(126 days)
The Paxman Scalp Cooler is indicated to reduce the likelihood of chemotherapy-induced alopecia (CIA) in women with breast cancer.
The Paxman Scalp Cooler is a self-contained, mobile, electrically-powered refrigeration unit that circulates a refrigerated liquid coolant, at a pre-set temperature and flow rate, through a cooling cap, which is fitted to the top of the patient's head and connected to the refrigeration unit by a pair of coolant lines. A touch screen controller with a menu-driven, graphical user interface, integrated into the refrigeration unit, allows the healthcare professional to initiate, monitor, and complete the scalp cooling process.
Two (2) models of the Paxman Scalp Cooler are available:
- . ORBIS I – featuring one pair of coolant lines for attaching a single cooling cap; designed for scalp cooling of one patient at a time; and,
- . ORBIS II – featuring two pairs of coolant lines for attaching two cooling caps; designed for scalp cooling of up to two (2) patients at a time.
The touch screen displays a menu-driven Graphical User Interface (GUI) that provides information to the user concerning the operational status of the scalp cooling unit; it also prompts the user to initiate certain actions relating to the scalp cooling procedure and provides a timer count-down function for scalp cooling sessions. The GUI does not, however, directly control the scalp cooling process as there are pre-established programs for the scalp cooling administration.
The touch screen controller provides feedback to the user concerning the status of the Paxman Scalp Cooler as it relates to achievement of the pre-set temperature of the coolant, operation of the recirculation pump and connection of a cooling cap to the software also provides a timer count-down function for the initiated pre- and post-infusion cooling procedure. At the pre-set time, a message is displayed on the touch screen and a buzzer sounds to alert the fact that the scalp cooling time is complete.
Here's a breakdown of the acceptance criteria and the study proving device performance, based on the provided text:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Success Metric) | Reported Device Performance (Cooling Group) | Reported Device Performance (Control Group) |
|---|---|---|
| Hair preservation (less than 50% hair loss) | 50.5% (48 out of 95 patients) | 0% (0 out of 47 patients) |
| Safety Profile | All adverse events (54 total in 28 patients) were Grade 1 or 2; no serious adverse device events. | Not applicable (no device used) |
Study Details
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Sample Size used for the test set and the data provenance:
- Sample Size: 142 evaluable patients (95 in cooling group, 47 in control group).
- Data Provenance: Prospective, randomized, two-arm study conducted across six (6) clinical sites in the United States.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Two (a delegated physician or nurse practitioner, and a second independent healthcare provider).
- Qualifications: "delegated physician or nurse practitioner" and "second independent healthcare provider who is blinded to study treatment." Specific experience levels are not detailed.
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Adjudication method for the test set:
- An alopecia assessment was performed "by a delegated physician or nurse practitioner and a second independent healthcare provider who is blinded to study treatment." This implies a form of independent assessment, potentially with reconciliation if there were discrepancies, though the specific adjudication method (e.g., 2+1, 3+1) is not explicitly stated. The "blinded" aspect for the second provider is noted.
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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:
- This was not an MRMC comparative effectiveness study involving AI assistance. It was a clinical trial comparing a medical device (scalp cooler) with a control group (no cooling) for reducing chemotherapy-induced alopecia.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This was not a standalone algorithm-only performance study. It was a device study involving human patients and a physical medical device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The primary effectiveness ground truth was expert assessment/consensus (alopecia assessment by a delegated physician or nurse practitioner and a second independent healthcare provider) and patient self-report (success in hair preservation by subject self, use of wigs and/or hair wrap, and Quality of Life questionnaires).
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The sample size for the training set:
- The document describes a clinical study to evaluate the safety and efficacy of the Paxman Scalp Cooler. It does not mention a "training set" as would be used in an AI/machine learning context. This device is a physical cooling unit, not an AI algorithm, so the concept of a training set is not applicable here.
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How the ground truth for the training set was established:
- As this is a physical medical device and not an AI algorithm, there is no "training set" or corresponding ground truth establishment process described in the context of machine learning. The clinical study described in the document served as the performance evaluation for the device itself.
§ 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.