(89 days)
The 2.0 PK Suture Anchor T and 2.0 PK Suture Anchor S is intended for use for the reattachment of soft tissue to bone for the following indications:
Shoulder: Capsular stabilization- Bankart repair, Anterior shoulder instability, Slap lesion repair, Capsular shift or capsulolabral reconstruction, Acromilavicular separation repairs, Deltoid repairs, Rotator cuff tear repairs and Biceps tenodesis.
Foot/Ankle: Hallux valgus repairs, Medial or lateral instability repairs/reconstruction. Achilles tendon repairs/reconstruction, Mid-foot reconstruction, Metatarsal ligament/tendon repairs/recontructions and Bunionectomy.
Elbow, Wrist, and Hand: Biceps tendon reattachment, Ulnar or radial collateral ligament reconstructions, Lateral epicondylitis repair, and Scapholunate ligament reconstruction,
Knee: Extra-capular repairs -Medial collateral ligament, Lateral ligament, Posterior oblique ligament, Patellar realignment and tendon repairs - Vastus medialis obliquous advancement and Illoiotibial band tenodesis.
The 2.0 PK Suture Anchor T and the 2.0 PK Suture Anchor S consist of a non-absorbable suture anchor with attached non-absorbable suture(s) preassembled to a stainless steel insertion device, and is provided sterile, for single use only. Both anchor models achieve fixation via ribbed/threaded design characteristics that are consistent with the repair of soft tissue to bone.
The provided text describes a 510(k) submission for a medical device, specifically the "2.0 PK Suture Anchor T and 2.0 PK Suture Anchor S." This is a premarket notification for a traditional medical device, not an AI/ML powered device. Therefore, many of the requested criteria such as "multi-reader multi-case (MRMC) comparative effectiveness study," "standalone (i.e. algorithm only) performance," "ground truth establishment," and "training set sample size" are not applicable.
The document focuses on demonstrating substantial equivalence to existing legally marketed predicate devices through performance testing. This means the acceptance criteria are largely based on showing comparable performance in defined mechanical tests rather than clinical accuracy studies.
Here's an interpretation of the available information regarding acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical acceptance criteria in a table format, nor does it provide detailed raw performance data. Instead, it makes a general statement of equivalency to predicate devices. The "acceptance criteria" are implicitly met if the device's performance in the Summary Performance Data demonstrates substantial equivalence to the predicate devices.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Insertion Properties | Substantially equivalent to Smith & Nephew 2.3 BIORAPTOR and Arthrex Mini BioSuture Tak™ anchors. |
| Fixation Properties | Substantially equivalent to Smith & Nephew 2.3 BIORAPTOR and Arthrex Mini BioSuture Tak™ anchors. |
| Safety and Efficacy | Differences from predicate devices do not raise new issues of safety and efficacy. |
| Clinical Indications | Intended for the same range of soft tissue to bone reattachment indications as predicate devices (Shoulder, Foot/Ankle, Elbow/Wrist/Hand, Knee). |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not explicitly state the sample size for the performance tests. It refers to "performance testing conducted" for insertion and fixation properties. The data provenance is not specified beyond being "conducted" by Smith & Nephew. It is certainly prospective testing, as it's performed to validate the new device. It is not clinical data but rather bench testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. This is a mechanical device, and "ground truth" for the test set would be objective measurements from engineering tests rather than expert consensus on medical images or diagnoses.
4. Adjudication Method for the Test Set
Not applicable. As noted above, this is not a diagnostic device involving expert review.
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 is a medical implant/fastener, not an AI-powered diagnostic or assistive technology.
6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done
Not applicable. This is a medical implant/fastener, not an AI-powered algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this device would be established by objective engineering measurements (e.g., pull-out strength, insertion force, material properties) during performance testing in a lab setting, compared against established standards or the performance of predicate devices. It is not pathology, outcomes data, or expert consensus in a clinical sense.
8. The Sample Size for the Training Set
Not applicable. This is a physical medical device, not an AI/ML model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As above, 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.