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K Number
K183162
Device Name
Affixus Hip Fracture Nail
Manufacturer
Biomet Inc.
Date Cleared
2018-12-14

(29 days)

Product Code
HSB
Regulation Number
888.3020
Type
Special
Panel
OR
Reference & Predicate Devices
K100238
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Affixus Hip Fracture Nail System is intented to treat stable proximal fractures of the femur including pertrochanteric fractures, intertrochanteric fractures, high subtrochanteric fractures of these fractures, including non-union, malunion and tumor resections. The Long Nail system is additionally indicated to treat pertrochanteric fractures associated with shaft fractures in osteoporotic bone (including prophylactic use) of the trochanteric and diaphyseal areas, impending pathological fractures, long subtrochanteric fractures, ipsilateral femoral fractures, proximal or distal non-unions, malunions, revision procedures and tumor resections.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) premarket notification from the FDA for a medical device called the "Affixus Hip Fracture Nail System." It is a regulatory clearance letter, not a study report. As such, it does not contain the detailed information about acceptance criteria and study data that you have requested for an AI/ML medical device.

The document discusses the substantial equivalence of the Affixus Hip Fracture Nail System to a previously cleared predicate device (K100238). It focuses on mechanical and material characteristics rather than AI/ML performance.

Therefore, I cannot provide the requested information based on the provided text. The document does not describe:

  1. A table of acceptance criteria and reported device performance for an AI/ML model. The acceptance criteria mentioned are related to equivalence with a predicate device, not performance metrics like sensitivity/specificity for an AI diagnosis.
  2. Sample sizes for a test set or data provenance for an AI/ML model.
  3. Number of experts and their qualifications for establishing ground truth.
  4. Adjudication method for a test set.
  5. Multi-reader multi-case (MRMC) comparative effectiveness study results.
  6. Standalone (algorithm only) performance.
  7. Type of ground truth used (expert consensus, pathology, outcome data).
  8. Sample size for a training set.
  9. How ground truth for a training set was established.

The "Summary of Performance Data (Nonclinical and/or Clinical)" section explicitly states:

  • Non-Clinical Tests: "Study of insertion torque before and after end-of o line cleaning operations"
  • Clinical Tests: "N/A"

This confirms that the clearance was based on non-clinical engineering tests, not clinical performance data or AI/ML model evaluations.

§ 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.