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The SeedNetGold™ with Renal Kit 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 SeedNetGold™ with Renal Kit 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 sebortheic 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, t 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 cancerous lesions)
• Proctology (ablation of benign or malignant growths of the anus or rectum, and hemorrhoids)

The SeedNetGold™ with Renal Kit is the exact same device as the cleared SeedNetGold™, which is a modification to the SeedNet Gold's cleared Prostate Kit and Prostate Template. The Renal Kit includes cryoneedles and thermal Galli Medical Intellus for use with the SeedNet Gold during renal cryoablation.

The provided text describes a 510(k) premarket notification for a medical device, the SeedNetGold™ with Renal Kit, and does not contain specific acceptance criteria, a detailed study proving performance, sample sizes, information about adjudicated ground truth, or MRMC study results as requested.

The document is a submission for a cryosurgical unit and primarily focuses on demonstrating substantial equivalence to a previously cleared predicate device (Galil's SeedNetGold™) rather than providing a detailed performance study with quantitative acceptance criteria.

Here's an analysis based only on the provided text, highlighting what's missing:

1. A table of acceptance criteria and the reported device performance

• Acceptance Criteria: Not explicitly stated in the document. The submission appears to rely on demonstrating that the new "Renal Kit" modification for the SeedNetGold™ system is "at least as safe and effective" as the previously cleared SeedNetGold™ with Prostate Kit and Prostate Template.
• Reported Device Performance: The document only makes a general statement: "Bench testing demonstrated that the SeedNetGold™ with Renal Kit is at least as safe and Deneffective as the cleared SeedNetGold™ with the Prostate Kit and Prostate Template in destroying encedive as the application of extreme cold temperatures during cryosurgical procedures." No specific performance metrics (e.g., freezing temperatures achieved, lesion size, ablation efficiency, time to freeze/thaw, etc.) are provided.

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 mentioned. The document refers to "Bench testing," which typically involves laboratory experiments rather than human or animal subjects, but no specifics are given.
• Data Provenance: Not mentioned. It's bench testing, so "country of origin" of data would refer to the lab location, which is not specified.

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 is not a study involving human interpretation or diagnosis where expert ground truth would be established. The "ground truth" for cryoablation devices typically involves physical measurements of freezing parameters in a controlled environment or tissue models.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable for this type of bench testing.

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 MRMC study was done. This device is a cryosurgical unit, not an AI-powered diagnostic tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable. This is a hardware device for surgical procedures, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• The ground truth for "bench testing" would likely be based on physical measurements and engineering specifications related to cryoablation performance (e.g., temperature probes confirming achieve freezing temperatures, imaging (ultrasound/MRI) confirming ice ball formation/size, tissue damage assessments in ex-vivo models). The document doesn't detail these specifics.

8. The sample size for the training set

• Not applicable. This is not a machine learning or AI device.

9. How the ground truth for the training set was established

• Not applicable. This is not a machine learning or AI device.

Summary of the Study (as described in the document):

The "study" described is primarily focused on demonstrating substantial equivalence for a modification (the Renal Kit) to an already cleared cryosurgical system (SeedNetGold™).

• Objective: To show that the SeedNetGold™ with Renal Kit is "at least as safe and effective" as the predicate device (SeedNetGold™ with Prostate Kit and Prostate Template).
• Methodology: "Bench testing" was performed.
• Findings: The bench testing "demonstrated that the SeedNetGold™ with Renal Kit is at least as safe and effective... in destroying tissue by the application of extreme cold temperatures during cryosurgical procedures."
• Conclusion: Based on the bench data, the device is considered substantially equivalent to the cleared predicate.

In essence, the provided 510(k) summary is a regulatory document arguing for substantial equivalence through bench testing, not a detailed clinical or performance study with quantified acceptance criteria as typically seen for novel devices or AI/diagnostic tools.

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