(160 days)
The Eleven Blade Solutions, Inc. Q-Fix™ Suture Anchor System is intended for soft tissue to bone fixation for:
Shoulder
Bankart lesion repair, SLAP lesion repair, Acromio-clavicular repair, Capsular shift/capsulolabral reconstruction, Deltoid repair, Rotator cuff repair, Biceps tenodesis
Foot and Ankle
Medial/lateral repair and reconstruction, Mid and forefoot repair, Hallux valgus reconstruction, Metatarsal ligament/tendon repair or reconstruction, Achilles tendon repair
Elbow
Ulnar or radial collateral ligament reconstruction, Lateral epicondylitis repair, Biceps tendon reattachment
Knee
Extra-capsular repair: MCL, LCL, and posterior oblique ligament, Illiotibial band tenodesis, Patellar tendon repair, VMO advancement, Joint capsule closure
Hand and Wrist
Collateral ligament repair, Sacpholunate ligament reconstruction, Tendon transfers in phalanx, Volar plate reconstruction
Hip
Acetabular labral repair
The Q-Fix™ Suture Anchor is an all-suture anchor device designed for soft tissue to bone fixation by expanding against bone when deployed. Made of a polyester sleeve-type structure with one or more strands of UHMWPE suture threaded through it, the anchor is provided preloaded on a disposable inserter. The inserter is used to deploy the anchor into the bone, with the suture remaining slideable within the anchor to facilitate attachment of the soft tissue. The one-time use anchor is provided sterile, preloaded on the inserter. Additional accessory instruments, including a drill bit and drill guide with obturator are single use devices provided sterile for use during the orthopedic procedure.
The Q-Fix™ Suture Anchor System is a medical device designed for soft tissue to bone fixation. The provided document is a 510(k) summary, which indicates that the device is seeking substantial equivalence to already marketed predicate devices. This type of submission focuses on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than proving absolute safety and efficacy through extensive clinical trials. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the demonstration of substantial equivalence through bench testing compared to predicate devices.
Here's an analysis based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative "acceptance criteria" in a table format with corresponding "reported device performance" values for the Q-Fix™ Suture Anchor System. Instead, it states that bench studies were conducted to evaluate performance characteristics and demonstrate equivalence to predicate devices. The implicit acceptance criterion is that the Q-Fix™ Suture Anchor System's performance characteristics are "equivalent to the predicate devices and thus provide equivalent fixation strength within their intended use."
The performance characteristics evaluated were:
| Performance Characteristic | Reported Device Performance (Implicit Acceptance) |
|---|---|
| Anchor Pull-out Strength | Equivalent to predicate devices |
| Cyclic Displacement | Equivalent to predicate devices |
| Device Insertion Testing | Equivalent to predicate devices |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "bench studies" for Anchor Pull-out Strength, Cyclic Displacement, and Device Insertion Testing. However, it does not specify the sample sizes used for these tests. It also does not provide information on the country of origin of the data or whether the studies were retrospective or prospective, as these are bench tests and not human or animal studies.
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 question is not applicable in the context of this 510(k) summary. The "ground truth" for bench testing of a suture anchor system is typically based on established engineering and biomechanical standards, not on expert clinical consensus. The assessments are objective measurements of physical properties.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This question is not applicable. Adjudication methods are typically used in clinical studies or image interpretation studies where expert consensus is needed. For bench testing of physical properties, measurements are objective and do not require expert adjudication in the same way.
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 question is not applicable. An MRMC comparative effectiveness study is used for evaluating diagnostic aids or imaging devices where human interpretation is involved. The Q-Fix™ Suture Anchor System is a surgical implant, and its performance is evaluated through biomechanical bench testing.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This question is not applicable. The Q-Fix™ Suture Anchor System is a physical medical device, not an algorithm or AI system. Its performance is inherent to its physical properties and design.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For the bench studies, the "ground truth" for assessing device performance is based on objective biomechanical measurements against established engineering and material science principles, and comparison to the performance characteristics of the predicate devices. It is not based on expert consensus, pathology, or outcomes data, as these are typically relevant for clinical studies.
8. The sample size for the training set
This question is not applicable. This device is a physical medical implant, not an AI or machine learning algorithm. Therefore, there is no "training set."
9. How the ground truth for the training set was established
This question is not applicable, as there is no "training set" for this type of device.
§ 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.