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K Number
K964521
Device Name
DEPUY DUPONT PHANTOM SUTURE ANCHOR
Manufacturer
DEPUY, INC.
Date Cleared
1997-02-06

(86 days)

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

The DePuy DuPont Phantom Suture Anchor is intended for use in the shoulder for soft tissue reattachment and capsular repair, including rotator cuff repairs, Bankart lesion repairs and SLAP lesion repairs.

Device Description

The Phantom Suture Anchor is a PLLA cortical screw with a flat tip and a rectangular head. Two holes run parallel to the axis of the screw. A #2 nonabsorbable polyester suture is prethreaded sequentially through these holes with a single loop at the tip of the screw. The suture anchors are available either pre-loaded on a driver or separately. The Phantom Suture Anchors are available in diameters of either 3.5 or 4.5mm.

AI/ML Overview

This document, K964521, is a 510(k) summary for a medical device (DePuy DuPont Phantom Suture Anchor) and it focuses on demonstrating substantial equivalence to predicate devices, not on proving device performance against specific acceptance criteria in the way that digital health or AI/ML devices might.

Therefore, the requested information elements related to acceptance criteria, specific study design (test sets, ground truth, experts, MRMC, standalone performance, training sets), and performance metrics like sensitivity/specificity are not applicable or cannot be extracted from this type of regulatory submission summary.

Here's a breakdown of why and what information can be extracted:

Information that CANNOT be extracted directly and is NOT APPLICABLE in this context:

  1. A table of acceptance criteria and the reported device performance: This document does not define explicit "acceptance criteria" in terms of clinical performance metrics (e.g., sensitivity, specificity, accuracy) for an AI/ML device. It focuses on mechanical properties (pull-out loads) compared to predicate devices.
  2. Sample size used for the test set and the data provenance: Not relevant for a mechanical device comparison. The "test set" here refers to cadaveric bone for mechanical testing.
  3. Number of experts used to establish the ground truth... and qualifications: Not applicable. Ground truth for a mechanical device isn't established by clinical experts in the same way.
  4. Adjudication method: Not applicable.
  5. If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable, as this is not an AI/ML diagnostic or imaging device.
  6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable, as this is a physical implantable device, not an algorithm.
  7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for a suture anchor is its mechanical strength and biological response, which is assessed through in vitro (cadaveric bone) and potentially in vivo (animal/human studies, if required for novel devices, but not detailed here beyond comparison) testing.
  8. The sample size for the training set: Not applicable; there is no "training set" for an AI/ML model here.
  9. How the ground truth for the training set was established: Not applicable.

Information that can be inferred or is directly stated from the provided text, related to the spirit of demonstrating safety and effectiveness:

  • Device Performance (as it relates to substantial equivalence):

    • Mechanical Testing: Mechanical testing in cadaver bone showed that the pull-out loads for the Phantom Suture were comparable to the pull-out loads for the Statak anchors. This is the primary "performance" metric mentioned.
    • Material: The Phantom Suture Anchor is a resorbable anchor manufactured from PLLA. (The predicate Acufex Suretac is polyglyconate, and Zimmer Statak is Ti-6Al-4V metal alloy).
    • Design: Both the Phantom suture anchors and the Stataks have a threaded design.

  • Study Information (related to the mechanical comparison):

    • Test Medium: Cadaver bone was used for mechanical testing.
    • Comparison: The device was compared to Zimmer Statak anchors for pull-out loads.

In summary, this 510(k) relies on demonstrating that the DePuy DuPont Phantom Suture Anchor performs at least as well (specifically, "comparable pull-out loads") as already legally marketed predicate devices (Zimmer Statak) concerning critical mechanical properties, and that its materials and design are also substantially equivalent, to show safety and effectiveness. It is not designed to fit the framework of an AI/ML device performance study with the detailed criteria you've outlined.

§ 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.