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The ERBE ERBOKRYO® CA Cryosurgical Unit and accessories are intended for devitalization (destruction) of tissue during surgical procedures by the application of extreme cold and for removal of foreign bodies, mucous plugs, necrotic tissue, and tissue biopsy by cryoadhesion.

Clinical Indications for Cryosurgery

| Gynecology | Cervical Erosions, Cervical Polyps, Condylomas, Chronic Cervicitis, Vulva
Carcinoma (palliative), Neoplasia |
|------------------|------------------------------------------------------------------------------------------------------------------------------------|
| Dermatology | Leukoplakia, Fibroma, Condylomas, Basal Cell Carcinoma, Skin Tumor
(palliative), Warts, Naephus |
| Ophthalmology | Ablatio Retinae, Glaucoma, Lid Tumor |
| ENT | Leukoplakia, Inoperable Tumor (palliative), Laryngeal Papilloma, Fibroma,
Angioma, Haemangioma |
| Thoracic Surgery | Post-Operative |
| Urology | Prostate Tumor (palliative), Condylomas, Penile Tumor (palliative) |
| Phlebology | Varicose Veins of the Lower Limbs (Cryo Stripping) |
| Proctology | Hemorrhoids (1st and 2nd Degree), Pari-Anal Condylomas, Anal Tumor
(palliative), Rectal Tumor (palliative), Acute Anal Fissures |
| Pulmonology | Tumors, Granulomatous Tissue, Malignant Lesions (palliative) |
| Pneumology | Tracheobronchial Stenoses (Cryorecanalization) |

The ERBE USA, Inc. ERBE ERBOKRYO® CA Cryosurgical Unit and Accessories is used to apply extreme cold to tissue during surgical procedures. It uses the Jouleused to apply extreme oold to toose aumy and Thompson principle where probe tip and the surrounding tissue. a fapid drop in temperature and frous Oxide) or CO2 (Carbon Dioxide) gas. The The unit is ascu with older 1120 (11) in the cryo probes are reusable and urnt and accessones are provided new surgical probes are provided in the Notes for Use.

The provided 510(k) summary (K051509) for the ERBE ERBOKRYO® CA Cryosurgical Unit and Accessories does not contain specific acceptance criteria or a detailed clinical study report with performance metrics in the format requested.

The document discusses the substantial equivalence of the modified device to its predicate (K934261), highlighting similarities in basic technology and indications for use, and differences related to materials and an added internal filter. The key part relevant to your request is the expansion of indications for use to include "removal of foreign bodies, mucous plugs, necrotic tissue, and tissue biopsy by cryoadhesion" and "Tracheobronchial Stenoses (Cryorecanalization) in Pneumology."

The 510(k) process primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring new, full-scale clinical trials with pre-defined acceptance criteria and performance metrics typically seen in a PMA or de novo submission.

However, I can extract the information regarding how the expanded indications were supported:

1. Table of Acceptance Criteria and Reported Device Performance:

• No specific quantitative acceptance criteria or device performance metrics (e.g., sensitivity, specificity, accuracy, success rates in a clinical trial) are defined or reported in the provided text for the expanded indications.
• The document implies that the device "can be used safely and effectively" for the new indications based on existing studies involving "cryosurgical units" and physician consensus.

2. Sample Size Used for the Test Set and Data Provenance:

• Not explicitly stated in terms of a formal "test set" for performance evaluation.
• The document refers to "all available/known studies involving 'cryosurgical units' in conjunction with the expanded indications for use." These studies provided "documentation provided demonstrates that the ERBE ERBOKRYO® CA Cryosurgical Unit and Accessories can be used safely and effectively to remove foreign bodies... and tissue biopsy by cryoadhesion."
• For Tracheobronchial Stenoses, it states, "The documentation also shows that physicians consider cryotherapy to be a safe procedure for the treatment of bronchial obstruction in Pneumology. Pneumologists in a number of change cases, and overall with patients with malignant tumors that cryotherapy is a good palliative treatment in these cases, and is suitable for patients with obstruction >50% (or not)."
• Data Provenance: Implied to be from existing scientific literature and clinical experience ("available/known studies," "physicians consider," "Pneumologists in a number of change cases"). No specific country of origin is mentioned, nor is it explicitly labeled as retrospective or prospective for a single study, but rather a review of existing evidence.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:

• Not specified as a formal "ground truth" establishment process for a specific test set.
• The text mentions "physicians" and "Pneumologists" without specifying their number, specific qualifications (e.g., years of experience, board certification), or their role in establishing a ground truth for a test set. This likely refers to their general clinical consensus and published findings.

4. Adjudication Method for the Test Set:

• Not applicable / Not specified. There is no mention of a formal adjudication method (like 2+1, 3+1) for a test set, as no dedicated clinical test set with independent expert adjudication is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No, an MRMC comparative effectiveness study is not mentioned. The document does not describe any study comparing human readers with and without AI assistance for this cryosurgical unit.

6. Standalone (Algorithm Only) Performance Study:

• No. This device is a cryosurgical unit, not an AI algorithm. Therefore, "standalone (algorithm only)" performance is not applicable. The device's performance is inherently linked to its use by a human operator.

7. Type of Ground Truth Used:

• For the expanded indications, the "ground truth" (or supporting evidence) appears to be based on:
  • Expert consensus/Clinical Opinion: "physicians consider cryotherapy to be a safe procedure," "Pneumologists in a number of change cases."
  • Outcomes Data (implied): "Patients tolerate the procedure well and show improvement in symptoms," "good palliative treatment."
  • Review of existing literature/studies: "All available/known studies involving 'cryosurgical units' in conjunction with the expanded indications for use have been provided."

8. Sample Size for the Training Set:

• Not applicable. There is no mention of a "training set" as this is not an AI/machine learning device undergoing such a development and validation process. The supporting evidence for the expanded indications comes from broader existing clinical knowledge and studies.

9. How the Ground Truth for the Training Set was Established:

• Not applicable. See point 8.

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