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Indications for Use statement for the ERBECRYO 2 cryosurgical unit:
"The ERBECRYO 2 cryosurgical unit and accessories are intended for cryoadhesion and devitalization of tissue by the application of extreme cold."

Indications for Use statement for the Erbe Flexible Cryoprobes:
"The Erbe Flexible Cryoprobes are intended for palliative devitalization) of tissue during interventional procedures by the application of extreme cold and cryoadhesion for applications such as the removal of foreign bodies, mucus plugs, blood clots, necrotic tissue, tissue tumors (palliative recanalization) and tissue biopsies."

The ERBECRYO® 2 Unit and Accessories are manufactured with various metals, plastics, silicone, adhesive, etc. The system consists of connecting hoses, an adapter, a switching valve (optional for using two gas cylinders), the Unit, electrical cables, the footswitch, and the flexible cryoprobes. The ERBECRYO® 2 unit is a standalone unit that can be placed on a table top or secured on a cart. The Cryosurgical Unit has a monochromatic display that provides operational information. The display is surrounded by buttons allowing for user interface (e.g., set the effect, select a program, etc.). Default settings are also displayed per the cryoprobe that is attached. The Cryorugical Unit is connected to an electrical power source, a carbon dioxide (CO2) source, the footswitch and a flexible cryoprobe. The Cryosurgical Unit displays errors and/or emits audio alarms to alert users of malfunctions or user errors. Typically, a cryoprobe is placed down the working channel of an endoscope (e.g., bronchoscope, etc.) that can accommodate the dimensional attributes (i.e., outer diameter and length) of the probe. Upon activation via the pedal of the footswitch, the Unit delivers the regulated flow of the CO2 to the tip of the flexible cryoprobe. Through the Joule-Thomson Effect and in the presence of moisture, an ice is formed and surrounding tissue is cooled. The extreme cold is used for cryoadhesion and/or devitalization (i.e., the destruction) of target tissue (Note: The smaller 1.1mm single use cryoprobes have an oversheath so that tissue frozen to the tip can be removed through the endoscope without having to remove the scope from the patient.). The Unit and all of the Accessories, except for the single use flexible cryprobes, are supplied non-sterile and are reusable. The single use cryoprobes are provided sterile and are single patient use.

The provided text describes a 510(k) premarket notification for the ERBECRYO 2 Cryosurgical Unit and Accessories (K190651), comparing it to a legally marketed predicate device (K151041). The document primarily focuses on demonstrating substantial equivalence rather than a clinical study establishing acceptance criteria for a new AI/software device. There is no mention of an AI/software component in this submission.

Therefore, many of the requested categories are not applicable to the information provided. The document describes a medical device (cryosurgical unit and cryoprobes) and its physical and performance characteristics, along with various standard tests to ensure its safety and effectiveness relative to a predicate device.

However, I can extract the relevant information where applicable and indicate "Not applicable" for items that are not present or relevant to this type of medical device submission.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is not an AI/software device and the submission focuses on substantial equivalence to a predicate, the "acceptance criteria" are generally compliance with recognized standards and demonstration that new features (like different cryoprobe dimensions or sterile single-use probes) do not raise new safety or effectiveness concerns. The performance reported relates to the cryosurgical function and material properties.

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 for Test Set: Not specified in terms of clinical trial patient numbers or image counts, as this is primarily a device safety and performance submission based on bench testing, ex-vivo, and in-vivo (animal) studies, and literature review.
  • Biocompatibility: "Erbe Flexible cryoprobes" tested. Specific number of probes or samples not given.
  • Sterilization Validation: "Mixed load sterilization cycle" validated. Specific number of samples not given.
  • Shelf Life Validation: "Sterilized samples" tested. Specific number of samples not given.
  • Performance Testing (Freezing, Biopsy Weight, In-vivo): "Comparative ex vivo tissue testing on three different tissues (bovine liver, porcine kidney and porcine lung)" and "animal testing in an in vivo porcine lung model" were conducted. Specific numbers of tissue samples or animals not given.
• Data Provenance:
  • Biocompatibility, Sterilization, Shelf Life, and Performance Testing were conducted by Erbe Elektromedizin GmbH, based in Germany. The specific testing facilities are not mentioned.
  • For the "removal of blood clots" indication, "peer-reviewed real world evidence (literature and published case reports)" were provided. This implies a retrospective review of existing published data globally.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• This is not applicable as there is no "ground truth" established by experts in the context of an AI/software device. The data is physical measurements, biological evaluations, and performance characteristics compared to a predicate device and existing literature.

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

• Not applicable, as there is no expert review or adjudication method described for establishing ground truth for an AI/software output. The testing methodologies are based on laboratory measurements and comparisons.

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 a submission for a physical cryosurgical unit and cryoprobes, not an AI or software device. No human reader studies with or without AI assistance were performed.

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

• Not applicable. This device does not involve an algorithm or AI.

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

• The "ground truth" in this context refers to the established scientific and engineering principles for device performance, safety standards, and comparative data against a legally marketed predicate device.
  • Benchmarking/Comparative Data: Performance as measured against the predicate device (e.g., freezing performance, biopsy weight).
  • Standard Compliance: Adherence to international standards (e.g., ISO 10993 for biocompatibility, ISO 11135 for sterilization, ISO 11607 for shelf life, IEC 60601 series for electrical safety).
  • Animal Model Data: In-vivo performance (porcine lung model).
  • Literature Review: Real-world evidence from peer-reviewed literature and published case reports for specific indications (e.g., removal of blood clots).
  • Laboratory Procedures: Sterility, shelf-life, and biocompatibility testing results.

8. The sample size for the training set

• Not applicable. This is not an AI/software device, so there is no training set.

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

• Not applicable. As there is no training set for an AI/software device.

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The ERBECRYO 2 Cryosurgical Unit and Accessories are intended for (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 (Cryo re-canalization) |

The ERBECRYO 2 Cryosurgical Unit and Accessories consists of a cryosurgical unit, probes with a cryosurgical tip, a connecting hose to be connected to a CO2 (Carbon Dioxide) gas bottle and a footswitch for activation. The system is mounted on a cart, which also carries up to two CO2 gas bottles.

The ERBECRYO 2 Cryosurgical Unit and Accessories is used to apply extreme cold to tissue during surgical procedures. The system uses the Joule-Thomson principle where pressurized gas expands through a fine orifice inside the tip of the cryosurgical probe producing a rapid drop in temperature and freezing the probe tip and the surrounding tissue.

The unit and accessories are provided non sterile. The cryoprobes are reusable and directions for cleaning and sterilizing the cryosurgical probes are provided in the Notes on Use.

Design and materials of the ERBECRYO 2 Cryosurgical probes are very similar to the predicate probes.

I am sorry, but based on the provided text, there is no information about a study that describes acceptance criteria and proves the device meets those criteria. The document is a 510(k) premarket notification for a medical device (ERBE ERBECRYO 2 Cryosurgical Unit and Accessories), which focuses on demonstrating substantial equivalence to a predicate device.

The document mentions "Physical and Performance Testing" and states that "The system conforms with the following standards" and lists several international standards (e.g., EN ISO 14971, ANSI/AAMI ES60601-1). It also notes that "The intended use was validated in comparative tissue studies against the predicate system. The performance was similar for both systems." However, it does not provide:

• A table of specific acceptance criteria.
• Reported device performance against such criteria.
• Details about sample sizes for test sets, data provenance, or ground truth establishment.
• Information on expert involvement or adjudication methods.
• Any multi-reader multi-case (MRMC) comparative effectiveness study or standalone algorithm performance.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study proving the device meets them from the given text.

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