LogoFDA 510(k) Search
K Number
K992348
Device Name
SYNTHES SPIRAL BLADE FOR HUMERAL NAIL (SBHN)
Manufacturer
SYNTHES (USA)
Date Cleared
1999-09-23

(71 days)

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

Synthes Spiral Blade for Humeral Nail is intended to stabilize fractures of the humerus.

Device Description

Synthes Spiral Blade is used in conjunction with Synthes Solid Humeral Nail. The Synthes SBHN has a self-cutting blade tip, is cannulated, has suture holes located around periphery of blade head, and is available in lengths ranging from 34 mm to 54 mm. A Locking End Cap is used to lock the Spiral Blade in place.

AI/ML Overview

I am sorry, but the provided text does not contain detailed information about acceptance criteria and a study proving a device meets those criteria. The document is primarily a 510(k) summary and an FDA clearance letter for a medical device called the "Synthes Spiral Blade for Humeral Nail."

The document focuses on the regulatory clearance process, device description, intended use, and substantial equivalence to a predicate device. It confirms that the FDA reviewed the submission and found the device substantially equivalent.

Therefore, I cannot provide the requested information, including:

  1. A table of acceptance criteria and reported device performance.
  2. Sample sizes or data provenance for a test set.
  3. Number and qualifications of experts for ground truth.
  4. Adjudication method.
  5. MRMC comparative effectiveness study details or effect size.
  6. Standalone performance study details.
  7. Type of ground truth used.
  8. Training set sample size.
  9. How ground truth for the training set was established.

This type of detailed study information is typically found in the full 510(k) submission or associated clinical/testing reports, which are not provided in this excerpt.

§ 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.