(25 days)
The SeedNet System is intended for cryogenic destruction of tissue during surgical procedures. The SeedNet System 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 has the following specific indications:
- Urology (ablation of prostate tissue in cases of prostate cancer and t Benign Prostate Hyperplasia "BPH")
- Oncology (ablation of cancerous or malignant tissue and benign I 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 I the female genitalia)
- General surgery (palliation of tumors of the rectum, hemorrhoids, ı anal fissures, pilonidal cysts, and recurrent cancerous lesions, ablation of breast fibroadenoma)
- ENT (Palliation of tumors of the oral cavity and ablation of . leukoplakia of the mouth)
- Thoracic surgery (ablation of arrhythmic cardiac tissue cancerous . lesions)
- Proctology (ablation of benign or malignant growths of the anus or # rectum, and hemorrhoids)
Cryosurgical unit with argon-cooled probes. The SeedNet Family System includes the SeedNet®/SeedNetGold® System, CryoThera® System, and Cryo-Hit® System. Modifications include the addition of a longer 17G (1.5mm) needle, a 90° needle, a needle/TS holder stand, and the addition of CT as an imaging modality to the device labeling, in addition to MRI and ultrasound.
Please find below the requested information based on the provided text.
Acceptance Criteria and Device Performance:
The document indicates that the modified SeedNet Family underwent a "comprehensive testing process as part of the design verification process." This implies that specific acceptance criteria were defined for these tests. However, the document does not explicitly state what these acceptance criteria were or provide detailed quantitative performance results against them. It broadly states that the device is "substantially equivalent in all aspects, e.g., technological characteristics, mode of operation, performance characteristics, intended use, etc., to the commercially available SeedNet Family."
Therefore, for the table, since specific numerical acceptance criteria and reported performance values are not provided, I will use the descriptive information available.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Technological Characteristics: Substantially equivalent to predicate devices (SeedNet®, SeedNetGold®, Cryo-Hit®, CryoThera® Systems, and Endocare CryoCare system). | The modified SeedNet Family includes: |
- Longer 17G (1.5mm) needle (modification of cleared 1.5mm stainless steel cryoneedle).
- 90° needle (modification of cleared 1.5mm stainless steel cryoneedle).
- Needle/TS holder stand.
- CT as an imaging modality in labeling (in addition to MRI and ultrasound).
Deemed substantially equivalent to predicate devices, indicating these modifications did not alter fundamental technological characteristics negatively. |
| Mode of Operation: Substantially equivalent to predicate devices. | No changes in the fundamental mode of operation (cryogenic destruction of tissue by applying extreme cold temperatures) reported, maintaining substantial equivalence. |
| Performance Characteristics: Substantially equivalent to predicate devices. | The device underwent "comprehensive electrical, mechanical and biocompatibility testing." The submission concludes that it "does not raise any new safety and/or effectiveness issues," implying performance characteristics are consistent with the predicate devices. Specific quantitative performance metrics (e.g., cooling rates, ice ball dimensions, mechanical strength) are not provided in this summary. |
| Intended Use: Identical to predicate devices, for cryogenic destruction of tissue across specified medical fields. | The intended use statement for the modified SeedNet Family is identical to the original SeedNet System, covering general surgery, dermatology, neurology, thoracic surgery, ENT, gynecology, oncology, proctology, and urology, with specific indications including ablation of prostate and kidney tissue, liver metastases, tumors, skin lesions, and warts. |
| Safety: No new safety issues raised. | Comprehensive electrical, mechanical, and biocompatibility testing conducted. The device was found not to raise any new safety issues. |
| Effectiveness: No new effectiveness issues raised. | Comprehensive electrical, mechanical, and biocompatibility testing conducted. The device was found not to raise any new effectiveness issues. |
Detailed Study Information:
-
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- The provided text does not specify a sample size for a test set, nor does it describe a study involving patient data (retrospective or prospective) for performance evaluation in the context of substantial equivalence. The "testing process" mentioned refers to design verification, including electrical, mechanical, and biocompatibility tests of the device itself, rather than a clinical performance study using patient data.
- No country of origin for such data is mentioned.
-
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):
- The document does not describe a study that involved establishing ground truth by human experts for a test set of medical images or patient outcomes. The testing reported is for device verification (electrical, mechanical, biocompatibility).
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- No adjudication method is mentioned as there is no described study involving expert review or a test set requiring adjudication in the context of clinical performance.
-
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 MRMC comparative effectiveness study is mentioned. This device is a cryosurgical unit, not an AI-assisted diagnostic tool for image interpretation, so such a study would not be relevant in this context.
-
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is a medical device (cryosurgical unit), not a software algorithm or AI. The performance discussed is about the physical device and its components.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the device verification mentioned (electrical, mechanical, biocompatibility testing), the "ground truth" would be established by engineering and laboratory standards, specifications, and reference materials. No clinical outcomes data, pathology, or expert consensus on clinical cases are mentioned as part of the evidence for substantial equivalence, beyond the broad claim that the device raises no new safety or effectiveness issues for its intended use.
-
The sample size for the training set:
- Not applicable. This is a physical medical device, not an AI or software algorithm that undergoes machine learning training.
-
How the ground truth for the training set was established:
- Not applicable as there is no training set for an AI algorithm.
§ 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.