(25 days)
The Shadow Knotless All-Suture Anchors are intended to be used for fixation of soft tissue to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, and hip in the following procedures:
Shoulder: Rotator Cuff Repair, Bankart Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Repair.
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair, Digital Tendon Transfers.
Knee: Medial Collateral Ligament Repair, Lateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis.
Hand/Wrist: Scapholunate Ligament Reconstruction of Collateral Ligaments, Carpal Ligament Reconstruction, Repair of Flexor and Extensor Tendons at the PIP, DIP, and MCP Joints for all Digits, Digital Tendon Repairs.
Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction.
Hip: Capsular Repair, Acetabular Labral Repair, Gluteal Tendon Repair.
The Shadow Knotless All-Suture Anchor is a modified version of the Responsive Arthroscopy (RA) Mini Stealth All-Suture Anchors that were previously cleared under K230094. The subject Shadow Knotless device is a suture anchor intended for the fixation of soft tissue to bone. The Shadow device features a knotless, push-in design and is comprised entirely of suture material configured to provide an anchor in bone. The anchor creates a secure fixation point for the reattachment of soft tissue to bone when it is inserted through a pilot hole and deployed against the inserter tip below cortical bone in the desired anatomy. The subject device four longitudinally arranged round bundles that bunch together and expand radially when deployed to achieve fixation. The provided suture passing loop allows the integrated repair suture to be passed through the anchor body when securing the desired soft tissue, while the knotless feature allows the repair suture to be locked in place without tying a knot. The anchors may be delivered arthroscopically using inserters and reusable surgical instruments such as drills, guide tubes, and probes, which are identical to those provided with the predicate Mini Stealth All-Suture Anchors (K230094). The subject Shadow anchors are pre-loaded on disposable inserters and provided sterile via ethylene oxide (EO), while the reusable instruments are non-sterile and are intended to be sterilized by the end user.
The subject Shadow device is designed for a 2.1mm diameter pilot hole and is comprised of braided nonabsorbable ultra-high molecular weight polyethylene (UHMWPE). It is provided with an attached USP #1 UHMWPE nonabsorbable repair suture tail and a UHMWPE suture passing loop that are used to facilitate a repair. All subject device materials are identical to those of the predicate Mini Stealth All-Suture Anchors (K230094).
The primary differences between the subject and predicate devices (K230094) are the additions of the knotless feature, integrated repair suture tail, and suture passing loop. However, these design characteristics are similar to those found in the predicate RA Wedge Push-In Suture Anchors previously cleared under K190446 and K181076. No other changes are being made to the inserters or other instrumentation that may be used during a procedure.
This document is a 510(k) Premarket Notification from the FDA regarding the "Shadow Knotless All-Suture Anchors." It details the device's description, indications for use, technological characteristics, and evidence of substantial equivalence to predicate devices.
The provided text describes a medical device (suture anchors) and its regulatory clearance process, not an AI/ML powered medical device. Therefore, the requested information regarding acceptance criteria and studies that prove an AI/ML device meets those criteria cannot be extracted from this document. The concepts of "test set," "training set," "ground truth," "MRMC studies," "human readers improve with AI," and "standalone algorithm performance" are specific to the development and validation of AI/ML models in a healthcare context, which are not discussed here.
The document primarily focuses on demonstrating substantial equivalence of a physical medical device (suture anchors) to existing cleared devices through bench testing of mechanical properties.
However, I can extract the information that is present concerning the device's performance through bench testing, which serves as its "acceptance criteria" for demonstrating substantial equivalence.
Based on the provided document, here's what can be extracted, interpreted within the context of a physical medical device clearance, not an AI/ML model:
There is no information in this document about an AI/ML-powered device. The device in question is the "Shadow Knotless All-Suture Anchors," which is a physical implantable medical device. Therefore, many of the requested points related to AI/ML validation (e.g., test/training sets, ground truth establishment, MRMC studies, human-in-the-loop performance) are not applicable.
However, I can interpret the "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of this physical device's non-clinical performance testing.
1. A table of acceptance criteria and the reported device performance:
The document states: "Performance testing consisted of design verification testing). All testing met acceptance criteria and demonstrated that the devices met design specifications and performed as intended."
While specific numerical acceptance criteria (e.g., "pullout force must be > X N") are not explicitly listed, the types of tests performed indicate the performance characteristics that were evaluated and met.
| Acceptance Criteria Category (Implied) | Reported Device Performance (Implied) |
|---|---|
| Insertion Force | Met acceptance criteria; performed as intended. |
| Cyclic Pullout Force | Met acceptance criteria; performed as intended. |
| Cyclic Suture Locking Force | Met acceptance criteria; performed as intended. |
| Suture Diameter Measurement | Met acceptance criteria; performed as intended (specifications were met). |
| Suture Tensile Strength | Met acceptance criteria; performed as intended. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated for each test. The document generally refers to "the subject devices" and "the predicate devices" being tested.
- Data Provenance: The testing was "Nonclinical performance testing" conducted to demonstrate that the device met established performance characteristics and design requirements. This implies laboratory bench testing, not clinical data from patients or a specific country. This is a prospective test specifically for this device's clearance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This is for a physical device, and "ground truth" as it pertains to expert annotation in AI/ML is not relevant here. The "ground truth" for these tests would be the measurement standards and engineering specifications.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. This concept pertains to resolving discrepancies in expert annotations for AI/ML validation. For bench testing, test results are compared against predefined engineering specifications.
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:
- Not applicable. This device is a physical medical implant, not an AI-powered diagnostic or assistive tool. MRMC studies are used to evaluate diagnostic imaging systems, often in the context of AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This applies to AI/ML algorithms. The performance testing described (mechanical tests) is inherent to the device itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For physical device testing, the "ground truth" is typically against engineering specifications, material standards, and performance benchmarks derived from predicate devices or established biomechanical principles. It's based on measured physical properties (e.g., force, diameter, strength).
8. The sample size for the training set:
- Not applicable. There is no AI/ML training set for this physical device.
9. How the ground truth for the training set was established:
- Not applicable. There is no AI/ML training set for this physical device.
In summary, the provided document is a 510(k) clearance letter for a physical medical device (suture anchors), not an AI/ML product. Therefore, most of the specific questions geared towards AI/ML validation are not addressed or applicable within this document. The "acceptance criteria" and "proof" for this device relate to its mechanical performance in non-clinical bench testing, demonstrating that it functions equivalently to previously cleared predicate devices.
§ 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.