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INTENDED USE

The Response Ortho Smart Fixator - Hexapod System is intended for use in adult patients and pediatric patients greater than 2 through 21 years of age for the treatment of open and closed fractures, arthrodesis and pseudoarthrosis of long bones, limb lengthening, deformity and angular correction, bony or soft tissue defect correction, and malunions. This is accomplished by construction of an external fixator frame and a computer-assisted planning and correction application. Based on surgeon input of examination and radiographic measurements, the software provides a schedule of adjustments for the fixator frame.

INDICATIONS FOR USE

The Smart Fixator - Hexapod System is indicated for adult patients and pediatric patients greater than 2 through 21 years of age for the following:

• Joint contracture resulting in loss of range of motion.
• Fractures and disease which generally may result in joint contractures or loss of range of motion.
• Fractures requiring distraction.
• Open and closed fracture fixation, including fractures of long bones (intracapsular, intertrochanteric, supracondylar, condylar).
• Correction of bony or soft tissue defects.
• Correction of bony or soft tissue deformities.
• Joint arthrodesis.
• Infected fractures or nonunion.
• Limb lengthening by epiphyseal or metaphyseal distraction.
• Pseudoarthrosis of long bones.

The Response Ortho Medical Smart Fixator - Hexapod System: a multilateral hexapod circular external fixator device used to stabilize and maintain alignment of complicated fractured bones, soft tissues and/or congenital deformity repairs of an extremity. The basic system consists of a minimum of two rings connected by six (6) telescopic struts that are lengthened and shortened independently. The struts' independent motion allows the position to adjust the position of one ring relative to the other. The system allows for movement in six different axes to correct difficult trauma extremity situations and/or congenital limb deformity correction. The Smart Fixator - Hexapod System capitalizes on the body's natural ability of osteogenesis, guiding the orientation and position of this new bone to the desired corrected location in a steadily controlled fashion. In addition to the hardware, the Smart Fixator - Hexapod System has a web-based software treatment planning tool with Radiographic Navigation. The surgeon enters data from direct examination, radiographic images and the fixator parameters into the software. The software is used preoperatively to plan the reconstruction/correction and identify the frame construction. Post operatively, the surgeon enters the X-ray images and the current frame parameters to establish an adjustment schedule for the patient during the healing process.

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JuggerKnot Soft Anchor OC are intended for use in soft tissue to bone fixation for the following indications: Knee MPFL Knee Patellar tendon repair Knee MCL Knee Quadriceps tendon repair Hip Acetabular labral repair Hip Proximal hamstring repair Hip Hip Labral reconstruction Foot and Ankle Achilles tendon repair Foot and Ankle Medial/lateral repair and reconstruction Foot and Ankle Plantar plate repair Foot and Ankle Mid- and forefoot repair Foot and Ankle Metatarsal ligament/tendon repair or reconstruction Shoulder Rotator Cuff Shoulder Shoulder Instability Shoulder Biceps Tenodesis Elbow Lateral epicondylitis repair Elbow Biceps tendon reattachment

The JuggerKnot Soft Anchor OC is identical to the previously cleared JuggerKnot Soft Anchor OC except for the presence of a bioceramics embedded in the anchor portion of the device. The JuggerKnot Soft Anchor OC is comprised of a suture sleeve structure and working suture. Nonabsorbable braided ultra-high molecular weight polyethylene (UHMWPE) sutures are spliced through a suture anchor sleeve comprised of non-absorbable braided polyester. Up to two nonabsorbable round or flat braided UHMWPE working sutures can be added inside the suture anchor sleeve. The UHMWPE sutures are available undyed (white) and black. The hydroxyapatite and bioceramic particles are embedded in the surface of the suture anchor material. Sutures supplied meet United States Pharmacopeia (USP) requirements for non-absorbable suture except for diameter. Suture dyes are FDA approved. The inserter is comprised of a metallic shaft with over molded handle. The device is sterilized by ethylene oxide gas and is provided sterile for single use. The JuggerKnot Soft Anchor OC are available in common sizes and lengths and will be sold sterile for single use. The device is intended for use in a hospital/clinic/surgical setting.

The provided text describes a medical device, the JuggerKnot Soft Anchor OC, and its clearance under a 510(k) premarket notification. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than conducting a full clinical trial to prove efficacy and safety from scratch.

Therefore, the specific information requested about acceptance criteria and a study proving the device meets those criteria (especially in terms of diagnostic performance, human reader improvement with AI assistance, standalone algorithm performance, and ground truth establishment for training and test sets) is not applicable in the context of this 510(k) submission.

The document focuses on non-clinical performance testing and substantial equivalence to a predicate device, as opposed to a diagnostic device for which such performance metrics would be relevant.

Here's a breakdown based on the information provided and what is implied by a 510(k) submission for this type of device:

1. A table of acceptance criteria and the reported device performance:

   • Acceptance Criteria: For this device (a bone fixation fastener), acceptance criteria are primarily related to mechanical performance, biocompatibility, sterilization, and material properties, demonstrating it is as safe and effective as the predicate.
   • Reported Device Performance:
     • Mechanical Testing: "performed comparably to the predicate device in insertion, cyclic and pullout testing."
     • Sterilization: "sterilization adoption validation"
     • Biocompatibility: "biocompatibility testing per ISO10993- 1:2018"
     • Stability: "stability testing on the product packaging per ISO 11607-1:2006"
     • Usability Engineering: "usability engineering validation with simulated use in a cadaveric models performed per EN62366: 2015"
     • Endotoxin/Pyrogenicity: "Endotoxin/pyrogenicity testing was performed per ANSI/AAMI ST72:2019, USP <161>, USP <151> and USP <85>."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

   • Test Set (for mechanical and other non-clinical tests): Not explicitly stated numbers for each test, but standard engineering and biological testing samples would have been used.
   • Data Provenance: The tests were likely conducted in laboratories or facilities chosen by the manufacturer, Riverpoint Medical, LLC, which is based in Portland, Oregon, USA. The studies are prospective in the sense that they were conducted for the purpose of this submission.
   • Animal Study: "An animal study was performed to evaluate the biological safety and in vivo performance associated with the JuggerKnot Soft Anchor OC." No specific animal numbers are provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

   • This is not applicable as the device is a medical implant (bone fixation fastener), not a diagnostic device requiring expert interpretation of images or other medical data for ground truth. Ground truth for this device relates to physical and biological properties.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • This is not applicable for the reasons stated above. Adjudication methods are typically for diagnostic interpretations.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • This is not applicable. The device is an implantable fastener, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • This is not applicable. The device is a physical implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • For the non-clinical tests, the "ground truth" is based on established engineering standards, material science properties, and biological safety parameters. For the animal study, the "ground truth" would be the observed biological response to the implant in vivo.

8. The sample size for the training set:

   • This is not applicable. This is a physical device submission; there is no "training set" in the context of machine learning or AI.

9. How the ground truth for the training set was established:

   • This is not applicable for the reason stated above.

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