(21 days)
The Smith & Nephew FOOTPRINT RCX PK Suture Anchor is intended for use for the reattachment of soft tissue to bone for the following indications:
Shoulder: Rotator cuff repair, Bankart repair. Slap lesion repair, Biceps tenodesis, Acromio-Clavicular separation, Deltoid repair, and Capsular shift or Capsulolabral reconstruction.
Foot/Ankle: Lateral stabilization, Medial stabilization, Achilles tendon repair, Hallux valgus reconstruction, Mid-foot reconstruction, Metatarsal ligament repair.
Knee: Medial collateral ligament repair, Lateral collateral ligament repair, Patellar tendon repair, Posterior oblique ligament repair, Illiotibial band tenodesis.
Hand/Wrist: Scapholunate ligament reconstruction, Ulnar collateral ligament reconstruction, Radial collateral ligament reconstruction.
Elbow: Biceps Tendon reattachment, Ulnar or radial collateral ligament reconstruction.
The FOOTPRINT RCX PK Suture Anchor is a suture anchor manufactured from PEEK polymer. The screw-in anchor can be loaded with up to four strands of suture and facilitates arthroscopic repair of soft tissue to bone. The design allows the surgeon to adjust the tension on the tissue intraoperatively and secure the repair.
This document is a 510(k) summary for a medical device (Suture Anchor), not a study analyzing the performance of an AI/ML diagnostic device with acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness studies is not present. This document describes the device itself and its equivalence to a predicate device.
However, I can extract the information that is available from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Reported Device Performance (Summary) |
|---|---|
| Substantial Equivalence | The Smith & Nephew FOOTPRINT RCX PK Suture Anchor is substantially equivalent to the predicate Smith & Nephew Twinfix PK FP suture anchor (K073509) in intendeed use, materials, and fundamental scientific technology. |
| Safety and Effectiveness | Performance testing demonstrates that the insertion and fixation properties are substantially equivalent to the predicate. The new device does not raise any new issues of safety and efficacy. |
Missing Information (Not provided in the document as it's not applicable to this type of submission):
- Sample size used for the test set and the data provenance.
- Number of experts used to establish the ground truth for the test set and their qualifications.
- Adjudication method for the test set.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, or the effect size of how much human readers improve with AI vs without AI assistance.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc).
- The sample size for the training set.
- How the ground truth for the training set was established.
Explanation Based on Document Type:
This document is a 510(k) Premarket Notification for a suture anchor, which is a physical medical device. The "performance testing" mentioned in the document refers to engineering and biomechanical tests (e.g., insertion force, pull-out strength, material properties) to demonstrate that the new device performs equivalently to a previously cleared predicate device. It is not a study involving diagnostic accuracy, therefore, the concepts of "test set," "ground truth," "experts," "AI," or "MRMC studies" are not applicable here. The "acceptance criteria" discussed would pertain to engineering specifications and regulatory requirements for proving substantial equivalence to a predicate device.
§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).