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turbodent touch is intended for a complete supra-gingival and sub-gingival prophylaxis treatment. The prophylaxis treatment is obtained by the projection of water, air and appropriate dental prophylaxis powders, onto the tooth surface. The device removes dental plaque, soft deposits, and surface stains from pits, grooves, interproximal spaces, or smooth surfaces of teeth. turbodent touch is intended for the following oral prophylaxis procedures:

• Plaque removal for placement of sealants
• Surface preparation prior to bonding/cementation of inlays, onlays, crowns and veneers
• Surface preparation prior to placing composite restorations
• Effective plaque and stain removal for orthodontic patients
• Cleaning prior to bonding ortho brackets
• Cleaning implant fixtures prior to loading
• Stain removal for shade determination
• Plaque removal prior to fluoride treatment
• Plaque and stain removal prior to whitening procedures

The turbodent touch is also intended for use as an air-polisher in patients suffering from periodontal disease. The turbodent touch is indicated for the non-surgical removal of subgingival plaque in pockets up to 5 mm after initial periodontal treatment.

turbodent touch can be considered a functionally segmented version of the combi touch device (K231391), incorporating exclusively the air polishing functionality. It shares the main components, materials, and manufacturing processes as the combi touch, from which it is derived. The indication for use of turbodent touch is aligned with the air polishing indication of the combi touch.

The turbodent touch uses an operating principle based on the mechanical action of an accelerated powder jet, obtained thanks to compressed air. The kinetic energy imparted to the particles is almost completely dissipated in the impact against the dental surface, producing a delicate but effective cleaning action. The action is completed by a jet of water which, taking advantage of the depression created around the nozzle, is arranged in a bell-like shape surrounding the air and powder mixed flow. The water flow produces a double effect: continuous washing of the area treated from excess powder, and prevention of environmental dissemination of powder in the operating area.

In detail, the turbodent touch is mainly based on one polisher channel and it is equipped with three handpieces, AIR-POLISHING 90°, AIR-POLISHING 120° AND AIR-POLISHING PERIO (handpieces are already cleared, K231391). The device has a touch keyboard, displaying all selectable functions and the value scales that can be set by the user by simply gently pressing the finger at the chosen buttons.

The user-configurable settings include depressurization of the powder containers for safe removal, no powder cleaning mode and consequently the possibility of excluding water as well, circuit filling/rinsing, and air-polishing modes. For each selected air-polishing mode (PROPHY or PERIO), it is possible to choose different power levels (LOW, MEDIUM and HIGH) within a certain range preset by the manufacturer. The air-polishing action is activated by means of a foot pedal.

The irrigation system is completely external with irrigation tubing connecting the handpiece to the machine that has access to the external water network.

The turbodent touch is not intended to interact with other devices during use. About patient interaction, the SUBGINGIVAL PERIO TIPS (already cleared, K231391) attached to the terminal part of the handpiece AIR-POLISHING PERIO, enter into direct contact with the patient's body during use to allow the intended therapeutic functions to take place. These medical devices are supplied sterile and certified by external suppliers. Possible contact of the patient with the external part of the handpiece must be considered in the evaluation.

The production processes carried out internally at Mectron for processing the components of turbodent touch system are mainly assembly processes according to specific workflows and a dedicated production line.

The provided text describes the 510(k) clearance for the "turbodent touch" device, which is an air polishing unit for dental prophylaxis. However, it does not contain any information about acceptance criteria or a study proving the device meets those criteria, especially not related to AI/ML performance.

The document details the device's function, comparison to a predicate device, and summaries of non-clinical testing (electrical safety, EMC, biocompatibility, software, performance, usability, distribution). Crucially, Section 9 explicitly states: "No clinical testing was conducted for this submission."

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, as the provided text lacks this information. The device is a physical dental instrument, not an AI/ML-driven diagnostic tool, and its clearance relies on substantial equivalence to a predicate, not on a performance study against specific acceptance metrics for AI output.

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The ATLAS Stim Headbox is a low power, constant current or voltage mode, bi-phasic stimulator intended for cortical or intracranial stimulation during electroencephalography examinations (i.e. stereoEEG).

The stimulation is applied to the brain using third-party stimulation probes (including cortical or intracranial electrodes) and the resulting cortical or deep brain potentials themselves are recorded using third-party cortical or intracranial electrodes.

The ATLAS Stim Headbox itself is an accessory to the ATLAS Neurophysiology System and ATLAS STIM Headbox software. The stimulation parameters, the electrodes selection and the activation of the stimulation current are all set-up and controlled from these devices. The ATLAS Stim Headbox can operate only when so connected and with the Pegasus and ATLAS Stim Headbox software; it cannot serve as a stand-alone stimulator.

The ATLAS Stim Headbox (ASHB) is a clinical headbox that allows 3rd party Macro electrode contact electrode arrays (ECoG, depth electrodes, grid array, strip array, etc.) to interface with the Neuralynx ATLAS Neurophysiology System, previously cleared in 510(k) K110967, which includes the Pegasus Software.

The ATLAS Stim Headbox is an accessory to the ATLAS Neurophysiology System (formerly known as SpikeTrax in K110967). The ATLAS Stim Headbox hardware consists of an encased amplifier and embedded firmware for generation and delivery of stimulation energy. The ATLAS Stim Headbox can deliver electrical stimulation current under the control of the associated ATLAS Stim Headbox Software which interfaces via a fiber optic ethernet communications connection.

The provided FDA 510(k) clearance letter and summary for the ATLAS Stim Headbox do not contain information about acceptance criteria or a study proving the device meets said criteria in the context of clinical performance or diagnostic accuracy. Instead, the document focuses on demonstrating substantial equivalence to predicate devices through technical comparisons and non-clinical performance testing (electrical safety, mechanical integrity, evoked response, electroencephalograph, and software regression).

Therefore, I cannot fulfill most of your request regarding acceptance criteria, reported device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth details.

The document primarily covers the safety and basic functional performance of the hardware and software as a medical device accessory, not its diagnostic or therapeutic accuracy for specific clinical outcomes that would require clinical studies with ground truth.

Here's a breakdown of what can be extracted from the provided text, and where information is missing:

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

The document does not present "acceptance criteria" in the sense of a clinical benchmark (e.g., sensitivity, specificity, accuracy) for a diagnostic output. Instead, it describes compliance with recognized standards and successful completion of verification and validation tests for safety and technical performance.

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

This information is not provided as the validation performed is non-clinical (device testing against engineering specifications and international standards), not a clinical study on patient data.

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

This information is not applicable/provided. The ground truth for device performance in this context is defined by international standards (e.g., IEC 60601) and engineering specifications. No clinical expert adjudication was mentioned for device functionality.

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

This information is not applicable/provided. No clinical adjudication method was mentioned for device functionality.

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

An MRMC study was not done. The device is an accessory for stimulation and recording of neural activity, not an AI-powered diagnostic tool for interpretation by human readers.

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

This is not applicable in the context of an "algorithm only" performance for a diagnostic task. The ATLAS Stim Headbox is a hardware accessory with embedded firmware and associated software, designed to be used in conjunction with other systems and by clinical professionals. It cannot operate as a stand-alone stimulator, as explicitly stated: "it cannot serve as a stand-alone stimulator."

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

The "ground truth" for the device's substantial equivalence and safety is primarily based on:

• International standards and engineering specifications: Compliance with IEC 60601 series, IEC 62304, IEC 62366.
• Functional verification: Demonstrating that the device's electrical characteristics (e.g., charge per phase, instantaneous current sum) meet safety limits and design specifications.
• Predicate device characteristics: The claim of substantial equivalence is made against the technical specifications and known performance of the predicate devices.

8. The sample size for the training set

This is not applicable/provided. The document describes a hardware device and its control software. There is no mention of "training set" in the context of machine learning for a diagnostic algorithm. Software regression testing refers to the iterative testing of the software itself against predefined functionalities and bug fixes, not the training of a model on a dataset.

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

This is not applicable/provided as there is no "training set" in the context of machine learning for a diagnostic algorithm.

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A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner. These gloves were tested for use with chemotherapy drugs, as per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

The SafeSource Direct Blue Powder-Free Nitrile Exam Gloves are a patient examination glove that is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner. These gloves were tested for use with chemotherapy drugs. The purpose of this submission is to add two additional sizes (AMERI-TUFF Series 4000 XS and XXL) and additional series (AMERI-TOUCH Series 5000 XS through XXL) of SafeSource Direct Blue Powder-Free Nitrile Exam Glove

This document is a 510(k) Summary for a medical device (SafeSource Direct Blue Powder-Free Nitrile Exam Gloves) seeking FDA clearance. The document focuses on demonstrating substantial equivalence to a predicate device, primarily through non-clinical performance data (i.e., laboratory testing). It does not involve a study of an AI-powered device or a human-in-the-loop performance study.

Therefore, many of the requested elements related to AI/MRMC studies, expert ground truth adjudication, and training/test set details for AI models are not applicable to this document. I will focus on the acceptance criteria and the study that proves the device meets those criteria, as detailed in the provided text.

Here's a breakdown based on the information provided in the document:

1. Table of Acceptance Criteria and Reported Device Performance

The device under review includes two series of gloves: AMERI-TUFF Series 4000 and AMERI-TOUCH Series 5000. Not all tests explicitly differentiate between the series in the summary table, but chemotherapy permeation times are distinct.

Width (mm):
XS: 70 ± 10
S: 80 ± 10
M: 95 ± 10
L: 110 ± 10
XL: 120 ± 10
XXL: 130 ± 10

Thickness (mm):
Finger: ≥ 0.05
Palm: ≥ 0.05 | Length (mm):
XS/S: ≥ 220 / Pass
M/L/XL/XXL: ≥ 230 / Pass

Width (mm):
XS: 70 ± 10 / Pass
S: 80 ± 10 / Pass
M: 95 ± 10 / Pass
L: 110 ± 10 / Pass
XL: 120 ± 10 / Pass
XXL: 130 ± 10 / Pass

Thickness (mm):
Finger: 0.05 / Pass
Palm: 0.05 / Pass |
| ASTM D5151 | Watertightness Test for Detection of Holes | Meet the requirements of ASTM D5151 AQL 2.5 | Complies with ASTM D6319-19 and ASTM D5151-06 (Though the table specifically lists "Complies with ASTM D6319-19 and ASTM D5151-06", the stated acceptance criteria for D5151 is AQL 2.5, implying the result also meets this). |
| ASTM D6124 | Powder Content | Meet the requirements of ASTM D6124

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TENS: To be used for the temporary relief of pain associated with sore or aching muscles in the shoulder, waist, back, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities. EMS: Intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.

Not Found

This document is a 510(k) clearance letter for a Transcutaneous Electrical Nerve Stimulator (TENS) and Electrical Muscle Stimulator (EMS) device, a regulatory document. It does not contain information about the acceptance criteria or a study proving the device meets acceptance criteria. The letter primarily states that the device is substantially equivalent to legally marketed predicate devices.

Therefore, I cannot provide the requested information based on the given context.

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Indicated for administering an adjustable mixture of Nitrous Oxide analgesic gas and Oxygen to a conscious, spontaneously breathing patient.

The device will be available in two models: (Details below) FLOWSTAR TOUCH DIGITAL MIXER FLOWMETER 50 %, and FLOWSTAR TOUCH DIGITAL MIXER FLOWMETER 70 %.

50% and 70% represent the maximum nitrous oxide concentration. The FlowStar Touch O2- N₂O Mixer for Analgesia is a device which can precisely dose a mixture of medical oxygen and medical nitrous oxide, depending on the adjusted mixture, for the sedation of patients in hospitals and at the dentist. The operator, a doctor or a dentist is able to adjust the total flow and the concentration of nitrous oxide of this flow. Depending on these settings the level of sedation of the patient can be controlled by the operator. The Baldus® Touch O2- N2O Mixer for Analgesia device has been created with the following safety features. The total flow emitted can consist of a maximum of 70 % nitrous oxide, the mix up of gas types is prevented by mechanical encodings and the flow of pure nitrous oxide in the absence of a missing oxygen supply is prevented by a fail-safe device. An integrated Touch pad is used to select the desired N₂O /O2 gas mixture. The total flow can consist of between 0 (100% O2) and 70 (30% O2) percent N₂O. The minimum output of 30 % O2 prevents from a hypoxic mixture for the patient. The FlowStar TouchO2- N2O Mixer for Analgesia device has an integrated O2 Flush function which delivers at least 30 l/min of pure oxygen to flush the N20 out of the patient circuit after the treatment. The FlowStar TouchO2- N₂O Mixer for Analgesia device has an alarm system which generates an alarm in the case of an insufficient O2 supply. The device will shut off the sedation when the O2 supply reaches a critical level. The gas mixture output of the FlowStar TouchO2- N2O Mixer for Analgesia device is connected to the Bag T. The Bag T is a device with two inputs and two outputs. One input is the gas mixture from the mixing device. The other input is a valve which opens when the adjusted total flow is too low for the patient. The gas mixture is then enriched with additional ambient air. The first output of the Bag T is for the connected breathing bag which is filled when the patient exhales and is emptied when the patient inhales. The second output leads the gas mixture to the scavenger system and finally to the patient. The main accessories for the proposed device are a Breathing Bag and a Double Mask Scavenger System.

The device includes a microprocessor-controlled valve system that precisely meters Oxygen and Nitrous Oxide gases for analgesic purposes. The inputs of the touchpad influence the gas flow inside of the device. The firmware is considered to be of a moderate level of concern.

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the FlowStar Touch Digital Mixer Flowmeter:

1. Table of Acceptance Criteria & Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in a tabulated format with specific numerical targets. Instead, it focuses on demonstrating substantial equivalence to a predicate device (Accutron Digital Ultra K052335) through comparisons of characteristics and compliance with recognized standards. The "performance" is implicitly demonstrated by meeting the standards and showing similar or improved characteristics compared to the predicate.

Below is a table summarizing the characteristics where performance could be inferred or compared:

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combi touch incorporates, within a single device, the functions of an ultrasonic scaler and of an air-polishing prophylaxis unit.

Ultrasonic scaler function:

combi touch, by using the appropriate associated inserts and the ultrasonic handpiece, is intended for use in the following dental applications:

• Removing supra and subgingival calculus deposits and stains from teeth
• Periodontal therapy and debridement for all types of periodontal disease, including periodontal pocket lavage with simultaneous ultrasonic tip movement
• Scaling and root planing
• Releasing crowns, bridges, inlays, and posts as well as condensing gutta percha
• Plugging for amalgam condensation
• Amalgam burnishing
• Preparing, cleaning and irrigating roots canals
• Cavity preparation
• Cleaning restorations and implant surfaces

Air-polishing prophylaxis function:

By using the appropriate air polishing handpiece, combi touch is intended for a complete supra-gingival and sub-gingival prophylaxis treatment.

The prophylaxis treatment is obtained by the projection of water, air and appropriate dental prophylaxis powders, onto the tooth surface. The device removes dental plaque, soft deposits, and surface stains from pits, grooves, interproximal spaces, or smooth surfaces of teeth.

combi touch is intended for the following oral prophylaxis procedures:

• Plaque removal for placement of sealants
• Surface preparation prior to bonding/cementation of inlays, onlays, crowns and veneers
• Surface preparation prior to placing composite restorations
• Effective plaque and stain removal for orthodontic patients
• Cleaning prior to bonding ortho brackets
• Cleaning implant fixtures prior to loading
• Stain removal for shade determination
• Plaque removal prior to fluoride treatment
• Plaque and stain removal prior to whitening procedure

combi touch is also intended for use as an air-polisher in patients suffering from periodontal disease. combi touch is indicated for the non-surgical removal of subgingival plaque in pockets up to 5 mm after initial periodontal treatment.

The combi touch combines, in a single appliance, a multi-purpose piezoelectric scaler and water jet, air, and powder polisher, intended for complete supra- and subgingival dental prophylaxis.

In regards to the various possible ultrasonic treatments, combi touch can be used either connected directly to the main water supply in the dental practice, or with independent irrigation through the special liquid container, which can hold different types of medical solutions.

The appliance is equipped with an automatic tuning circuit which compensates the wear of the inserts, thus always allowing operation in conditions of maximum efficiency.

The operating principle of the polisher is based on the mechanical action obtained from a jet of various crystal types accelerated by a flow of compressed air. The kinetic energy thus imprinted at the particles, dissipates almost completely due to impact against the surface of the enamel, producing a gentle but effective cleaning action. The action is completed by a jet of water which, using the vacuum created around the air-polishing handpiece, has a bellshape around the main flow, thus producing a double effect: to prevent much of the rebound and the leakage of the cloud of powder and perform continuous washing of the treated area, dissolving the powder.

The provided documentation describes the acceptance criteria and a study demonstrating that the Mectron S.p.A. "Combi Touch" device meets these criteria. The device is an ultrasonic scaler and air-polishing prophylaxis unit.

Here's the breakdown of the requested information:

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

The acceptance criteria are implicitly defined by the comparison to the predicate device and the adherence to various non-clinical performance standards. The "reported device performance" is essentially that the "combi touch" meets or is comparable to the predicate device in all measured aspects and complies with the listed standards.

Study Proving Acceptance Criteria:

The documentation states that:

"The data presented in this submission demonstrates the identities existing between the combi touch device and the predicate devices, and thus support a finding of substantial equivalence between the subject device and the referenced predicated devices, which are already in commercial distribution in the United States."

And critically, regarding performance testing:

"The results of the tests indicated that combi touch, when used in combination with the commercially-available prophylaxis powders identified above: 1) was effective in the removal of simulated plaque from dental surfaces. 2) did not cause any damages to dental surfaces, as verified by the examination of tooth surfaces morphology after the treatment; 3) proved to be safe and effective for its intended use, producing erosion that is comparable to, or even lower than, the erosion produced by the predicate device."

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

The document explicitly states: "Animal or clinical testing were not required to prove combi touch's substantial equivalence when compared to the predicate/reference devices." This implies that the testing for the "Combi Touch" device focused on non-clinical performance and engineering standard compliance rather than a traditional clinical study with patient data.

• Sample Size for Test Set: Not specified for any clinical data. For the non-clinical performance involving "simulated plaque from dental surfaces" and "examination of tooth surfaces morphology," the specific sample size of tested dental surfaces or teeth is not provided within this document.
• Data Provenance: Not specified, as it's primarily non-clinical testing.

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, as this was not a clinical study involving human ground truth assessment. The assessment of "simulated plaque" and "tooth surfaces morphology" would likely involve expert evaluation, but the number and qualifications are not detailed.

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

Not applicable, as this was not a clinical 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 device is an ultrasonic scaler/air-polisher, not an AI-powered diagnostic or assistive tool, and no MRMC study was conducted.

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

Not applicable. This device does not feature an AI algorithm for standalone performance evaluation.

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

For the non-clinical performance tests mentioned (plaque removal, dental surface damage/erosion), the ground truth appears to be based on:

• Objective measurements of simulated plaque removal.
• Laboratory examination of tooth surface morphology (e.g., microscopy) to assess damage/erosion after treatment.
• Comparison against the performance of the predicate device under similar testing conditions.

8. The sample size for the training set

Not applicable. This device does not appear to employ machine learning or AI that would require a 'training set.'

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

Not applicable.

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The FibroScan® device (Models: 502 Touch, 530 Compact, 430 Mini+, 230, and 630) is intended to measure liver stiffness (E) using Vibration Controlled Transient Elastography™ (VCTE™) at 50 Hz shear wave frequency and liver ultrasound attenuation coefficient (CAP™)* at 3.5 MHz. FibroScan® 630 Expert is also intended to measure spleen stiffness using VCTE™ at 100 Hz shear wave frequency.

FibroScan liver stiffness measurements (LSM) by VCTE™ may aid the physician in determining the likelihood of cirrhosis and may be used, taken in context with other clinical and laboratory data, as an aid in the assessment of liver fibrosis. FibroScan CAP™ measurements may be used, taken in context with other clinical and laboratory data, as an aid in the assessment of hepatic steatosis.

FibroScan® is indicated as a non-invasive aid for the clinical management, diagnosis, and monitoring of adult and pediatric patients with confirmed or suspected liver disease, as part of an overall assessment of the liver. Results in the pediatric population should be interpreted while considering the clinical condition and the overall patient profile.

The FibroScan® device is intended for use by healthcare professionals in hospitals, clinics or any facility where healthcare is provided.

*CAP™ refers to ultrasound attenuation coefficient (originally defined as Controlled Attenuation Parameter). CAP™ on S+ probe is only available with SmartExam capability.

FibroScan® System consists of a system unit and a hand-held probe. It is based on Vibration-Controlled Transient Elastography (VCTE™) technology and is designed to perform non-invasive measurements of liver/spleen shear wave speed and estimate tissue stiffness. The probe, containing a mechanical vibrator, produces low-amplitude elastic waves that travel through the skin and intercostal space into the liver/spleen. Ultrasound is used to track the shear (elastic) wave, measure its speed and provide estimated stiffness. The results are displayed on the system unit.

The provided text is a 510(k) summary for the Echosens FibroScan® device. It details the device's indications for use and compares it to predicate devices. However, the document does not contain specific acceptance criteria or an explicit study proving the device meets acceptance criteria in the format of a clinical trial with predefined endpoints and statistical significance levels.

Instead, the submission relies on the concept of substantial equivalence to previously cleared devices (K203273 and K212035) and a comprehensive review of existing clinical literature and practice guidelines to support the expanded indications for use and labeling changes. The argument is that since the fundamental technology and hardware are the same as the cleared predicate devices, and the software updates do not impact performance, new clinical performance data in the form of a dedicated prospective study was not required.

Therefore, the requested information cannot be fully extracted in the typical format of a clinical study report. Here's what can be inferred and stated based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

As stated, the document does not present explicit acceptance criteria or a dedicated performance study with specific metrics in tabular format. The "performance" described is the device's consistent and robust correlation with established medical conditions, supported by existing literature.

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

• Test Set (Clinical Evidence for expanded claims): The "test set" for the expanded indications are collections of retrospective clinical literature reviews and professional guidelines.
  • Liver Fibrosis/Cirrhosis: 3 longitudinal studies (290 patients), 18 meta-analyses (369 studies, >40,000 patients).
  • Hepatic Steatosis: 6 meta-analysis publications (138 studies, ~12,900 patients).
  • Probe Use across Morphology: 41 papers (~8,570 patients).
    • S+ probe: 3 studies (n=250)
    • M+ probe: 29 studies (n=5,950)
    • XL+ probe: 9 studies (n=2,369)
  • Pediatric Use: 24 papers (n=6,573) for diagnosis, 6 additional papers (n=293) for monitoring.
  • Suspected Liver Disease: 10 studies (n=5,650 patients).
  • Active Implants: 2 studies (141 patients).
  • Pregnant Women: 3 studies (611 pregnant women).
• Data Provenance: The document does not specify the country of origin for the individual studies in the clinical literature review but indicates it's a "comprehensive clinical literature," implying international data. All studies are retrospective in the context of this submission, meaning they were published prior to this 510(k) submission.

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

The document does not specify the number of experts used to establish the ground truth for the test set in the context of this submission. The ground truth for the underlying studies in the literature review would have been established by the relevant medical professionals (e.g., pathologists for liver biopsies, radiologists, hepatologists) in those individual studies. The statement "Papers used in support of the changes were focused on studies in which FibroScan® results are compared to the ground truth of liver biopsy" indicates the ultimate gold standard used in many of these studies.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method for a test set in the formal sense (e.g., 2+1, 3+1). The "adjudication" is implicitly done through the scientific peer-review process of the published literature and the consensus reflected in professional clinical guidelines that support the use of FibroScan.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done as part of this 510(k) submission. The submission is based on substantial equivalence and a literature review supporting expanded indications for a device with established efficacy.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

The FibroScan® device, by its nature, is a diagnostic imaging tool that measures physical parameters (liver stiffness, attenuation). While it generates quantitative data (LSM, CAP values), these are intended to be used by a healthcare professional "in context with other clinical and laboratory data, as an aid in the assessment." Therefore, it inherently involves human interpretation. The question of "algorithm only" performance typically applies to AI-driven diagnostic image analysis systems providing a direct diagnosis or flagging pathologies. FibroScan provides quantitative measurements for interpretation by a human.

7. Type of Ground Truth Used

The primary ground truth for the majority of the supporting literature, especially for liver fibrosis and steatosis, is liver biopsy. The document explicitly states: "Papers used in support of the changes were focused on studies in which FibroScan® results are compared to the ground truth of liver biopsy." For other claims, the "ground truth" would be established clinical diagnoses, patient outcomes, and medical assessments based on a combination of clinical, laboratory, and other imaging data.

8. Sample Size for the Training Set

The document does not specify a "training set" sample size for this 510(k) submission. The FibroScan® device is based on physical measurement principles (VCTE™ and CAP™) rather than a machine learning algorithm that requires a separate training set in the typical sense. The underlying algorithms for shear wave speed and attenuation calculation would have been developed and validated through engineering and physical modeling, potentially with internal data, but this is not a "training set" for an AI model.

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

As there is no "training set" in the context of an AI/ML algorithm development as typically understood, this question is not directly applicable. The core technology relies on well-established physics. The calibration and validation of the device's measurements against physical phantoms or established reference standards would be part of its engineering development, rather than establishing "ground truth" for a training set of patient data.

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The CLEAR + BRILLIANT TOUCH® System is indicated for use in dermatological procedures requiring the coagulation of soft tissue and general skin resurfacing procedures.

The CLEAR + BRILLIANT TOUCH® Laser System is the second generation of the Clear+Brilliant line of products. Clear+Brilliant products use non-ablative laser designed for use in dermatological procedures intended to improve the appearance of a patient's skin. The system incorporates self-diagnostic algorithms to ensure its correct operation. The CLEAR + BRILLIANT TOUCH® Laser System is part of the family of Solta Medical products using the fractional photothermolysis principle to resurface the skin.

CLEAR + BRILLIANT TOUCH® Laser System is comprised of four sub-systems:

• 1. Console
• 2. Handpieces: 1440nm and 1927nm (Perméa) handpieces
• 3. Treatment Tip
• 4. Credit Key

The console and up to two handpieces are connected mechanically and electrically by an umbilical cable. The treatment tip is mechanically and magnetically secured to the handpiece. All components must be properly connected and fully functional for the system to be operable. The system will not permit laser energy output until the treatment tip is in contact with the patient's skin.

The embedded processor and software control the precise delivery of the fractional laser treatment by directing the electrical and mechanical components that determine the position, spacing, and focus of the optical output. The processor and software also monitor the status of a treatment and the system and present this information to the operator on the touchscreen.

The Credit Key is the replaceable accessory allowing access to treatment credits and is attachable to the console. It is removable and is disposed of after the credit balance reaches zero.

The solid-state design of CLEAR + BRILLIANT TOUCH® Laser System limits maintenance and minimizes utility requirements.

The provided document does not contain information about specific acceptance criteria, reported device performance, or a clinical study for the CLEAR+BRILLIANT TOUCH® Laser System as it would for an AI/ML powered device. This document is a 510(k) premarket notification for a medical device that utilizes laser technology for dermatological procedures, not an AI/ML diagnostic or prognostic tool.

Here's a breakdown of why the requested information cannot be fully provided based on the input text:

• Type of Device: The CLEAR+BRILLIANT TOUCH® Laser System is a physical laser device, not a software algorithm that performs diagnostics or prognostics. Therefore, the typical acceptance criteria and study designs (like standalone performance, MRMC studies, ground truth establishment) for AI/ML devices do not apply.
• 510(k) Clearance: This is a 510(k) submission, which aims to demonstrate substantial equivalence to a legally marketed predicate device. The focus is on comparing technological characteristics, safety standards compliance, and non-clinical performance (like electrical safety, electromagnetic compatibility, biocompatibility, and software validation), rather than a clinical effectiveness study with specific diagnostic performance metrics like sensitivity or specificity.

However, I can extract the relevant information that is present in the document.

Information Present in the Document:

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

The document lists various non-clinical performance tests and standards to which the device must conform, and it states that the device "passed all the above applicable standards testing." These standards serve as the "acceptance criteria" for safety and basic performance.

The overall performance evaluation states: "The product performance testing demonstrates that the functional requirements have been met and that CLEAR+BRILLIANT TOUCH® Laser System is equivalent to the predicate device."

The following requested information is NOT applicable or NOT found in the provided document, as it pertains to AI/ML or clinical efficacy studies that are typically not part of a 510(k) submission for this type of laser device:

2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable for a laser device's non-clinical performance testing.
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. Ground truth for a laser device's safety and performance involves engineering and standards compliance, not medical expert interpretation of data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable, as this is a laser device, not an AI/ML-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the context of an AI/ML device. For this laser device, the "ground truth" for non-clinical testing is adherence to established engineering, electrical, biocompatibility, and safety standards.
8. The sample size for the training set: Not applicable (no AI/ML training set).
9. How the ground truth for the training set was established: Not applicable (no AI/ML training set).

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The Unistik® Touch is a puncture device to obtain micro blood samples. Unistik Touch has a sharps prevention feature to protect the user from a needlestick injury.

The Unistik® Touch contact-activated safety lancets are hand-held disposable devices intended for performing controlled skin punctures of the fingertips in adults and children, by means of a needle lancing mechanism. Unistik® Touch safety lancets are indicated for use where a capillary blood specimen is required for the purposes of performing in-vitro diagnostic (IVD) assays, e.g. for blood glucose monitoring in patients with diabetes. The Unistik® Touch contact-activated safety lancets are available in five different variants of needle gauge as follows: Needle gauge 16G, Penetration Depth 2.0 mm Needle gauge 21G, Penetration Depth 2.0 mm Needle gauge 23G, Penetration Depth 2.0 mm Needle gauge 28G, Penetration Depth 1.8 mm Needle gauge 30G, Penetration Depth 1.5 mm The Unistik® Touch contact-activated safety lancets are intended for prescription and over-the-counter use and to be used by self-testing patients, care-givers and healthcare professionals. The devices are designed to perform a controlled skin puncture on the fingertip, in order for caregivers and healthcare professionals to obtain capillary blood specimens from patients for IVD assays, and also for lay (home) users to be able to perform a skin puncture on themselves where an IVD self-testing regime is required. The intended user population includes male and female. right or left-handed self-administering patients, care givers and healthcare professionals. The frequency of use and intended patient population is dependent on the given diagnostic regime. Unistik® Touch contact-activated safety lancets are sterile single-use devices with integral sharps protection whereby the lancet blade or needle is shielded before and after use to prevent needlestick injuries, so mitigating the hazard of transmission of blood-borne infectious agents. Furthermore, the devices automatically self-disable after a single use, thus preventing any hazards of re-use. The Unistik® Touch contact-activated safety lancets achieve their intended purpose of performing controlled skin punctures of the fingertips in adults and children, by means of a needle lancing mechanism with a pre-loaded steel spring for propelling the lancet holder forward when the device is activated and subsequently automatically retracting it. After retraction, the lancet holder is automatically locked into the device such that the device cannot be re-used and the needle tip is safely shielded. The lancet needles are moulded into the lancet holder component such that the needle tip is sealed by complete encapsulation in overmoulded plastic. The complete lancet holder component is then sterilised by gamma irradiation, so after irradiation the sterility of the needle tip is maintained by encapsulation within the plastic. The sterile seal is only broken when the user twists off and removes the lancet cap immediately before use. The needle tip is the exposed needle length after the cap is removed, and this is the only part of the needle that will penetrate the patient's skin during use. Therefore, the encapsulation of the needle tip by plastic overmoulding performs the function of primary packaging, whereby a sterile seal is maintained until the point of use.

The Unistik® Touch Single-Use Safety Lancets were evaluated through a series of non-clinical performance studies, primarily bench testing and a simulated clinical use study.

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

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

• Simulated Clinical Use Study: 500 device samples were used.
• Data Provenance: The document does not specify the country of origin of the data, nor whether it was retrospective or prospective, beyond stating it was a "simulated clinical use study."

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

• This information is not provided in the document. The studies described are non-clinical, primarily bench testing, and a simulated clinical use study. The performance criteria are objective measurements against established standards (e.g., ISO, FDA guidance).

4. Adjudication method for the test set:

• This information is not applicable and not provided. The studies involved objective measurements against predefined acceptance criteria rather than subjective expert 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:

• No, an MRMC comparative effectiveness study was not done. This device is a blood lancet, not an AI-assisted diagnostic tool for human readers.

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

• Not applicable. This device is a physical medical device, not an algorithm. The "standalone" performance here refers to the device's inherent functional performance without human interaction regarding its analytical functions (e.g., accurate puncture depth, safety mechanism activation). This was assessed through the various bench tests.

7. The type of ground truth used:

• The ground truth for the bench testing was based on objective, verifiable measurements and physical characteristics outlined in the acceptance criteria (e.g., freedom from burrs, adherence to dimensions, pH values, metal content, puncture depth measurements, force to activate safety features).
• For the simulated clinical use study, the ground truth was based on demonstrating that the device "met the pre-established criteria" for its safety mechanism, as evaluated against FDA Guidance and ISO 23908.

8. The sample size for the training set:

• Not applicable. This is a physical medical device, not an AI/ML algorithm that requires a training set in the conventional sense.

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

• Not applicable. As noted above, this is a physical medical device and does not involve a training set for an AI/ML algorithm.

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The Home use hair removal device is an over-the-counter device intended for removal of unwanted body hair and/or facial hair.

The Precise Touch Pro Home use hair removal device is a personal. light-based, hair reduction device intended to be sold over-the-counter directly to the end user. The device provides hair reduction using Intense Pulsed Light (IPL) technology to perform hair removal. The device mainly consists of IPL main body, AC adapter and device stand three parts and it is only powered by the external power adapter, as well as the treatment window located in the main body which is the source of optical radiation, namely a Xenon flashlamp and the built-in skin sensor to detect the body skin area. If the device is not properly applied to the expected treatment area (in full contact with the skin), the device cannot be automatic triggered a pulse emitting.

The provided text does not contain information about acceptance criteria for a device's performance, nor does it describe a study proving the device meets specific performance criteria related to medical effectiveness (e.g., hair reduction efficacy percentages).

The document is a 510(k) summary for a home-use hair removal device (Precise Touch Pro) and focuses on demonstrating substantial equivalence to predicate devices, not on proving de novo clinical efficacy against specific acceptance criteria.

The "Performance Data" section primarily addresses:

1. Biocompatibility Testing: Ensuring the materials are safe for body contact.
2. Electrical Safety and Eye Safety: Compliance with relevant international standards.
3. Software Verification and Validation: Assuring software functions correctly and mitigates risks.

These are safety and engineering performance aspects for regulatory compliance, not efficacy performance related to the device's intended use of hair removal in terms of, for example, a targeted percentage reduction in hair.

Therefore, I cannot provide the requested information regarding acceptance criteria for device performance and a study proving it, as that information is not present in the provided text.

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