(222 days)
The modified SeedNet™ System is intended for cryogenic destruction of tissue during surgical procedures. is indicated for use as a cryosurgical tool in the fields of general surgery, dermatology, neurology, 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 modified SeedNet 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 ablation of benign tumors, and palliative intervention)
Dermatology (ablation or freezing of skin cancers and other cutaneous disorders)
Gynecology (ablation of malignant neoplasia or benign dysplasia of the female genitalia)
General surgery (destruction of warts or lesions, palliation of tumors of the oral cavity, rectum and skin, and ablation of leukoplakia of the mouth, 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, hemorroids, anal fissures, perianal conylomata, pilonidal cysts, actinic and seborrheic keratoses, cavernous hemanglomas, and recurrent cancerous lesions)
Thoracic surgery (ablation of arrhythmic cardiac tissue, and ablation of cancerous lesions)
Proctology (ablation of benign or malignant growths of the anus or rectum, and ablation of hemorrhoids)
The Galil Medical's SeedNet™ System is a modification of Galil Medical LTD's cleared SeedNet™ System with STPS (K010991). The SeedNet™ System is the exact same device as the SeedNet™ except for the following modifications to its technological characteristics:
Addition of 2 and 3 mm probes which are included in the previously cleared the Cryo-Hit™, to which the SeedNet™ is a modification.
Addition of flexible probes as an accessory to the SeedNet™
The systems computer screens, but not its software algorithm have slightly been modified.
This document is a 510(k) summary for the Galil Medical SeedNet™ System, specifically focusing on modifications to an already cleared device. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the context of typical AI/software device evaluation.
The provided text describes a medical device (cryosurgical unit) and its modifications, focusing on demonstrating substantial equivalence to predicate devices for regulatory approval. This type of submission (510(k)) for a physical medical device typically relies on demonstrating that the device is as safe and effective as a legally marketed predicate device, rather than providing the detailed performance studies with acceptance criteria, ground truth, and expert evaluation that are common for AI/software devices.
Therefore, most of the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment cannot be found in the provided document.
Here is what can be inferred or explicitly stated based on the text, with clear indications for what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
- Not applicable / Not present in this document. This document is a 510(k) summary for a physical cryosurgical unit, focused on demonstrating substantial equivalence to predicate devices. It does not define specific performance metrics or acceptance criteria for device output in the way a software or AI device might (e.g., sensitivity, specificity, accuracy thresholds). The "performance" being evaluated implicitly is its ability to perform cryoablation for the stated indications, similar to its predicates.
2. Sample size used for the test set and the data provenance
- Not applicable / Not present in this document. As this is a submission for a physical medical device demonstrating substantial equivalence, there isn't a "test set" of data in the sense of an AI/software evaluation. There is no mention of a clinical study or specific data used to "test" the modified device's performance against a gold standard. The evaluation relies on the known performance and safety of the predicate devices and the minor nature of the modifications.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable / Not present in this document. There is no "test set" or ground truth established in the context of an AI/software evaluation.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable / Not present in this document. There is no "test set" requiring adjudication.
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
- No, a MRMC comparative effectiveness study was not done. This is a physical cryosurgical unit, not an AI-assisted diagnostic or treatment planning system. Therefore, the concept of "human readers improve with AI assistance" does not apply.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. The device is a cryosurgical unit; it is not an algorithm evaluated for standalone performance. While it has "computer screens" and "software algorithm" (mentioned as "slightly modified" but not the focus of the submission), the core intent is a physical procedure performed by a human.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable / Not present in this document. No ground truth is mentioned as being used for performance evaluation of this physical device in the manner typical for AI/software. The "truth" in this context is the established safety and efficacy of cryoablation devices for the indicated uses, as demonstrated by the predicate devices.
8. The sample size for the training set
- Not applicable / Not present in this document. This is not an AI/machine learning model where a "training set" would be used.
9. How the ground truth for the training set was established
- Not applicable / Not present in this document.
§ 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.