(75 days)
The SeedNet™ System (SeedNet Gold™ System) is intended for cryogenic destruction of tissue during surgical procedures.
It is indicated for use as a cryosurgical tool in the fields of general surgery, dermatology, neurology (including cryoanalgesia), thoracic surgery, ENT, gynecology, oncology, proctology, and urology. The system is designed to destroy tissue by the application of extreme cold temperatures including prostate and kidney tissue, liver metastases, tumors, skin lesions, and warts.
The SeedNet™ System (SeedNet Gold™ System) has the following specific indications:
Urology (ablation of prostate tissue in cases of prostate cancer and Benign Prostate Hyperplasia "BPH")
Oncology (ablation of cancerous or malignant tissue and benign tumors and palliative intervention)
Dermatology (ablation or freezing of skin cancers and other cutaneous disorders. Destruction of warts or lesions, angiomas, sebaceous hyperplasia, basal cell tumors of the eyelid or canthus area, ulcerated basal cell tumors, dermatofibromas small hemanglomas, mucocele cysts, multiple warts, plantar warts, actinic and seborrheic keratoses, cavernous hemanglomas, perianal condylomata, and palliation of tumors of the skin)
Gynecology (ablation of malignant neoplasia or benign dysplasia of the female genitalia)
General surgery (palliation of tumors of the rectum, hemorrhoids, anal fissures, pilonidal cysts, and recurrent cancerous lesions.)
ENT (Palliation of tumors of the oral cavity and ablation of leukoplakia of the mouth).
Thoracic surgery (ablation of arrhythmic cardiac tissue and cancerous lesions,)
Proctology (ablation of benign or malignant growths of the anus or rectum and hemorrhoids)
The SeedNet™ System (SeedNet Gold™ System) may be used with a magnetic resonance imaging (MRI) device or an ultrasound device to provide real-time visualization of the cryosurgical procedure.
The Galil Medical's SeedNet™ System is a modification of Galil Medical LTD's cleared SeedNet™ System (K011950). The SeedNet™ System is the exact same device as the SeedNet™ except for the following modifications to its technological characteristics:
- The inclusion of cryoanalgesia as an example of the device's cleared neurology general indication.
- The addition of a 4.5 mm surface probe.
- Addition of trade name: SeedNetGold™ System.
- Provision of the use of the modified SeedNet system together with magnetic resonance imaging (MRI) device.
The provided text is a 510(k) summary for the Galil Medical - SeedNet™ System, a cryosurgical unit. It describes the device, its indications for use, technological characteristics, and substantial equivalence to predicate devices. However, it does not contain any information about acceptance criteria, performance studies, sample sizes, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance.
Therefore, I cannot fulfill your request for that specific information based on the provided text. The document focuses on regulatory approval based on demonstrating equivalence, not on detailed performance study results.
Here's what I can extract from the provided text, but it will be very limited given the absence of the requested information:
1. A table of acceptance criteria and the reported device performance:
- Cannot be provided. The document does not mention any acceptance criteria or report specific device performance metrics (e.g., sensitivity, specificity, accuracy, precision). It primarily focuses on the device's intended use and technological characteristics in comparison to predicate devices.
2. Sample size used for the test set and the data provenance:
- Cannot be provided. No test set, data provenance, or sample sizes for any studies are mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Cannot be provided. No information about experts or ground truth establishment for a test set is present.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Cannot be provided. No mention of adjudication methods.
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:
- Cannot be provided. This document is for a cryosurgical unit, not an AI-assisted diagnostic device. Therefore, no MRMC study or AI assistance is discussed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Cannot be provided. The device is a cryosurgical tool, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- Cannot be provided. No ground truth for any study is mentioned.
8. The sample size for the training set:
- Cannot be provided. No training set is mentioned as this device is a physical cryosurgical unit, not an AI model.
9. How the ground truth for the training set was established:
- Cannot be provided. No ground truth for a training set is mentioned.
§ 878.4350 Cryosurgical unit and accessories.
(a)
Identification —(1)Cryosurgical unit with a liquid nitrogen cooled cryoprobe and accessories. A cryosurgical unit with a liquid nitrogen cooled cryoprobe and accessories is a device intended to destroy tissue during surgical procedures by applying extreme cold.(2)
Cryosurgical unit with a nitrous oxide cooled cryoprobe and accessories. A cryosurgical unit with a nitrous oxide cooled cryoprobe and accessories is a device intended to destroy tissue during surgical procedures, including urological applications, by applying extreme cold.(3)
Cryosurgical unit with a carbon dioxide cooled cryoprobe or a carbon dioxide dry ice applicator and accessories. A cryosurgical unit with a carbon dioxide cooled cryoprobe or a carbon dioxide dry ice applicator and accessories is a device intended to destroy tissue during surgical procedures by applying extreme cold. The device is intended to treat disease conditions such as tumors, skin cancers, acne scars, or hemangiomas (benign tumors consisting of newly formed blood vessels) and various benign or malignant gynecological conditions affecting vulvar, vaginal, or cervical tissue. The device is not intended for urological applications.(b)
Classification. Class II.