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The Paxman Scalp Cooler is indicated to reduce the likelihood of chemotherapy-induced alopecia (CIA) in cancer patients with solid tumors.

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 touchscreen 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.

The provided text is a 510(k) summary for the Paxman Scalp Cooler, which is a medical device intended to reduce chemotherapy-induced alopecia. The document outlines the device's characteristics, indications for use, and a comparison to a predicate device. It also summarizes clinical performance data.

However, the document does not contain the specific information typically associated with acceptance criteria and a study proving a new device meets these criteria in the context of an Artificial Intelligence/Machine Learning (AI/ML) device. Instead, this 510(k) is for an expansion of the indication for use of an already cleared device, stating that "No additional testing was conducted for this 510(k) to support substantial equivalence." The supporting clinical data provided are summaries of existing published and non-published studies, primarily focusing on the device's performance in different patient populations and with various chemotherapy regimens.

Therefore, I cannot extract information related to acceptance criteria, sample sizes for a test set, expert involvement, adjudication methods, MRMC studies, standalone performance, ground truth establishment for novel AI/ML device validation.

The closest I can get to "acceptance criteria" based on the provided text would be the success rates observed in the clinical studies, which demonstrate whether the device performed as intended in reducing alopecia.

Here's an attempt to organize the available relevant information from the document, with caveats where the requested information is not present:

Study Proving Device Meets Acceptance Criteria (as interpreted from a 510(k) for an expanded indication)

The Paxman Scalp Cooler's expanded indication for use (from "women with breast cancer" to "cancer patients with solid tumors") was supported by a review of published and non-published clinical data from the Paxman Scalp Cooling System. This was not a new clinical study specifically designed to establish performance for the expanded indication, but rather a compilation of existing evidence. The previous 510(k) (K163484) for the device's initial clearance would have included performance testing, but the details are not fully provided here, beyond a general statement that "All tests met the pre-determined specifications and acceptance criteria and demonstrated the Paxman Scalp Cooler to be safe and effective as labeled."

1. Table of Acceptance Criteria (Interpreted from Clinical Outcomes) and Reported Device Performance

Since this is a 510(k) for an expanded indication and not a new clinical trial with pre-defined acceptance criteria for a novel device, I will present the success rates and observations from the most relevant studies for showing the device's effectiveness in reducing chemotherapy-induced alopecia for solid tumors. The "acceptance criteria" here are implied by the positive outcomes and conclusions drawn in the existing literature.

• Success rates varied from 8% (TAC chemotherapy) to 95% (paclitaxel treatment).
• For the SCALP study (K163484 predicate), 53.1% (95% CI, 44.5%-61.4%) had successful hair preservation in the cooling group vs. 0% in control group (95% CI, 0%-6.6%).
• Alopecia occurrence with 3-weekly docetaxel: Paxman: 23% vs. No cooling: 74%.
• Alopecia occurrence with weekly docetaxel: Paxman: 7% vs. No cooling: 17%.
• 69.7% of patients completed sensor-controlled scalp cooling, with 58.6% experiencing complete hair preservation (DS 0) and 11.1% partial success (DS 1-2).
• 91.21% overall scalp cooling had excellent results in the Lebanese study, with 6/6 (100%) patients on TAC showing no signs of hair loss. | - Dutch Scalp Cooling Registry (2012, 2017)
• Paxman Coolers Limited SCALP study (Nangia J, et al. 2017)
• Betticher DC, et al. (2013) (Paxman Swiss Clinical Studies of Efficacy)
• Kurbacher CM, et al. (2017)
• Paxman Lebanese Clinical Studies of Efficacy |
  | Patient Tolerability and Comfort | - "Well-tolerated and were infrequently discontinued by patients."
• "The sensation of cold was sometimes reported, no serious adverse events occurred, and patient ratings of cooling therapy were generally favorable."
• SCALP study: 71 device-related adverse events, all grades 1 and 2. No serious device-related adverse events.
• 85% of patients (Massey C, 2004) described it as very comfortable, reasonably comfortable or comfortable.
• 73.3% of patients (El-saka RO, et al., 2009) were comfortable during cooling.
• 5% of patients (Betticher DC, et al., 2013) reported adverse events (most frequently sensation of cold).
• 5% of patients (Paxman UK Clinical Study of Efficacy) discontinued scalp cooling.
• 5% of patients (Paxman Netherlands Clinical Study of Efficacy/2) discontinued due to intolerance. | - General conclusion from clinical literature
• Nangia J, et al. (2017)
• Massey C (2004)
• El-saka RO, et al. (2009)
• Betticher DC, et al. (2013)
• Paxman UK Clinical Study of Efficacy
• Paxman Netherlands Clinical Study of Efficacy/2 |
  | No significant long-term adverse effects (e.g., increased scalp metastasis) | - "No unfavorable development of disease due to scalp cooling has been documented in patients with solid tumors."
• "No difference in overall mortality was observed between scalp-cooled patients and non-scalp-cooled patients."
• Scalp cooling had "no negative effect on survival." | - van den Hurk, CJ, et al. (2013)
• Lemieux J, et al. (2015) |

2. Sample sizes for the test set and data provenance:

• Test Set Sample Sizes:
  • Dutch Scalp Cooling Registry: Over 6000 cancer patients enrolled (since 2006, up to 2017 data points provided in tables). Specific patient counts provided for different years (e.g., n=1411 for 2006-2010, n=4864 for 2010-2015, n=827 for 2015-2017).
  • Paxman Coolers Limited SCALP study (NCT01986140): 182 women with stage 1 or II breast cancer (119 in cooling group, 63 in no cooling group). The publication reports on an interim analysis of n=142 patients (95 in cooling, 47 in control).
  • Massey C (2004): 94 breast cancer patients.
  • Bini M, et al. (2004): 47 breast cancer patients.
  • Betticher DC, et al. (2013): 238 patients with solid tumors (128 Paxman, 77 cool cap, 39 no cooling).
  • Kurbacher CM, et al. (2017): 99 female patients.
  • Silva G, et al. (2016): 20 female patients.
  • Paxman Lebanese Clinical Studies of Efficacy: 91 cancer patients.
• Data Provenance: The studies summarized are from various international locations including the Netherlands (Dutch Registry, Paxman Netherlands studies), UK (Massey C, Paxman UK study), Switzerland (Betticher DC, Paxman Swiss studies), Brazil (Silva G), Lebanon (Paxman Lebanese study), and the US (Nangia J, et al. - SCALP study).
• Retrospective or Prospective:
  • Dutch Scalp Cooling Registry: Retrospective (registry data collection).
  • Paxman Coolers Limited SCALP study (Nangia J, et al.): Randomized, multi-center, prospective clinical trial.
  • Lemieux J, et al. (2015): Retrospective cohort study.
  • Massey C (2004): Open, non-randomized, observational, multi-center.
  • Bini M, et al. (2004): Observational, single-center.
  • Falanga M, et al. (2010): Observational, single-center (pilot study).
  • El-saka RO, et al. (2009): Randomized.
  • Betticher DC, et al. (2013): Open-label, prospective, non-randomized.
  • Kurbacher CM, et al. (2017): Retrospective analysis.
  • Silva G, et al. (2016): Observational.
  • Boyle F, et al. (2015): Focus group/semi-structured interview (qualitative).
  • Kinoshita T, et al. (2015): Case review.
  • Letchford DB, et al. (2016): Ongoing prospective cohort.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided as the summarized studies are clinical trials and observational studies, not typically "ground truth" establishment for an AI/ML algorithm's test set. Hair loss assessment was done by clinicians, nurses, or through patient self-reporting, often using standardized scales (WHO grading system, CTCAE v4.0).

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

This information is not applicable as it's not a reader study for an AI/ML algorithm's test set. Hair loss assessment methods varied by study (e.g., blinded clinician, patient's clinician, patient self-reporting).

5. 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 information is not applicable. The studies describe the effectiveness of the device (scalp cooler) itself, not the assistance of an AI to human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

This information is not applicable. The device is a physical cooling system, not a software algorithm.

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

The "ground truth" for the effectiveness of the device in these studies was primarily clinical outcomes data related to hair preservation (e.g., success defined as not needing a wig/head cover, or specified grades of alopecia using scales like WHO grading system and CTCAE). Safety data involved reporting of adverse events. Survivability data were also used in some studies.

8. The sample size for the training set:

This information is not applicable as the device is a physical medical device, not an AI/ML algorithm that requires a "training set."

9. How the ground truth for the training set was established:

This information is not applicable for the same reason as above.

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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

Study Details

1. 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.

2. 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.

3. 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.

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:

   • 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.

5. 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.

6. 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).

7. 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.

8. 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.

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