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The major intended use of the Amertek Sure-Point Tracker™ is the same as that of its unmodified predecessors cleared in K011581 and K972152: to allow precision ultrasound probe alignment and radioactive seed implantation in brachytherapy treatments. A specific application is the treatment of prostate (or other) cancer. The Amertek Sure-Point Tracker 100 also allows data from the use of probe location indicators to be fed directly into the brachytherapy planning program, such as that of Varian.

Like other basic stabilizers and steppers (e.g. Barzell-Whitmore Omnistand; Tayman Accuquide; Teknar, Proscan), this device is applicable in other surqical procedures or specialties which require accurate instrument fixation, such as cryosurgery, biopsy, and remote afterloading equipment (HDR) such as that used with the Nucletron device.

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The provided text describes a 510(k) premarket notification for the Amertek™ Sure-Point Tracker System. This device is described as a "Stepping and Stabilization Device, and template" for use with ultrasound probes, specifically for brachytherapy treatments (e.g., prostate cancer) and other surgical procedures requiring accurate instrument fixation.

However, the document does not contain specific acceptance criteria, a study that proves the device meets those criteria, or any of the detailed information requested in your prompt (e.g., sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details).

Instead, the submission states that the device is "substantially equivalent" to predicate devices already cleared for marketing. This means the FDA's decision was based on the device having the same intended uses, similar technological characteristics, and comparable materials as existing devices, rather than on new performance studies with specific acceptance criteria.

Therefore, I cannot provide a table of acceptance criteria or details about a study proving the device meets them, as this information is not present in the provided text. The submission explicitly states:

• "We have not found a specific guidance document on this subject, but believe we have complied fully with general guidance documents and usual practices in preparing premarket notifications." (Page 1)
• The "510(k) 'Substantial Equivalence' Decision-Making Process (Detailed) from ODE Guidance Memorandum #86-3 was followed as described below:
  1. These products have the same intended uses, as the classified device and those cleared for marketing as equivalent to it by the 510(k) process...
  2. The technological characteristics for this product are the same as those for the predicate devices and those currently on the market.
  3. Descriptive information provided shows that the materials from which Amertek™ is made are substantially equivalent those of similar products, used for identical purposes, currently on the market." (Page 0)

The lack of such detailed performance study information is common in 510(k) submissions where substantial equivalence is claimed based on similarity to predicate devices, rather than novel performance claims requiring new clinical or analytical studies.

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The CRYO-HIT™ System for MRI 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, 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 CRYO-HIT™ System for MRI, like the already cleared CRYO-HIT™ System 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 ablation of benign tumors, and palliative intervention)

Dermatology (ablation or freezing of skin cancers and other cutaneous disorders)

Gynecology (ablation of malignant neoplasia or benign dysplasia of the female genitalia)

General surgery (destruction of warts or lesions, palliation of tumors of the oral cavity, rectum and skin, and ablation of leukoplakia of the mouth, 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, hemorroids, anal fissures, perianal conylomata, pilonidal cysts, actinic and seborrheic keratoses, cavernous hemanglomas, and recurrent cancerous lesions)

Thoracic surgery (ablation of arrhythmic cardiac tissue, and ablation of cancerous lesions)

Proctology (ablation of benign or malignant growths of the anus or rectum, and ablation of hemorrhoids)

The CRYO-HIT™ System for MRI may be used with a magnetic resonance imaging (MRI) device or an ultrasound device to locate the target tissue, ensure correct placement of the probes and monitor the size of the iceball. The MRI or ultrasound device provides real-time visualization of the cryosurgical procedure.

The CRYO-HIT™ system for MRI is the exact same device as Galil Medical LTD's cleared System (K991517) except for the following technological modification: (1)- the additional MRI kit and (2) the availability of more probe types: 2 mm probe, surface probe, and disk shaped probe (The probes cleared for use with the modified CRYO-HIT™ System under K991272 include the same 2 mm probes, surface and disk shape probes, proposed for use with the CRYO-HIT™ for MRI).

The provided text describes the CRYO-HIT™ System for MRI and its indications for use, but it does not contain specific information about acceptance criteria, device performance studies, sample sizes, expert ground truth establishment, or any comparative effectiveness studies.

The document is a 510(k) summary and a subsequent correction letter from the FDA, focusing on substantial equivalence to a predicate device (CRYO-HIT™ 200 System, K991517) based on similar intended use, principle of operation, and technological characteristics. It highlights the modifications (MRI kit and additional probe types) that distinguish the new device from the predicate.

Therefore, I cannot fulfill the request for information regarding acceptance criteria, study details, and sample sizes as this information is not present in the provided text.

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