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The LIFENET System is an optional data transmission system that provides the capability to transmit real time 12-Lead ECG reports and other physiological data to a receiving destination at a remote location. Data received from the field can be used for diagnosis, disposition, and therapy decisions by qualified medical personnel.

The system is an optional data transmission system that is used in conjunction with monitoring devices. The system provides real time data transfer from the originating/transmitting device to a user selected remote receiving destination (RD). The users of the LIFENET System are qualified medical professionals and include Advanced Life Support providers (e.g. Paramedics) and Basic Life Support providers (e.g. Emergency Medical Technicians) in a variety of hospital and pre-hospital settings. The system is used in various areas of the hospital such as critical areas (emergency departments, critical care, operating room, etc.) and general duty floors (e.g. medical/surgical, clinics, physician offices, and cardiac catheterization labs). The system is also used for hospital transport (air and ground ambulance, in-hospital transport, etc). The modified system includes optional data management features that provide the user with expanded data management capabilities and increased efficiencies. Additionally, a new feature, the LIFENET Consult, provides users the capability to forward unattered patient information for review and comment, by initiating a clinician consult. Upon receipt of patient data, health care professionals, using a hand held wireless device are able to view patient information and provide a "consult" reply to the hospital user intended for purposes of diagnosis, disposition, and therapy decisions.

The provided text describes a 510(k) premarket notification for the Physio-Control Inc LIFENET System. This system is an optional data transmission system for physiological monitors, allowing real-time transfer of 12-lead ECG reports and other physiological data. The text explicitly states that the "modified LIFENET System performs and functions in the same manner as the predicate system" and that its "Technological Characteristics" are similar to the previously cleared predicate device.

The FDA 510(k) submission process for this device focuses on demonstrating substantial equivalence to a legally marketed predicate device (LIFENET System (K093925)). When substantial equivalence is claimed through this pathway, the focus is often on comparing the new device's technological characteristics and performance to the predicate device, rather than requiring new clinical studies to establish independent acceptance criteria and performance against a gold standard for specific diagnostic or therapeutic outcomes.

Therefore, the provided document DOES NOT contain information regarding:

• A table of acceptance criteria and reported device performance.
• Sample sizes used for a test set, data provenance, number of experts for ground truth, or adjudication method for a test set.
• A multi-reader multi-case (MRMC) comparative effectiveness study or its effect size.
• A standalone algorithm-only performance study.
• 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.

The document's conclusion states: "The information in this 510(k) demonstrates that the modified LIFENET® System is substantially equivalent to the predicate LIFENET System with respect to safety, effectiveness, and performance." This indicates that the demonstration of effectiveness relied on showing similar functionality and performance to the predicate device, not on new studies specifically establishing performance against explicit acceptance criteria.

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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:

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.

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