reported Device Performance:
For this type of device, the "acceptance criteria" refer to compliance with material standards, mechanical performance benchmarks, and sterility requirements. The "reported device performance" refers to the results of the non-clinical tests demonstrating this compliance.
| Acceptance Criteria Category | Reported Device Performance (as per document) |
|---|---|
| Material Composition | Composed of titanium alloy (ASTM F136 Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401)). |
| Mechanical Performance | Mechanical testing was conducted according to ASTM F543 and the related FDA-published "Metallic Bone Screws and Washers - Performance Criteria for Safety and Performance Based Pathway". The document implicitly states that the device was found to be sufficiently equivalent in performance to the predicate device. |
| Sterility/Pyrogenicity | Pyrogenicity testing was conducted using the bacterial endotoxins test on the subject device per ANSI/AAMI ST 72. The device is described as "sterile." |
| MRI Compatibility | Engineering analysis was provided to evaluate MR compatibility of the subject device per ASTM F2182 (RF Heating), ASTM F2062 ()/ASTM F2213 (Induced Force /Induced Torque), and ASTM F2119 (Image Artifact). |
| Design Characteristics | Similar design to the predicate, including being fully threaded, self-tapping on both distal and proximal threads, and availability with a 30° chamfered head. Adds longer lengths compared to the predicate. |
B. Sample size used for the test set and the data provenance:
- Sample Size: Not applicable in the context of a "test set" for diagnostic performance. The tests described are engineering and material tests, not clinical studies with patient data.
- Data Provenance: Not applicable. The "data" comes from laboratory and engineering testing, not patient populations.
C. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. "Ground truth" in this context would refer to the established material properties, mechanical limits, and sterility standards defined by the ASTM and ANSI/AAMI standards, which are developed by committees of experts, but not in the sense of adjudicating individual cases for a diagnostic study.
D. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This is methodology for expert review of cases, not for material or mechanical testing.
E. 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:
- No. This is relevant for diagnostic imaging devices, especially those incorporating AI. This device is an orthopedic implant.
F. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is relevant for AI/ML devices.
G. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for this device's performance is adherence to established engineering standards and material specifications (e.g., ASTM F543 for mechanical testing, ASTM F136 for material composition, ANSI/AAMI ST 72 for pyrogenicity, ASTM F2182, F2062, F2213, F2119 for MRI compatibility). The performance is compared against these predefined standard criteria and the characteristics of the legally marketed predicate device.
H. The sample size for the training set:
- Not applicable. This device is not an AI/ML algorithm that requires a training set.
I. How the ground truth for the training set was established:
- Not applicable.
In summary: The provided document is a 510(k) summary for an orthopedic implant. The "acceptance criteria" and "proof" primarily revolve around demonstrating compliance with recognized engineering standards, material specifications, and substantial equivalence to a predicate device through non-clinical testing. This differs significantly from the type of performance evaluation and ground truth establishment required for diagnostic software or AI/ML devices.
§ 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.