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Halyard Purple Nitrile-XTRA* Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Fentanyl Citrate in Simulated Gastric Acid are disposable devices intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

The following chemotherapy drugs and concentration had NO breakthrough detected up to 240 minutes:

• Arsenic Trioxide (1 mg/ml)
• Bendamustine, (5 mg/ml)
• Blenoxane (15 mg/ml)
• Bleomycin (15 mg/ml)
• Bortezomib (1 mg/ml)
• Busulfan (6 mg/ml)
• Carboplatln (10 mg/ml)
• Carfilzomib (2 mg/ml)
• Cetuximab (2 mg/ml)
• Cisplatin (1 mg/ml)
• Cyclophosphamide (Cytoxan) (20 mg/ml)
• Cytarabine (100 mg/ml)
• Dacarbazine (DTIC) {10 mg/ml)
• Daunorubicin {5 mg/ml)
• Decitabine (5 mg/ml)
• Docetaxel (10 mg/ml)
• Doxorubicin HCL (2 mg/ml)
• Ellence (2 mg/ml)
• Erbitux (2 mg/ml)
• Eribilin Mesylate (0.5 mg/ml)
• Etoposide (Toposar) (20 mg/ml)
• Fludarabine (25 mg/ml)
• Fulvestrant (50 mg/ml)
• Gemcitabine (Gemzar) (38 mg/ml)
• Idarubicin (1 mg/ml)
• Ifosfamide (IFEX) (50 mg/ml)
• Irinotecan (20 mg/ml)
• Mechlorethamine HCL (1 mg/ml)
• Melphalan (5 mg/ml)
• Methotrexate (25 mg/ml)
• Mitomycin C (0.5 mg/ml)
• Mitoxantrone (2 mg/ml)
• Oxaliplatin (2 mg/ml)
• Paclitaxel (Taxol) (6 mg/ml)
• Paraplatin (10 mg/ml)
• Pemetrexed Disodium (25 mg/ml)
• Pertuzumab (30 mg/ml)
• Raltitrexed (0.5 mg/ml)
• Rituximab (Rituxan) (10 mg/ml)
• Temsirolimus (25 mg/ml)
• Thiotepa (10 mg/ml)
• Topotecan HCL (1 mg/ml)
• Trastuzumab (21 mg/ml)
• Trisenox (1 mg/ml)
• Velcade (1 mg/ml)
• Vinblastine (1 mg/ml)
• Vinorelbine (10 mg/ml)

Carmustine (3.3 mg/ml) permeation occurred at 60.0 minutes.

The following hazardous drugs (opioids) and concentration had NO breakthrough detected up to 240 minutes:

• Fentanyl Citrate Injection (100 mcg/2 ml)
• Gastric Acid Fluid/Fentanyl Citrate Injection Mix (50/50 Solution)

Caution: Testing showed a minimum breakthrough time of 60.0 minutes with Carmustine.

The following hazardous drugs and concentration had NO breakthrough detected up to 240 minutes:

• Cytovene (10 mg/ml)
• Retrovir (10 mg/ml)
• Triclosan (2 mg/ml)
• Zoledronic Acid (0.8 mg/ml)

Halyard Purple Nitrile-XTRA* Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Fentanyl Citrate in Simulated Gastric Acid are disposable, 12"purple-colored, chlorinated, nitrile, powder-free, textured fingertip, ambidextrous, nonsterile patient examination gloves.

The provided text is an FDA 510(k) clearance letter and summary for a medical glove, not an AI-powered medical device. Therefore, many of the requested fields related to AI study design (like "multi-reader multi-case (MRMC) comparative effectiveness study," "standalone performance," "number of experts," etc.) are not applicable and cannot be found in the document.

However, I can extract the acceptance criteria and performance data for the glove based on the provided information, focusing on the non-clinical and clinical tests described.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

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The Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA) Test Kit-Qualitative is a fluorescence immunoassay intended for the qualitative detection of fentanyl in human urine at a cutoff concentration of 1.0 ng/mL. The assay is intended for use with Healgen® Immunofluorescence analyzer OG-H180. This in vitro diagnostic device is for prescription use only.

This assay provides only a preliminary analytical test result. A more specific alternate chemical method must be used to obtain a confirmed analytical result. Gas Chromatography-Mass Spectrometry (GC-MS) and Liquid Chromatography-Mass Spectrometry (LC-MS) are the preferred confirmatory methods. Clinical consideration and professional judgment should be applied to a Fentanyl test result, particularly when a preliminary positive result is obtained.

The Healgen® Immunofluorescence analyzer OG-H180 is a portable fluorescence instrument for in vitro diagnostic use only. The analyzer is designed to detect test results from in vitro diagnostic tests on clinical specimens. This analyzer can be used in a laboratory or point-of-care setting.

The AccuFluor Fentanyl FIA Test Kit-Qualitative is a rapid fluorescence immunoassay based on the principle of competitive binding, which uses fluorescent microspheres-labeled antibody as the indicator marker to qualitatively detect fentanyl in human urine. Drugs which may be present in the urine specimen compete against the drug conjugate for binding sites on the antibody.

During testing, a urine specimen migrates upward by capillary action. Fentanyl, if present in the urine specimen below 1.0 ng/mL, will not saturate the binding sites of antibody-coated particles in the test device. The antibody coated fluorescence particles will then be captured by immobilized Fentanyl conjugate, and the signal will be detected in the test line (T) region to show a negative result. The signal will not be detected in the test line (T) region if the Fentanyl level exceeds 1.0 ng/mL because all the binding sites for the anti-Fentanyl antibodies will be saturated and the result will show as positive. To serve as a procedural control, a signal will be detected at the control line (C) region indicating the proper volume of specimen has been added and membrane wicking has occurred. The test is interpreted by the Healgen® Immunofluorescence analyzer OG-H180 and the result will be interpreted by the analyzer.

The provided FDA 510(k) clearance letter pertains to the Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA) Test Kit - Qualitative and the Healgen® Immunofluorescence Analyzer (OG-H180). This document outlines the general regulatory approval and provides some performance characteristics, but it is not a comprehensive study report detailing all aspects of the acceptance criteria and the full study that proves the device meets those criteria.

Specifically, the document does not explicitly state "acceptance criteria" as a defined set of metrics and thresholds prior to presenting performance data. Instead, it presents results from various analytical performance studies which are implicitly used to demonstrate equivalence to a predicate device. Similarly, it does not describe "human expert ground truth establishment," "adjudication methods," or "MRMC comparative effectiveness studies" because these are typically relevant for AI/ML-based diagnostic devices utilizing image interpretation or complex decision support, which is not the primary function described for this immunoassay and analyzer.

This device is an in vitro diagnostic (IVD) test for qualitative detection of fentanyl in urine, which relies on a chemical reaction read by an analyzer. Therefore, the "study" described is a series of analytical performance tests, rather than a clinical study with human readers and ground truth established by medical experts in the way that would be done for an AI radiology device, for example.

Despite these limitations in the provided text for certain categories, I will extract and infer information where possible based on the provided document and common IVD device clearance practices.

Acceptance Criteria and Device Performance for Healgen® AccuFluor Fentanyl FIA Test Kit

1. Table of Acceptance Criteria and Reported Device Performance

As noted, the document does not explicitly list pre-defined "acceptance criteria" with specific numerical thresholds for all metrics. However, based on the provided performance data, here's an interpretation of the implied criteria and the reported performance. The "acceptance criteria" inferred here are based on what constitutes successful demonstration of performance for an IVD device of this type, often aiming for high accuracy, precision, and lack of interference, especially around the cutoff concentration.

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

• Analytical Precision: 60 replicates per concentration (6 replicates/day for 10 days) per lot, across 9 concentration levels, for 3 device lots. Total: 60 * 9 * 3 = 1620 individual tests.
• Interference: Samples with various interfering substances were tested, each at both drug-free and ±50% Cut-Off spiked fentanyl concentrations, using three batches of device. (Exact number of tests not specified, but implies a comprehensive set).
• Specificity: Various drug metabolites and other compounds tested, each using three batches of device. (Exact number of tests not specified).
• Effect of Urine Specific Gravity and pH: Samples across the specified ranges were tested at -50% and +50% Cut-Off levels by three different operators using three device lots. (Exact number of tests not specified).
• Method Comparison (Clinical Samples): 80 unaltered clinical samples (40 negative, 40 positive). These samples were run at three different testing sites.
• Data Provenance: The document does not explicitly state the country of origin for the clinical samples. It does state they were "unaltered clinical samples," implying they were retrospective real-world samples collected from patients. It does not indicate if they were prospective.

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

• Not Applicable in the traditional sense for this device. For this IVD device, the primary ground truth for its performance studies (precision, specificity, method comparison) is established by analytical gold standards, specifically:
  • LC/MS-MS (Liquid Chromatography-Mass Spectrometry/Mass Spectrometry) for confirming fentanyl concentrations in precision studies and as the comparator method in the method comparison study.
  • This is a highly accurate and precise laboratory method for quantifying drug concentrations, and its results are considered the "ground truth" for chemical concentration data.
• There were "three different operators" for the specific gravity/pH study, but these are not "experts" in the sense of medical professionals establishing a clinical diagnosis ground truth. They are laboratory personnel performing the test.

4. Adjudication Method for the Test Set

• Not Applicable in the traditional sense. Given that the ground truth is established by LC-MS/MS, there is no human "adjudication" process like consensus reading by multiple radiologists for image interpretation. The LC-MS/MS results serve as the definitive reference.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

• No, an MRMC comparative effectiveness study was not done. This type of study (comparing human readers with and without AI assistance on complex interpretation tasks) is not applicable to a qualitative immunoassay and analyzer like the Healgen AccuFluor Fentanyl FIA Test Kit, which determines the presence or absence of a substance based on a fluorescent signal. The device performance is assessed on its analytical accuracy against a gold standard method.

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

• Yes, the performance presented is primarily standalone. The Healgen® Immunofluorescence Analyzer (OG-H180) automatically interprets the fluorescent signal from the test kit. The performance data (precision, specificity, interference, method comparison) directly reflects the analytical capability of the device and test kit combination, without any human interpretation or intervention in the final "positive" or "negative" determination. A human loads the sample and the device performs the analysis and provides the result.

7. The Type of Ground Truth Used

• Analytical Gold Standard (LC-MS/MS): This is the primary method used to establish the true concentration of fentanyl in samples for precision studies and as the comparative reference for clinical samples.
• Spiked Samples: For analytical performance studies (precision, interference, specificity), known concentrations of fentanyl or interfering substances were added to negative urine samples, establishing a controlled ground truth.

8. The Sample Size for the Training Set

• Not explicitly stated in the document, and likely not applicable in the typical AI/ML sense. This device is an immunoassay, not an AI/ML diagnostic algorithm that undergoes a "training" phase with a large dataset. Immunoassays are based on biochemical principles and do not "learn" from data in the same way. Performance is optimized during development and validated analytically.

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

• Not Applicable / Not Described. As it's not an AI/ML device relying on a training set, the concept of establishing ground truth for training does not apply here. The analytical performance is characterized through rigorous testing under controlled conditions and comparison to established reference methods (like LC-MS/MS).

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The IPL Hair Removal Device is an over-the-counter device indicated for the removal of unwanted hair such as but not limited to small areas such as underarm and facial hair below the chin line and large areas such as legs.

The device is also indicated for the permanent reduction in hair regrowth, defined as the long term, stable reduction in the amount of hair regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.

The IPL Hair Removal Device is a personal, light-based, hair reduction device intended to be sold over-the-counter directly to the end user.

The device provides hair reduction using Intense Pulsed Light technology(suitable for model T21A, T21B and T22A, T22B). The device provides hair reduction using Intense Pulsed Light technology and cooling technology (suitable for model T14B, T16B, T19B, T15B, T17C, T18B, T21C, T21D, T25B, T25C).

The Intense Pulsed Light technology works below the skin's surface and does not involve any cutting or pulling, reducing hair growth with minimal pain. The device is only powered by the external power adapter and its IPL emission activation is by finger switch. The device contains a Quartz glass Xenon lamp and a skin sensor to detect appropriate skin contact. If the device is not properly and fully applied to the skin of the treatment area, the device will not emit light pulses; If the device is properly and fully applied to the skin of the treatment area, the device can emit light pulses in as quickly as 0.5 seconds. In automatic mode, it supports continuous flashing and automatic light emission.

In auto-recognition skin color mode, the skin tone sensor can detect and identify the color of skin, and determine the required intensity based on the recognized skin color. Make sure the skin tone sensor is in full contact with the skin. If a valid skin color is detected, the corresponding energy level is displayed. If it is not in full contact with the skin, the energy level is 0 and no light pulses are emitted.

The cooling technology based on the temperature difference electrical phenomenon through the semiconductor cooling chip inside the IPL main device and uses the principle of the Peltier effect to achieve the purpose of cooling function. The cooling panel is located around the light-emitting window (suitable for model T14B, T16B, T19B) and does not affect the irradiated area (spot size) of the light outlet; The cooling panel is constructed with sapphire, (suitable for model T15B, T17C, T18B, T21C, T21D, T25B, T25CB) and does not affect the irradiated area (spot size) of the light outlet.

The device is available in two designs: straight-panel and gun-shaped, both featuring a compact and lightweight form factor. Moreover, The enterprise has reserved an ample quantity of lamp heads to ensure maintenance accessibility and end-user convenience.

The provided FDA 510(k) clearance letter and summary contain information about the IPL Hair Removal Device. However, they do not include any specific details about acceptance criteria or a clinical study proving the device meets those criteria for hair reduction efficacy and safety on human subjects.

The document primarily focuses on technical comparisons to predicate devices and adherence to various electrical, photobiological, and biocompatibility safety standards. It mentions "Performance data supports that the device is safe and as effective as the predicate device for its intended use" (Page 7), but it does not describe what this performance data entails in terms of clinical efficacy trials.

Therefore, I cannot provide a detailed response to your request for acceptance criteria and a study that proves the device meets them, as the necessary information is not present in the provided text.

Specifically, the following information is missing from the provided document:

1. A table of acceptance criteria and the reported device performance for clinical efficacy: The document states the device is indicated for "permanent reduction in hair regrowth," but no quantitative acceptance criteria (e.g., "X% hair reduction in Y% of subjects") or corresponding performance results from a clinical study are provided.
2. Sample size used for the test set and data provenance: No clinical study data involving human subjects is described, so sample size and data provenance are not available.
3. Number of experts used to establish the ground truth and qualifications: This would be relevant for clinical efficacy studies (e.g., expert assessment of hair counts or density). Such information is not present.
4. Adjudication method for the test set: Not applicable as no clinical efficacy study details are provided.
5. MRMC comparative effectiveness study: Not mentioned, as no clinical efficacy study is described.
6. Standalone (algorithm only) performance: Not applicable for a hair removal device, as its performance is inherently human-applied.
7. Type of ground truth used: For hair removal, ground truth would typically be objective measurements of hair count/density or expert photographic assessment. No such details are given.
8. Sample size for the training set: Not applicable, as this device is not an AI/ML algorithm that requires a "training set" in the context of clinical efficacy demonstration.
9. How the ground truth for the training set was established: Not applicable.

The "Performance Data" section (Page 16) only lists compliance with:

• Biocompatibility Testing: ISO 10993 standards for cytotoxicity, irritation, and skin sensitization.
• Electrical Safety and EMC Safety: IEC 60601 series standards.
• Eye Safety: IEC 62471 standard.
• Software Verification and Validation: Stating "all software requirement specifications are met and all software hazards have been mitigated."

These are all technical and safety performance data points, not clinical efficacy data to support the "permanent reduction in hair regrowth" claim. The FDA clearance is based on substantial equivalence, implying that the device's technical specifications and safety profile are similar enough to previously cleared devices, which would have had their own supporting clinical data. However, the details of this device's specific clinical performance data are not included in this summary.

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The Reprocessed HARMONIC 700, 5 mm Diameter Shears with Advanced Hemostasis are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instruments can be used as an adjunct to or substitute for electrosurgery, lasers and steel scalpels in general, pediatric, gynecologic, urologic, thoracic procedures, and sealing and transection of lymphatic vessels. The instruments allow for the coagulation of vessels up to and including 7 mm in diameter, using the Advanced Hemostasis hand control button.

The reprocessed HARMONIC 700 with Advanced Hemostasis are designed for soft tissue incisions requiring bleeding control and minimal thermal injury. The instruments serve as an adjunct to or substitute for electrosurgery, lasers, and steel scalpels in various procedures, including general, pediatric, gynecologic, urologic, and thoracic surgeries, as well as in the sealing and transection of lymphatic vessels. They enable the coagulation of vessels up to 7 mm in diameter using the Advanced Hemostasis hand control button.

The instruments are available in three (3) shaft lengths: 23cm, 36cm, and 45cm lengths (HAR723, HAR736, and HAR745 respectively). Each shaft length has a diameter of 5 mm. The following features are essential to the control and performance of the device:

• An actuating trigger that closes and releases the clamp arm, securing tissue against the scalpel rod.
• MIN/MAX control buttons that adjust energy levels between minimum and maximum modes on the generator, enabling vessel sealing up to 5 mm.
• An Advanced Hemostasis button that allows the clinician to activate an additional energy mode, enabling vessel sealing up to 7 mm.
• A rotation knob to rotate the shaft 360° unless energy is being delivered.
• A torque wrench, a sterile, single-use component, used to apply the correct amount of torque when attaching the Hand Piece to the device.

The instruments connect to a generator and hand piece, which are essential for the device's functionality but are outside the scope of this submission.
The hand piece is a reusable component that attaches to the device and plugs into the generator, allowing the device to interface with the generator. This component contains the transducer, which converts electrical power to ultrasonic mechanical energy.

The generator is a reusable component that generates the electrical signal. Colored light indicators on the front panel of the generator visually communicate device status information to the user.

This document is a 510(k) premarket notification for reprocessed medical devices, not an AI medical device. Therefore, the questions related to AI device performance, such as MRMC studies, training and test sets, ground truth establishment, and expert adjudication, are not applicable to the content provided.

However, I can extract the acceptance criteria and the study that proves the device meets those criteria from the provided text, focusing on the reprocessed medical device context.

Here's the information based on the provided FDA 510(k) letter for the Reprocessed HARMONIC 700 Shears:

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

The document describes functional performance tests conducted to demonstrate safety and effectiveness. While explicit numerical acceptance criteria values are not provided, the general categories of testing imply the criteria for performance equivalence to the predicate device. The reported performance is that the device meets these criteria and is at least as safe and effective as the predicate.

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

• Sample Size: The document does not specify the exact sample sizes (number of devices or tests) for each bench and laboratory test.
• Data Provenance: The studies were conducted as part of the manufacturer's premarket notification submission to the FDA. They are internal validation studies performed by Stryker Sustainability Solutions. The document does not specify country of origin for the data or whether it was retrospective or prospective, but these studies for 510(k) submissions are typically prospective and specifically designed for the submission.
  • For the preclinical laboratory evaluations, an "animal model" was used.

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):

This information is not applicable to traditional reprocessing medical device submissions. Ground truth in this context is established through engineering specifications, material science, and performance testing against established standards and predicate device performance, not expert consensus on medical images or patient outcomes.

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

Not applicable. Adjudication methods like 2+1 or 3+1 refer to human expert review processes for AI model output or image interpretation, which is not relevant for this type of device submission. Device performance is determined through standardized engineering and biological tests.

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 reprocessed surgical instrument, not an AI-assisted diagnostic or therapeutic device. MRMC studies are specific to evaluating human reader performance with and without AI assistance in diagnostic imaging.

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

Not applicable. This is not an AI algorithm. Its performance is inherent to its physical properties and functionality.

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

The "ground truth" for this device's performance is established by:

• Engineering specifications and design requirements: The device must meet predefined physical, mechanical, and electrical parameters.
• Performance of the original (new) predicate device: The reprocessed device must demonstrate substantial equivalence in performance to the original, legally marketed predicate device.
• Established industry standards: Compliance with standards like ISO 10993-1 (Biocompatibility) and ISO 11135 (EO Sterilization) serves as a ground truth for safety aspects.
• Preclinical (animal) studies: In vivo performance (e.g., thermal spread, hemostasis) in animal models serves as a proxy for clinical performance.

8. The sample size for the training set:

Not applicable. There is no "training set" in the context of a reprocessed medical device. The device itself is manufactured and reprocessed, not "trained" like a machine learning model.

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

Not applicable, as there is no training set for this type of device.

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The Duoblade Plus SE (Models: DB1EP, DB1EP-T, DB1EP-H, DB1EP-TH), and Duoblade Prime (Models: DB1P, DB1P-T, DB1P-H, DB1P-TH) are intended for general electrosurgical applications, including cutting and coagulation. These models are designed without shaft extension functionalities. The Model: DB1EP, DB1EP -T, DB1EP-H, DB1EP-TH are compatible with the smoke evacuation system, removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system.

The Electrosurgical Cutting and Coagulation Device and Accessories (Model: Duoblade Plus SE, Duoblade Prime) is a single-use, monopolar RF device designed to be used with a qualified Generator as part of the Surgery System. It uses high-frequency energy (RF Monopolar Energy) to generate heat for tissue cutting and coagulation. It can be operated using the integrated hand switch or a qualified Footswitch. The device's design simplifies functionality by excluding shaft extension features. The models of Duoblade Plus SE and Duoblade Prime are identified according to with/without a suction function (removing smoke), and a swivel function.

• Suction & swivel function (Duoblade Plus SE): DB1EP, DB1EP-T, DB1EP-H, DB1EP-TH
• No Suction & swivel function (Duoblade Prime): DB1P, DB1P-T, DB1P-H, DB1P-TH
  The scope of the submission only includes the addition of model without functions, such as swivel function, shaft extension function and appearance change for marketing purpose.

The provided FDA 510(k) clearance letter and summary are for an electrosurgical device (Duoblade Plus SE, Duoblade Prime), not an AI/software device that would involve a test set, ground truth experts, or MRMC studies. The document primarily focuses on demonstrating substantial equivalence to a predicate device through comparison of features, materials, and established non-clinical tests relevant to electrosurgical devices (e.g., biocompatibility, sterility, electrical safety, thermal effects on tissue).

Therefore, I cannot extract the information required by your prompt regarding acceptance criteria, test set details, ground truth establishment, or human reader effectiveness studies, as these concepts are not applicable to the type of device described in this 510(k) submission.

The document states:

• "No clinical studies were considered for this submission." This directly indicates that there was no human-in-the-loop performance study, nor any evaluation of "how human readers improve with AI vs without AI assistance" because there's no AI component.
• "The thermal effects of a subject device are the same as the predicate device." This highlights that the performance demonstration relies on equivalence to a previously cleared device, not on new independent performance metrics against a defined acceptance criterion of the type you've outlined. The non-clinical test mentioned ("Thermal effects on tissue") is a comparative study against a positive control device, not a test with a specific quantitative acceptance criterion for the new device on its own.

In summary, because this 510(k) submission is for a physical electrosurgical device and not an AI/software product, the requested information about acceptance criteria for AI performance, test sets, ground truth experts, and MRMC studies is not present in the provided text.

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IPL Hair Removal Device is an over-the-counter device intended for removal of unwanted body hair.

The IPL Hair Removal Device is a personal, light-based, hair reduction device intended to be sold over-the-counter directly to the end user. The device provides hair reduction using Intense Pulsed Light (IPL) technology, and it works below the skin's surface and does not involve any cutting or pulling, reducing hair growth with minimal pain. The IPL Hair Removal Device is only powered by the external power adapter and its IPL emission activation is by finger switch. The device contains a Xenon lamp and its built-in skin sensor to detect appropriate skin contact. If the device is not properly and fully applied to the treated skin, the device will not emit the light pulse. There are HCT-1208/HCT-1208B/HCT-1208L 3 models in this application. Their work principle, intended use, structure, appearance，size，and operation are the same, with differences being product function are slight differences, but these parameters are within the predicate device and do not affect or change the intended use of the device.

This document is an FDA 510(k) clearance letter for an IPL Hair Removal Device (HCT-1208/HCT-1208B/HCT-1208L). The request asks to describe the acceptance criteria and the study that proves the device meets those criteria, specifically concerning performance beyond basic safety and electrical testing.

However, the provided 510(k) clearance letter and summary primarily focus on establishing substantial equivalence to predicate devices through comparisons of technical specifications and robust safety testing (biocompatibility, electrical safety, eye safety, and software verification).

There is no detailed information provided in this document regarding a clinical performance study (e.g., patient trials, or studies that measure the actual effectiveness of hair removal) beyond the statement that "Performance data supports that the device is safe and as effective as the predicate device for its intended use." The "Performance Data" section specifically lists only safety and software V&V, not clinical efficacy.

Therefore, I cannot fully complete all sections of your request as the provided text does not contain the specific clinical performance study details you are asking for. The clearance is based on the device being "substantially equivalent" to predicate devices that are already cleared for the specified indications for use, and a demonstration that the new device meets relevant safety standards and its software functions as intended.

Here's what can be extracted and inferred based on the provided document:

Acceptance Criteria and Device Performance (Based on Provided Document)

While the document doesn't detail specific clinical efficacy acceptance criteria for the hair removal function, it does outline acceptance criteria for safety and technical performance, which are crucial for FDA clearance. The "study" proving these are met refers to the various engineering and safety tests performed.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Clinical Performance Test Set: Not applicable / Not specified in this document for a clinical efficacy study. The document focuses on bench testing and safety compliance.
• Safety Testing (Biocompatibility, Electrical, Eye): The "sample size" for these tests would typically refer to the number of devices or material samples tested. This information is not detailed in the provided 510(k) summary (e.g., how many units underwent electrical safety testing).
• Data Provenance: Implied to be from the manufacturer's own testing conducted in China (where the manufacturer is located). The nature of these tests (e.g., bench testing) makes the "retrospective or prospective" classification less applicable than for clinical data.

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

• Not applicable for this type of submission. This 510(k) relies on standardized engineering and safety tests, and establishing "ground truth" for these types of tests is typically based on adherence to the specified international standards (e.g., IEC, ISO) and laboratory procedures, rather than expert consensus on observational data.

4. Adjudication Method for the Test Set

• Not applicable for this type of submission. Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies where expert readers or evaluators independently assess data (e.g., medical images). The tests described here are compliance tests against predefined standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No. An MRMC study is a specific type of clinical study used primarily for medical imaging devices to evaluate human reader performance with and without an AI algorithm. This document describes a physical hair removal device, not an imaging device, and does not mention any clinical comparative effectiveness study, especially not one involving human readers.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Not applicable for this type of device. This device is a direct-use consumer product. While it has "Software Verification and Validation," this refers to the embedded software controlling the device's functions (e.g., light emission, skin sensor), not a standalone diagnostic algorithm whose performance would be measured independently.

7. The Type of Ground Truth Used

• For safety and electrical performance: Ground truth is established by the requirements and methodologies outlined in the referenced international standards (e.g., ISO 10993 for biocompatibility, IEC 60601 series for electrical safety). The device's performance is measured against the specifications and limits defined by these standards.
• For substantial equivalence: The ground truth is the performance and safety data of the legally marketed predicate devices, against which the subject device is compared. The argument is that the subject device's technical characteristics and tested safety performance are "substantially equivalent" to these predicates.

8. The Sample Size for the Training Set

• Not applicable. This document describes the clearance of a physical medical device, not a machine learning or AI model that requires a "training set" of data. The software verification mentioned refers to traditional software testing methodologies.

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

• Not applicable. (See point 8).

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The KALA Therapy Wand (Model: KALA-03) is intended for the treatment of facial wrinkles, and mild to moderate inflammatory acne. The red light is intended for the treatment of wrinkles, and the blue light is intended for the treatment of mild to moderate inflammatory acne.

The KALA Therapy Wand (Model: KALA-03) is indicated for over-the-counter aesthetic use. The red light is intended for the treatment of wrinkles, and the blue light is intended for the treatment of mild to moderate inflammatory acne. The device is vibrating in red light model. The device is powered by a Lithium-Ion rechargeable battery, and it has a charging cable, USB charging stand, protective goggles, storage case and instruction manual.

The wand can be rotated 135 degrees in either direction.

There are two switches of the device: one function is red light to wrinkle removal and vibration for relax, the other function is blue light to treat mild to inflammatory acne.

The device will automatically shut down after 12 minutes of operation. The recommended treatment time is 3 minutes per area. After every three minutes of treatment, the device will vibrate to indicate the time. If you need to continue treatment, simply turn on the device again.

The provided FDA 510(k) clearance letter and summary for the KALA Therapy Wand (Model: KALA-03) primarily focus on demonstrating substantial equivalence to predicate devices through non-clinical testing. This type of clearance generally does not require extensive clinical performance studies with detailed acceptance criteria and human reader studies as would be seen for a new or complex AI/ML-driven diagnostic device.

Based on the provided information, the device is a light-based therapy device for over-the-counter use, intended for aesthetic purposes (facial wrinkles and mild to moderate inflammatory acne). The "study" proving the device meets acceptance criteria is a non-clinical performance testing approach demonstrating compliance with relevant electrical safety, electromagnetic compatibility, photobiological safety, battery safety, and biocompatibility standards. Software verification and validation, and usability validation were also performed.

Here's the breakdown of the information requested, as extractable from the provided document:

Acceptance Criteria and Device Performance

Since this is a non-clinical submission, the "acceptance criteria" are compliance with established safety and performance standards. There isn't a table of statistical performance metrics, but rather successful adherence to defined technical and safety requirements.

Table of Acceptance Criteria and Reported Device Performance (Non-Clinical Compliance)

Study Details (as applicable for a non-clinical submission):

1. Sample sizes used for the test set and the data provenance:

   • Test Set (Device Testing): The "test set" here refers to the device prototypes/units that underwent the non-clinical tests. The document does not specify the number of units tested for electrical safety, EMC, etc., which is typical for such submissions.
   • Data Provenance: The testing was conducted by or for the manufacturer (Shenzhen Kaiyan Medical Equipment Co., Ltd) in China, as indicated by the submitter's information. It's inherently "prospective" in the sense that the tests were performed on the device designed for submission.

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

   • This is a non-clinical submission for a device used for aesthetic purposes. The concept of "ground truth" established by medical experts (like radiologists for image analysis) is not applicable here. The "ground truth" for these tests is defined by the passing criteria of the international standards themselves (e.g., specific thresholds for electrical leakage, EMC emissions, irradiance, etc.). Compliance is assessed by qualified test engineers and labs.

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

   • Not applicable. Adjudication methods are typically used in clinical studies, especially those involving subjective assessments or disagreements among human readers. Non-clinical testing against objective standards does not involve expert adjudication in this manner.

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:

   • No. An MRMC study is not relevant for this type of aesthetic, light-based therapy device where the claim is not for assisting human readers in diagnosis. The clearance is based on safety and functional equivalence.

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

   • Not applicable. This device is not an algorithm for diagnosis or image analysis. It is a physical device providing light therapy. Its "standalone" performance refers to its ability to meet the specified technical parameters and safety standards.

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

   • The "ground truth" for demonstrating substantial equivalence and safety in this context is compliance with recognized international consensus standards (e.g., IEC, ISO). The performance is measured against these technical specifications, not against clinical outcomes or expert consensus on medical conditions.

7. The sample size for the training set:

   • Not applicable. This device does not involve a machine learning algorithm that requires a "training set" in the traditional sense of AI/ML software. The software component, as described, is for controlling device functions ("Basic Documentation Level software"), not for learning from data.

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

   • Not applicable, as there is no training set for an AI/ML algorithm.

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Iconix Speed Anchors are intended to be used for soft-tissue to bone fixation in the shoulder. They are indicated for use in rotator cuff repair.

The Iconix Speed Anchors are soft-tissue to bone fixation devices, provided preloaded on a disposable self-punching inserter. The device is composed of a braided polyester anchor body that contains two or three working sutures. The anchor is inserted into the bone using a self-punching mechanism, and the polyester sheath bunches as the anchor is deployed to allow for fixation in bone.

Sutures supplied meet United States Pharmacopeia (USP) requirements for non-absorbable suture except for diameter. Suture dyes are FDA approved. The inserters are comprised of metallic shaft with over molded handle. The device is sterilized by ethylene oxide gas and is provided sterile for single use. Iconix Speed Anchors are available in common sizes and lengths and will be sold sterile for single use. The device is intended for use in a hospital/clinic/surgical setting.

The classification for the Iconix Anchor is FDA Class II device with product classification 21 CFR §888.3040: Smooth or threaded metallic bone fixation fastener, Product Code MBI.

The provided FDA 510(k) clearance letter and summary for the Iconix Speed Anchor does not describe a study that involves software performance, AI algorithms, or human-in-the-loop assessments. Instead, it describes mechanical and biological performance testing for a physical medical device (bone anchor).

Therefore, I cannot provide details for most of your requested points, as they are specific to AI/software device studies.

However, I can extract the information related to the device's performance testing and acceptance criteria as described in the document.

1. Table of Acceptance Criteria and the Reported Device Performance

The 510(k) summary states that "Results of performance testing for the Iconix Speed Anchor device concluded that the device performed comparably to the predicate device in insertion, cyclic and pullout testing and the validations performed demonstrated that the Iconix Speed Anchor met all requirements for its intended use."

However, the document does not explicitly state specific quantitative acceptance criteria (e.g., "pullout strength > X N") or the exact reported performance values for the Iconix Speed Anchor in these tests. It only states that the device performed "comparably" to the predicate.

The following information cannot be provided as the provided document describes a physical medical device (bone anchor), not an AI/software device study.

2. Sample size used for the test set and the data provenance: Not applicable. The "test set" in this context refers to physical units of the device subjected to mechanical and biological testing, not a dataset for an AI model. The document does not specify the number of samples for each mechanical test.
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 a physical device's mechanical performance is typically established through direct physical measurement under controlled conditions, not expert consensus.
4. Adjudication method: Not applicable.
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.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used: For mechanical tests (insertion, cyclic, pullout), the "ground truth" is the measured physical performance of the device. For biological tests, it's compliance with ISO standards. For usability, it's observation in cadaveric models.
8. The sample size for the training set: Not applicable. The device is a physical product, not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established: Not applicable.

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The Medical Diode Laser Hair Removal Device (PZ-606VI, PZ-BDT68-01, PZ-BDT68-02, PZ-BDT68-03, PZ-BDT68-04) is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI), including tanned skin.

Permanent hair reduction is 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.

The proposed device, Medical Diode Laser Hair Removal Device (PZ-606VI、PZ-BDT68-01、PZ-BDT68-02、PZ-BDT68-03、PZ-BDT68-04), is a surgical device, which is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI);

The device incorporates a diode laser that emits invisible infrared laser radiation centered on a wavelength of 808 nm. According to the selective light absorption theory, the laser can be preferentially absorbed by the melanin in the hair follicle, thus achieving the purpose of permanent hair removal. Permanent hair reduction is 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. Hair growth must remain stable for a certain amount of time and must exceed the entire growth cycle of the hair follicle. Permanent hair removal does not mean that all hair in the treated area is completely lost. Special cooling technology is applied simultaneously during treatment to cool the skin and protect skin.

There are 5 models included, PZ-606VI, PZ-BDT68-01, PZ-BDT68-02, PZ-BDT68-03 and PZ-BDT68-04, the five models have the same intended use, mechanism of action and principle, only the minimum values of energy density and pulse duration are different.

The provided FDA 510(k) clearance letter and synopsis are for a Medical Diode Laser Hair Removal Device. This document is a regulatory submission for a physical medical device, not an AI/software as a medical device (SaMD). Therefore, the information requested in your prompt regarding acceptance criteria and studies for AI/SaMD (e.g., sample size for test/training sets, data provenance, expert adjudication, MRMC studies, standalone performance, ground truth establishment) is not applicable to this device submission.

The document describes the device, its intended use, a comparison to a predicate device, and the non-clinical tests performed to demonstrate substantial equivalence for a hardware device. It explicitly states: "No clinical study is included in this submission."

Therefore, I cannot provide a table of AI acceptance criteria or details about AI-specific studies as requested, because this information is not present in the provided document and is not relevant to the type of device being cleared.

However, I can extract the acceptance criteria and performance information that is relevant to this type of physical device, based on the non-clinical testing mentioned:

Acceptance Criteria and Reported Device Performance (Non-Clinical for a Physical Device)

Regarding the AI/SaMD specific questions from your prompt:

1. Sample size used for the test set and the data provenance: Not applicable. No AI/SaMD test set described.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No AI/SaMD ground truth described.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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: Not applicable.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
7. The sample size for the training set: Not applicable.
8. How the ground truth for the training set was established: Not applicable.

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