(110 days)
The Cayenne Medical, Inc. Short SureLock™ All- Suture Anchor is intended to reattach soft tissue to bone in orthopedic surgical procedures. The system may be used in either arthroscopic or open surgical procedures. After the anchor is deployed in the bone, the floating sutures can be used to reattach soft tissue, such as ligaments, tendons, or joint capsules to the bone. The suture anchor system thereby stabilizes the damaged soft tissue, in conjunction with appropriate postoperative immobilization, throughout the healing period.
The Cayenne Medical, Inc. Short SureLock™ All-Suture Anchors are intended to be used for the reattachment of soft tissue to bone for the following indications:
Foot and Ankle
- । Hallux valgus reconstruction
- । Midfoot reconstruction
Hand and Wrist
- -Ulnar or lateral collateral ligament reconstruction
- Repair/reconstruction of collateral ligaments
- Flexor and extensor tendon at the PIP, DIP, and MCP joints for all digits —
- -Scapholunate ligament reconstruction
The Short SureLock™ All-Suture Anchor is a sterile (using ethylene oxide sterilization method), manually operated, single procedure all suture anchor device for reattachment of soft tissue to bone. The all-suture anchor is preloaded with floating suture with needles and loaded on a disposable inserter. Short SureLock™ All-Suture Anchor incorporates design features that facilitate suture anchor placement under arthroscopic, open, or limited access conditions in soft tissue to bone reattachment procedures.
The Short SureLock™ All-Suture Anchor is offered in two configurations, 1.4mm anchor with one size 0 Ultra High Molecular Weight Polyethylene (UHMWPE) suture strand with attached needles and 1.4mm anchor with one size 2-0 UHMWPE suture strand with attached needles. The anchors and floating sutures are made out of non-absorbable Ultra High Molecular Weight Polyethylene (UHMWPE) surgical sutures. The needles attached to the floating suture are made out of medical grade stainless steel.
The anchor is formed by passing one end of a length of suture perpendicularly back through itself in alternating directions a number of times. This results in a construct resembling a ladder. The four suture tails are cut and trimmed. A floating suture is passed through the loops in the anchor to form the anchor construct.
The disposable inserter has a working shaft length of 4.14 cm with an outer shaft diameter of 4.0 mm. The inserter shaft is made out of surgical grade stainless steel and the handle and knob are made out of ABS plastic. The inserter pushes the suture anchor construct into a hole drilled in the bone. The knob on the inserter handle is rotated to apply tension to the floating suture limbs to expand and deploy the anchor in the bone tunnel. The floating suture limbs with needles are then released from the inserter and the inserter is removed.
The provided text is a 510(k) Summary for a medical device (Short SureLock™ All-Suture Anchor) and a corresponding FDA letter. This type of document focuses on demonstrating substantial equivalence to a previously cleared predicate device rather than establishing acceptance criteria and proving performance through a clinical study in the way a new drug or high-risk device might.
Therefore, many of the requested elements (e.g., acceptance criteria, detailed study design with sample sizes, expert ground truth, MRMC study, training set) typically associated with AI/ML device performance or clinical trials are not applicable to this 510(k) submission.
Here's an analysis based on the information available:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated as pass/fail thresholds in the traditional sense for a clinical or AI performance study. Instead, the acceptance criteria for a 510(k) are implicitly:
- Demonstrate that the new device is as safe and effective as a legally marketed predicate device.
- Show that differences in technological characteristics do not raise different questions of safety and effectiveness.
- For mechanical properties, demonstrate "comparable" performance to the predicate device.
- Reported Device Performance:
Performance Metric Acceptance Criteria (Implicit) Reported Performance Pull-out strength Comparable to predicate device "Testing showed that the Short SureLock™ Anchor ultimate pull-out strength was comparable to that of the predicate device." Biocompatibility Biocompatible for intended use (Implied by use of medical grade stainless steel and UHMWPE, common in medical devices; no specific results given for this device, but usually relies on material characterization and ISO standards) Sterility Sterile "...sterile (using ethylene oxide sterilization method)..." Indications for Use Broader indications for use should not raise different questions of safety and effectiveness. "The subject device has a broader indication for use... The two added indications for use do not raise different questions of safety and effectiveness."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not explicitly stated. The document mentions "Mechanical testing (pull-out strength) was performed" and implicitly implies a sufficient number of devices for the tests to be considered statistically valid and comparable.
- Data Provenance: Not applicable. The testing described is in vitro mechanical testing, not human data.
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)
- Not applicable. This device is a physical medical implant. Ground truth is established through physical and material science testing, not expert consensus on interpretations of data (like in an AI/ML context).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. See point 3.
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. This is not an AI/ML device. It's a surgical implant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. Not an AI/ML device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- The "ground truth" for the mechanical testing would be the physical measurements of pull-out strength obtained from standardized mechanical testing equipment, following established test methods (e.g., ASTM standards). The comparison is against the predicate device's performance under similar testing conditions.
8. The sample size for the training set
- Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. See point 8.
In summary: The provided document is a 510(k) premarket notification for a Class II medical device (suture anchor). The "study" proving it meets "acceptance criteria" is a non-clinical mechanical testing comparison against a legally marketed predicate device, demonstrating substantial equivalence in terms of safety and effectiveness for its intended use, rather than a clinical trial or AI performance study with detailed clinical metrics and ground truth establishment.
§ 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.