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The DigniCap Delta® Scalp Cooling System is indicated to reduce the likelihood of chemotherapy-induced alopecia in cancer patients with solid tumors.

The DigniCap Delta Scalp Cooling System ("DigniCap Delta")is a device that is intended to function as a cooling system to reduce the likelihood of chemotherapy-induced alopecia in cancer patients with solid tumors. The proposed therapy of the new device is comparable to the therapy of the predicate device, DigniCap Scalp Cooling System (K170871).

DigniCap Delta cools fluid to a prescribed set temperature and circulates that cooled fluid through a cooling wrap and then back to the device. This mode of operation is equivalent to other scalp cooling devices. User operation of the DigniCap Delta system is carried out on the illuminated graphics display with the integrated touch control, located on the front of the unit. The navigation and selection buttons on the display are used to interface with the device.

The provided text is a 510(k) Premarket Notification for the DigniCap Delta Scalp Cooling System. This document focuses on demonstrating substantial equivalence to a predicate device (DigniCap Scalp Cooling System, K170871) rather than establishing new acceptance criteria and proving device performance against them through a clinical study.

Therefore, the requested information (acceptance criteria, study details, sample sizes, expert qualifications, adjudication, MRMC, standalone performance, ground truth, training set information) for a new, independent study demonstrating fundamental device performance against specific acceptance criteria is largely not present in this document.

Instead, the document details non-clinical bench testing to demonstrate that the modifications in the DigniCap Delta (subject device) do not raise new questions of safety or effectiveness compared to the already cleared predicate device.

However, I can extract the information that is present and indicate where the requested information is not applicable or not provided.

Description of Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

1. Table of acceptance criteria and the reported device performance:

Since this 510(k) relies on substantial equivalence and non-clinical bench testing for minor modifications, there isn't a table of "acceptance criteria" for a new clinical efficacy study in the traditional sense. The "acceptance criteria" are implied by the performance requirements tested during non-clinical bench testing to ensure the device performs as intended and is safe. The "reported device performance" is a summary statement that the device met these requirements.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• Sample Size for Test Set: Not applicable. No clinical test set (patient-based) was used as this submission relies on non-clinical bench testing and substantial equivalence to a predicate device.
• Data Provenance: Not applicable. The data is from non-clinical bench testing, not patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

• Not applicable. There was no clinical test set requiring expert-established ground truth for a diagnostic or treatment outcome. Non-clinical testing results are verified against established engineering and regulatory standards by qualified personnel within the testing process.

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

• Not applicable. No clinical test set was used requiring adjudication.

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:

• Not applicable. This device is a scalp cooling system, not an AI diagnostic tool involving human readers.

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

• Not applicable. This device is a physical cooling system, not an algorithm. Its operation is "standalone" in that it performs its cooling function independently, but this is not the typical interpretation of "standalone" performance for an AI/algorithm-based device.

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

• For the non-clinical testing, the "ground truth" refers to established engineering specifications, published standards (e.g., ISO 10993-1, IEC 60601 series), and the intended functional performance of the device (e.g., maintaining specific temperatures, correct alarm function).

8. The sample size for the training set:

• Not applicable. This device does not involve a "training set" in the context of machine learning or AI.

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

• Not applicable. No training set was used.

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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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