(45 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.
Galil Medical's SeedNet™ System with the SmartWarmer is a modification of Galil Medical LTD's cleared SeedNet™ System (K021261). The SeedNet™ System is the exact same device as the SeedNet™ except for the substitution of the SmartWarmer™ for Gaymar's warmer and Barnant's pump as the device's transurethral warmer ("TUW") accessory.
The provided text describes the Galil Medical SeedNet™ System, a cryosurgical unit. However, it does not contain specific acceptance criteria or an explicit study detailing performance outcomes against such criteria in a quantifiable manner as you've requested.
The document is a 510(k) summary for a medical device modification, focusing on demonstrating substantial equivalence to a predicate device. The core of its performance testing section states:
"Bench testing demonstrated that the SeedNet with modified TUW is at least as safe and effective as the cleared TUW in maintaining the urethra temperature during cryosurgical procedures."
This statement confirms that testing was done to ensure the modified device (SeedNet with SmartWarmer) performs at least as well as the previously cleared device (SeedNet with Gaymar/Barnant warmer) in maintaining urethra temperature.
Given the information, I cannot fill out the detailed table and answer all questions as requested. Here's a breakdown of what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety: Device maintains urethral temperature profile during cryosurgical procedures equal to or better than predicate device. | "Bench testing demonstrated that the SeedNet with modified TUW is at least as safe and effective as the cleared TUW in maintaining the urethra temperature during cryosurgical procedures." |
| Effectiveness: Device effectively performs cryosurgical ablation. | "Bench testing demonstrated that the SeedNet with modified TUW is at least as safe and effective as the cleared TUW in maintaining the urethra temperature during cryosurgical procedures." (Effectiveness is inferred from maintaining temperature, which is critical for ablation.) |
Note: Specific quantitative thresholds (e.g., "temperature variation within X degrees Celsius," "maintains Y minimum temperature for Z duration") are not provided in this document. The criteria are implicitly tied to the performance of the predicate device.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified. "Bench testing" is mentioned, implying a controlled lab environment, but the number of tests or samples is not given.
- Data Provenance: Not specified. Origin of data (e.g., country) is not mentioned. The study is described as "Bench testing," which is typically a prospective design in a controlled environment, not retrospective clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable. This type of information is relevant for studies involving human interpretation (e.g., image analysis). Since the testing described is "bench testing" for a cryosurgical unit's temperature regulation, expert consensus on "ground truth" in this context is not relevant. The ground truth would be physical measurements of temperature.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. See point 3.
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 not an AI/software device or an imaging device requiring human reader interpretation. It is a cryosurgical unit.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical medical device, not an algorithm. The "bench testing" performed is inherently "standalone" in the sense that it's testing the device's physical performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The ground truth for the bench testing would be physical measurements of temperature during simulated cryosurgical procedures, compared against predefined target temperatures or the performance of the predicate device.
8. The sample size for the training set
- Not Applicable. This device, as described, is not an AI/machine learning model, so there is no "training set."
9. How the ground truth for the training set was established
- Not Applicable. See point 8.
§ 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.