(66 days)
The Harmonic Shears are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instruments can be used as an adjunct to or substitute for electrosurgery, lasers, and steel scalpels in general, plastic, pediatric, gynecologic, urologic, exposure to orthopedic structures (such as spine and joint space) and other open and endoscopic procedures.
The Harmonic Scalpel 5mm Instruments with Protective Sleeve is indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instruments can be used as an adjunct to or substitute for electrosurgery, lasers, and steel scalpels in general, plastic, gynecologic, exposure to orthopedic structures (such as spine and joint space), ENT (Ears, Nose, Throat), including tissues of the soft palate, oral structures, and oropharyngeal airway, and thoracic surgery, including mobilization of the Internal Mammary Artery (IMA).
The Harmonic Scalpel 10cm Sharp Curved Blade Instruments are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instrument can be used as an adjunct to or substitute for electrosurgery, lasers, and steel scalpels in general, plastic, gynecologic, exposure to orthopedic structures (such as spine and joint space) and thoracic surgery.
The Harmonic Scalpel 10cm Curved Blade Instrument is intended to cut and coagulate soft tissue. It is to be used when bleeding control and minimal thermal injury are desired. The instrument can be used as an adjunct to or substitute for electrosurgery, lasers, and steel scalpels in general, plastic, gynecologic, exposure to orthopedic structures (such as spine and joint space, ENT (Ears, Nose, Throat) and thoracic surgery, including mobilization of the Internal Mammary Artery (IMA).
The Harmonic Scalpel 5 mm Instruments are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instruments can be used as an adjunct to or substitute for electrosurgery, lasers, and steel scalpels in general, exposure to orthopedic structures (such as spine and joint space), plastic, gynecologic, and thoracic surgery, including mobilization of the Internal Mammary Artery (IMA).
The Harmonic Scalpel 10 mm LaparoSonic Instruments are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instruments can be used as an adjunct to or substitute for electrosurgery, lasers, and steel scalpels in general, gynecologic, and exposure to orthopedic structures (such as spine and joint space).
The Harmonic Scalpel Blades and Shears are ultrasonic surgical instruments for the cutting and coagulation of soft tissue incisions when bleeding control and minimal thermal injury are desired. The device system has three essential parts: the generator/ footswitch, the hand piece and the instruments, which are available in various lengths shapes and types. The selection of the appropriate instrument is a matter of surgeon preference.
This document, K060245, is a 510(k) premarket notification for the Harmonic Scalpel Blades and Shears by Ethicon Endo-Surgery, Inc. It seeks to demonstrate substantial equivalence to a predicate device for an expanded set of indications for use.
Based on the provided text, a traditional "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of an AI/ML medical device submission (which would typically involve performance metrics like sensitivity, specificity, AUC, etc.) are not applicable.
This device is a surgical instrument (ultrasonic surgical device), not an AI/ML algorithm. The performance data presented is in the form of a clinical literature search, not a study with specific acceptance criteria that an AI algorithm would need to meet. The submission is focused on demonstrating the device's substantial equivalence to a legally marketed predicate device based on its technological characteristics and proposed expanded indications for use.
Therefore, the specific questions related to AI/ML device performance, such as sample size for test sets, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details, cannot be answered from the provided text because these elements are not relevant to this type of device submission.
Here's how to interpret the provided information in the context of the device:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: For this type of device (ultrasonic surgical instrument), the "acceptance criteria" for regulatory clearance are primarily focused on demonstrating substantial equivalence to a predicate device in terms of safety and effectiveness for its intended use. This typically involves showing that the technological characteristics are the same, and that any new or expanded indications for use are supported by existing clinical evidence or the predicate's established safety profile.
- Reported Device Performance: The primary "performance data" cited is a clinical literature search.
| Acceptance Criteria (Implied for Substantial Equivalence of Surgical Instrument) | Reported Device Performance (as stated in 510(k) Summary) |
|---|---|
| Device has same technological characteristics as predicate. | "The Harmonic Scalpel Blades and Shears technological characteristics are the same as the predicate device. No changes (materials construction, specifications, manufacturing or sterilization processes) to the currently marketed device." (Page 1) |
| Device is safe and effective for its intended uses. | "A clinical literature search was performed to show the use of the devices in providing exposure to orthopedic structures such as the hip, knee, shoulder, and spine." (Page 1) |
| Expanded indications for use are supported. | "The device differs only in the indications." (Page 1). The literature search supports the use in orthopedic structures for the expanded indications. |
2. Sample size used for the test set and the data provenance: Not applicable. This is not an AI/ML device, so there isn't a "test set" in the computational sense. The "performance data" is a literature review, not a specific data set. The provenance of the literature is not specified beyond being "a clinical literature search."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. There is no "test set" for an AI/ML algorithm. The "ground truth" for the device's safety and effectiveness for its intended use is established through its technological equivalence to a predicate device and existing clinical literature.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No test set or adjudication process as understood for AI/ML performance assessment.
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 surgical instrument, not an AI-assisted diagnostic or therapeutic device for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical surgical instrument, not an algorithm.
7. The type of ground truth used: For this submission, the "ground truth" for demonstrating substantial equivalence is based on the technological characteristics of the device being identical to the predicate, and existing clinical literature supporting the safety and efficacy of the technology (ultrasonic surgical instruments) for the stated indications, particularly the newly expanded ones involving orthopedic structures.
8. The sample size for the training set: Not applicable. This is not an AI/ML device, and there is no "training set."
9. How the ground truth for the training set was established: Not applicable. There is no "training set" or explicit ground truth establishment process in the AI/ML sense for this device.
N/A