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K Number
K070843
Device Name
SYNTHES ADOLESCENT LATERAL ENTRY FEMORAL NAIL SYSTEM
Manufacturer
SYNTHES (USA)
Date Cleared
2007-05-02

(36 days)

Product Code
HSB
Regulation Number
888.3020
Type
Traditional
Panel
OR
Reference & Predicate Devices
K961965,K102604
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Synthes Adolescent Lateral Entry Femoral Nail System will be intended to stabilize fractures of the femoral shaft, subtrochanteric fractures, ipsilateral neck/shaft fractures, impending pathologic fractures, non-unions and malunions in adolescent and small stature adult patients.

Device Description

Synthes Adolescent Lateral Entry Femoral Nail System is composed of cannulated femoral nails, solid 5.0 mm recon locking screws and cannulated end caps. Recon locking screws, as well as Synthes commercially available 4.0 mm locking screws, are used to secure the nail in the bone.

AI/ML Overview

The provided text is a 510(k) summary for the Synthes Adolescent Lateral Entry Femoral Nail System. This document is a premarket notification to the FDA for a medical device and, as such, outlines the device's description, intended use, and claims of substantial equivalence to predicate devices. It does not contain information about studies proving the device meets specific acceptance criteria in the context of AI/ML device performance.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving a device meets them because the provided document does not describe such a study for an AI/ML device. The document pertains to a traditional medical device (an intramedullary fixation rod system) and focuses on regulatory clearance based on substantial equivalence, not performance metrics derived from a study like those typically associated with AI/ML systems.

Specifically, the document focuses on:

  • Device Name: Synthes Adolescent Lateral Entry Femoral Nail System
  • Classification: Class II, Intramedullary fixation rod and accessories
  • Predicate Devices: Smith & Nephew's Adolescent Nail, Biomet's Pediatric Locking Nail System
  • Intended Use: To stabilize various femoral fractures in adolescent and small stature adult patients.
  • Substantial Equivalence: The primary claim for regulatory clearance, meaning it is as safe and effective as a legally marketed device.

There is no mention of:

  1. Acceptance criteria and reported device performance: These are not defined in the context of numerical metrics for an AI/ML system.
  2. Sample size for test set and data provenance: No test set is described.
  3. Number of experts and their qualifications for ground truth: No ground truth establishment process is mentioned.
  4. Adjudication method: Not applicable.
  5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not conducted or mentioned.
  6. Standalone (algorithm-only) performance study: Not applicable.
  7. Type of ground truth used: Not applicable.
  8. Sample size for the training set: Not applicable.
  9. How ground truth for the training set was established: Not applicable.

§ 888.3020 Intramedullary fixation rod.

(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.