FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

as a cryosuraical tool for destruction of unwanted tissue in the fields . of dermatology, general surgery, neurosurgery, thoracic surgery, urology, proctology, oncology, gynecology and ENT;
to ablate prostatic tissue; .
for the ablation of prostatic tissue in cases of prostate cancer and . benian prostatic hyperplasia;
for ablation of cancerous or malignant tissue; .
for ablation of benign tumors; .
for palliative intervention; .
for ablation or freezing of skin cancers and other cutaneous . disorders;
for the ablation of malignant neoplasia or benign dysplasia of the . female genitalia;
for ablation of leukoplakia of mouth, angiomas, sebaceous . hyperplasia, basal cell tumors of the eyelid and canthus area, ulcerated basal cell tumors, dermatofibromas, small hemangiomas, mucocele cysts, multiple warts, plantar warts, hemorrhoids, and fissures, peri-anal condylomata, pilonidal cysts, actinic and seborrheic keratoses, cavernous hemanaiomas, recurrent cancerous lesions;
for the destruction of warts or lesions: ●
for the palliation of tumors of the oral cavity, rectum, and skin;. .
for ablation of arrhythmic cardiac tissue; ●
. for the ablation of benign or malignant growths of the anus and rectum;
for the ablation of hemorrhoids; ●

Nitrous Oxide:

as a tool in the destruction of unwanted tissue in the fields of . dermatology, gynecology, general surgery, and urology;

Carbon Dioxide:

as a tool in the destruction of unwanted tissue in the fields of . dermatology, gynecology, and general surgery;

Argon and Krypton:

as a cryosurgical tool in general surgery, dermatology, neurology, . thoracic surgery, ENT, gynecology, oncology, proctology, and urology for the ablation of tissue including liver metastases, skin lesions, warts and prostate tissue;

Device Description

The CMS Blizzard 700 Series Models 710, 711, 712, 720, 721 and 722 are simple, portable cryosurgical devices. All models feature physician-selected cryogen choices as well as a selection of cryoprobes of various sizes and shapes. Models 710, 711 and 712 are single cryoport devices while models 720, 721 and 722 have a two cryoport capacity. Although all models operate in the exact same way, their casings differ to allow desired positioning. The 710 and 720 are wheeled pole type configuration; the 711 and the 721 are tabletop configuration; while the 712 and the 722 are suitcase or attaché type configuration.

The devices are used to destroy unwanted tissue by the application of cold to the selected site. The cryogen is forced through the cryoprobe under pressure. The cryoprobe having been placed in the appropriate position, then becomes cold and freezes the tissue.

AI/ML Overview

The provided 510(k) summary for the K980670 device (CMS Blizzard 700 Series) does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the context of performance metrics like accuracy, sensitivity, or specificity.

This document is a 510(k) premarket notification for a medical device, which focuses on demonstrating substantial equivalence to a predicate device rather than conducting new clinical trials for performance claims against pre-defined acceptance criteria, especially in the way an AI/ML device submission would.

The document primarily provides:

Device Description: What the device is and how it works (a cryosurgical unit designed to destroy unwanted tissue by applying cold).
Comparison to Predicate Devices: Detailed tables comparing features (cryogens, number of cryoprobes, cryogen containers, size, cryoprobe types, control) of the CMS Blizzard 700 Series to its own previous models (Cryo-lite™ System, AccuProbe® 600 Series) and competitor devices (Cabot Medical Cryomedics MT700, Erbe Erbokryo CA). This is the core of demonstrating substantial equivalence.
Indications for Use: A comprehensive list of medical applications for which the device is intended, varying by the cryogen selected.
FDA Correspondence: An FDA letter confirming substantial equivalence.

Therefore, I cannot extract the requested information as it is not present in the provided text.

Here's a breakdown of why and what kind of information is missing, based on your request:

Table of Acceptance Criteria and Reported Device Performance: This document does not establish specific performance metrics (like accuracy, sensitivity, specificity) for the device. The "performance" being demonstrated is similarity in function and safety features to legally marketed predicate devices, not a quantitative performance score against a benchmark.
Sample Size used for the test set and data provenance: No test set is described. The approval is based on "substantial equivalence" to existing devices, inferring that if the predicate devices are safe and effective, and the new device is sufficiently similar, it also meets those standards.
Number of experts used to establish the ground truth for the test set and qualifications of those experts: Not applicable. Ground truth for a test set is not mentioned as no performance study of this nature was conducted or reported.
Adjudication method: Not applicable.
Multi-Reader Multi-Case (MRMC) comparative effectiveness study: Not applicable. This type of study is specifically relevant for AI/ML devices assessing impact on human reader performance. The device here is a physical cryosurgical unit, not an AI diagnostic tool.
Standalone (algorithm-only) performance: Not applicable. The device is not an algorithm.
Type of ground truth used: Not applicable.
Sample size for the training set: Not applicable. This device is not an AI/ML model that requires a training set.
How the ground truth for the training set was established: Not applicable.

In summary, the provided text describes a traditional medical device (cryosurgical unit) submission for 510(k) clearance, which relies on demonstrating substantial equivalence to predicate devices. It does not involve the types of acceptance criteria, performance studies, or AI/ML specific data (training/test sets, ground truth, expert review) that your prompt is looking for.

Summary

Regulation Number and Section

§ 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.