(91 days)
The ICONIX All Suture Anchor System is intended to be used for soft-tissue to bone fixation in the foot, ankle, knee, hip, hand, wrist, elbow and shoulder. Specific Indications are listed below.
Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction
Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Repair
Hand/Wrist: Scaphulolunate Ligament Reconstruction, Carpal Ligament Reconstruction, Repair/Reconstruction of Collateral Ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP and MCP Joints for all Digits, Digital Tendon Repair
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus Reconstruction, Digital Tendon Transfers, Mid-foot Reconstruction
Knee: Medial Collateral Ligament Repair. Lateral Collateral Ligament Repair. Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis.
Hip: Capsular Repair, Acetabular Labral Repair, Gluteal Tendon Repair
The ICONIX All Suture Anchors are intended for single use only.
The ICONIX All Suture Anchors are soft-tissue fixation devices with a push-in design, provided preloaded on a disposable inserter. They are composed of a sheath structure that contains one or more working sutures. As the anchor is deployed, the sheath bunches and fixates in bone.
The provided text describes the ICONIX All Suture Anchor System and its expanded indications for use. However, it does not include information about acceptance criteria or a study that specifically proves the device meets such criteria in terms of performance metrics like sensitivity, specificity, or reader improvement. This is likely because the device is a medical implant (suture anchor) and not an AI-powered diagnostic or assistive tool, which typically have performance metrics and studies as detailed in the prompt.
The "study" mentioned here is confined to non-clinical comparative bench testing to support expanded indications, not a clinical study involving human performance or diagnostic accuracy.
Here's an analysis based on the provided document, addressing the prompt's questions where possible and noting where information is not applicable or unavailable:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Stated Goal) | Reported Device Performance |
|---|---|
| Statistically equivalent fixation strength to predicate devices for Gluteal Tendon Repair of the Hip in non-clinical bench testing. | The results of the non-clinical evaluation indicate that the ICONIX All Suture Anchors provide statistically equivalent fixation strength to the predicate devices, and will be functional within the intended use. |
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 for Test Set: Not explicitly stated in the document. The text only mentions "comparative bench testing" for "cyclic testing followed by ultimate tensile strength".
- Data Provenance: The study was "non-clinical comparative bench testing," implying it was conducted in a lab setting, likely within the United States where Stryker Endoscopy is based (San Jose, CA). It is prospective in nature for device validation.
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 to this type of device and study. The testing involved mechanical properties (fixation strength, tensile strength) which are measured quantitatively, not subjectively assessed by human experts for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This question is not applicable as the "test set" involves physical device performance, not human interpretation or diagnostic assessment.
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, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic or AI-assisted devices that involve human interpretation of medical images or data. The ICONIX All Suture Anchor System is a physical surgical implant.
- Therefore, an effect size of human improvement with/without AI assistance is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- This question is not applicable. This device is a physical medical implant, not an algorithm, and does not have standalone "algorithm only" performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this device's performance was established via objective mechanical measurements of fixation strength and ultimate tensile strength in a bench testing environment according to engineering principles. It was compared against the performance of predicate devices.
8. The sample size for the training set
- This question is not applicable as there is no "training set" in the context of mechanical bench testing for a physical medical device. This term is specific to machine learning and AI model development.
9. How the ground truth for the training set was established
- This question is not applicable since there is no training set for this type of device validation.
Summary of the Study:
The "study" described in the document is a non-clinical comparative bench test. Its purpose was to demonstrate that the ICONIX All Suture Anchors, when used for Gluteal Tendon Repair of the Hip (an expanded indication), show equivalent mechanical fixation strength to predicate devices. This type of testing is standard for demonstrating substantial equivalence for physical medical devices, especially when expanding indications without significant design changes. Clinical testing was explicitly stated as "not required for this submission." The FDA's 510(k) clearance (K133671) acknowledges this bench testing as sufficient to support the claim of substantial equivalence.
§ 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.