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The intended use of the Candela Dynamic Cooling Device is to minimize thermal injury to non-vascular skin structures during laser therapy of benign cutaneous vascular lesions, and to reduce pain associated with laser treatment.

Candela's Dynamic Cooling Device consists of 1) a source of skin refrigerant fluid (CFC R-12), 2) an electronically controlled solenoid delivery valve, and 3) electronic timing circuitry. The Dynamic Cooling Device is connected in line with an SPTL laser's triggerswitch system so that activation of the triggerswitch controls the delivery of a pulsed spray of CFC R-12 just prior to the delivery of a laser pulse. The pulsed spray of skin refrigerant cools the skin as it evaporates. Thermal injury to non-vascular structures is minimized and pain associated with the laser treatment is reduced.

The provided text is a 510(k) summary for the Candela Dynamic Cooling Device, submitted in 1996. It details the device's purpose and general information but does not contain the specific information required to answer your questions about acceptance criteria, study details, and performance metrics.

This document is focused on establishing "substantial equivalence" to predicate devices, which is a regulatory pathway for approval, rather than demonstrating clinical or technical performance through detailed studies with specific metrics.

Therefore, I cannot populate the table or answer the specific questions because the foundational information is absent from the provided text. The document states:

• "Candela's Dynamic Cooling Device has undergone and passed testing during its development designed to assess the performance of components and finished devices, including dimensional testing, functional properties, function according to its intended use, ease of use and durability."

However, it does not provide the results of this testing, the acceptance criteria used, or any details about sample sizes, ground truth establishment, or expert involvement.

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for use in the treatment of pigmented lesions and tattoos.

The Candela Q-Switched Alexandrite Lasers utilize an alexandrite rod (crystal) which emits pulsed energy at 755 nm in the near-infrared region of the electromagnetic spectrum. An electro-optical Q-Switch is employed to control pulse duration. Energy from the laser is directed to the targeted area via an optical fiber/handpiece delivery system. The Candela Q-Switched Alexandrite Lasers are designed with five major components:

• the high voltage power supply and modulator system; 1)
• 2. the optical laser head;
• 3. the circulator system;
• 4. the microprocessor-based system controller and user display panel;
• 5. the optical delivery system.

The Candela Q-Switched Alexandrite Lasers are equipped with safety interlock systems to protect patients and operators. Users of the device make selections from an on-board control panel to regulate operation during treatment.

The provided 510(k) summary for the Candela Q-Switched Alexandrite Lasers does not contain the requested information about acceptance criteria and a study proving the device meets those criteria from an AI/algorithm performance perspective.

This document describes a medical device, specifically a laser, and its substantial equivalence to predicate devices (other lasers). The "Testing" section mentions "component testing and functional testing of the completed laser," which refers to engineering and quality control tests for the physical device, not an AI or algorithm performance study with ground truth and expert adjudication.

Therefore, I cannot populate the table or answer the specific questions related to AI/algorithm performance. The summary explicitly states: "No new questions of safety and efficacy are raised by the introduction of this device into commercial distribution," which points to a traditional substantial equivalence argument for a physical medical device, not a software or AI-driven diagnostic or prognostic tool.

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The Candela HCS 2000 Urethral Warmer Catheter System is designed to transfer heat into the urethral membrane during cryosurgical ablation of prostatic tissue using the Cryotech LCS 3000 Cryosurgical System.

The principal components of the Candela Urethral Warmer are: (1) a saline bottle filled with a saline solution; (2) infrared lamps; (3) a temperature controller; (4) a roller pump; (5) delivery tubing and a balloon catheter with a radiopaque marker at its center; (6) pump tubing (7) return tubing; (8) a urethral/bladder sound (K950633); and (9) a console. The console houses the saline reservoir, the infrared lamps, and the roller pump and digital temperature readouts and buttons for operating the device appear on the front of the console.

Here's a breakdown of the acceptance criteria and study information for the Candela HCS 2000 Urethral Warmer Catheter System, based on the provided text:

Summary of Acceptance Criteria and Device Performance:

Detailed Study Information:

1. Sample size used for the test set and the data provenance:

   • Temperature Control Study: Not explicitly stated as a "test set" in the traditional sense of patient data. The test involved repeated cycling (20 times for over-temperatures and 20 times for under-temperatures) of the alarm system in a bench setting.
   • Heating Effectiveness Study (Dog Kidney): 1 dog (retrospective or prospective not specified, but implied prospective for the study).
   • Heating Effectiveness Study (Beef Liver): 1 slab of beef liver (ex-vivo, thus no country of origin or retrospective/prospective).
   • Low Volume Alarm Study: Multiple tests across 15-minute intervals (number of samples not explicitly stated beyond "a set of tests"). Bench testing.
   • Pressure Resistance Study: Bench testing of tubing and catheter.
   • Balloon Catheter Compliance Study: Bench testing.
   • Biocompatibility: Referenced existing data, not a new study with a "test set" in this submission.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. These were primarily bench tests and animal/ex-vivo models where objective measurements (temperature, volume, pressure, physical observation of freezing) served as the "ground truth." No human expert consensus was required to interpret these physical parameters.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. The "ground truth" was established by direct physical measurements and observations rather than expert review or interpretation.

4. 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 medical device (urethral warmer), not an AI/imaging diagnostic device.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device. The "performance" is its mechanical and thermal functionality.

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

   • Temperature Control: Direct measurement of saline temperature against pre-set acceptable range.
   • Heating Effectiveness: Direct observation of tissue freezing (or lack thereof) via thermocouples and stained tissue (Tripan Blue).
   • Low Volume Alarm: Direct measurement of saline loss volume.
   • Pressure Resistance: Direct measurement of pressure and physical observation of rupture/integrity.
   • Balloon Catheter Compliance: Direct measurement of priming volume and balloon diameter.
   • Biocompatibility: Existing biocompatibility data and prior regulatory clearances for similar materials.

7. The sample size for the training set: Not applicable. This is a medical device, not a machine learning algorithm.

8. How the ground truth for the training set was established: Not applicable.

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