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The Red Light Hair Growth Cap is indicated to treat Androgenetic Alopecia and promote hair growth in males who have Norwood-Hamilton Classifications of IIa-V patterns of hair loss and to treat Androgenetic Alopecia and promote hair growth in females who have Ludwig-Savin Scale I-1 to I-4, II-1, II-2 or frontal patterns of hair loss; both with Fitzpatrick Skin Types I-IV.

The Red Light Hair Growth Cap is an over the counter (OTC) home-use, non-invasive device indicated to treat androgenetic alopecia and promote hair growth in males who have Norwood-Hamilton Classifications of IIa-V patterns of hair loss and to treat Androgenetic Alopecia and promote hair growth in females who have Ludwig-Savin Scale I-1 to I-4, II-1, II-2 or frontal patterns of hair loss; both with Fitzpatrick Skin Types I-IV.

The Red Light Hair Growth Cap is a portable, therapeutic device whose purpose is to provide even, cool, narrow-band wavelengths of polychromatic light (660nm red light) produced by LEDs to treat androgenetic alopecia and promote hair grown.

The device comprises of a wearable soft textile cap, a controller, an AC adaptor and a USB cable. The device can be powered by the AC adaptor which connected to the mains directly, also it can be powered by a power bank. The device is operated by the controller. There are 2 buttons on controller, ON/Off button is used to turn on/off the device, time button is used for setting treatment time from 10 to 30 minutes, each press in 5-minute increments./decrements. The device will shut off automatically after reach treatment time.

The provided FDA 510(k) clearance letter and summary for the "Red Light Hair Growth Cap" do not contain the detailed clinical study information typically associated with acceptance criteria, reported device performance for clinical endpoints, sample sizes for test/training sets, expert qualifications, or adjudication methods for AI/software devices. This is because the device, an "Infrared Lamp" (a physical medical device), was cleared based on its substantial equivalence to predicate devices and extensive non-clinical (electrical safety, EMC, software verification/validation) testing, rather than a clinical effectiveness study.

The summary clearly states: "Clinical testing was not needed for this 510(k). The non-clinical performance testing described above is sufficient to support that the device can be used safely and effectively."

Therefore, I cannot directly extract the requested information (points 1-9) in the manner typically expected for an AI/software medical device that undergoes rigorous clinical validation with specific performance metrics against a ground truth.

However, I can describe the acceptance criteria and study type that proves the device meets those criteria based on the provided document:

Acceptance Criteria and Study for the Red Light Hair Growth Cap

The Red Light Hair Growth Cap (LP-RJVGRW-BLK) received FDA 510(k) clearance based on its substantial equivalence to legally marketed predicate devices, combined with comprehensive non-clinical performance testing. The core "acceptance criteria" for this specific submission were centered around safety and effectiveness being comparable to existing devices and meeting established electrical and software safety standards.

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

Since this was a 510(k) based on substantial equivalence and non-clinical testing, the "acceptance criteria" are primarily related to safety standards and comparison to predicate device characteristics. There are no specific clinical performance metrics for "hair growth" reported in this document.

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

• Test Set (Clinical): Not applicable. Clinical testing was explicitly stated as "not needed" for this 510(k). The evaluation relied on non-clinical engineering and software testing.
• Data Provenance: The document does not specify country of origin for any safety testing data, only that the sponsor is Shenzhen Idea Light Limited, China. The testing itself is non-clinical (lab-based engineering/software V&V).

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

• Not applicable. There was no clinical "test set" requiring expert ground truth establishment for clinical endpoints.

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

• Not applicable. There was no clinical "test set" requiring adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not applicable. This device is not an AI/software diagnostic tool; it is a therapeutic device that does not involve human readers interpreting output or AI assistance.

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

• Not applicable. This is a physical therapeutic device, not an algorithm.

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

• For the non-clinical testing, the "ground truth" refers to the established requirements and specifications of the referenced IEC standards (e.g., IEC 60601-1 for electrical safety) and FDA software guidance. Compliance with these standards served as the "ground truth" for safety and performance.
• For substantial equivalence for indications for use, the "ground truth" was the cleared indications for use of the predicate devices.

8. The sample size for the training set

• Not applicable. This device is not an AI/machine learning model and therefore does not have a "training set" in the context of data-driven algorithm development.

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

• Not applicable, as there is no training set.

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The KALA Red Light Face Mask (Model: KALA-01) is an over-the-counter device that is intended to emit energy in the red and near-infrared spectrum and is intended for the use in the treatment of full-face wrinkles.

The KALA Red Light Face Mask (Model: KALA-01) is an over-the-counter device that is intended to emit energy in the blue region of the light spectrum and is intended for the use in the treatment of mild to moderate acne vulgaris of the face.

KALA Red Light Face Mask is a home wearable light-emitting diode phototherapy device with three proven wavelengths of light 630nm Red light, 830nm Near infrared red light and 465nm blue light, all of these lights are known to treat wrinkles and mild to moderate acne vulgaris of the face. Among them, the device emits energy in red and near-infrared spectrum to treat full-face wrinkles, emits energy in the blue region of the light spectrum to treat mild to moderate acne vulgaris of the face.

The system consists of a flexible silicone mask that contains LEDs and a controller. The mask is worn on the face and is held in place by Head Straps. The mask compromises of 2 surfaces. An inner surface that contacts the skin and an outer surface. Both surfaces are constructed of silicone.

The controller contains a rechargeable Lithium battery, the power supply (adaptor) is used to charge the Lithium battery and be connected to a suitable mains outlet via a 2 or 3 pin input socket and wall plug. The KALA Red Light Face Mask cannot be operated while charging. The controller switches the LEDs ON/OFF and controls power to the mask. Switch the controller ON and allow the mask to run for Red + NIR or Blue modes and 10- or 20-minutes treatment time program. The cable for connecting with the controller is detachable.

The device is not used to make measurements of any sort, or to draw any conclusions regarding the indication to treat. The device does not require checks on the light output as the LEDs do not dim with age to any practical extent.

The provided FDA 510(k) clearance letter and summary for the KALA Red Light Face Mask (KALA-01) primarily focus on non-clinical performance testing and substantial equivalence to predicate devices, rather than a detailed study demonstrating the device meets clinical acceptance criteria.

The document states, "Clinical testing was not needed for this 510(k). The non-clinical performance testing described above is sufficient to support that the device can be used safely and effectively." This indicates that the regulatory clearance was based on demonstrating the device's technical performance, safety, and similarity to already approved devices, rather than a clinical trial with specific acceptance criteria related to efficacy (e.g., wrinkle reduction or acne treatment efficacy percentages).

Therefore, the following information will be based on the provided non-clinical performance testing and will highlight the absence of clinical study data as explicitly stated in the document.

Acceptance Criteria and Device Performance (Non-Clinical)

Since no clinical study focusing on efficacy endpoints (like wrinkle reduction percentage or acne lesion count reduction) was presented as part of the 510(k) summary, the acceptance criteria and performance reported here are for the non-clinical performance tests conducted to ensure the device's safety and fundamental operational characteristics.

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

Study Details (Based on Non-Clinical Testing)

As explicitly stated in the 510(k) summary, no clinical testing was performed or required for this clearance. The "study" here refers to the collection of non-clinical tests performed to demonstrate safety and technical performance.

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

• Sample Size: The document does not specify a "sample size" in the context of a patient cohort. For the non-clinical tests, it would typically refer to a statistically relevant number of devices or components tested. This information is not provided in detail, but it's understood that typical engineering and safety tests involve a representative sample of manufactured units or materials.
• Data Provenance: The tests were conducted in a lab setting, likely by the manufacturer or accredited testing facilities. The country of origin for the data (tests) is not explicitly stated beyond the manufacturer being in Shenzhen, China. The nature of these tests is prospective in the sense that they are planned tests on the device or its components to demonstrate compliance with standards.

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

• This concept is not applicable to the non-clinical performance and safety tests described. These tests involve objective measurements against established engineering and safety standards (e.g., electrical safety, optical power, material biocompatibility). "Ground truth" in this context is the standard itself (e.g., IEC 60601-1 requirements).
• For biocompatibility, the equivalence relies on the materials being identical to those of a previously cleared device (K202390), implicitly accepting that the ground truth for those materials' biocompatibility was established in the prior clearance.

4. Adjudication Method for the Test Set:

• None in the sense of clinical adjudication by multiple human experts. The compliance for non-clinical tests is determined by adherence to predefined, objective criteria outlined in the relevant international standards (e.g., IEC, ISO). Test reports are typically reviewed by regulatory bodies like the FDA.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

• No. An MRMC study is relevant for evaluating the performance of diagnostic devices or AI systems where human readers interpret medical images or data. This device is a therapeutic light-emitting mask, and no such study was conducted or presented for its 510(k) clearance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was done:

• Not applicable. This device does not involve a diagnostic algorithm or AI for interpretation that would necessitate a "standalone" or "human-in-the-loop" performance evaluation. Its performance is based on its physical emission characteristics and safety features.

7. The Type of Ground Truth Used:

• For the non-clinical tests, the "ground truth" is defined by international safety and performance standards (e.g., IEC 60601 series, IEC 62471, ISO 10993 series) and the specified technical requirements for the device (e.g., power density, leakage current limits).
• For biocompatibility, the ground truth is established by the prior clearance (K202390), based on the assumption that the identical materials have already demonstrated acceptable biocompatibility.

8. The Sample Size for the Training Set:

• Not applicable. The provided documentation does not describe any training set, as it does not involve machine learning or AI models that require specific training data.

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

• Not applicable, as there was no training set.

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FertiCult™ Flushing medium are intended for in vitro procedures involving human gametes (sperm and oocytes), including washing of gametes, sperm swim-up procedures, intra-uterine insemination (IUI) of the spermatozoa and sperm injection during intracytoplasmic sperm injection (ICSI). FertiCult™ Flushing medium can also be used human embryo washing and holding, and for embryo transfer (ET) in the uterine cavity. The medium is NOT intended for oocyte pick-up and follicle flushing. FertiCult Flushing medium is used during assisted reproductive Technology (ART) procedures of patients and couples undergoing infertility treatments.

FertiCult Flushing medium and FertiCult Flushing medium with phenol red and gentamicin intended for in vitro procedures involving human gametes (sperm and oocytes), including washing of gametes, sperm swim-up procedures, intra-uterine insemination (IUI) of the spermatozoa and sperm injection during intracytoplasmic sperm injection (ICSI). FertiCult Flushing media can also be used for human embryo washing and holding, and for embryo transfer (ET) in the uterine cavity.

The base formulation contains Water, Sodium Chloride, Potassium Chloride, Calcium Chloride Dihydrate, Magnesium Sulphate Heptahydrate, Sodium Dihydrogen Phosphate Dihydrate, Sodium Pyruvate, Glucose Monohydrate, Sodium Lactate, Sodium hydrogen carbonate, HEPES, Human Serum Albumin.

A FertiCult Flushing media variant contains Phenol red and Gentamicin.

The products can be used up to 7 days after opening, when sterile conditions are maintained, and the products are stored at 2-8°C.

The provided FDA 510(k) clearance letter pertains to the FertiCult Flushing medium and FertiCult Flushing medium with phenol red and gentamicin. This document demonstrates the substantial equivalence of the new device to a predicate device, as required for FDA clearance.

Here's an analysis of the acceptance criteria and the studies performed, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria listed are primarily for the physical, chemical, and biological properties of the media, ensuring its quality and suitability for use in Assisted Reproductive Technology (ART) procedures.

• Historically accepted biological performance indicators: Mouse Embryo Assay (MEA) results (development to expanded blastocyst), as specified by the 2021 FDA guidance.
• Observed physical and chemical characteristics: Absence of precipitates.

These are objective, quantifiable, or universally accepted biological endpoints, rather than expert consensus on a subjective interpretation.

8. The Sample Size for the Training Set

Not applicable. This device is a culture medium, not an AI/ML algorithm that requires a training set. The performance testing described validates the manufacturing quality and biological compatibility of the product.

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

Not applicable, as this is not an AI/ML device requiring a training set.

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Penumbra Reperfusion Catheters and Separators

As part of the Penumbra System, the Reperfusion Catheters and Separators are indicated for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral – M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset. Patients who are ineligible for thrombolytic drug therapy or who failed thrombolytic drug therapy are candidates for treatment.

Penumbra 3D Revascularization Device

As part of the Penumbra System, the Penumbra 3D Revascularization Device is indicated for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral - M1 and M2 segments) within 8 hours of symptom onset. Patients who are ineligible for thrombolytic drug therapy or who failed thrombolytic drug therapy are candidates for treatment.

Penumbra Aspiration Tubing

As part of the Penumbra System, the Penumbra Sterile Aspiration Tubing is indicated to connect the Penumbra Reperfusion Catheters to the Penumbra Aspiration Pump.

Penumbra Aspiration Pump

The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems.

The Penumbra System is comprised of the following devices:

• Penumbra Reperfusion Catheter
• . Penumbra 3D Revascularization Device
• Penumbra Aspiration Pump
• . Penumbra Aspiration Pump Canister/Tubing
• Penumbra Aspiration Tubing
• Penumbra Separator .

The Penumbra System is designed to remove thrombus and restore blood flow in the neurovasculature using aspiration. The Reperfusion Catheter delivers aspiration from the pump directly to the site of occlusion to remove the clot. The 3D Revascularization Device is used with Reperfusion Catheters to facilitate aspiration and removal of the thrombus when needed. Alternatively, a Separator may be used to clear the lumen of the Reperfusion Catheter should it become blocked with thrombus. The Reperfusion Catheter is introduced through a guide catheter or long femoral sheath and into the intracranial vasculature and guided over a neurovascular guidewire to the site of the primary occlusion. The Penumbra Reperfusion Catheter is used with the Penumbra Aspiration Pump to aspirate thrombus from an occluded vessel. The Penumbra Reperfusion Catheter is connected to the Penumbra Aspiration Pump using the Penumbra Aspiration Tubing and the Penumbra Aspiration Pump Canister. The Penumbra Reperfusion Catheter is provided with a steam shaping mandrel, rotating hemostasis valve (RHV), peelable sheath, and optionally, SENDit Technology (cleared under K191946). The Penumbra 3D Revascularization Device is provided with an introducer sheath. The Penumbra Separator is provided with an introducer and torque device. The devices are visible under fluoroscopy.

The provided text describes specific acceptance criteria and performance data for the Penumbra System (Reperfusion Catheter RED 72). However, it notes that no animal or clinical studies were conducted for this particular device submission (K242104). The evidence for meeting acceptance criteria comes solely from bench and biocompatibility testing. Therefore, information regarding sample sizes for test sets, data provenance, number and qualifications of experts, adjudication methods, MRMC studies, standalone performance, and training set details, which are typically associated with clinical or AI/algorithm performance studies, are not applicable or available in this document.

Here's a summary of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance: Not applicable. The document states that "No animal or clinical study was conducted as bench and biocompatibility testing were determined sufficient for verification and validation purposes." The tests listed are primarily bench (in-vitro) tests on manufactured units or material samples. The specific number of units or samples tested for each bench test is not provided in this summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The "ground truth" for these engineering and biocompatibility tests is based on established scientific principles, industry standards, and specified material properties, not expert consensus on medical images or diagnoses.

4. Adjudication method for the test set: Not applicable. Adjudication methods are typically employed in clinical studies or studies involving human assessment of data, which were not performed in this case.

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: No MRMC study was performed as this device is a physical medical device (catheter system) and not an AI-powered diagnostic or assistive tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used:
* Bench Testing: Engineering specifications, material properties, and functionality performance standards.
* Biocompatibility Testing: Established biological safety standards (ISO 10993 series, USP standards, 21 CFR Part 58 GLP).

8. The sample size for the training set: Not applicable. This is a physical medical device, not an algorithm that requires a training set.

9. How the ground truth for the training set was established: Not applicable.

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RED is used to evaluate the neuromuscular function of the patient's ability to expel its contents from the rectum and as a qualitative test for rectal hypersensitivity. RED helps identify patients with rectal hypersensitivity who experience desire or urge-to-defecate at lower volumes of distension. RED is intended to be used in a clinical setting by trained health care providers in adult populations.

RED has been designed to duplicate test performance of traditional balloon expulsion test (BET) and manual sensation testing devices without needing electronics or software. The RED catheter consists of an open-cell foam ball encased inside of a balloon, coupled to a hollow catheter. The insertion end of the device has a rounded tip for comfortable insertion through the anus. Once inserted and opened, the catheter normalizes to atmospheric pressure which allows the foam to passively and safely expand to its original size. The volume of air it displaces when inflated in room air is 52ml. This passive expansion provides the same function as filling an empty balloon with water or air. When expanded, the volume of material inside the patient's rectum is perceived by the patient similar to how patients perceive stool, and this may trigger the desire to defecate. This is measured by asking patients the questions on perceived desire to defecate according to the London Classification that define the evaluation of rectal sensation. After the sensation evaluation, while in the seated or left lateral decubitus position, the patient is instructed to attempt to expel the device in a set amount of time. If the patient is unable to expel the device, the practitioner may gently remove the balloon manually.

The acceptance criteria and study proving the device meets these criteria are described below:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: 60 adults
• Data Provenance: Prospective clinical trial. The country of origin is not explicitly stated in the provided text.

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

The document does not explicitly state the number of experts or their qualifications used to establish the ground truth for the clinical trial. However, it mentions that patients with functional constipation were "defined by Rome IV criteria," which are internationally recognized diagnostic criteria established by experts in gastroenterology. The evaluation for rectified hypersensitivity also involved "querying on the patient perception to defecate," suggesting reliance on patient self-report interpreted within clinical guidelines.

4. Adjudication method for the test set:

The document does not explicitly describe an adjudication method (e.g., 2+1, 3+1). The "ground truth" for functional constipation was based on Rome IV criteria, and rectal hypersensitivity was determined by patient perception to defecate when the RED device was distended. This suggests reliance on established diagnostic criteria and patient report rather than an expert adjudication process for image or data interpretation.

5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance:

A multi-reader, multi-case (MRMC) comparative effectiveness study was not conducted. The RED device is described as operating without electronics or software, and is not an AI-assisted device. The study focused on the device's standalone performance and its comparison to traditional methods in terms of accessibility and ease of use.

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

Yes, a standalone performance study was done for the device in the context of its intended use. The RED device itself is a mechanical device, and its "standalone performance" refers to its ability to perform the balloon expulsion test and facilitate the qualitative assessment of rectal hypersensitivity as described, without additional electronic or software components. The clinical trial evaluated its performance in these applications.

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

• For functional constipation: Expert consensus-based diagnostic criteria (Rome IV criteria).
• For rectal hypersensitivity: Primarily patient perception/self-report regarding the desire or urge-to-defecate at lower volumes of distension, interpreted qualitatively.

8. The sample size for the training set:

The provided text describes a clinical trial for performance evaluation, not a machine learning model, therefore, there is no "training set" in the context of an algorithm.

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

As there is no machine learning model or training set, this question is not applicable.

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The HIGHERDOSE Red Light Hat is a home wearable light-emitting diode phototherapy device with proven wavelengths of light 650nm±10nm Red light, which are used to treat Androgenetic Alopecia and promote hair growth in males who have Norwood- Hamilton Classfications of Ila - V patterns of hair loss and to treat Androgenetic Alopecia and promote hair growth in females who have Ludwig-Savin Scale 1-1 to 1-4, 11-1, 11-2 or frontal patterns of hair loss; both with Fitzpatrick Skin Types 1 - 1V.

The HIGHERDOSE Red Light Hat is a home wearable light-emitting diode phototherapy device with proven wavelengths of light 650nm±10nm Red light, which are used to treat Androgenetic Alopecia and promote hair growth in males who have Nowood- Hamilton Classifications of Ila - V patterns of hair loss and to treat Androgenetic Alopecia and promote hair growth in females who have Ludwig-Savin Scale I-1 to I-4, II-1, II-2 or frontal patterns of hair loss; both with Fitzpatrick Skin Types I - IV.

The device is designed as wearable product, and it consists of the main unit, the controller and a power cable, as well as it is powered by the built-in rechargeable lithium battery.

The hat compromises of 2 surfaces. An inner surface that contacts the skin and an outer surface. Both surfaces are constructed of cotton.

The controller contains a rechargeable Lithium battery, the power supply (adaptor) is used to charge the Lithium battery and is connected to a suitable mains outlet via a 2 or 3 pin input socket and wall plug. The HIGHERDOSE Red Light Hat cannot be operated while charging. The controller switches the LEDs ON/OFF. Switch the controller ON and allow the hat to run for 10 minutes treatment program. The cable for connecting with the controller is detachable.

The device is not used to make measurements of any sort, or to draw any conclusions regarding the indication to treat. The device does not require checks on the light output as the LEDs do not dim with age to any practical extent.

The provided text describes a 510(k) submission for the HIGHERDOSE Red Light Hat (HG-120K), seeking substantial equivalence to predicate devices for treating Androgenetic Alopecia and promoting hair growth.

However, the documentation does not contain information regarding a clinical study with acceptance criteria and reported device performance related to hair growth outcomes. Instead, it focuses on non-clinical performance testing (electrical safety, EMC, usability, software verification, and biocompatibility) to demonstrate safety and effectiveness for a device marketed as an Over-The-Counter Infrared Lamp.

The document explicitly states: "Clinical testing was not needed for this 510(k). The non-clinical performance testing described above is sufficient to support that the device can be used safely and effectively." This means that the FDA's clearance for this device was based on a comparison to predicate devices and engineering/safety tests, not on new clinical data demonstrating its efficacy in hair growth.

Therefore, it is not possible to extract the requested information from the provided text regarding:

1. A table of acceptance criteria and reported device performance for hair growth.
2. Sample size and data provenance for a test set proving hair growth efficacy.
3. Number and qualifications of experts for ground truth establishment for hair growth.
4. Adjudication method for a hair growth test set.
5. MRMC comparative effectiveness study for human readers with and without AI assistance for hair growth.
6. Standalone performance of an algorithm without human-in-the-loop for hair growth.
7. Type of ground truth used for a hair growth study.
8. Sample size for a training set (as no AI algorithm for diagnosis/prognosis is implied).
9. How ground truth for a training set was established.

The document primarily addresses the substantial equivalence requirements by comparing the technical specifications and intended use of the HIGHERDOSE Red Light Hat with previously cleared infrared lamp devices, and by demonstrating compliance with relevant electrical and safety standards.

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The ACUSON Redwood ultrasound imaging system is intended to provide images of, or signals from, inside the body by an appropriately trained healthcare professional in a clinical setting for the following applications: Fetal, Abdominal, Pediatric, Small Parts, OB/GYN (useful for visualization of the ovaries, follicles, uterus, and other pelvic structures), Adult, Pediatric and Neonatal Cardiac, Pelvic, Neonatal Cephalic, Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, Transcranial, and Peripheral Vascular.

The system supports the Ultrasound-Derived Fat Fraction (UDFF) measurement tool to report an index that can be useful as an aid to a physician managing adult patients with hepatic steatosis.

The system also provides the ability to measure anatomical structures: fetal, abdominal, pediatric, small organ, neonatal cephalic, adult cephalic, cardiac (adult, pediatric and neonatal), transesophageal, transrectal, transvaginal, peripheral vessel, musculoskeletal (conventional), musculoskeletal (superficial), and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.

The ACUSON Redwood Diagnostic Ultrasound System is multi-purpose, mobile, softwarecontrolled, diagnostic ultrasound system with an on-screen display for thermal and mechanical indices related to potential bio-effect mechanisms. Its function is to acquire harmonic ultrasound echo data and display it in B-Mode, M-Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Color M mode, Doppler Tissue Image mode, Amplitude Doppler Mode, Combination modes, Harmonic Imaging and 3D Imaging modes, and 4D imaging modes on a flat panel display for diagnostic ultrasound imaging.

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:

Preamble: The provided document is a 510(k) summary for the ACUSON Redwood Diagnostic Ultrasound System. The core of the study described focuses on the new "Ultrasound-Derived Fat Fraction (UDFF)" feature. The general diagnostic ultrasound system itself is noted to use "the same technology and principles as existing predicate devices" and therefore "clinical studies were not required to support substantial equivalence" for its broader functionality. The following information pertains specifically to the UDFF feature.

Acceptance Criteria and Device Performance (UDFF Feature)

Further Study Details for UDFF Feature:

1. Sample Sizes Used for the Test Set and Data Provenance:

   • Study 1: N = 30 subjects
     • Ethnicity/Country: 15 from USA, 15 from Korea
     • Sex: 15 Male, 15 Female
     • Retrospective or Prospective: Not explicitly stated, but the description of "To verify the clinical reliability...To record the UDFF measurement acquisition time" suggests it was a prospective data collection for this study.
   • Study 2: N = 28 subjects
     • Ethnicity/Country: 28 from Korea
     • Sex: 20 Male, 8 Female
     • Retrospective or Prospective: Not explicitly stated, but given the objective "To verify that UDFF of ACUSON Redwood shows good agreement with MRI-PDFF" and "To verify the clinical accuracy...", it implies prospective data collection where both UDFF and MRI-PDFF were acquired for correlation.

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

   • Study 1: This study primarily focused on comparing the ACUSON Redwood UDFF to the ACUSON Sequoia UDFF and internal consistency (test-retest reliability). Ground truth, in the sense of a definitive diagnostic outcome, was not the primary endpoint that would require expert adjudication. The "ground truth" here is the measurement from the established predicate device (ACUSON Sequoia UDFF) and the consistency of the Redwood's own measurements.
   • Study 2: The ground truth for this study was MRI-PDFF (Magnetic Resonance Imaging Proton Density Fat Fraction). This MRI-PDFF is considered a quantitative reference standard for liver fat quantification. The document does not specify the number of human readers/experts directly involved in establishing the MRI-PDFF values for the study, as MRI-PDFF is typically an objective, quantitative measurement derived from MRI sequences and software, rather than a subjective expert read needing adjudication.

3. Adjudication Method for the Test Set:

   • Not applicable as the ground truths (predicate device measurements and MRI-PDFF) are presented as objective measurements and not subjective expert interpretations requiring adjudication.

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 comparative effectiveness study involving human readers and AI assistance was not mentioned or performed for the UDFF feature as described. The UDFF is a standalone software tool for measurement.

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

   • Yes, the studies evaluate the performance of the UDFF software tool itself in its ability to quantify fat fraction, either compared to a predicate device's software tool (Study 1) or to MRI-PDFF as a reference standard (Study 2). The results (Pearson Correlation, ICC, bland-Altman, AUROC) are metrics of the algorithm's performance.

6. The type of ground truth used:

   • Study 1: The ground truth was the Ultrasound-Derived Fat Fraction (UDFF) measurement obtained from the predicate device (ACUSON Sequoia), and the internal consistency of the ACUSON Redwood UDFF measurements (test-retest).
   • Study 2: The ground truth was MRI-PDFF (Magnetic Resonance Imaging Proton Density Fat Fraction), which is a quantitative imaging biomarker considered a non-invasive gold standard for liver fat content.

7. The sample size for the training set:

   • The document does not provide information regarding the sample size of any training set used for the UDFF algorithm. This section focuses on validation studies.

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

   • The document does not provide information regarding how the ground truth for any potential training set was established.

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Denture Base Resin is a light-curable resin indicated for the fabrication of:
•individual and fixed permanent full single crowns, permanent partial crowns in front and posterior area
•denture bases
Denture Base Resin is intended exclusively for professional dental work.

The Denture Base Resin is an alternative to traditional heat cured and auto polymerization resins. The resins are available in two (2) different colors ( white, red). Denture Base Resin can be used with PioNext D Series. PioNext D Series printers include a 3D printing system that utilizes Digital Light Process (DLP) technology, with automatic feeding process, and a UV LED (405nm) curing process. The dental appliance is then cured in the PioNext UV-02 curing chamber and sent back to the dentist for try-in and final adjustment.

I'm sorry, but this document does not contain the information required to answer your request. The provided text is a 510(k) premarket notification letter from the FDA regarding a "Denture Base Resin" device.

It does not provide details about acceptance criteria or a study proving that an AI/software-based device meets these acceptance criteria. Instead, it focuses on dental resin material properties and non-clinical performance tests, not AI or software performance.

Therefore, I cannot provide:

• A table of acceptance criteria and reported device performance for an AI/software.
• Sample sizes used for test sets or data provenance for AI/software.
• Number of experts or their qualifications for establishing ground truth for AI/software.
• Adjudication methods for AI/software test sets.
• Information about MRMC comparative effectiveness studies or effect sizes for AI assistance.
• Standalone performance of an AI algorithm.
• Type of ground truth for an AI/software.
• Sample size for training sets for an AI/software.
• How ground truth was established for training sets for an AI/software.

The document discusses "Denture Base Resin" and its properties, and confirms its substantial equivalence to predicate devices based on non-clinical performance tests related to dimensional stability, color stability, translucency, flexural strength, freedom from porosity, and water solubility. There is no mention of AI, machine learning, or software performance evaluation in this context.

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The HIGHERDOSE Red And Infrared Light Mask (Model: MK66-L) is an over the counter device that is intended for the use in the treatment of full-face wrinkles.

The HigherDose Red and Infrared Light Mask is a home wearable light-emitting diode phototherapy device with two proven wavelengths of light 630nm and 830nm(near infrared light ) for treatment of fullface wrinkles,

The face mask combine Red (630nm)and near infrared light (830nm).Harnessed at the perfect measurement to rejuvenate the skin, these two wavelengths work below the skin's surface to stimulate the natural rejuvenation process ,creating a complexion that is visibly growing and noticeably healthier looking.

The mask is worn on the face and is held in place by head straps , The mask compromises of 2 surfaces. An inner surface that contacts the skin and an outer surfaces are constructed of silicone.

The controller contains a rechargeable Lithium battery, the power supply (adaptor) is used to charge the Lithium battery and is connected to a suitable mains outlet via a 2 or 3 pin input socket and wall plug. The HIGHERDOSE Red And Infrared Light Mask cannot be operated while charging.

The device is not used to make measurements of any sort, or to draw any conclusions regarding the indication to treat. The device does not require checks on the light output as the LEDs do not dim with age to any practical extent.

The provided document is a 510(k) premarket notification for a medical device (HIGHERDOSE Red and Infrared Light Mask). It primarily focuses on demonstrating substantial equivalence to already marketed predicate devices, rather than presenting a detailed clinical study for novel performance claims.

Therefore, the information required to fully answer your request regarding acceptance criteria and performance studies for an AI/software-based device, particularly those concerning human-in-the-loop performance, expert ground truth, and training data provenance, is not present in this document.

However, I can extract the information provided about the non-clinical performance testing of this light therapy mask, which is a hardware device with some embedded software for control (e.g., timer).

Here's a breakdown of what can be inferred and what is explicitly stated:

Device: HIGHERDOSE Red and Infrared Light Mask (MK66-L)

Indications for Use: The HIGHERDOSE Red And Infrared Light Mask (Model: MK66-L) is an over the counter device that is intended for the use in the treatment of full-face wrinkles.

Non-Clinical Performance Testing (Hardware and Embedded Software)

The document lists several non-clinical performance tests conducted, relevant to the safety and fundamental operation of the device, rather than its clinical efficacy in treating wrinkles which is established by substantial equivalence to predicates.

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

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

• Sample Size: "The test sample is the final, finished product." For each test, it implies at least one production unit was tested. The specific number of units is not stated, but typically for these types of tests, a small representative sample or even a single unit is sufficient to demonstrate compliance with standards.
• Data Provenance: Not specified, but generally, these tests are conducted by accredited labs. The manufacturer is based in Shenzhen, Guangdong, China. These are typically lab bench tests, not involving human subjects or real-world data collection in the sense of a clinical trial.

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 and not provided. These are engineering/safety/performance tests against established international standards, not diagnostic device studies requiring medical expert ground truth.

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

• Not applicable. These are objective engineering tests with pass/fail criteria based on standards.

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

• No MRMC or comparative effectiveness study was conducted or reported. This device is a direct-to-consumer light therapy mask, not an AI-assisted diagnostic tool.

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

• Not applicable in the context of an AI algorithm. The device has embedded software for basic control (like a timer), and "Software verification and validation testing" was conducted for this embedded software, considered a "moderate" level concern. However, this is not a standalone AI algorithm being evaluated for diagnostic or interpretive performance.

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

• For the non-clinical tests, the "ground truth" is adherence to the specified international safety and performance standards (e.g., IEC 60601-1, IEC 62471), determined through objective measurements and validated test methodologies.

8. The sample size for the training set

• Not applicable. This is not an AI/ML device that requires a "training set." The embedded software is deterministic and not trained on data.

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

• Not applicable, as there is no training set mentioned for this product.

Summary regarding AI/Software-based device criteria:

The provided document is not for a device that fits the typical "AI/software-based device" criteria you've outlined (e.g., requiring MRMC studies, expert ground truth for image interpretation, or large training datasets). This 510(k) is for a hardware device (a light therapy mask) with embedded software for basic functionality (like a timer). The review focuses on demonstrating safety, fundamental performance, and substantial equivalence to existing predicate devices based on non-clinical engineering and safety standards. No clinical efficacy study data is presented, as it was deemed "not needed for this 510(k)" due to the substantial equivalence pathway.

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The REDEMPTION™ Charcot Plating System bone plates and screws are indicated for use in bone fractures, osteotomies, and fixation of bones and bone fragments in the upper and lower extremities, primarily of the hand, wrist, foot, and digits. Specific examples include: medial column fusion (talus, navicular, cuboid, first metatarsal) for patients with osteopenic bone in neuropathic osteoarthropathy (Charcot).

The REDEMPTION™ Charcot Plating System contains bone plates, screws, and accompanying instruments to aid in the surgical procedures. The system is a multi-indication reconstruction solution providing polyaxial locking technology and low-profile design. The system is optimized for use in osteopenic bone, such as those of neuropathic osteoarthropathy (Charcot) patients.

The system contains poly-axial locking and non-locking 4.0mm and 5.5mm diameter screws with threads optimized for osteopenic bone purchase.

All implant components are manufactured from titanium (Ti-6AI-4V, ASTM F136).

Specific instrumentation including wires, drills, torx drivers, and drill guides are required for use with the system. The REDEMPTION™ instruments are manufactured from stainless steel, with a few Aluminum and Silicone components.

I am sorry, but the provided text from the FDA 510(k) K233816 document for the "REDEMPTION™ Charcot Plating System" does not contain any information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the context of an AI/ML medical device.

The document describes a traditional 510(k) submission for a metallic bone fixation system (plates and screws), not an AI/ML-driven diagnostic or therapeutic device. The "Performance Data" section details mechanical and material testing for the bone fixation system, such as:

• Static four-point bend testing per ASTM F382-17
• Screw Torsional Properties per ASTM F543-17 A1
• Screw Insertion and Removal Torque per ASTM F543-17 A2
• Screw Pullout Testing per ASTM F543-17 A3
• Cleaning and sterilization validations

These tests are standard for orthopedic implants to demonstrate structural integrity, and biocompatibility, and ensure the device can be properly cleaned and sterilized.

Therefore, I cannot provide the requested information regarding:

1. A table of acceptance criteria and reported device performance for an AI/ML device.
2. Sample size, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, or ground truth types, as these are concepts applicable to AI/ML software validation, not the mechanical testing of orthopedic hardware described in this document.

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