(277 days)
The DigniCap™ Scalp Cooling System is indicated to reduce the likelihood of chemotherapy induced alopecia in women with breast cancer.
The Dignitana DigmiCap™ Scalp Cooling System consists of a computer controlled system that includes a refrigerated tank containing the cooling agent that is maintained at -8 ± 1 ℃. The liquid coolant circulates from the cooling unit to and through the channels of the cap and back to the cooling unit. The scalp temperature is monitored by three separate thermometers. Deviations from the pre-set temperature are automatically adjusted by the system (scalp temperature can be controlled with an accuracy of ±2.0℃).
The DigniCap™ Scalp Cooling System components include the following:
Digni C3 system - Is a refrigerator unit with an integral control system operated via a touch screen monitor and is capable of controlling two separate cooling caps independently of each other. Scalp cooling is performed in conjunction with a silicon inner cap (DigniCap™), an outer neoprene cap (DigniTherm™), and the liquid coolant (DigniCool™).
DigniCap™ - A soft, tight-fitting silicon cap which has two separate cooling circuits, one for the front of the head and one for the back of the head plus a third sensor for overall safety control.
DigniCool™ - The liquid coolant monopropylene glycol (MPG5).
DigniTherm™ - The outer neoprene cap that insulates and keeps the inner cap in place. To improve cooling and ensure proper fitting, this cap is covers the DigniCap™ and includes a chin strap which is used to hold the cap in place. This neoprene cover cap, called the DigniTherm™, comes in different sizes and is colored coded to match the corresponding correct silicone Cooling Cap. In addition to acting as a means of maintaining cooling cap placement, this outer cap also provides insulation which improves cooling efficiency
DIGNISTICK™ – A component used to save data from a treatment or for troubleshooting when inserted in the slot. It can also be used to update software.
DIGNICARD™ – A key card which has to be inserted in order to start a treatment.
Acceptance Criteria and Device Performance for DigniCap™ Scalp Cooling System
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Primary Endpoint) | Reported Device Performance (Pivotal Study) |
|---|---|
| Success of the DigniCap™ Scalp Cooling System to prevent hair loss, defined as a maximum Dean score of ≤ 2 (meaning ≤ 50% hair loss) up to 4 weeks after the last chemotherapy treatment graded by the patient, in at least 50% of patients with a lower bound of the 95% CI greater than 40%, and statistical superiority over a concurrent control group. | 67 out of 101 evaluable patients (66.3%) in the DigniCap™ group achieved treatment success (Dean score ≤ 2). (95% CI, 56.2, 75.4%) and 0% in the control group. This demonstrated statistical superiority. |
2. Sample Size and Data Provenance
- Pivotal Study (effectiveness and safety):
- Test Set Sample Size: 101 evaluable patients in the treatment group, 16 patients in the control group.
- Data Provenance: Prospective, multi-center (6 sites), concurrent controlled clinical study conducted in the U.S. (based on the FDA De Novo submission context).
- Feasibility Study (safety and feasibility):
* Test Set Sample Size: 19 evaluable patients.
* Data Provenance: Prospective, 2-site clinical study conducted in the U.S.
3. Number of Experts and Qualifications for Ground Truth
- Pivotal Study:
- For the primary effectiveness endpoint (Dean score ≤ 2), the assessment was based on patient self-assessment of standardized photographs. This does not involve independent expert grading in the primary outcome.
- For an independent secondary assessment, "An independent panel review of the photographs was conducted and 73 patients (72%) were rated as treatment successes." The qualifications of these panel members are not specified in the provided text.
- Feasibility Study:
- Hair loss was assessed by an independent panel consisting of: a hair dresser, a patient advocate, and a dermatologist specializing in hair. The number of experts within this panel is three. Specific years of experience are not provided for the individual experts.
4. Adjudication Method for the Test Set
- Pivotal Study: The primary endpoint was patient self-assessment against standardized photographs. This implies individual assessment rather than a consensus or adjudication method among multiple graders for the primary endpoint. For the independent panel review (secondary), the adjudication method is not described beyond "review of photographs."
- Feasibility Study: Hair loss assessment was done by an "independent panel" by "review of photographs blinded to patient and sequence." The specific adjudication method (e.g., majority vote, discussion to consensus) is not specified.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- A MRMC comparative effectiveness study, in the typical sense of evaluating human reader performance with and without AI assistance, was not performed.
- The pivotal study was a controlled clinical trial comparing the device (with human users) to a control group without the device. The "effect size of how much human readers improve with AI vs without AI assistance" is not applicable as this is a device for patients, not an AI diagnostic tool for readers. The study did, however, demonstrate a significant improvement in hair retention for patients using the device compared to those who did not.
6. Standalone (Algorithm Only) Performance
- A standalone (algorithm only) performance study was not performed or is not applicable in this context. The DigniCap™ Scalp Cooling System is a physical device used by patients, not an AI algorithm intended for automated analysis. The "software" component mentioned in the device description primarily controls cooling mechanisms, not performs diagnostic analysis.
7. Type of Ground Truth Used
- Pivotal Study (Primary Endpoint): Patient self-assessment based on the Dean Scale using standardized photographs.
- Pivotal Study (Secondary Independent Assessment): Independent panel review of photographs based on the Dean Scale.
- Feasibility Study: Independent panel review of photographs based on the Dean Scale, and also patient assessment following the Dean Scale.
8. Sample Size for the Training Set
- The provided text describes clinical studies (feasibility and pivotal) that serve as testing for the device's efficacy and safety. It does not describe a "training set" in the context of machine learning. The DigniCap™ is a mechanical device with software controls, not a machine learning model that requires a training set of data to learn from.
9. How the Ground Truth for the Training Set was Established
- As explained above, there is no mention of a "training set" in the machine learning sense in the provided document. The clinical studies represent testing of the device's performance, not training of an algorithm.
§ 878.4360 Scalp cooling system to reduce the likelihood of chemotherapy-induced alopecia.
(a)
Identification. A scalp cooling system to reduce the likelihood of chemotherapy-induced alopecia is a prescription device intended to reduce the frequency and severity of alopecia during chemotherapy in which alopecia-inducing chemotherapeutic agents are used.(b)
Classification —Class II (special controls). The special controls for this device are:(1) Non-clinical performance testing must demonstrate that the device meets all design specifications and performance requirements, and that the device performs as intended under anticipated conditions of use. This information must include testing to demonstrate accuracy of the temperature control mechanism.
(2) Performance testing must demonstrate the electromagnetic compatibility and electrical safety of the device.
(3) Software verification, validation, and hazard analysis must be performed.
(4) The patient contacting components of the device must be demonstrated to be biocompatible. Material names must be provided.
(5) Labeling must include the following:
(i) A statement describing the potential risk of developing scalp metastasis.
(ii) Information on the patient population and chemotherapeutic agents/regimen for which the device has been demonstrated to be effective.
(iii) A summary of the non-clinical and/or clinical testing pertinent to use of the device.
(iv) A summary of the device technical parameters, including temperature cooling range and duration of cooling.
(v) A summary of the device- and procedure-related adverse events pertinent to use of the device.
(vi) Information on how the device operates and the typical course of treatment.
(6) Patient labeling must be provided and must include:
(i) Relevant contraindications, warnings, precautions, and adverse effects/complications.
(ii) Information on how the device operates and the typical course of treatment.
(iii) Information on the patient population for which there is clinical evidence of effectiveness.
(iv) The potential risks and benefits associated with use of the device.
(v) Postoperative care instructions.
(vi) A statement describing the potential risk of developing scalp metastasis.