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K Number
K162685
Device Name
2-Piece Hammertoe Correction System
Manufacturer
Life Spine, Inc.
Date Cleared
2017-06-09

(256 days)

Product Code
HWC
Regulation Number
888.3040
Type
Traditional
Panel
Orthopedic
Reference & Predicate Devices
K130859,K153065,K142585,K050259,K142478,K990804,K022726
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The 2-Piece Hammertoe Correction System is indicated for small bone reconstruction limited to inter-digital repair and fusion of the lesser toes.

Device Description

The 2-Piece Hammertoe Correction System is a two-piece construct, each with a threaded shaft that is inserted in the proximal and middle phalanges, so that each implants threads fixate on the phalangeal canal of the toe and stabilize the joint. The implant is fabricated and manufactured from the following: 1) Titanium (Ti 6A1-4V ELI). All implants are intended for single use only and should not be reused under any circumstances. Do not use any of the 2-Piece Hammertoe Correction System components with components from any other system or manufacturer. The 2-Piece Hammertoe Correction System components should never be reused under any circumstances.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called the "2-Piece Hammertoe Correction System." This document is a regulatory filing with the US FDA and does not contain detailed acceptance criteria, study data, or performance metrics in the way your request describes for assessing AI or diagnostic device performance.

Therefore, I cannot provide the requested information about acceptance criteria and a study proving the device meets them, including:

  1. A table of acceptance criteria and the reported device performance: This document is a clearance letter, not a detailed study report.
  2. Sample size used for the test set and the data provenance: Not applicable; no such test set is described.
  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
  4. Adjudication method: Not applicable.
  5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: Not applicable; this is a hardware device, not an AI or diagnostic tool.
  6. If a standalone performance study was done: "Bench Top Validations" and "Custom Shear Testing" were performed for substantial equivalence, but the details (like specific performance metrics, sample sizes, or results against acceptance criteria) are not provided.
  7. The type of ground truth used: Not applicable in the context of device performance metrics for diagnostic accuracy. For a mechanical device, performance would relate to strength, durability, biocompatibility, etc.
  8. The sample size for the training set: Not applicable.
  9. How the ground truth for the training set was established: Not applicable.

What the document does provide is:

  • Device Name: 2-Piece Hammertoe Correction System
  • Indications for Use: "for small bone reconstruction limited to inter-digital repair and fusion of the lesser toes."
  • Material: Titanium (Ti 6A1-4V ELI) manufactured according to ASTM F136.
  • Performance Data Mentioned: "Custom Shear Testing and Bench Top Validations were included to demonstrate the substantial equivalency of the 2-Piece Hammertoe Correction System." This indicates that some form of testing was done to support the claim of substantial equivalence to predicate devices, but the specific results and acceptance criteria are not detailed in this public FDA letter.
  • Conclusion: The information demonstrates substantial equivalency.

This document serves as an FDA clearance letter based on a 510(k) submission, confirming that the device is substantially equivalent to a predicate device. It does not typically include the granular details of performance studies or acceptance criteria that would be found in a full clinical trial report or a detailed engineering validation document.

§ 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.