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The Chemo Mouthpiece is intended to be used to cool the oral mucosa to reduce the incidence and severity of chemotherapy induced oral mucositis in adult patients.

The Chemo Mouthpiece is a device that reduces the temperature in the oral cavity to reduce the incidence and severity of oral mucositis (OM) associated with chemotherapy. The device is completely passive (e.g. there are no electrical components) and is designed to manually circulate saline solution and purified water inside a mouthpiece worn by the patient. The Chemo Mouthpiece (CMP) is designed with an inner chamber, an outer chamber, and breathing tubes. Prior to use the device is placed inside a standard freezer for a minimum of 6 hours, which freezes the water solid in the inner chamber, while the saline solution chamber in the outer chamber becomes cold but remains in liquid form. The device is then retrieved from the freezer and placed by the user in the oral cavity per the instructions for use. Cryotherapy is maintained continuously as the user squeezes the device to circulate the cold saline solution around the in the device. Breathing tubes that run throughout the length of the device facilitate breathing during device use.

The Chemo Mouthpiece is intended to cool the oral mucosa to reduce the incidence and severity of chemotherapy-induced oral mucositis in adult patients. The 510(k) summary provides details of the non-clinical performance testing conducted to demonstrate that the device meets its performance specifications.

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size Used for the Test Set and Data Provenance:

The provided text only refers to non-clinical performance testing. It does not mention a "test set" in the context of clinical data, nor does it provide sample sizes for any of the non-clinical tests. Therefore, there is no information about data provenance (country of origin, retrospective/prospective) related to a test set of patient data. The tests are laboratory-based.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Not applicable. The reported studies are non-clinical performance tests (cooling capacity, mechanical integrity, shelf-life, biocompatibility) of the device itself, not studies evaluating diagnostic or therapeutic accuracy against a clinical ground truth.

4. Adjudication Method for the Test Set:

Not applicable. There is no clinical test set with associated ground truth requiring adjudication. The studies are technical performance evaluations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was not done. The document focuses on the technical performance of the device and its substantial equivalence to a predicate, not on human reader performance with or without AI assistance.

6. If a Standalone (Algorithm only without Human-in-the-Loop Performance) Was Done:

Not applicable. The Chemo Mouthpiece is a passive medical device, not an algorithm or AI system. Its performance is evaluated directly through physical and chemical testing, not through algorithmic output.

7. The Type of Ground Truth Used:

For the non-clinical tests, the "ground truth" is defined by the technical specifications and standards against which the device's performance is measured.

• Device Cooling Test: Ground truth is the defined temperature range or cooling capacity that the device is expected to achieve, and comparison to the predicate device's cooling.
• Mechanical Integrity Testing: Ground truth is the defined mechanical durability and integrity requirements under simulated worst-case conditions.
• Shelf Life and Package Integrity Testing: Ground truth includes the defined package seal integrity after accelerated aging and the thermal specifications for the aged device.
• Biocompatibility: Ground truth is established by the specified ISO and USP standards (ISO 10993-5, ISO 10993-10, ISO 10993-11, USP).

8. The Sample Size for the Training Set:

Not applicable. This is a passive medical device, not an AI/ML algorithm requiring a training set.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as no training set is relevant for this device.

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The Cooral Device is intended to cool the oral mucosa during chemotherapy treatments to reduce the likelihood and severity of chemotherapy induced Oral Mucositis in adult patients.

The Cooral System is an intraoral mouthpiece that cools the oral mucosa using a water coolant which circulates internally through the mouthpiece for patients undergoing chemotherapy treatment to reduce the likelihood and severity of oral mucositis. Oral mucositis is one of the most common, debilitating complications of cancer treatment. The device consists of an energy control unit with a computerized control system to which an intraoral mouthpiece is connected via plastic tubing. Liquid coolant (sterile water) is circulated from the tank through the plastic tubes of the intraoral mouthpiece and is designed to specifically cool the areas where the major arteries enter the oral cavity. The cooling is initiated 30 minutes prior to start of chemotherapy infusion and continues 30 minutes after termination of the infusion time can vary between 15 min to 3 hours based on the half-life of the chemotherapeutics.

The Cooral System pushes temperature-controlled coolant which results in heat exchange between the Cooral System, and the patient's oral mucosa. The coolant temperature is controlled by a thermostat and its temperature probe. The Cooral System maintains a controlled coolant temperature at 8°C during the entire treatment period.

The device is intended to use is intended to reduce the severity and likelihood of oral mucositis in patients undergoing chemotherapy treatment. The device is a system made out of different components.

The device consists of three components:

• 1. Computerized Control System (ECU 200 refrigeration and control unit)
• 2. Plastic tubing connecting the ECU to the mouthpiece
• 3. Intraoral Mouthpiece

The provided text describes the Cooral System, an intraoral cooling device intended to reduce the likelihood and severity of chemotherapy-induced oral mucositis. However, the document does not describe an AI/algorithm-based device and therefore does not contain information typically found in acceptance criteria or study designs for AI/ML medical devices. The study detailed is a clinical trial comparing the Cooral System to ice cooling, focusing on its efficacy and tolerability for preventing oral mucositis.

Therefore, I cannot extract information related to AI/ML specific acceptance criteria, sample sizes for training/test sets, expert adjudication methods, MRMC studies, standalone performance, or ground truth establishment for AI/ML algorithms from the provided text.

Based on the information provided, here's a breakdown of the clinical study conducted for the Cooral System, interpreted in the context of device performance, not AI/ML performance:

Acceptance Criteria (Implied Clinical Performance)

While the document doesn't explicitly list "acceptance criteria" in a table for an AI/ML device, the clinical study aimed to demonstrate the device's efficacy and tolerability. The "results" section implicitly serves as the performance assessment against the study objectives.

Table of Implied "Acceptance Criteria" and Reported Device Performance (Clinical Study Outcomes)

• Cooral Mean Peak OMAS Total Score: 0.988 (N=84)
• Ice Mean Peak OMAS Total Score: 1.239 (N=88)
• Mean Difference: -0.251
• p-value: 0.3518 (Not statistically significant)

Lymphoma Subgroup (Table 3):

• Cooral Mean Peak OMAS Score: 1.769 (N=13)
• Ice Mean Peak OMAS Score: 3.077 (N=13)
• Mean Difference: -1.308
• p-value: 0.0499 (Statistically significant for this subgroup, specifically "a statistically significant, higher percentage of freedom from severe OM which is represented by peak OMAS score of ≥3" - actual reported p=0.047 in text, 0.0499 in Table 3). |
  | Secondary Objective: Tolerability (Discomfort) | Statistically significant reduction in reported discomfort compared to ice. | Full Analysis Set (Table 2):
• Cooral: 4/80 (5.00%) reported discomfort
• Ice: 14/87 (16.09%) reported discomfort
• Odds Ratio: 0.274 (95% CI 0.086-0.873)
• p-value: 0.0285 (Statistically significant) |
  | Safety | Acceptable safety profile, no new or unexpected serious adverse events. | No device-related serious adverse events observed (Table 2, Adverse Events). Adverse events were temporary and transient (e.g., poor fit, rubbing discomfort, difficulties swallowing in ICD group; chills, numbness, teeth hypersensitivity in Ice group). |

Study Details (Clinical Study, Not AI/ML)

1. Sample Size Used for the Test Set and Data Provenance:

   • Sample Size: A total of 183 participants were randomized: 90 to the Cooral Device group and 93 to the Ice group.
   • Data Provenance: The study was conducted in five hospital sites in Sweden. The clinical trial was a prospective, randomized controlled trial.

2. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts:

   • The "ground truth" for oral mucositis (OM) assessment was established using the Oral Mucositis Assessment Scale (OMAS total).
   • Experts: Dental staff in charge of assessing OM were used. They were blinded to the interventions.
   • Qualifications: The document does not specify the specific qualifications (e.g., years of experience, types of dental professionals) of the dental staff.

3. Adjudication Method for the Test Set:

   • The document states that the dental staff in charge of assessing OM were "blinded" to the interventions. It does not explicitly mention a multi-reader or adjudication process (e.g., 2+1, 3+1) among the dental staff for establishing the OMAS scores per patient. It implies that the scores were collected directly without a formal adjudication for consistency between multiple assessors for the same patient.

4. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

   • No. This was a clinical trial comparing a device (Cooral System) to a standard practice (ice cooling) in patients, assessing clinical outcomes (oral mucositis severity, tolerability). It was not an MRMC study comparing human reader performance with and without AI assistance.

5. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

   • Not applicable. The Cooral System is a physical medical device, not an algorithm. Its performance is assessed in a clinical setting in patients in conjunction with healthcare professionals.

6. The Type of Ground Truth Used:

   • The primary ground truth for efficacy was the Oral Mucositis Assessment Scale (OMAS total), which is a validated assessment scale based on direct clinical observation (ulceration and erythema graded by dental staff).
   • For tolerability, ground truth was established through subjective questionnaires filled out by patients (e.g., Numeric Pain Rating, questionnaire on discomfort/side effects) and daily online diaries.

7. The Sample Size for the Training Set:

   • Not applicable. This is a physical device, not an AI/ML algorithm requiring a training set.

8. How the Ground Truth for the Training Set Was Established:

   • Not applicable. As above, this is not an AI/ML device.

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