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K Number
K250844
Device Name
PULLUP®; PULLUP® CLIP; BT LOOP®; PULLUP® TEX CLIP; RIGIDLOOP™ T; RIGIDLOOP™ Clip; RIGIDLOOP™ BTB; RIGIDLOOP™ Suture Loop
Manufacturer
Science & Bio Materials (S.B.M.) SAS
Date Cleared
2025-06-02

(74 days)

Product Code
MBI
Regulation Number
888.3040
Type
Traditional
Panel
OR
Reference & Predicate Devices
K202193,K151004
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The PULLUP®, BT LOOP®, PULLUP® CLIP and PULLUP® TEX CLIP cortical fixation devices are indicated in adults for reconstruction of the anterior cruciate ligament.

  • PULLUP®, PULLUP® CLIP, PULLUP® TEX CLIP must be used with a Soft Tissue Transplant.
  • BT LOOP® must be used with a Bone Tendon Bone Transplant.

The RIGIDLOOP™ T, RIGIDLOOP™ BTB, RIGIDLOOP™ Clip and RIGIDLOOP™ Suture Loop cortical fixation devices are indicated in adults for reconstruction of the anterior cruciate ligament.

  • RIGIDLOOP™ T, RIGIDLOOP™ Clip, RIGIDLOOP™ Suture Loop must be used with a Soft Tissue Transplant.
  • RIGIDLOOP™ BTB must be used with a Bone Tendon Bone Transplant.
Device Description

  • PULLUP®: comprises a titanium button-plate, and an adjustable nonabsorbable braided loop. The system is preloaded with traction and flip threads, and is designed to be used with a soft tissue graft. Standard and XL sizes.

  • BT LOOP®: comprises a titanium button-plate, and an adjustable nonabsorbable braided loop. The system is preloaded with traction and flip threads, as well as a temporary split suture, and is designed to be used with a bone-tendon-bone graft. It is assembled on a holder that can be mounted on the GraftTech® preparation station. Standard and XL sizes.

  • PULLUP® CLIP: comprises a titanium button-plate only, is designed to be used with a soft tissue graft, and can either be connected to another PULLUP® CLIP button-plate by using the PULLUP® TEX CLIP nonabsorbable braided loop, or can be connected to another PULLUP® device. Standard and XL sizes.

  • PULLUP® TEX CLIP: Comprises a nonabsorbable braided loop. One size only.

Standard models are used for cortical tunnels with a diameter of 4.5 mm; XL models are used for cortical tunnels with a diameter between 5 and 10 mm.

The implants are supplied sterile, individually packaged, ready to use.

The PULLUP®, PULLUP® CLIP, BT LOOP® and PULLUP® TEX CLIP devices are also sold under the trade names RIGIDLOOP™ T, RIGIDLOOP™ Clip, RIGIDLOOP™ BTB and RIGIDLOOP™ Suture Loop respectively.

AI/ML Overview

I apologize, but based on the provided FDA 510(k) Clearance Letter (K250844), the device in question is a bone fixation fastener, specifically for anterior cruciate ligament (ACL) reconstruction.

The document describes non-clinical tests performed to demonstrate substantial equivalence, such as:

  • Ultimate failure load (post-fatigue tensile strength) and fatigue displacement
  • Biocompatibility testing (ISO 10993-1:2018)
  • Bacterial endotoxin testing (ISO 11737-3:2023)
  • Shelf-life, storage, and stability testing (ISO 11607-1:2019 for packaging)
  • Sterile adoption (ISO 11137-1:2006)
  • MRI safety evaluation (ASTM F2503 - 20, IEC 62570:2014, FDA guidance)

The provided text explicitly states "Not Applicable" for clinical tests and indicates that "Changes in design are minor, and do not raise new or different questions of safety and effectiveness compared with the predicate device." This means that no human clinical study was conducted or reported in this 510(k) submission to assess the device's performance in terms of diagnostic accuracy or human-AI interaction.

Therefore, I cannot provide the information requested regarding:

  1. A table of acceptance criteria and reported device performance directly related to AI or diagnostic accuracy.
  2. Sample size for a test set (as no clinical test set for AI performance was mentioned).
  3. Number of experts or their qualifications for establishing ground truth.
  4. Adjudication method.
  5. MRMC comparative effectiveness study.
  6. Standalone AI performance.
  7. Type of ground truth used (in an AI context).
  8. Sample size for a training set (AI model training).
  9. How ground truth for a training set was established (AI model training).

The 510(k) summary focuses on the mechanical, material, and safety aspects of the physical implant device, demonstrating its equivalence to existing predicate devices through bench testing and material science principles, not through AI performance or diagnostic accuracy studies.

§ 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.