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EGENS Pregnancy Test Midstream I is intended for the qualitative detection of human chorionic gonadotropin (hCG) in urine, as an aid in early detection of pregnancy, in some cases as early as five (5) days before the expected period, i.e., as early as six (6) days before the day of the missed period.

EGENS Pregnancy Test Midstream II is intended for the qualitative detection of human chorionic gonadotropin (hCG) in urine, as an aid in early detection of pregnancy, in some cases as early as five (5) days before the expected period, i.e., as early as six (6) days before the day of the missed period.

EGENS Pregnancy Test Midstream I and EGENS Pregnancy Test Midstream II are used for in vitro qualitative detection of Human Chorionic Gonadotropin (HCG) in human urine, and are designed to be tested in dip or midstream mode. The test device consists of a single test strip assembled in a plastic housing, with an absorbent tip. The only difference between EGENS Pregnancy Test Midstream I and EGENS Pregnancy Test Midstream II is the plastic casing. The device is in a ready-to-use format.

Here's an analysis of the acceptance criteria and study details for the EGENS Pregnancy Test Midstream I and II, based on the provided text:

EGENS Pregnancy Test Midstream I and II: Acceptance Criteria and Supporting Study

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal "acceptance criteria" with numerical thresholds for performance metrics. Instead, it demonstrates the device's analytical and clinical performance through various studies. The key performance characteristics are compared against the predicate device and established expectations for pregnancy tests.

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

• Analytical Performance (Precision/Sensitivity):
  • Sample Size: For each hCG concentration (0, 2.5, 5, 6.5, 8, 9, 10, 15, 25, 50 mIU/mL), 5 replicates were tested per day for 5 days for each of 3 device lots. This totals 5 (replicates) * 5 (days) * 3 (lots) = 75 tests per hCG concentration. With 10 concentrations, this is 750 tests per device type (Midstream I or II). The combined data for both dip and midstream methods suggests 150 total results per concentration from the 3 lots (50 per lot).
  • Data Provenance: Negative female urine spiked with WHO-traceable hCG standard. This is laboratory-controlled, prospective data. The country of origin of the urine samples is not explicitly stated but presumably from the manufacturer's location or a related lab.
• Hook Effect Test:
  • Sample Size: Not explicitly stated, but negative urine samples were spiked with 7 varying hCG concentrations. "All tested concentrations gave a positive result." This implies each concentration was tested at least once, and likely in replicates to confirm.
  • Data Provenance: Laboratory-controlled, prospective data using spiked negative urine samples.
• Specificity and Cross-Reactivity:
  • Specificity (Non-pregnant females): 300 urine samples.
  • Cross-Reactivity (hLH, hFSH, hTSH, hCG ß-core fragment): 30 replicates per test (negative and positive urine samples spiked with cross-reactants) using three device lots. This means 30 * 3 = 90 tests per cross-reactant condition.
  • Data Provenance: Prospective collection of urine samples and laboratory-controlled spiking for cross-reactivity. The "300 urine samples" for specificity were "collected from healthy, nonpregnant female in pre-menopausal (ages 1840 years old), peri-menopausal (4155 years old) and post-menopausal (>55 years old) groups. 100 people for each age group."
• Interfering Substance Study:
  • Sample Size: Urine samples containing 0, 5, and 10 mIU/mL hCG were spiked with "the interfering substance to obtain the certain desired test concentration." The number of replicates is not specified for each substance, but implies testing was sufficient to determine no effect.
  • Data Provenance: Laboratory-controlled, prospective data using spiked urine samples.
• Method Comparison Study (with Predicate Device):
  • Sample Size:
    • 206 urine samples initially: 100 for Midstream I, 106 for Midstream II.
    • Additional 100 urine samples tested by both Midstream I and Midstream II, and both in-stream and dip methods, yielding 200 results for each device.
    • Total urine samples used for method comparison involving "real" samples: 206 + 100 = 306 unique samples.
  • Data Provenance: Prospective collection of urine samples from women presenting to test for pregnancy. This represents clinical, prospective data.
• Lay Person Study:
  • Sample Size (Clinical Samples): 306 women's individual urine samples. 200 for Midstream I, 106 for Midstream II.
  • Sample Size (Spiked Samples): 400 spiked urine samples (100 samples each for 5, 6.5, 8, 10 mIU/mL hCG) were tested by 200 lay persons.
  • Data Provenance: Prospective collection of urine samples and clinical prospective testing by lay users, with concurrent professional testing as ground truth. (Spiked samples were laboratory-controlled, prospective).
• Early Pregnancy Test Study:
  • Sample Size: 585 urine samples collected from 65 pregnant women (65 characterized cycle segments of conceptive cycles).
  • Data Provenance: Prospective collection of samples from pregnant women. This is clinical, prospective data.

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

• General Ground Truth for Clinical Samples: For the "professional testing" mentioned in the Lay Person Study and the "Method Comparison Study," the ground truth was presumably established by a laboratory assay (e.g., quantitative hCG measurement) or by the predicate device's results. The document refers to "professional results" and "predicate device" as the comparators.
• Qualifications of Experts: The document does not specify the number or qualifications of "experts" (e.g., laboratory technicians, clinical professionals) who interpreted the ground truth results for clinical studies. For the "professional testing" in the lay person study, it's implied clinical laboratory personnel.

4. Adjudication Method for the Test Set

The document does not explicitly describe an adjudication method like 2+1 or 3+1. For quantitative results (like hCG levels used for spiking or professional ground truth), there wouldn't typically be adjudication in the same way as for human interpretation of images. For the method comparison and lay person studies, the "professional result" or "predicate device" served as the established outcome against which the new device was compared. Discrepancies, if any, would likely be analyzed, but a formal adjudication process (i.e., multiple readers resolving disagreements) is not mentioned.

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 Comparative Effectiveness Study: This is not an AI-assisted device, but rather a lateral flow immunoassay (pregnancy test). Therefore, an MRMC comparative effectiveness study involving human readers improving with AI assistance is not applicable to this device. The "readers" are the lay users or professionals interpreting the test result line.

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

• Algorithm Only Not Applicable: This is a diagnostic test where the user interprets a visual result (line appearing). There is no "algorithm" in the sense of a software-based diagnostic tool that operates without human intervention. The device's performance is inherently "standalone" in that it provides a result without additional computational input, but it still requires human visual interpretation.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

• Analytical Studies (Sensitivity, Hook Effect, Cross-Reactivity, Interfering Substances): Ground truth was established by spiking known concentrations of hCG or interfering substances into negative urine samples, traceable to WHO International Standard.
• Specificity Study (Non-pregnant females): Ground truth was established by clinical assessment (healthy, non-pregnant status of donors) and presumably confirmation of negative hCG status by a laboratory method.
• Method Comparison Study: Ground truth was the result of the legally marketed predicate device (Wondfo One Step HCG Urine Pregnancy Test Strip, Cassette, Midstream).
• Lay Person Study: Ground truth was professional testing results (presumably a laboratory hCG assay or the predicate device).
• Early Pregnancy Test Study: Ground truth was based on characterized cycle segments of conceptive cycles from pregnant women, meaning the women were confirmed pregnant and samples were collected relative to their Expected Menstrual Period (EMP). This is a form of clinical outcomes data coupled with the expected physiological presence of hCG.

8. The Sample Size for the Training Set

• No Explicit Training Set: Lateral flow immunoassays like this device typically do not have a "training set" in the machine learning sense. The device's performance is based on its chemical and biological components (antibodies, membrane, etc.) which are developed and optimized through R&D. The studies described are for validation and characterization of the finished device's performance, not "training."

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

• As there is no explicit "training set" in the context of machine learning for this device, this question is not applicable. The device's operational characteristics (e.g., antibody binding, flow dynamics) are established through a traditional scientific and engineering development process, not a data-driven training regimen.

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The powdered free sterile natural rubber latex surgical gloves is a device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.

The device is a sterile, single-use, non-pyrogenic, latex surgical glove. The proposed device is made of natural rubber latex. Per standard ASTM D3577-09(15), the rubber surgical gloves classification is: "Type 1-gloves compounded primarily from natural rubber latex." The proposed device is provided EO sterilized to achieve the sterility Assurance Level (SAL) of 10-6. The gloves are powdered free and available in four sizes 7, 7.5, 8, 8.5 to be suitable for user's hand. The Glove palm has textured surface.

The provided text is a 510(k) Summary for a medical device: "Powdered Free Sterile Natural Rubber Latex Surgical Gloves." This document describes the device, its intended use, and comparative non-clinical performance testing against a predicate device to demonstrate substantial equivalence.

It does not describe:

• An AI/ML-driven device.
• A study proving an AI/ML meets acceptance criteria.
• Any ground truth establishment or expert adjudication.
• Multi-reader multi-case (MRMC) comparative effectiveness studies.
• Standalone algorithm performance.
• Training set details.

Therefore,Based on the provided FDA 510(k) Summary for "Powdered Free Sterile Natural Rubber Latex Surgical Gloves," the document does not describe an AI/ML-driven device or any study related to AI/ML performance.

The 510(k) submission focuses on demonstrating substantial equivalence of the surgical gloves to a predicate device through non-clinical performance testing. The information requested in the prompt, such as acceptance criteria for AI/ML performance, sample sizes for test/training sets, expert adjudication, MRMC studies, and ground truth establishment, are not applicable to the content of this document, as it pertains to a physical medical device (surgical gloves) and not a software algorithm or AI.

Therefore, I cannot extract the requested information from the provided text.

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The PP CARE Nitrile Examination Gloves is a disposable devices intended for medical purposes that are worn on the examiner's hands to prevent contamination between patient and examiner.

PP CARE Nitrile Examination Gloves are Class I patient examination gloves bearing the product code LZA (21CFR880.6250). The gloves are made from acrylonitrile butadiene rubber. These gloves are blue in color and are powder free.

The document provided focuses on the substantial equivalence determination for PP CARE Nitrile Examination Gloves (K212629) based on non-clinical testing. It does not describe a clinical study or AI/algorithm performance. Therefore, many of the requested points are not applicable.

Here's the information that can be extracted from the provided text regarding the non-clinical testing:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Water Tightness Test: 200 samples were tested.
• Data Provenance: The tests described are non-clinical (laboratory/materials testing) and were performed by EG Group Product and Service Co., Ltd. in Thailand. The data is thus prospective for the purpose of this submission and originates from Thailand.
• For other tests like Dimensions, Physical Properties, Powder Residue, the sample sizes are not explicitly stated but are implied to be sufficient for demonstrating compliance with the respective ASTM standards.
• For biocompatibility tests (Skin Irritation, Sensitization, Cytotoxicity, Systemic Toxicity), specific animal models are mentioned (New Zealand White Rabbits, Guinea Pigs, Swiss Albino Mice), indicating laboratory testing.

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

• Not applicable. This document describes non-clinical performance and biocompatibility testing of medical gloves, not a study requiring expert clinical judgment for ground truth. The "ground truth" here is compliance with established international standards (ASTM, ISO, EN).

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

• Not applicable. This is not a study requiring adjudication of expert interpretations.

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

• Not applicable. This is not a study involving human readers or AI.

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

• Not applicable. This document is about medical gloves, not an algorithm or AI device.

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

• The "ground truth" for the device's performance against its acceptance criteria is defined by compliance with established international standards (ASTM D6319-19, EN 455-1:2000) and ISO 10993 series for biocompatibility. These standards set the benchmarks for physical properties, barrier integrity, and biological safety.

8. The sample size for the training set:

• Not applicable. This is not an AI/machine learning study.

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

• Not applicable. This is not an AI/machine learning study.

Summary of the Study that Proves Device Meets Acceptance Criteria:

The device's compliance with acceptance criteria is demonstrated through a series of non-clinical tests performed in accordance with recognized international standards. These tests assessed:

• Dimensional properties: Length, width, and thickness as per ASTM D6319-19.
• Physical properties: Tensile strength and ultimate elongation (before and after aging) as per ASTM D6319-19.
• Powder Residue: Measurement of powder content as per ASTM D6319-19.
• Water Tightness: To detect holes, conducted in accordance with EN 455-1:2000.
• Biocompatibility:
  • Skin Irritation (ISO 10993-10:2010(E) using New Zealand White Rabbits)
  • Skin Sensitization (ISO 10993-10:2010(e) using Guinea Pigs)
  • In Vitro Cytotoxicity (ISO 10993-5:2009(E) by elution method)
  • Acute Systemic Toxicity (ISO 10993-11:2017 using Swiss Albino Mice)

The results show that the PP CARE Nitrile Examination Gloves meet or exceed all specified acceptance criteria derived from these standards for physical and barrier properties, and demonstrate acceptable biocompatibility (despite an "100% cytotoxic" in vitro result, which was mitigated by a successful acute systemic toxicity test, deeming the device non-toxic under study conditions). These non-clinical tests collectively provide the evidence that the device meets its performance requirements and is substantially equivalent to the predicate device.

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For Prescription and Home Use by prescription from a medical professional:

The Stella BIO is a neuromuscular electronic stimulator indical supervision for adjunctive therapy in the treatment of medical diseases and conditions

As a powered muscle stimulator, Stella BIO is indicated for the following conditions:

• · Relaxation of muscle spasms,
• · Prevention or retardation of disuse atrophy,
• · Increasing local blood circulation,
• · Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis,
• · Maintaining or increasing range of motion,
• · Muscle re-education.

As a transcutaneous electrical nerve stimulator for pain relief. Stella BIO is indicated for the following conditions:

• · Symptomatic relief and management of chronic (long-term), intractable pain,
• · Adjunctive treatment in the management of post-surgical pain and post traumatic acute pain.

As a biofeedback device, Stella BIO is indicated for:

· Biofeedback, relaxation and muscle re-education.

As an external functional neuromuscular stimulator, Stella BIO is indicated for the following conditions: · Helps to relearn voluntary motor functions of the extremities.

As a non-implanted electrical continence device, Stella BIO is indicated for the following conditions:

· Acute and ongoing treatment of stress, urge or mixed urinary incontinence and where the following results may improve urinary control: inhibition of the detrusor muscles through reflexive mechanisms and strengthening of pelvic floor muscles.

· Incontinence treatment for assessing EMG activity of the pelvic floor and accessory muscles such as abdominal and the gluteus muscles.

Patient population: Stella BIO Prescription and Home Use by prescription from a medical professional can be used on adults aged 22 yrs and older.

Environments of Use: Clinics, hospital and home environments.

Platform: Stella BIO is a battery-powered, wireless device, accessible through software.

The Stella BIO is a neuromuscular electronic stimulator, non-implantable incontinence device and biofeedback device, designed for stationary use in the clinics and hospitals by the medical professionals as well as in the home environment by the patient.

Stella BIO is a single presentation device (one hardware) with a single software for Prescription and Home Use by prescription from a medical professional.

For the Prescription and Home Use by prescription from a medical professional Software License, the medical professional has the ability to adjust, monitor and progress the therapy. This License comes with two User Manuals:

• User Manual for the medical professionals (including instructions on how to adjust parameters ● of the programs and prescribe exercises for patients)
• User Manual for the patient (including instruction on how to use programs prescribed and adjusted by the medical professional)

The Stella BIO is a battery-powered, wireless device, accessible through software on a mobile device (PC, tablet or smartphone). Statistics reqarding the completed treatment can be retrieved from the PC.

In order to gain a proper understanding of Stella BIO, it is important to read the manual before beginning to use the Stella BIO.

This document is a 510(k) summary for the Stella BIO device, which is a neuromuscular electronic stimulator, non-implantable incontinence device, and biofeedback device. The purpose of this summary is to demonstrate that the Stella BIO device is substantially equivalent to a legally marketed predicate device, the Stiwell med4 (K080950).

Key Acceptance Criteria and Device Performance:

The document primarily focuses on demonstrating substantial equivalence by comparing the Stella BIO to its predicate device across various "designations" (Powered Muscle Stimulator, Functional Electrical Stimulation, Transcutaneous Electrical Nerve Stimulation, Incontinence Programs, Biofeedback). Instead of defining explicit acceptance criteria with numerical targets as one might for a diagnostic AI, the acceptance criteria here are implicitly met by demonstrating that any differences between the new device and the predicate device, or adherence to relevant voluntary standards (IEC, ANSI/AAMI, FDA guidance), do not raise new questions of safety or effectiveness.

Therefore, the "acceptance criteria" table below is constructed by extracting the key comparative metrics and the conclusions drawn regarding their impact on safety and effectiveness.

1. Table of Acceptance Criteria (Implicit) and Reported Device Performance:

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The illumiflow 148 Laser Cap is indicated to promote hair growth in males with androgenic alopecia who have Norwood-Hamilton classifications of Ila to V or females with androgenic alopecia who have Ludwig-Savin Hair Classifications of I-II and both with Fitzpatrick Skin Phototypes I to IV

Similar to the original illumiflow 272 Laser Cap and the predicate LaserCap 120, the modified illumiflow 148 Laser Cap is a low-level laser therapy (LLLT) helmet device containing red. visible light diode lasers operating at 650 nanometers, designed to deliver non-thermal energy to the hair follicles used to promote hair growth via photobiostimulation of the scalp.

The illumiflow 148 Laser Cap utilizes 148 laser diodes to deliver laser stimulation to the scalp. The device is operated via a single button on the battery pack, and has an audible timer that automatically turns the lasers off after a 30-minute treatment session.

Here's an analysis of the provided text regarding the illumiflow 148 Laser Cap, addressing your questions about acceptance criteria and study proving device performance:

Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting a full clinical study to prove novel efficacy or new safety profiles. Therefore, some of the information you requested, particularly those related to detailed clinical study design (like MRMC studies, specific sample sizes for test/training sets in a clinical trial context, and ground truth establishment for clinical data), is either not present or is addressed in the context of equivalence to previously cleared devices.

Acceptance Criteria and Device Performance (Context of 510(k) - Substantial Equivalence)

For a 510(k) submission like this, "acceptance criteria" are not typically framed as specific performance metrics in a clinical study to prove de novo efficacy, but rather as demonstrations that the device is as safe and effective as a predicate device. The performance is assessed against the predicate's known safety and efficacy profile through non-clinical testing and comparison of technological characteristics.

Here's the closest interpretation of your request based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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The Ives MR Conditional Cup Electrodes are intended for use in the general recording and monitoring of the electroencephalography (EEG), evoked potential (EP) as well as ground and reference related to the EEG and EP recording.

The Cup Electrodes are intended to be left in place during MR imaging at 1.5T and 3T as well as during CT scanning.

The extension cable must be disconnected from the Ives MR Conditional Cup Electrodes before scanning and MUST remain disconnected throughout the entire MR scan. EEG or EP should not be recorded throughout the entire the CT and MR imaging.

The cutaneous surface electrode (CPE) are electrodes that are all applied to the surface of the patient's skin, they are non-invasive. These electrodes are used for the recording of electroencephalography (EEG), evoked potential (EP) as well as the ground and reference associated with the recording. They consist of a disc or cup made from a variety of materials, which include, conductive plastic and Ag-Ag/Cl, materials that have long been used for this intended purpose throughout the industry and compatible to the MR environment. The conductive cup electrode is permanently connected to a PVC insulated copper lead wire varying in length from 6" to 9". This joint is then covered in a heatshrink tube to provide a strain relief. The lead wires are staggered in length (6" to 9") and terminate in a small mass connector that conforms to DIN 42-802 for electrical safety. A blue sponge is provided to locate the lead wire termination off of the scalp and at the top of the patient's head. To permit EEG monitoring, this small mass connector mates with a harness system as per K062880 (an Ives EEG Solutions 510K describing a Subdermal Wire Electrode System) which connects to the EEG recording instrument using molded "touch-proof" connectors which also conform to DIN 42-802. The Harness is disconnected for imaging. The electrode lead length is as short as possible to connect directly with the 10-20 EEG scalp site. This prevents coiling of the lead wires and as short as possible lead length to reduce or eliminate the RF heating antenna effect during MR scanning sequences. Electrode and lead materials are selected to avoid use of any magnetic ferrous metals.

The provided document describes the FDA 510(k) premarket notification for the Ives MR Conditional Cup Electrode, focusing on its substantial equivalence to predicate devices and its MR Conditional properties.

Here's an analysis of the acceptance criteria and the study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a formal "acceptance criteria" table with corresponding "reported device performance" in the way one might expect in a detailed study report. However, it implicitly defines acceptance criteria through its claims of MR Conditional compatibility and the supporting non-clinical testing.

Here's a reconstruction of the implicit acceptance criteria and the device's performance based on the non-clinical testing section:

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

• Sample Size for Test Set: The document mentions "clinical testing" for image artifact, but does not specify the sample size (e.g., number of electrodes, number of subjects/patients) used for this testing.
• Data Provenance: The document does not explicitly state the country of origin. Given the FDA submission and the company name ("Ives EEG Solutions, Inc." and "Newburyport, Massachusetts"), it is highly probable the testing was conducted in the United States. The document is a regulatory submission, not a research paper, so detailed provenance is not typically included here unless specifically requested by the FDA for certain study types. The testing described is non-clinical (thermal, electromagnetic compatibility) and clinical (image artifact assessment), implicitly making it prospective for the purpose of this submission.

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

This information is not provided in the document. The testing described focuses on physical properties (heating, artifact) rather than diagnostic accuracy or interpretation requiring ground truth established by medical experts for a test set. The "clinical testing" mentioned for image artifact would typically be assessed by radiologists, but the number and qualifications are not stated.

4. Adjudication Method for the Test Set

This information is not provided in the document. This type of adjudication method (e.g., 2+1) is relevant for studies involving human interpretation of data, such as diagnostic accuracy studies, which is not the primary focus of the non-clinical and basic clinical compatibility testing described here.

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

No, an MRMC comparative effectiveness study was not done and is not applicable here. This document is about the MR compatibility and basic safety of an EEG electrode, not about the diagnostic effectiveness of an AI algorithm or human readers. The device itself is an electrode, not an AI diagnostic tool.

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

No, a standalone study of an algorithm performance was not done. The device is an electrode, not an algorithm.

7. Type of Ground Truth Used

For the non-clinical testing (thermal, magnetic compatibility), the "ground truth" is established by:

• Physical measurements and scientific principles: Temperature rise is directly measured. Magnetic field interactions are assessed based on material properties and measured forces/torques.
• Established MR safety standards: Testing methods and thresholds are derived from recognized industry standards and regulatory guidance for MR compatibility.

For the "clinical testing" of image artifact, the "ground truth" implicitly refers to the direct observation and measurement of the artifact on MR images by qualified personnel (likely radiologists or MR physicists), compared against a baseline expectation or standard for acceptable artifact. It's not ground truth in the sense of a disease diagnosis but rather a direct physical effect.

8. Sample Size for the Training Set

Not Applicable. This device is a physical medical instrument (an electrode), not an AI algorithm. Therefore, there is no "training set" in the context of machine learning. The non-clinical and clinical testing performed relates to the physical safety and compatibility of the device.

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

Not Applicable. As there is no AI algorithm and no training set, there is no ground truth to be established for a training set.

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The MEDICON Spinal Spreading Systems are used to spread soft tissue and maintain surgical access in spine surgery and may only be used by surgeons with proper training and adequate experience in spine surgery.

The MEDICON Spinal Spreading System is made up of multiple reusable manual spreader systems. The spreaders include components for all approaches in spine surgery, including those specifically for cervical spine surgery, as well as inter-laminar, trans-laminar, extra-foraminal and dorsolateral approaches. The multiple components support classic and minimally invasive procedures. The components are made from a radiolucent x-ray compatible material, from titanium, some from stainless steel, and some from anodized aluminum.

This document describes the MEDICON Spinal Spreading Systems, a set of reusable manual retractor systems used in spine surgery. The information provided is for regulatory clearance (510(k)) and focuses on demonstrating substantial equivalence to predicate devices rather than proving specific performance characteristics of an AI/ML device. Therefore, many of the requested details concerning AI/ML device acceptance criteria and study designs are not applicable or cannot be extracted from this medical device submission.

Here's an analysis based on the information provided, highlighting the differences due to the nature of the device:

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

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

This information is not applicable as this is not an AI/ML device, but a physical medical instrument. The "test set" here refers to the physical devices undergoing non-clinical technical testing. Specific sample sizes for each test (e.g., number of blade supports tested) are not provided, only the qualitative outcome. The data provenance is internal testing performed by the manufacturer, MEDICON eG, which is based in Germany.

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 is not applicable. "Ground truth" in the context of expert consensus is relevant for diagnostic or AI/ML devices where interpretation is involved. For a physical surgical instrument, the acceptance criteria are based on objective engineering and sterilization standards.

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

This is not applicable. Adjudication methods like 2+1 or 3+1 refer to how discrepancies in expert interpretations (e.g., in reading medical images) are resolved to establish a ground truth. For the physical testing of surgical instruments, results are objective and measured against established standards, not subject to expert interpretation discrepancies in the same way.

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

This is not applicable. An MRMC study is designed to evaluate the performance of diagnostic systems or AI assistance in a clinical setting with human readers. This device is a surgical instrument, not a diagnostic or AI-assisted system. No clinical studies (including MRMC) were performed.

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

This is not applicable. There is no algorithm or AI component in this medical device.

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

The "ground truth" for this device's performance is established by adherence to recognized engineering standards for mechanical strength, biocompatibility standards, and sterilization validation standards. This is not an expert consensus or pathology-based ground truth typical for AI/ML or diagnostic devices.

8. The sample size for the training set

This is not applicable. This is a physical medical device, not an AI/ML system, so there is no training set.

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

This is not applicable. No training set exists for this device.

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The illumiflow Laser Cap is indicated to promote hair growth in males with androgenic alopecia who have Norwood-Hamilton classifications of IIa to V or females with androgenic alopecia who have Ludwig-Savin Classifications of I – II and both with Fitzpatrick Skin Phototypes I to IV.

The illumiflow Laser Cap is a dome-shaped low level laser therapy (LLLT) device designed to promote hair growth in women and men by exposing the entire scalp to the photobiostimulation of 272 visible red light-emitting diodes at 650-nm and 5mW each. The cap is designed with an outer plastic cover and a protective inner liner (containing the electronics and laser array) and is powered by an included Battery Pack.

The provided text describes the regulatory clearance for the "Illumiflow Laser Cap." However, it does not contain the information requested regarding acceptance criteria and a study that proves the device meets those criteria, particularly in the context of an AI/human-in-the-loop system for a medical imaging device.

The document is a 510(k) summary for a low-level laser therapy (LLLT) device intended to promote hair growth. The studies mentioned are primarily:

• Biocompatibility testing: To ensure materials are safe for patient contact.
• Non-clinical performance testing: To confirm compliance with design specifications and electrical safety/EMC standards (e.g., IEC 60825-1, IEC 60601-1).
• Usability testing: To confirm that lay users can understand labeling and use the device safely and correctly.

There is no mention of:

• A table of acceptance criteria for diagnostic/AI performance metrics (e.g., sensitivity, specificity, AUC).
• Sample sizes for test sets used to evaluate AI performance.
• Data provenance for such test sets.
• Number or qualifications of experts for ground truth establishment.
• Adjudication methods.
• Multi-Reader Multi-Case (MRMC) studies or comparative effectiveness with human readers.
• Standalone algorithm performance.
• Type of ground truth used (e.g., pathology, outcomes data).
• Training set details (size, ground truth establishment).

The device is a direct-to-consumer therapy device, not a diagnostic imaging device utilizing AI. Therefore, the detailed AI-related study information you requested is not present in this document.

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EGENS Urine Test Cup THC-MDMA is a rapid test for the qualitative detection of Cannabinoids and Methylenedioxymethamphetamine in human urine at a cutoff concentration of 50 ng/mL respectively. EGENS Urine Test Cup THC-MDMA test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. CCMS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.

For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use.

EGENS Urine Test DipCard THC-MDMA is a rapid test for the qualitative detection of Cannabinoids and Methylenedioxymethamphetamine in human urine at a cutoff concentration of 50 ng/mL and 500 ng/mL, respectively. EGENS Urine Test DipCard THC-MDMA test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.

For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use.

EGENS Urine Test Cassette Marijuana is a rapid test for the qualitative detection of Cannabinoids in human urine at a cutoff concentration of 50 ng/mL.

EGENS Urine Test Cassette Marijuana test provides only preliminary test results. A more specific alternative chemial method must be used in order to obtain a confirmed analytical result. CC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.

For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use.

EGENS Urine Test MDMA uses immunochromatographic assays for Methylenedioxymethamphetamine. These tests are lateral flow systems for the qualitative detection of Methylenedioxymethamphetamine in human urine. EGENS Urine Test Marijuana (THC) uses immunochromatographic assays for Cannabinoids. These tests are lateral flow systems for the qualitative detection of Cannabinoids in human urine. Each test is the first step in a two-step process. The second step is to send the sample for laboratory testing if preliminary positive results are obtained.

This document describes the performance of the EGENS Urine Test Marijuana (THC) and EGENS Urine Test MDMA devices. Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for these devices are implicitly defined by their performance around the cutoff concentrations. For instance, samples significantly below the cutoff should test negative, and samples significantly above should test positive, with the most variability expected around the cutoff. The reported performance is based on precision studies and lay-user studies.

Precision Study Performance (Examples from THC DipCard and MDMA DipCard):

Lay-User Study Performance (Examples from THC Cassette and MDMA DipCard):

The acceptance criteria are generally that the device correctly identifies negative samples as negative and positive samples as positive, with some allowance for variability around the cutoff concentration. The high agreement percentages for samples significantly away from the cutoff (100% for -100%, -75%, -50% and +50%, +75%) demonstrate the device meets these criteria. The variability around the -25% and +25% cut-off points is expected for qualitative tests designed to provide a preliminary result.

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

• Precision Studies: For each concentration level (-100%, -75%, -50%, -25%, at cut-off, +25%, +75%, +100% cut-off) and for each of the three lots, tests were performed two runs per day by three operators for 25 days.
  • Total tests per concentration per lot: 2 runs/day * 3 operators = 6 tests per day. Over 25 days, this is 6 * 25 = 150 tests per concentration per lot. The results shown for each lot represent 50 tests (-/+) which implies 50 individual sample aliquots were tested (likely 1 aliquot per operator per day over some period, or 2 aliquots per day for 25 days by one operator per lot, etc., but the interpretation from the table is 50 results per lot per concentration).
  • Data Provenance: Not explicitly stated, but assumed to be internal laboratory testing (in-house). The document does not specify the country of origin for the samples themselves. These samples were prepared by spiking known concentrations into urine.
• Method Comparison Studies (Clinical Samples):
  • Sample Size: 80 "unaltered clinical samples" for Cannabinoids (40 negative and 40 positive) for each format (DipCard, Cup, Cassette). 80 "unaltered clinical samples" for MDMA (40 negative and 40 positive) for each format (DipCard, Cup).
  • Data Provenance: "in-house" (presumably for testing execution). The origin of the "unaltered clinical samples" is not specified (e.g., country of origin, retrospective/prospective collection).
• Lay-user Study:
  • Sample Size: 700 lay persons in total.
    • 100 tested for drug-free samples only.
    • 360 for Cannabinoids samples only.
    • 240 for Methylenedioxymethamphetamine samples only.
  • Each participant was given 1 blind-labeled sample.
  • For each drug and concentration level shown in the tables (e.g., Cannabinoids -100%, -75% etc.), 20 samples were tested.
  • Data Provenance: Not explicitly stated beyond "performed at three intended user sites." The origin of the urine specimens (drug-free pooled urine spiked with drugs) is consistent with controlled laboratory preparation.

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

• For Precision, Cut-off, Interference, and Specificity Studies: The ground truth was established by preparing urine samples with known, spiked concentrations of the analytes. No human experts were used for this ground truth creation.
• For Method Comparison Studies (Clinical Samples): The ground truth was established by GC/MS (Gas Chromatography/Mass Spectrometry), which is a highly accurate and generally accepted confirmatory method for drug testing. No human experts were involved in establishing this ground truth, as it is an analytical chemical method.

4. Adjudication Method for the Test Set

• Precision, Cut-off, Interference, and Specificity Studies: Ground truth was based on spiked concentrations. Discrepancies between expected results and device results were noted and analyzed, but no adjudication by human experts was described as the samples had known concentrations.
• Method Comparison Studies (Clinical Samples): The device results were compared directly to the GC/MS results. Discordant results are presented, but there is no mention of an adjudication process (e.g., by experts) to resolve these discrepancies in the context of the study's conclusions. GC/MS results are generally considered the gold standard for confirmation.
• Lay-user Study: The ground truth was established by GC/MS for the spiked samples. The lay-users' interpretations of the device results were compared to these GC/MS confirmed concentrations.

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, an MRMC comparative effectiveness study was not performed.
• These devices are qualitative urine drug screening tests for direct visual interpretation. They are not AI-assisted imaging or diagnostic devices that would typically involve human readers interpreting complex images with or without AI assistance. The "Viewers" mentioned in the method comparison study are likely laboratory assistants reading the test strips, and their role is to interpret the visual lines on the test, not to make complex diagnostic decisions.

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

• Yes, a standalone performance was done for the device itself. The device itself is a standalone, rapid immunoassay that produces a visual result inherently. There is no separate "algorithm" being evaluated beyond the chemical assay's performance.
• The "Precision" studies and "Cut-off" studies directly demonstrate the device's performance in detecting specific concentrations without human interpretation variability influencing the reported percentage agreements at extreme concentrations.
• The "Method Comparison Studies" compare the device's visual output (as interpreted by "Viewers") directly against GC/MS. This is a measure of the device's accuracy in producing a result that then is read.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

• Spiked Samples (for Precision, Cut-off, Interference, Specificity, and Lay-user Studies): Known concentrations of target analytes (Cannabinoids, MDMA) added to urine. This is a highly controlled laboratory method to establish ground truth.
• Gas Chromatography/Mass Spectrometry (GC/MS) (for Method Comparison Studies and confirmation for Lay-user Study samples): This is an advanced analytical chemical method, considered a gold standard for confirming the presence and concentration of drugs in urine.

8. The Sample Size for the Training Set

• Not applicable. These are lateral flow immunochromatographic assays, not machine learning or AI models with "training sets." The device's performance is based on its chemical and biological components, which are designed and manufactured, not "trained" in the computational sense.

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 EGENS Urine Test Cup Morphine - Methamphetamine is a rapid test for the qualitative detection of Morphine and Methamphetamine in human urine at a cutoff concentration of 300 ng/mL and 1000 ng/mL, respectively.

EGENS Urine Test Cup Morphine - Methamphetamine test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.

For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use.

The EGENS Urine Test DipCard Morphine - Methamphetamine is a rapid test for the qualitative detection of Morphine and Methamphetamine in human urine at a cutoff concentration of 300 ng/mL and 1000 ng/mL, respectively.

EGENS Urine Test DipCard Morphine - Methamphetamine test provides only preliminary test results. A more specific alternative chemical must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use.

EGENS Urine Test Morphine-Methamphetamine test uses immunochromatographic assays for Morphine and Methamphetamine. The test is a lateral flow system for the qualitative detection of Morphine and Methamphetamine in human urine. The test is the first step in a two-step process. The second step is to send the sample for laboratory testing if preliminary positive results are obtained.

The provided document describes the performance characteristics of the EGENS Urine Test Cup Morphine - Methamphetamine and EGENS Urine Test DipCard Morphine - Methamphetamine devices.

Here's an analysis based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal "acceptance criteria" but rather presents performance characteristics from various studies. For the purpose of this response, I infer the reported performance to be the intended criteria and thus list the results.

Morphine (MOP) and Methamphetamine (MET) Detection
Cut-off for Morphine: 300 ng/mL
Cut-off for Methamphetamine: 1000 ng/mL

2. Sample Size and Data Provenance

• Precision Studies: For each concentration level (-100%, -75%, -50%, -25%, cut-off, +25%, +50%, +75%, +100% cut-off), 50 tests were performed per lot. With 3 lots and 9 concentrations, this is 50 * 3 * 9 = 1350 tests per drug for each device format (Cup/DipCard).
  • Data Provenance: Not explicitly stated, but the studies were conducted in-house. This typically implies controlled lab conditions rather than real-world patient samples, but the samples themselves are referenced as "samples with concentrations."
• Cut-off Studies: A total of 125 morphine samples and 125 methamphetamine samples were used, equally distributed across 5 concentration levels (-50%, -25%, cut-off, +25%, +50%).
  • Data Provenance: Not explicitly stated, but implied to be controlled, spiked samples.
• Interference/Specificity Studies: Samples were prepared by adding potential interfering substances or drug metabolites to urine containing target drugs. The quantity of samples is not explicitly given but implied to be sufficient for testing (e.g., "These samples were tested using three batches...").
  • Data Provenance: Not explicitly stated, likely controlled lab conditions.
• Effect of Specific Gravity and Urine pH: 12 urine samples covering normal, high, and low specific gravity ranges, and urine pH adjusted to 4.00-9.00 in 1 pH unit increments. These were spiked samples.
  • Data Provenance: Not explicitly stated, likely controlled lab conditions.
• Laboratory Comparison Studies: 80 "unaltered clinical samples" (40 negative and 40 positive) for each drug (Morphine and Methamphetamine) per device format (DipCard, Cup). This means 80 * 2 (drugs) * 2 (formats) = 320 samples in total for this part of the study.
  • Data Provenance: "Clinical samples" are explicitly stated, implying these are from actual patients rather than purely synthetic or spiked lab samples. The country of origin is not specified but the study was performed "in-house."
• Lay-User Study: 560 lay persons. The study used 80 "drug-free samples", 240 "morphine samples", and 240 "methamphetamine samples". Within these, the document describes 20 samples per concentration level (-100%, -75%, -50%, -25%, +25%, +50%, +75% of cut-off) per drug.
  • Data Provenance: Urine samples were "spiked drugs into drug free-pooled urine specimens." So, these were controlled, spiked samples, not unalterted clinical samples.

3. Number of Experts and their Qualifications for Ground Truth

• Laboratory Comparison Studies: "Three laboratory assistants" were involved in running the tests. Their qualifications are not specified beyond being "laboratory assistants."
• Precision, Cut-off, Interference, Specific Gravity/pH Studies: "Three operators" repeatedly tested the samples. Their qualifications are not specified.
• Lay-User Study: The "lay persons" were the "users" in this study, not "experts" establishing ground truth. There were 560 lay users. Their qualifications were described as having "diverse educational and professional backgrounds and ranged in age from 21 to >50 years."

4. Adjudication Method for the Test Set

• Laboratory Comparison Studies: The collected results from the three viewers/operators were directly compared to the GC/MS results. There is no explicit mention of an adjudication process (e.g., 2+1, 3+1) among the viewers to establish a consensual device output. Each viewer's result was compared to GC/MS independently.
• Other Studies (Precision, Cut-off, Interference, etc.): The results were aggregated from multiple operators/lots, but the tables present aggregated counts (e.g., 50-/0+, 33+/17-), not individual operator adjudication.
• Lay-User Study: Each participant was given one blind-labeled sample and a device. Their individual results were recorded and compared to the GC/MS ground truth. No adjudication between lay users is mentioned.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

There is no mention of a formal MRMC comparative effectiveness study or analysis of how much human readers improve with AI vs. without AI assistance. The study involves human readers (operators/lay users) interpreting the results of the device, but it does not compare their performance with and without an AI or advanced assistance system. It is a standalone device performance comparison against GC/MS.

6. Standalone Performance Study (Algorithm only without Human-in-the-loop)

The devices described (EGENS Urine Test Cup and DipCard) are rapid, qualitative immunoassay tests that rely on visual interpretation of results (presence or absence of colored lines). They are not "algorithms" in the computational sense, and there is no "algorithm only" or "standalone" performance without human-in-the-loop, as human interpretation of the visual result is integral to the device's function. The "laboratory comparison study" and "lay-user study" assess the device's performance when interpreted by humans.

7. Type of Ground Truth Used

• Analytical Performance Studies (Precision, Cut-off, Interference, Specificity, Specific Gravity/pH): The ground truth was established by precise spiking of known concentrations of the target drug or interfering substances into drug-free urine.
• Laboratory Comparison Studies: GC/MS (Gas Chromatography/Mass Spectrometry) was used as the preferred confirmatory method and thus, the primary ground truth reference.
• Lay-User Study: GC/MS was used to confirm the concentrations of the spiked samples, serving as the ground truth.

8. Sample Size for the Training Set

The document describes premarket notification (510(k)) studies to demonstrate substantial equivalence, not the development of a predictive model or algorithm that would typically involve a "training set." Therefore, no training set size is mentioned or applicable in the context of these device types and studies. The tests are immunoassays, not machine learning models.

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

As stated above, this document does not describe the development of a device requiring a "training set" for a machine learning algorithm. The "training set" concept is not applicable here.

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