FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

· Mono or Bi-Cortical osteotomies in the foot or hand
· Distal or Proximal metatarsal or metacarpal osteotomies
· Weil osteotomy
· Fusion of the first metatarsophalangeal joint and interphalangeal joint
· Fixation of osteotomies for Hallux Valgus treatment (such as Scarf, Chevron, etc.)
· Akin type osteotomy
· Arthrodesis base first metatarsal cuneiform joint to reposition and stabilize metatarsus varus primus
· Calcaneus/cuboid arthrodesis
· Talar/navicular arthrodesis

Device Description

The PROSTEP™ MICA™ Screws are intended for use in bone reconstruction, osteotomy, arthrodesis, fracture repair, and fracture fixation of bones appropriate for the device. MICA™ Screws are fully threaded, cannulated screws manufactured from titanium alloy. The screws are available in diameters of 3-4 mm in various lengths.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information based on the provided FDA 510(k) summary for the PROSTEP™ MICA™ Screw System:

It's important to note that this 510(k) submission is for a medical device (a bone screw system), not an AI/Software as a Medical Device (SaMD). Therefore, the typical criteria and study methodologies for SaMD (like AI performance, MRMC studies, training data, ground truth establishment for AI) are not applicable here. The "study" in this context refers to non-clinical testing to demonstrate substantial equivalence to a predicate device.

Acceptance Criteria and Reported Device Performance

The acceptance criteria and performance for this device are focused on non-clinical attributes rather than clinical or AI-based performance.

1. Table of Acceptance Criteria and Reported Device Performance:

Validation and/or Verification Method	Acceptance Value/Criteria	Results
Packaging Integrity and Shelf-Life	As established in ISO 11607:2006	Pass
Sterilization	As established in ISO 11137-2:2013	Pass
Bacterial Endotoxins Testing	≤ 20 EU/device	Pass

Study Details (Non-Clinical, as applicable to a medical device)

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size: The document does not specify exact sample sizes for each non-clinical test (e.g., how many packages were tested for integrity, how many devices for sterilization). Instead, it refers to industry standards (ISO) that would outline the appropriate sampling methods.
Data Provenance: Not applicable in the context of clinical data. These are laboratory/benchtop testing results. The testing would have been conducted by the manufacturer or a contracted lab. The country of origin for the data is implicitly the country where the manufacturer (Wright Medical Technology, Inc.) is based and where their testing facilities or partners are located (Memphis, Tennessee, USA). The tests are prospective in the sense that they were designed and executed to specifically evaluate the device's adherence to the specified standards prior to submission.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Not applicable. Ground truth for these non-clinical tests is established by adherence to recognized international standards (ISO) and laboratory testing protocols, measured by calibrated equipment and scientific methods, rather than expert human interpretation of data.

4. Adjudication Method for the Test Set:

Not applicable. These are objective laboratory tests with defined pass/fail criteria according to international standards. There is no human adjudication process in the sense of consensus on interpretation.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No. An MRMC study is relevant for AI or imaging interpretation devices where human readers' performance is being evaluated or augmented by AI. This is a non-clinical submission for a bone screw, so such a study was not performed.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:

No. This question applies to AI algorithms. The PROSTEP™ MICA™ Screw System is a physical medical device; it does not have an "algorithm" in this sense.

7. The Type of Ground Truth Used:

The "ground truth" for this device's acceptance is based on established international standards (ISO 11607:2006 for Packaging, ISO 11137-2:2013 for Sterilization) and objective laboratory measurements (e.g., Bacterial Endotoxins ≤ 20 EU/device). This contrasts with expert consensus, pathology, or outcomes data which are typically used for clinical performance evaluations.

8. The Sample Size for the Training Set:

Not applicable. This is a physical device, and the concept of a "training set" is relevant for machine learning/AI algorithms.

9. How the Ground Truth for the Training Set was Established:

Not applicable. There is no training set for this type of device.

Summary Takeaway: The K181377 submission for the PROSTEP™ MICA™ Screw System relies entirely on non-clinical evidence (benchtop testing and adherence to recognized standards) to demonstrate its safety and effectiveness and substantial equivalence to a predicate device. Clinical evidence was explicitly stated as "N/A" because the changes to the device (primarily packaging configuration) were not deemed to raise new questions of safety or effectiveness that would necessitate clinical trials.

Summary

Regulation Number and Section

§ 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.