(266 days)
The Unity Ultrasonic System consists of an electrical generator and ultrasonic handpieces. The system is to be used with Unity single patient use absorbable (PLLA) implants intended for use as fasteners (anchors) in the fixation of tissue, ligament, tendon, and bone. The system is indicated in general soft tissue approximation/ligation.
The Unity Ultrasonic System with PLLA Fasteners is designed for the fixation of soft tissue, ligament, tendon, and bone. Absorbable poly-L-lactic acid (PLA) implant materials are ultrasonically welded, staked, and/or joined to secure soft tissue, ligament, tendon, and bone at a repair site. An electrical generator provides ultrasonic energy to the end effector of a handpiece to fix the implant materials together and secure soft tissue, ligament, tendon, and/or bone. Energy applied to the trailing end of the implant portion contacting the handpiece end effector joins this implant portion to the other implant portion in securing soft tissue, ligament, tendon, and bone. Ultrasonic handpieces with end effectors designed to accommodate Unity Implants are product specific and include a force sensor mechanism that allows the surgeon feedback on the amount of load they are applying to the handpiece. Feedback is provided to the surgeon through an audible tone.
The provided document describes a 510(k) premarket notification for the "Unity Ultrasonic System with PLLA Fasteners." The submission is primarily focused on demonstrating substantial equivalence to a predicate device, specifically a modification adding a 40 kHz handpiece to an existing ultrasonic system.
Here's an analysis of the provided information concerning acceptance criteria and the study:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical strengths and failure modes among the two handpieces and their respective implants when ultrasonically welded are comparable. | "Implant strengths were statistically equivalent among the respective implants tested." |
| Defined electrical safety and EMC test plan with related acceptance criteria met. | "An electrical safety and EMC test plan with related acceptance criteria was defined." (Implies criteria were met as no failure is reported and the device received substantial equivalence.) |
| Risk evaluation of the 40 kHz handpiece to its predicate demonstrates similar design, packaging, labeling, and sterilization techniques that raise no concerns regarding safe and effective use. | "A risk evaluation of the 40 kHz handpiece to its predicate demonstrated similar design, packaging, labeling, and sterilization techniques that raise no concerns regarding the safe and effective use of the Unity Ultrasonic System with PLLA Fasteners." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes for the mechanical strength testing or the electrical safety/EMC testing. The description "Implant strengths were statistically equivalent" suggests that a sufficient number of implants were tested to perform statistical analysis, but the exact number is not provided.
The data provenance is not explicitly stated (e.g., country of origin). However, given that it is a FDA 510(k) submission, it is assumed the testing was conducted under appropriate regulatory guidelines. The study appears to be prospective as it involves new design verification testing for the modified device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not applicable to this submission. The device is a medical fixation system, and the testing involves mechanical, electrical, and risk evaluations, not interpretation by medical experts to establish a "ground truth" derived from clinical data or images. "Ground truth" in this context refers to the defined objective standards for device performance.
4. Adjudication Method for the Test Set
This is not applicable as the testing involved objective measurements of mechanical strength and electrical safety, not subjective interpretations requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic imaging devices where human readers interpret medical images. This submission describes a surgical fixation device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This is not applicable. The device is a physical medical device (ultrasonic system and fasteners), not an algorithm or AI system. Therefore, standalone performance in the context of AI is not relevant.
7. The Type of Ground Truth Used
The "ground truth" for the tests performed was based on:
- Defined engineering specifications and performance targets for mechanical strength. The statistical equivalence to the predicate established the acceptable performance.
- Established industry standards and regulatory requirements for electrical safety (EMC test plan).
- Risk assessment methodology to compare the new 40 kHz handpiece against the predicate, focusing on design, packaging, labeling, and sterilization techniques to ensure no new or increased risks.
8. The Sample Size for the Training Set
This is not applicable. The device is a physical medical device and does not involve AI or machine learning, which would typically require a training set.
9. How the Ground Truth for the Training Set Was Established
This is not applicable as 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.