(214 days)
The FuzeFix Mini System is intended for use in the stabilization of bone fractures, osteotomies, non-unions, and reconstruction, tendon reattachment, and arthrodesis of the hand, foot, wrist, and ankle. The FuzeFix Mini System is indicated for: scaphoid fractures, metacarpal fractures, phalangeal fractures, ulnar styloid fractures, small ioint fusions, humeral head fractures, intercarpal fractures, tarsal fusions, patellar fractures, interfragmentary ulnar fractures, small hand and wrist bone fractures, forefoot interfragmentary fractures, trapezial fractures, metatarsal fractures, radial head fractures, osteo-chondral fractures, interphalangeal fractures, malleolar fractures, metaphyseal fractures, interfragmentary radius fractures, distal metatarsal osteotomies, midfoot interfragmentary fractures. Not intended for use in the spine.
The FuzeFix Large System is intended for use in the stabilization and fixation of bone fractures, osteotomies, non-unions, and reconstruction, tendon reattachment, and arthrodesis of the hand, foot, wrist, and ankle. The FuzeFix Large System is indicated for: joint reconstructions, joint fusions, multiple fragment joint fractures, simple metaphyseal fractures of the wrist, ankle, elbow, and shoulder, metatarsal fractures and other fractures of the foot, ligament fixation of the proximal humerus, malleolar fractures, navicular fractures of the calcaneus, fractures of the talus, arthrodesis of the ankle joint, and fractures of the tarsal region. The devices and implants are not intended for use in the spine.
The FuzeFix Headless FT System is intended for use in the stabilization and fixation of bone fractures, osteotomies, non-unions, and reconstruction, tendon reattachment, and arthrodesis of the hand, foot, wrist, and ankle. The FuzeFix Headless FT System is indicated for: Osteochondral fragments (talar vault, femoral condyle), apical fragments (radial head, patellar rim, navicular, metacarpal/metatarsal), cancellous fragments (talus), Carpal, meta-carpal, and small hand bone, tarsal and metatarsals, phalanges, Intra-articular fractures, ankle, proximal and distal humerus, proximal and distal radius, proximal and distal ulna, osteochondral fixation and fractures, Osteochondritis Dissecans, Fixation of fractures and osteotomies about the knee, Oblique fractures of the fibula, Reconstructive surgeries of the foot, and malleolar fixation. Not intended for use in the spine.
The FuzeFix Twist Off System is intended for use in the stabilization of bone fractures. osteotomies, and for bone reconstruction of the hand and foot. The FuzeFix Twist Off System is indicated for: fixation of small bone fragments, Weil osteotomy, mono-cortical fixation, osteotomies and fractures fixation in the foot and hand.
The FuzeFix Screw System consists of headed and headless, partial and full threaded cannulated, self-compressive screws and snap off screws and washers for the management of orthopedic osteotomies and trauma. The screws are self-drilling, self-tapping. The system consists of multiple screw lengths and diameters, and the necessary instruments to facilitate the placement of these implants.
The provided document describes the Fusion Orthopedics, LLC FuzeFix Screw System and its substantial equivalence to predicate devices, based on non-clinical testing. It explicitly states that "No clinical studies were performed." Therefore, the information requested about acceptance criteria and studies proving the device meets them, in the context of clinical performance or AI/software, is not largely applicable or available in this document.
However, I can extract information related to the device's non-clinical performance acceptance criteria and the study that proves it meets them, as documented for regulatory submission.
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria and reported device performance in terms of specific numerical values for each test. Instead, it lists the types of non-clinical tests performed and states that the "testing demonstrated that the subject device meets the recommended maximum endotoxin level of 20 EU per device" and "The results of these evaluations indicate that the FuzeFix Screw System is equivalent to predicate devices." This implies that the device met the acceptance criteria for each test by showing equivalence or compliance with established standards.
| Acceptance Criteria (Implied by Test Type) | Reported Device Performance |
|---|---|
| Torque to Failure (ASTM F543-07 Annex A1) | Device performance was found to be "equivalent to predicate devices." |
| Axial Pullout Strength (ASTM F543-07 Annex A2) | Device performance was found to be "equivalent to predicate devices." |
| Driving/Insertion and Removal Torque (ASTM F543-07 Annex A3) | Device performance was found to be "equivalent to predicate devices." |
| Engineering analyses | Device performance was found to be "equivalent to predicate devices." |
| Pyrogenicity (Limulus amebocyte lysate (LAL) assay) | Meets the recommended maximum endotoxin level of 20 EU per device. |
The underlying acceptance criteria for "equivalence" would be that the device's mechanical properties (torque, pullout, driving/insertion/removal torque) perform within a comparable range or demonstrate similar failure modes and strengths to the established predicate devices, as typically determined through statistical comparison or by falling within a predefined performance envelope during mechanical testing.
2. Sample size used for the test set and the data provenance
The document does not specify the sample sizes used for each non-clinical test (e.g., number of screws tested for torque to failure). It also does not explicitly mention data provenance in terms of country of origin for these non-clinical tests, and non-clinical tests are inherently "prospective" in the context of generating new data for regulatory submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable. The "ground truth" for non-clinical mechanical and biocompatibility testing is established by conforming to recognized industry standards (e.g., ASTM F543-07 for mechanical tests, and general biocompatibility standards for pyrogenicity). It does not involve expert readers or clinical ground truth determination.
4. Adjudication method for the test set
This question is not applicable as the tests are non-clinical, objective measurements against established standards, not subjective interpretations requiring adjudication.
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
No such study was performed, as stated in the document: "No clinical studies were performed." This is not an AI/software device, but a physical medical implant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. This is a physical medical implant, not an AI algorithm.
7. The type of ground truth used
For the non-clinical tests, the "ground truth" is based on:
- Established Industry Standards: ASTM F543-07 Annex A1, A2, and A3 for mechanical properties (torque to failure, axial pullout, driving/insertion/removal torque).
- Biocompatibility Standards: Implicit standards leading to the "recommended maximum endotoxin level of 20 EU per device" for pyrogenicity.
- Predicate Device Performance: The primary comparative "ground truth" for equivalence claims is the performance of the legally marketed predicate devices.
8. The sample size for the training set
This question is not applicable. There is no artificial intelligence or machine learning component mentioned that would require a training set.
9. How the ground truth for the training set was established
This question is not applicable. There is no artificial intelligence or machine learning component mentioned.
§ 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.