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Ice Cooling IPL Hair Removal Device with sapphire treatment window is indicated for the removal of unwanted hair. The device is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.

Ice Cooling IPL Hair Removal Device with sapphire treatment window is indicated for the removal of unwanted hair. The device is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.

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Ice Cooling IPL Hair Removal Device with sapphire treatment window is indicated for the removal of unwanted hair. The device is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.

Ice Cooling IPL Hair Removal Device is an over-the-counter, home-use and personal device for hair reduction by using Intense Pulsed Light (IPL) with safety and efficacy. It is designed with a lamp that can emit continuously double or triple pulses per shot. It works below the skin's surface and does not involve any cutting or pulling, reducing hair growth with nearly painless pain and nearly heatless.
The device is only powered by the external power adapter and its IPL emission activation is by finger switch. This product adopts sapphire treatment window that is suitable for multiple hair removal areas. It contains a skin sensor to detect appropriate skin contact, if the device is not in full contact with the skin, the device cannot emit the treatment light pulses. Besides, the device has the ice cooling function that will be activated throughout the whole hair removal process to provide users with a more comfortable and safer experience.

The provided FDA 510(k) clearance letter and summary for the "Ice Cooling IPL Hair Removal Device" describe a medical device submission and its review. However, it does not contain the specific information required to describe acceptance criteria and associated study results for an AI/ML-based medical device.

The document primarily focuses on:

• Regulatory classification and product codes: Identifying the device as Class II, Product Code OHT, under 21 CFR 878.4810.
• Intended use: Hair removal and permanent reduction in hair regrowth.
• Comparison to predicate devices: Demonstrating substantial equivalence in terms of intended use, design, specifications, and performance (e.g., wavelength range, energy density, spot size).
• Performance data (Non-Clinical): Referring to biocompatibility testing, electrical safety (EMC), light safety, software verification and validation (not AI-specific performance), and usability testing, all against established industry standards (IEC, ISO).

Crucially, there is no mention of:

• AI/ML components: The device is described as an Intense Pulsed Light (IPL) device, and its operation does not inherently involve AI/ML. "Software Verification and Validation" is a standard requirement for electronic medical devices and does not imply AI.
• Clinical study data for performance metrics: The performance data section refers only to non-clinical tests (biocompatibility, electrical safety, light safety, software V&V, usability). It does not provide details on clinical efficacy (hair reduction) studies with specific performance metrics, sample sizes, or ground truth establishment relevant to the device's hair removal claim. The "permanent reduction in hair regrowth" indication implies clinical testing, but the details are not present in this summary.
• Expert consensus, MRMC studies, or specific AI performance metrics like sensitivity, specificity, AUC: These are typical elements of a study proving an AI device meets acceptance criteria.

Therefore, it is not possible to fill in the requested table and answer the questions based solely on the provided text, as the device described is not an AI/ML medical device, and the document focuses on non-clinical substantial equivalence rather than detailed clinical performance of the hair removal efficacy.

Hypothetical Example (if this were an AI/ML device and the text provided the necessary details):

If, for instance, the device had an AI component to detect skin type or predict hair regrowth, and the document detailed a study on this AI component, the information could be extracted like this (this is purely illustrative and not based on the provided text):

Hypothetical Acceptance Criteria and Study for an AI-Powered Hair Removal Device

Let's imagine this device also had an AI feature, for example, an integrated AI system that analyzes skin pigmentation to recommend optimal IPL settings to minimize adverse events and maximize efficacy.

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance

• AI Skin Type Classification Test Set: 1500 images/cases (1000 for training, 500 for validation/testing).
• Adverse Event/Efficacy Test Set (Clinical Trial): 300 participants.
• Data Provenance:
  • Skin images for AI classification: Retrospective dataset collected from dermatology clinics in North America (USA, Canada) and Europe (UK, Germany).
  • Clinical trial for adverse events/efficacy: Prospective, multi-center, randomized controlled trial conducted in the USA (5 sites) and China (3 sites).

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

• Skin Type Ground Truth: 3 board-certified dermatologists, each with a minimum of 10 years of experience in aesthetic dermatology and laser/IPL treatments. All were trained to consistently apply Fitzpatrick Skin Type scale.
• Adverse Event/Efficacy Ground Truth: Clinical investigators (dermatologists) at each trial site, with at least 5 years of experience in IPL/laser treatments, reviewed and graded adverse events and hair reduction independently at follow-up visits.

4. Adjudication method for the test set

• Skin Type Ground Truth: For the AI classification test set, initial skin type labels were provided by one expert. For any ambiguous cases (e.g., initial disagrement or boundary cases), a 3-expert consensus (2+1 majority rule) was used. If a consensus was not reached (e.g., 1-1-1 split), the case was excluded from the ground truth set.
• Adverse Event/Efficacy Ground Truth: For clinical trial outcome adjudication, two independent, unblinded dermatologists graded outcomes (hair reduction percentage, adverse events) at each follow-up visit. In case of discrepancy, a third blinded dermatologist acted as an adjudicator to reach a consensus.

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

• Yes, an MRMC study was performed to assess the impact of AI-recommended settings vs. manual-expert settings on clinical outcomes.
• Study Design: 10 IPL therapists/dermatologists (readers) were recruited. They each reviewed 50 simulated patient profiles (cases) and recommended IPL settings.
  • Group A (without AI): Readers used standard clinical guidelines and their experience.
  • Group B (with AI assistance): Readers were provided with the AI system's recommended settings and could choose to accept, modify, or reject them.
• Effect Size: The AI-assisted group (Group B) demonstrated a statistically significant improvement in the rate of optimal setting selection (leading to good outcomes without adverse events) by 15% (Cohen's d = 0.65) compared to the unassisted group (Group A). Specifically, the rate of selecting optimal, safe, and effective settings increased from 70% (unassisted) to 85% (AI-assisted).

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

• Yes, a standalone performance evaluation of the AI skin type classification module was conducted prior to its integration into the device and the MRMC study. This included the accuracy, sensitivity, and specificity metrics mentioned in section 1.

7. The type of ground truth used

• Expert Consensus: For skin type classification (AI module training and testing).
• Clinical Outcomes Data: For validating the safety and efficacy of AI-recommended settings (adverse event rates, hair reduction percentage from prospective clinical trial data).

8. The sample size for the training set

• AI Skin Type Classification: 15,000 unique skin images with associated Fitzpatrick Skin Type labels.

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

• The ground truth for the training set was established by three experienced board-certified dermatologists, similar to the test set experts. Each image was independently reviewed and labeled by all three. If discrepancies occurred, a consensus process involving discussion and re-evaluation was used to arrive at a final label. This iterative process ensured high-quality, reliable ground truth data for training the AI model.

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Ice Cooling IPL Hair Removal Device with sapphire treatment window is indicated for the removal of unwanted hair. The device is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.

Ice Cooling IPL Hair Removal Device is an over-the-counter, home-use and personal device for hair reduction by using Intense Pulsed Light (IPL). It is designed with dual lamps that work together and can emit mutipulses per shot. It works below the skin's surface and does not involve any cutting or pulling, reducing hair growth with nearly painless pain.

The device is only powered by the external power adapter and its IPL emission activation is by finger switch. This product adopts sapphire treatment window that is suitable for multiple hair removal areas. It contains a skin sensor to detect appropriate skin contact, if the device is not in full contact with the skin, the device cannot emit the treatment light pulses. Besides, the device has the ice cooling function that will be activated throughout the whole hair removal process to provide users with a more comfortable experience.

Ice Cooling IPL Hair Removal Device includes the following models: UI20S DB, UI20S RE, UI20S PW, UI20S GP, UI20S GR, UI20S BK, UI20 DB, UI20 RE, UI20 PW, UI20 GP, UI20 GR, UI20 BK. Their intended use, performance and operation are basically identical. The model differences are enclosure color, a detachable accessory cover and skin recognition(only for UI20S series with an accessory cover and with skin recognition). (UI20 series：UI20 DB, UI20 RE, UI20 PW, UI20 GP, UI20 GR, UI20 BK; UI20S series：UI20S DB, UI20S RE, UI20S PW, UI20S GP, UI20S GR, UI20S BK).

The provided text does NOT describe a study that proves the device meets specific acceptance criteria related to its performance in hair removal (e.g., efficacy percentages, safety profiles, or long-term hair reduction outcomes). This 510(k) clearance letter primarily focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics, safety, and electrical/software compliance, rather than detailed clinical performance studies with specific patient outcomes.

The "Summary of performance testing" section specifically lists tests related to:

• Biocompatibility: Ensuring materials are safe for human contact.
• Electrical Safety and EMC: Compliance with standards for electrical operation and electromagnetic compatibility.
• Eye Safety: Compliance with photobiological safety standards.
• Software Verification and Validation: Ensuring software functions correctly and mitigates risks.
• Usability: Evaluation of user interface and safety from a human factors perspective.

These are all crucial for demonstrating the safety and basic functionality of the device, and that it is as safe and effective as previously cleared devices. However, they do not include the type of clinical trial data (e.g., hair regrowth measurements at 6, 9, 12 months) that would typically involve acceptance criteria for efficacy in hair reduction for a new device claiming permanent hair reduction.

Therefore, I cannot extract a table of acceptance criteria and reported device performance from this document for the stated indications, nor details about sample sizes, ground truth establishment, or expert involvement for performance efficacy studies. The document implicitly relies on the predicate devices having established this efficacy.

If this were a submission for a novel device, or if the manufacturer needed to prove clinical efficacy independently, this section would contain a detailed description of a clinical study, including:

• Acceptance Criteria for Efficacy: e.g., "At least X% reduction in hair count at 6 months post-treatment in Y% of subjects."
• Safety Criteria: e.g., "Incidence of adverse events (e.g., burns, hyper/hypopigmentation) not exceeding Z%."
• Study Design: Sample size, retrospective/prospective, blinding.
• Outcome Measures: How hair reduction was measured (e.g., photodocumentation, hair counts).
• Ground Truth: How hair counts were objectively determined.
• Statistical Analysis: How the data proved the criteria were met.

Conclusion:

Based only on the provided FDA 510(k) clearance letter, I cannot fulfill most of the requested points regarding acceptance criteria and performance studies because the document focuses on demonstrating substantial equivalence based on technological and safety standards, not on presenting new clinical efficacy data for hair removal. The implicit "proof" of efficacy lies in the substantial equivalence to predicate devices that have already established their efficacy for the stated indications.

The document states:
"Performance data supports that the device is safe and as effective as the predicate devices for its intended use." This is a claim of equivalence, not a direct presentation of primary efficacy data for this specific device.

Therefore, the requested table and specific details regarding MRMC studies, standalone performance, ground truth derivation for efficacy, and training/test set sample sizes for hair removal efficacy are not present in this 510(k) summary. The "performance data" referred to in the document pertains to the safety and engineering characteristics listed in the "Summary of performance testing" section.

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Ice Cooling IPL Hair Removal Device with sapphire treatment window is indicated for the removal of unwanted hair. The device is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.

Ice Cooling IPL Hair Removal Device is an over-the-counter, home-use and personal device for hair reduction by using Intense Pulsed Light (IPL). It is designed with a lamp that can emit single pulse, double pulse or triple pulse per shot. It works below the skin's surface and does not involve any cutting or pulling, reducing hair growth with nearly painless pain. The device is only powered by the external power adapter and its IPL emission activation is by finger switch. This product adopts sapphire treatment window that is suitable for multiple hair removal areas. It contains a skin sensor to detect appropriate skin contact, if the device is not in full contact with the skin, the device cannot emit the treatment light pulses. Besides, the device has the ice cooling function that will be activated throughout the whole hair removal process to provide users with a more comfortable experience.

This FDA 510(k) clearance letter pertains to an Ice Cooling IPL Hair Removal Device, not an AI/algorithm-based diagnostic device. Therefore, the information typically requested in your prompt regarding acceptance criteria and studies proving the device meets those criteria (e.g., sample size for test/training sets, data provenance, expert ground truth, MRMC studies, standalone performance, etc.) is not applicable to this type of medical device clearance.

The 510(k) summary for this IPL device focuses on demonstrating substantial equivalence to predicate devices through:

• Identical Intended Use: Hair removal and permanent reduction in hair regrowth.
• Similar Technological Characteristics: Comparison of physical dimensions, power supply, light source, energy medium, wavelength range, energy density, output energy, spot size, pulse duration, pulsing control, delivery device, output intensity levels, and software/firmware. Minor differences are addressed by showing they do not raise new safety or efficacy concerns.
• Performance Data (Non-Clinical Testing):
  • Biocompatibility Testing: Ensuring materials in contact with the body are safe (per ISO 10993 series).
  • Electrical Safety and EMC (Electromagnetic Compatibility): Compliance with relevant IEC 60601 standards to ensure electrical safety and proper operation in the presence of electromagnetic disturbances.
  • Light Safety: Compliance with IEC 62471 for photobiological safety.
  • Software Verification and Validation: Ensuring software functions correctly and mitigates hazards, consistent with a "Basic Documentation Level."
  • Usability: Evaluation and validation per IEC 60601-1-6 and FDA guidance on Human Factors and Usability Engineering.

To directly answer your prompt, but acknowledging its non-applicability to this specific device:

1. A table of acceptance criteria and the reported device performance:

   Acceptance Criteria (General for IPL Device)	Reported Device Performance (Summary of Non-Clinical Testing)
   Biocompatibility (Safety of body-contacting parts)	Passed ISO 10993-10 (skin sensitization), ISO 10993-23 (irritation), ISO 10993-5 (in vitro cytotoxicity).
   Electrical Safety (Prevention of electric shock, fire, etc.)	Passed IEC 60601-1 (general safety), IEC 60601-1-2 (EMC), IEC 60601-1-11 (home healthcare), IEC 60601-2-57 (non-laser therapeutic equipment), IEC 60601-2-83 (home light therapy equipment).
   Electromagnetic Compatibility (EMC)	Passed IEC 60601-1-2 (EMC requirements and tests).
   Light Safety (Patient eye/skin safety from light emission)	Passed IEC 62471 (photobiological safety of lamps and lamp systems).
   Software Functionality and Safety	Software documentation consistent with "Basic Documentation Level" submitted. System testing demonstrated all software requirements met and hazards mitigated to acceptable levels.
   Usability (Safe and effective use by intended user)	Evaluated and validated according to IEC 60601-1-6 and FDA guidance "Applying Human Factors and Usability Engineering to Medical Devices."
   Performance within specified output parameters (Energy density, wavelength, etc.)	Output specifications (e.g., energy density 1.8-6.67 J/cm², wavelength 550-1200nm) are provided and considered substantially equivalent to predicates, with minor differences justified as not raising safety/efficacy issues. Temperature Test Report and Usability evaluation conducted to verify safe multi-pulse use.

2. Sample sizes used for the test set and the data provenance: Not applicable to this type of device and submission. The "test set" here refers to specific non-clinical engineering tests (e.g., electrical safety, biocompatibility) where sample sizes are determined by standard testing protocols for equipment, not by a patient/image dataset. The data provenance is primarily from the manufacturer's internal testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an IPL device is established through engineering specifications and physical measurements, and by adherence to recognized consensus standards for safety and performance, not by expert interpretation of clinical data in the context of diagnostic AI.

4. Adjudication method for the test set: Not applicable. Adjudication methods like 2+1 or 3+1 apply to clinical data interpretation, typically in diagnostic studies.

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 is an IPL device, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. There is no AI algorithm being evaluated for standalone performance in this submission.

7. The type of ground truth used: For this device, "ground truth" refers to:

   • Physical Measurements/Engineering Specifications: Ensuring the device operates within its stated parameters (e.g., energy output, wavelength).
   • Compliance with Recognized Consensus Standards: Adherence to standards like IEC 60601 series, IEC 62471, and ISO 10993 series, which define safety and performance requirements.
   • Usability Testing Outcomes: Observing real users to ensure the device can be used safely and effectively.

8. The sample size for the training set: Not applicable. There is no "training set" in the context of an IPL device clearance, as it's not an AI/machine learning model.

9. How the ground truth for the training set was established: Not applicable for the same reason as above.

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Ice Cooling IPL Hair Removal Device with sapphire treatment window is indicated for the removal of unwanted hair. The device is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.

Ice Cooling IPL Hair Removal Device is an oversonal device for har reduction by using Intense Pulsed Light (PL). It is designed with a lamp that can emit continuously double of this surface and does not involve any cuting or pulling, reducing har growth with nearly painless pain. The device is only powered by the external pover adapter activation is by finger switch. This product adopts spphire treatment window that is suitable for multiple hair removal areas. It contains a skin contact, if the device is not in full contact with the skin, the device canot emit the treatment light pulses. Besides, the device tunction that will be activated throughout the whole hair removal process to provide users with a more comfortable experience.

The provided text is a 510(k) summary for the Ice Cooling IPL Hair Removal Device. It details the device's characteristics, comparison to predicate devices, and performance data submitted to support substantial equivalence.

However, the document does not contain the specific information requested regarding an AI/algorithm-based device, namely:

• Acceptance criteria table and reported device performance for an AI/algorithm. The document focuses on performance data for a non-AI medical device (biocompatibility, electrical safety, light safety, software verification, usability).
• Sample size and data provenance for a test set.
• Number of experts and qualifications for ground truth establishment.
• Adjudication method for the test set.
• Information about a multi-reader multi-case (MRMC) comparative effectiveness study.
• Stand-alone (algorithm-only) performance.
• Type of ground truth used (expert consensus, pathology, outcomes data, etc.) for an AI/algorithm.
• Sample size for the training set.
• How ground truth for the training set was established.

The device in question, an "Ice Cooling IPL Hair Removal Device," is regulated as a "Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology" (21 CFR 878.4810). While it mentions "Software Verification and Validation" and "Software documentation consistent with Basic Documentation Level," this typically refers to embedded software for device control and safety features, not a diagnostic or prognostic AI algorithm that processes image data to provide clinical insights, which would require the kind of performance study details requested in your prompt.

Therefore, I cannot provide the requested information based on the provided text. The document does not describe a study involving an AI model for which such specific performance metrics and ground truth establishment details would be relevant.

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The IceCaps (IceCap 2, IceCap 2 Small, IceCap Neonate (Sizes XS, S, & M)) are medical devices used as EEG electrodes. They are used by Healthcare Professionals on a patient in case of neurological disorders with a short or long-term EEG record (up to 72 hours).
IceCap 2 shall be placed on patients weighing at least 10 kg (22.05 lbs) and having a head circumference above 43 cm (16.93 inches).
IceCap Neonate shall be placed on the head of babies, newborns and premature babies.

The IceCaps (IceCap 2, IceCap 2 Small, IceCap Neonate (Sizes XS, S, & M)) are medical devices used as EEG electrodes.
The IceCaps are a single use cap which connects to the marketed EEG recorders using an IceAdapter or Touchproof adapter.
The electrodes placement in IceCap Product line is done accordingly to the 10/20 system.
The conductive tracks of the Flexible Printed Circuit are used to conduct EEG signals from the electrodes to the connectors.
IceCap 2 shall be placed on patients weighing at least 10 kg (22.05 lbs) and having a head circumference above 43 cm (16.93 inches).
IceCap Neonate (M,S,XS) shall be placed on the head of babies, newborns and premature babies.

The IceCap product line does not perform comparative effectiveness studies with human readers or standalone algorithm performance studies. The device is a cutaneous electrode, and its evaluation focuses on safety and performance according to relevant standards, not on AI-driven diagnostic accuracy.

Here's a breakdown of the acceptance criteria and supporting studies for the IceCap product line:

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided document does not explicitly state the sample size used for specific test sets (e.g., for fit-to-form, impedance, or usability tests). It mentions that the "clinical data were not necessary to determine substantial equivalence," indicating that animal or human subject testing for diagnostic or comparative effectiveness was not performed as a primary means of establishing substantial equivalence for this type of device.

The document does not provide information on the country of origin of the data or whether the data was retrospective or prospective. The studies primarily involve non-clinical performance and safety testing.

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

As this device is an EEG electrode, the primary "ground truth" for its performance is its ability to meet electrical and biocompatibility standards, and to effectively acquire EEG signals as confirmed by non-clinical tests. There is no mention of human experts being used to establish a ground truth for a diagnostic outcome, as the device itself does not provide diagnostic interpretations.

4. Adjudication Method for the Test Set

Not applicable. The evaluation performed is based on compliance with harmonized standards and engineering tests, not on human-based adjudication of diagnostic outcomes.

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. The IceCap product line is an EEG electrode, not an AI-powered diagnostic tool. Therefore, MRMC studies with human readers are not relevant to its clearance.

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

Not applicable. The device is a hardware component (EEG electrode) and does not involve a standalone algorithm for performance evaluation in a diagnostic context.

7. The type of ground truth used

The ground truth used for evaluating the IceCap product line is based on established engineering standards and regulatory requirements for medical devices, particularly for cutaneous electrodes. This includes:

• Performance standards: e.g., electrical impedance, signal integrity (implied by "general quality of signal").
• Safety standards: e.g., electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), usability for medical electrical equipment in the home healthcare environment (IEC 60601-1-11).
• Biocompatibility standards: (ISO 10993-1) for materials in contact with the patient.
• Functional tests: Fit-to-form, usability for installation.
  The "truth" is whether the device meets these specified, measurable criteria.

8. The Sample Size for the Training Set

Not applicable. This device is a hardware product (EEG electrode) and does not involve AI or machine learning algorithms that require a training set.

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

Not applicable. This device is a hardware product (EEG electrode) and does not involve AI or machine learning algorithms that require a training set or ground truth for training.

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Ice Cooling IPL Hair Removal Device with sapphire treatment window is indicated for the removal of unwanted hair. The device is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.

Ice Cooling IPL Hair Removal Device is an over-the-counter, home-use and personal device for hair reduction by using Intense Pulsed Light (IPL). It is designed with dual lamps that work together and can emit mutipulses per shot. It works below the skin's surface and does not involve any cutting or pulling, reducing hair growth with nearly painless pain. The device is only powered by the external power adapter and its IPL emission activation is by finger switch. This product adopts sapphire treatment window that is suitable for multiple hair removal areas. It has skin-safe detection. It contains a skin sensor to detect appropriate skin contact, if the device is not in full contact with the skin, the device cannot emit the treatment light pulses. Besides, the device has the ice cooling function that will be activated throughout the whole hair removal process to provide users with a more comfortable experience.

The provided text is an FDA 510(k) clearance letter for an "Ice Cooling IPL Hair Removal Device." It describes the device, its intended use, and a comparison with predicate devices to establish substantial equivalence. However, this document does not contain, nor is it expected to contain, the detailed acceptance criteria and study results typically found in a clinical study report for device performance, especially for AI/ML-driven devices involving expert interpretation or comparative effectiveness studies.

The document focuses on:

• Substantial Equivalence: Demonstrating the new device is as safe and effective as legally marketed predicate devices.
• Performance Data (Non-Clinical): Summarizing tests for biocompatibility, electrical safety and EMC, eye safety, software verification and validation, and usability. These are largely engineering and safety tests rather than evaluations of device clinical effectiveness (e.g., hair removal efficacy).

Therefore, I cannot fulfill your request for acceptance criteria and study details related to "device performance" in the context of an AI/ML device (e.g., human reader improvement with AI assistance, standalone algorithm performance, ground truth establishment by experts, MRMC studies) because this information is not present in the provided FDA clearance letter.

The device described is an IPL (Intense Pulsed Light) hair removal device, which is a physical device that emits light to reduce hair growth. It does have software/firmware control, but it's not presented as an AI/ML-driven diagnostic or imaging interpretation device that would involve the kind of "acceptance criteria" you've outlined (e.g., related to sensitivity, specificity, or expert consensus on interpretations). The "performance data" here relates to the safety and fundamental operation of the physical device as required for a 510(k) submission.

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Ice Cooling IPL Hair Removal Device with sapphire treatment window is indicated for the removal of unwanted hair. The device is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.

Ice Cooling IPL Hair Removal Device is an over-the-counter, home-use and personal device for hair reduction by using Intense Pulsed Light (PL). It is designed with clual lamps that work together and can emit single, continuously double or triple pulses per shot. It works below the sky cutting or pulling, reducing hair growth with nearly pain. It has three modes: Fast Mode, Normal Mode and High Mode. The device is only powered by the external pover adapter and its by finger switch. This product adopts sapplive treatment window that is suitable for multiple hair removal areas. It has skin sensor to detect appropriate skin contact, if the device is not in full contact with the skin, the device cannot emit the treatment light plas the ice cooling finction that will be activated throughout the whole hair removal process to provide users with a more comfortable experience.

The provided text describes the regulatory filing for the "Ice Cooling IPL Hair Removal Device" and includes a comparison to predicate devices, but it does not contain information about a specific study proving the device meets acceptance criteria in the manner requested (e.g., clinical trial with performance metrics like sensitivity, specificity, accuracy, or effectiveness of AI assistance to human readers).

The document details:

• Indications for Use: Removal of unwanted hair and permanent reduction in hair regrowth (defined as reduction at 6, 9, and 12 months post-treatment regime).
• Comparison to Predicate Devices: A table comparing characteristics like regulation number, product code, light source, wavelength range, energy density, and pulse duration.
• Performance Data (Summary of performance testing): This section outlines bench testing and compliance with various international standards related to biocompatibility, electrical safety and EMC, light safety, software verification/validation, and usability. It does not include clinical efficacy data or performance metrics directly addressing the "permanent reduction in hair regrowth" claim.

Therefore, I cannot fulfill the request to provide:

1. A table of acceptance criteria and reported device performance related to a clinical outcome.
2. Sample size for a clinical test set or its provenance.
3. Number and qualifications of experts for ground truth.
4. Adjudication method for a clinical test set.
5. MRMC study effect size.
6. Standalone performance.
7. Type of ground truth used for clinical effectiveness.
8. Sample size for a clinical training set.
9. How ground truth for a clinical training set was established.

The performance data summarized focuses on safety, electrical compliance, usability, and software testing, rather than a clinical study evaluating the device's hair removal efficacy against specific performance targets. The "conclusion" states the device "is as safe, as effective, and performs as well as the legally marketed predicate device," which is a statement of substantial equivalence based on the engineering and safety tests, and similarity to predicate devices, not on a new clinical effectiveness study presented in this summary.

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The Boston Scientific disposable IceRod Cryoablation Needle, IceSphere Cryoablation Needle, IceSeed Cryoablation Needle, IcePearl Cryoablation Needle, and IceForce Cryoablation Needle (CX Needles) are meant to be connected to a Boston Scientific ICEfx Cryoablation System or Visual-ICE Cryoablation System when performing cryoablative tissue destruction through application of extremely cold temperatures. The needles are intended to convert high-pressure gas to either a very cold Freezing application or to a warm Thawing application.

The Boston Scientific CX Needles, when used with ICEfx Cryoablation System or Visual-ICE Cryoablation System, are indicated for use as a cryosurgical tool in the fields of general surgery, dermatology, neurology (including cryoanalgesia), thoracic surgery (with the exception of cardiac tissue), ENT, gynecology, oncology, proctology, and urology. The CX Needles are designed to destroy tissue (including prostate and kidney tissue, liver metastases, tumors, and skin lesions) by the application of extremely cold temperatures.

The CX Needles have the following specific indications:

· Urology - Ablation of prostate tissue in cases of prostate cancer and Benign Prostate Hyperplasia (BPH)

· Oncology - Ablation of cancerous or malignant tissue and benign tumors, and palliative intervention. Palliation of pain associated with metastatic lesions involving bone in patients who have failed or are not candidates for standard radiation therapy.

· Dermatology - Ablation or freezing of skin cancers and other cutaneous disorders. Destruction of warts or lesions, angiomas, sebaceous hyperplasia, basal cell tumors of the eyelid or canthus area, ulcerated basal cell tumors, dermatofibromas, small hemangiomas, mucocele cysts, multiple warts, actinic and seborrheic keratosis, cavernous hemangiomas, peri-anal condylomata, and palliation of the skin

• Gynecology – Ablation of malignant neoplasia or benign dysplasia of the female genitalia

· General surgery - Palliation of tumors of the rectum, anal fissures, pilonidal cysts, and recurrent cancerous lesions, ablation of breast fibroadenomas

• ENT Palliation of tumors of the oral cavity and ablation of leukoplakia of the mouth
• · Thoracic surgery (with the exception of cardiac tissue)
• Proctology Ablation of benign or malignant growths of the anus or rectum

Boston Scientific Corporation's (BSC) IceSeed 1.5 CX Straight Cryoablation Needle, IceSphere 1.5 CX Straight Cryoablation Needle, and IceRod 1.5 CX Straight Cryoablation Needle (hereafter referred collectively as the Straight Needles) are sterile, single use, disposable devices used in conjunction with a Boston Scientific cryoablation system for cryoablative destruction of tissue during surgical procedures under CT guidance. The Straight CX Needles are disposable 1.5 mm needles that have a sharp cutting tip, a color-coded handle, a gas tube, and a connector. The needles convert high-pressure gas to either a very cold freezing application or to a warm thawing application. Active tissue thawing may also be achieved by activating the heating element inside the Straight CX Needles.

The provided document is a 510(k) summary for Boston Scientific's IceSeed 1.5 CX Straight Needle, IceSphere 1.5 CX Straight Needle, and IceRod 1.5 CX Straight Needle. It focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a clinical study with acceptance criteria for a new device's performance.

Therefore, the specific information requested, such as acceptance criteria, reported device performance for these criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment from a clinical effectiveness study, is not available in this document.

The document primarily describes engineering and functional verification testing to show that the new straight needles perform similarly to existing predicate bent-tip needles.

Here's a breakdown of what is available related to your request, and what is not:

1. A table of acceptance criteria and the reported device performance:

• Acceptance Criteria (Implied by equivalence to predicate devices and functional requirements): The document states that "Verification testing was conducted on the Straight CX Cryoablation Needles to ensure that the design, functionality, and performance met all the specified requirements and that the features of the needle satisfy its intended use." It also notes that "Test results demonstrated that the Straight CX Cryoablation Needles meets defined specifications."

  • Specific performance parameters are mentioned as matching the predicate devices, such as:
    • Shaft working length: 175mm
    • Shaft Diameter: 1.5mm
    • Markings: Thin and Thick marks at specific distances
    • Length of low friction coating on shaft: Specific starts and ends from the tip
    • Active zone Indicator: Specific starts from the tip and band length
    • Freezing cryogen: Argon 99.995%
    • Thawing gas: Helium 99.998%
    • Isotherm diameter: (IceSeed: -40°C: 15 ± 3 mm, -20°C: 24 ± 3 mm, 0°C: 37.5 ± 3 mm; IceSphere: -40°C: 16 ± 3 mm, -20°C: 26 ± 3 mm, 0°C: 39 ± 3 mm; IceRod: -40°C: 17 ± 3 mm, -20°C: 28 ± 3 mm, 0°C: 43 ± 3 mm)
    • Isotherm height: (IceSeed: -40°C: 21 ± 4 mm, -20°C: 28 ± 4 mm, 0°C: 41 ± 4 mm; IceSphere: -40°C: 24 ± 4 mm, -20°C: 32 ± 4 mm, 0°C: 45 ± 4 mm; IceRod: -40°C: 41 ± 4 mm, -20°C: 47 ± 4 mm, 0°C: 60 ± 4 mm)

• Reported Device Performance: The document generally states that "Test results demonstrated that the Straight CX Cryoablation Needles meets defined specifications, is substantially equivalent to the predicate devices, and does not raise any new issues of safety and effectiveness for its intended use." It implicitly means the new devices performed within the acceptable ranges for the parameters listed above, matching the predicate devices. No specific raw data or numerical results of the functional tests are provided.

2. Sample size used for the test set and the data provenance:

• Not Available. The document refers to "verification testing" and "functional testing" but does not specify sample sizes for these tests. There is no mention of a "test set" in the context of clinical data or patient studies. The provenance of any data is not mentioned, as it's primarily bench testing.

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

• Not Applicable / Not Available. This information relates to clinical studies and expert review for ground truth, which is not described in this 510(k) summary.

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

• Not Applicable / Not Available. Adjudication methods are typically used in clinical studies for establishing ground truth, which is not detailed here.

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 / Not Available. This device is a cryoablation needle, a surgical tool. It is not an AI-assisted diagnostic or decision-support system, so an MRMC study with AI assistance is irrelevant.

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

• Not Applicable / Not Available. As above, this is a physical medical device, not a standalone algorithm.

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

• Not Applicable / Not Available (for clinical ground truth). The "ground truth" for the device's performance is established by industrial standards and in-house functional requirements, and comparison to the parameters of the predicate device. It's engineering and performance specifications, not clinical outcomes or expert consensus on diagnoses.

8. The sample size for the training set:

• Not Applicable / Not Available. There is no mention of a training set as this is about a physical medical device, not a machine learning model.

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

• Not Applicable / Not Available. As there is no training set, this question is not applicable.

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Ice Cooling IPL Hair Removal Device with sapphire treatment window is indicated for the removal of unwanted hair. The device is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.

Ice Cooling IPL Hair Removal Device is an over-the-counter, home-use and single-person-use device for hair reduction by using Intense Pulsed Light (IPL). It works below the skin's surface and does not involve any cutting or pulling, reducing hair growth with minimal pain. This product emits light pulses and is designed to be suitable for multiple hair removal areas (such as: lips, underarms, bikini lines, arms, legs, etc.). The device is only powered by the external power adapter and its IPL emission activation is by finger switch. The device contains a skin sensor to detect appropriate skin contact. If the device is not in full contact with the skin, the device cannot emit the treatment light pulses. The device includes a cooling function to cool the skin during the hair removal process to provide users with a more comfortable experience.

The provided text is a 510(k) summary for the Shenzhen Ulike Smart Electronics Co., Ltd. Ice Cooling IPL Hair Removal Device. It describes the device, its intended use, and its comparison to predicate devices, along with performance testing. However, it does not contain the specific details about clinical study results, acceptance criteria, or the methodology that would be required to answer all the questions in the prompt.

Here's an analysis based on the available information:

Acceptance Criteria and Reported Device Performance:
The document does not explicitly state quantitative acceptance criteria for performance metrics related to hair removal (e.g., specific percentages of hair reduction deemed acceptable). It only mentions the "permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime" as part of the Indications for Use.

The document does not report specific quantitative performance data for the hair reduction effectiveness of the device. Instead, it refers to "Performance data supports that the device is safe and as effective as the predicate devices for its intended use" as a general statement for substantial equivalence.

Therefore, for the specific request of a table of acceptance criteria and reported device performance related to the primary indication of hair removal, the necessary information is not present in the provided text.

The document does list standards and tests for safety and general performance, which implies that the device met the requirements of these standards. For example:

Missing Information:

The following information is not available in the provided text:

2. Sample size used for the test set and the data provenance: There is no mention of a clinical test set or the number of participants.
3. Number of experts used to establish the ground truth for the test set and qualifications: This information would be relevant for clinical studies, which are not detailed here.
4. Adjudication method for the test set: Not applicable as no clinical test set is described.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and effect size: This type of study is not mentioned. The device is a "home-use" device, so human-in-the-loop performance is not evaluated in the context of an MRMC study with AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: While the device functions autonomously for hair removal, the performance described is purely device-centric rather than an "algorithm only" evaluation in the context of diagnostic AI.
7. The type of ground truth used: As no clinical study results are detailed, no specific ground truth for hair removal efficacy is provided or referenced.
8. The sample size for the training set: Not applicable as this document does not describe the development or evaluation of an AI/ML training set.
9. How the ground truth for the training set was established: Not applicable.

Summary based on available info:

The document primarily focuses on establishing "substantial equivalence" to predicate devices through technical comparisons and compliance with relevant safety and performance standards (biocompatibility, electrical safety, light safety, software, usability). It asserts that performance data supports the device's safety and effectiveness, but it does not present the detailed clinical study design, results, or specific acceptance criteria for hair removal efficacy that would directly answer your questions about acceptance criteria and how a study proves it. For a medical device of this type, a clinical study would typically be conducted, and those results would contain the information you are requesting. This 510(k) summary only notes that such data was "provided in support of the substantial equivalence determination" but does not elaborate on the specific findings or methodology of that data.

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