(84 days)
The Boston Scientific disposable IceRod Cryoablation Needle, IceSphere Cryoablation Needle, IceSeed Cryoablation Needle, IcePearl Cryoablation Needle, and IceForce Cryoablation Needle (CX Needles), when used with a Boston Scientific ICEfx Cryoablation System or Visual-ICE Cryoablation System, are designed to destroy tissue by the application of extremely cold temperatures.
The Boston Scientific CX Needles, when used with ICEfx Cryoablation System or Visual-ICE Cryoablation System, are indicated for use as a cryosurgical tool in the fields of general surgery, dermatology, neurology (including cryoanalgesia), thoracic surgery (with the exception of cardiac tissue), ENT, gynecology, oncology, proctology, and urology. The CX Needles are designed to destroy tissue (including prostate and kidney tissue, liver metastases, tumors, and skin lesions) by the application of extremely cold temperatures.
The CX Needles have 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 hemangiomas, mucocele cysts, multiple warts, plantar warts, actinic and sebortheic keratosis, cavernous hemangiomas, peri-anal 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, anal fissures, pilonidal cysts, and recurrent cancerous lesions, ablation of breast fibroadenomas
- ENT Palliation of tumors of the oral cavity and ablation of leukoplakia of the mouth
- · Thoracic surgery (with the exception of cardiac tissue)
- Proctology Ablation of benign or malignant growths of the anus or rectum
Additionally, when used with the Visual-ICE Cryoablation System, the CX Needles are indicated for use in the field of Oncology for palliation of pain associated with metastatic lesions involving bone in patients who have failed or are not candidates for standard radiation therapy.
Boston Scientific Corporation's (BSC) IceSeed 1.5 CX 90° Needle and IceSeed 1.5 CX S 90° Needle (IceSeed CX Needles) are sterile, single use, disposable devices used in conjunction with a Boston Scientific cryoablation system for cryoablative destruction of tissue during surgical procedures under CT guidance. The IceSeed CX Needles are disposable 1.5 mm needles that have a sharp cutting tip, a colorcoded handle, a gas tube, and a connector. The IceSeed CX Needles offer a handle configured in a 90° angled configuration to aid positioning of the needle within the CT imaging system gantry. The needles convert high-pressure gas to either a very cold freezing application or to a warm thawing application. Active tissue thawing is may also be achieved by activating the heating element inside IceSeed CX Needles.
The provided text is a 510(k) Premarket Notification from the FDA for medical devices (cryoablation needles). It details the device's description, intended use, and a comparison to predicate devices, ultimately concluding substantial equivalence.
However, the document does not contain any information about an AI/ML powered medical device, acceptance criteria related to AI/ML performance, or any studies involving AI/ML models, human readers, or ground truth establishment based on expert consensus, pathology, or outcomes data.
The "Performance Data and Substantial Equivalence" section only mentions:
- Functional testing (electrical heater requirements, functional requirements)
- System compatibility testing
- Labeling review
These are standard engineering and regulatory tests for physical medical devices and are not related to the performance evaluation of an AI/ML algorithm.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves an AI/ML device meets the acceptance criteria, as the input document does not pertain to an AI/ML device.
§ 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.