(355 days)
The Flower Suture Anchor Set is intended to be used to aid arthroscopic and orthopedic reconstructive procedures needing soft tissue fixation, due to injury or degenerative disease.
The FlowerAnchor. 3.0mm is indicated for use in soft tissue reattachment procedures in the shoulder, elbow, wristhand. foot/ankle and knee. Specific indications are as follows:
· Shoulder indications: Bankart repair, rotator cuff repair, capsule repair, capsule repair or capsulolabral reconstruction, acromio-clavicular separation, deltoid repair, biceps tenodesis.
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· Wrist/hand indications: Scapholunate ligament reconstruction.
· Foot/Ankle indications: Tendon repair/reconstruction, hallux valgus reconstruction, lateral stabilization, medial stabilization, mid- and forefoot reconstructions. -
· Elbow indications: Biceps tendon reconstruction, ulnar or radial collateral ligament reconstruction.
• Knee indications: Lateral collateral ligament repair, medial collateral ligament repair, posterior oblique ligament repair, patellar ligament/tendon repair, iliotibial band tenodesis, joint capsule closure, extracapsular repair, vastus medialis obliquus (VMO) muscle advancement.
The FlowerAnchor, 5.0mm and FlowerAnchor, Knotless is indicated for soft tissue reattachment procedures in the shoulder, elbow, wrist/hand, foot/ankle and knee. Specific indications are as follows:
• Shoulder indications: Bankart repair, rotator cuff repair, capsule repair, capsule repair or capsulolabral reconstruction, acromio-clavicular separation,deltoid repair, biceps tenodesis.
- Wrist/hand indications: Ulnar/Radial collateral ligament reconstruction, scapholunate ligament reconstruction.
· Foot/Ankle indications: Achilles tendon repair/reconstruction, hallux valgus reconstruction, lateral stabilization, medial stabilization, mid- and forefoot reconstructions.
· Elbow indications: Biceps tendon reconstruction, ulnar or radial collateral ligament reconstruction, lateral epicondylitis repair.
• Knee indications: Lateral collateral ligament repair, medial collateral ligament repair, posterior oblique ligament repair, patellar ligament/tendon repair, iliotibial band tenodesis, joint capsule closure.
The Flower Suture Anchor Set consists of FlowerAnchor, 3.0mm, FlowerAnchor, 5.0mm, and FlowerAnchor, Knotless with lengths of 10mm and 17mm, respectively. The anchors are screw-like in shape and made of PEEK. The anchors are threaded with ultra-high molecular weight polyethylene (UHMWPE) non-absorbable sutures. The 3.0mm and 5.0mm anchors, USP Size 0 and Size 2 sutures, and inserters and the Knotless anchor and inserter are supplied as a single assembly, sterilized by ethylene-oxide, nonpyrogenic, and ready-for-surgery.
Accessories of Taps and Drill Bit Kits are supplied sterile by means of gamma radiation with the Flower Suture Anchor Set.
This document is a 510(k) Premarket Notification from the FDA for a medical device called the "Flower Suture Anchor Set." It does not present a study proving the device meets acceptance criteria in the context of an AI/ML-driven solution or diagnostic tool. Instead, it demonstrates substantial equivalence to existing predicate devices based on mechanical and biological performance testing for hardware.
Here's why the requested information about AI model acceptance criteria and study data cannot be provided from this document:
- Device Type: The "Flower Suture Anchor Set" is a physical orthopedic surgical device (suture anchors made of PEEK for soft tissue reattachment). It is not an AI/ML diagnostic tool, an image analysis algorithm, or any software-based medical device.
- Regulatory Pathway: The 510(k) pathway is for demonstrating substantial equivalence to a legally marketed predicate device, primarily through engineering testing, material compatibility, and comparison of physical characteristics and intended use. It does not typically involve clinical studies with human readers or AI performance metrics.
- Performance Data Section: The "Performance Data" section describes mechanical testing (insertion, pull-out, fatigue), biocompatibility testing (cytotoxicity), and adherence to sterilization standards for the physical device. These are standard engineering tests for implants and surgical tools, not AI model validation.
Therefore, since the document pertains to a physical medical device and not an AI/ML system, the following requested information cannot be extracted or inferred:
- A table of acceptance criteria and the reported device performance: The acceptance criteria relate to mechanical strength, biocompatibility, and sterilization for a surgical anchor, not diagnostic accuracy metrics (e.g., sensitivity, specificity, AUC) typically associated with AI.
- Sample size used for the test set and the data provenance: Not applicable to AI testing. The "test set" here refers to physical samples of the suture anchors subjected to mechanical and biological tests.
- Number of experts used to establish the ground truth...: Not applicable. Ground truth for a physical device is established through engineering and laboratory measurements, not expert consensus on images.
- Adjudication method: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done...: Not applicable as there are no "human readers" involved in the performance of a suture anchor.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. The device performs a mechanical function.
- The type of ground truth used: For a physical device, ground truth is based on physical measurements and material standards.
- The sample size for the training set: Not applicable. This is a manufactured product, not an AI model requiring a training set.
- How the ground truth for the training set was established: Not applicable.
In summary, this document is entirely outside the scope of AI/ML medical device regulation and testing. It provides information relevant to the substantial equivalence of a physical surgical implant, not the acceptance criteria or performance studies of an AI model.
§ 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.