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K Number
K013415
Device Name
SYNTHES ANKLE ARTHRODESIS PLATE
Manufacturer
SYNTHES (USA)
Date Cleared
2002-01-11

(88 days)

Product Code
HRS
Regulation Number
888.3030
Type
Traditional
Panel
OR
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Synthes Ankle Arthrodesis Plate is intended for arthrodesis of the ankle and the distal tibia.

Device Description

The Synthes Ankle Arthrodesis Plate is a minimally contoured metal plate that utilizes traditional internal plate/screw fixation to promote fusion or “arthrodesis” of the ankle.

AI/ML Overview

The provided document is a 510(k) premarket notification for the Synthes Ankle Arthrodesis Plate. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive clinical trials to prove safety and effectiveness against specific acceptance criteria.

Therefore, the document does not contain information about acceptance criteria or a study proving the device meets those criteria in the way a clinical trial would. Instead, it refers to documentation provided to the FDA that demonstrated substantial equivalence to an existing device.

Here's why the requested information cannot be extracted from this document:

  1. Acceptance Criteria & Device Performance Table: Not applicable for a 510(k) submission focused on substantial equivalence. This document doesn't define performance metrics or provide a table showing how the device met them.

  2. Sample Size, Test Set Data Provenance: Not applicable. There's no mention of a test set of human subjects or data from such a study.

  3. Number of Experts & Qualifications: Not applicable. This type of submission doesn't involve expert establishment of ground truth for a test set.

  4. Adjudication Method: Not applicable.

  5. MRMC Comparative Effectiveness Study: Not applicable. This isn't a study comparing human readers with and without AI assistance.

  6. Standalone Performance Study: Not applicable. There is no algorithm, and therefore no standalone performance study in the context of AI/medical image analysis.

  7. Type of Ground Truth: Not applicable. There is no ground truth established for this type of device.

  8. Sample Size for Training Set: Not applicable. There's no machine learning algorithm, and thus no training set.

  9. Ground Truth for Training Set Establishment: Not applicable.

In summary, the provided document is a regulatory filing for a medical device (an ankle arthrodesis plate) based on substantial equivalence, not a study evaluating an AI/software device against predefined acceptance criteria.

§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.

(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.