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The Motif Aura Glow breast pump (Model Motif Aura Glow) is a powered breast pump intended to be used by lactating women to express and collect milk from their breasts. It is intended for a single user.

The Motif Aura Glow breast pump (Model Motif Aura Glow) is a powered breast pump intended to be used by lactating women to express and collect milk from their breasts, it is intended for a single user. The Motif Aura Glow breast pump (Model Motif Aura Glow) is powered by a lithium battery, utilizing an embedded control program to manage all device functions. The main components of this pump include: Pump, valve, control board, and milk collector. The user interface allows the user to switch from massage, expression, cluster feeding, and general pumping modes and control the vacuum levels within those modes.

Massage, expression, and general pumping modes consist of 9 vacuum levels. Cluster feeding mode consists of 5 vacuum levels. The Motif Aura Glow breast pump (Model Motif Aura Glow) is capable of providing vacuum levels from 40-160 mmHg with cycling rates from 75-120 cycles per minute in massage mode, vacuum levels from 120-245 mmHg with cycling rates from 30-85 cycles per minute in expression mode, vacuum levels from 40-200 mmHg with cycling rates from 45-120 cycles per minute in cluster feeding mode, and vacuum levels from 60-245 mmHg with cycling rates from 30-120 cycles per minute in general pumping mode. The Motif Aura Glow breast pump (Model Motif Aura Glow) is charged with a 5 V DC adaptor and powered by an internal rechargeable lithium-ion polymer battery. The motor unit operates on embedded software. Software updates by end-users are not supported. The subject device is for repeated use by a single user in a home environment. The device is provided not sterile.

The motor unit operates on a rechargeable battery and does not function when charging. The rechargeable battery can be charged from the external USB adapter if the motor unit is not in operation.

The breast pump expresses milk by creating a seal around the nipple using the flange and applying and releasing suction to the nipple. The milk is collected in a milk collection container, which can be used for storage. To prevent milk from flowing into the vacuum system, a backflow protection membrane physically separates the milk-contacting pathway from the vacuum system.

All other components (i.e., motor unit/housing) of the subject device are not in contact with the breast. All milk contacting components are compliant with 21 CFR 174-179.

Based on the provided FDA Clearance Letter for the Motif Aura Glow breast pump (Model Motif Aura Glow), here's an analysis of the acceptance criteria and the study that proves the device meets them:

Important Note: This document is an FDA Clearance Letter, which is a summary of the FDA's decision regarding substantial equivalence. It does not contain detailed study reports or raw data typically found in clinical trial results or full submission documents. Therefore, some of the requested information (especially quantitative effectiveness data for AI-assisted human reading, if this were an AI device) is not present here, as this is a breast pump, not an AI diagnostic device. I will address each point based on the information available and indicate where information is not applicable (N/A) or not provided in this specific document.

Device: Motif Aura Glow breast pump (Model Motif Aura Glow)

Device Type: Powered Breast Pump (Medical Device, not an AI/Software as a Medical Device for diagnostic purposes)
Product Code: HGX
Regulatory Class: Class II

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a breast pump and not a diagnostic AI device, the "acceptance criteria" revolve around functional performance, safety, and equivalence to a predicate device, rather than diagnostic metrics like sensitivity/specificity.

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

• Test Set Sample Size: The document does not specify the sample sizes for the individual performance, safety, or biocompatibility tests. It only states that "Testing was conducted" and "Performance testing was conducted." For a physical device like a breast pump, "test set" typically refers to the number of units tested. This information is not detailed in the summary letter.
• Data Provenance: The manufacturer is "Shenzhen TPH Technology Co., Ltd." in Shenzhen, Guangdong, China. The testing was conducted as part of their 510(k) submission to the US FDA. The document does not specify whether the tests themselves were conducted in China or elsewhere, nor whether they were retrospective or prospective studies (this concept mostly applies to clinical data collection, which is not detailed here for this device type).

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

• Not Applicable (N/A): For a breast pump, there isn't a concept of "ground truth" established by experts in the same way as for a diagnostic AI device (e.g., radiologists interpreting images). The acceptance criteria are based on engineering specifications, safety standards, and functional performance. The "ground truth" is typically defined by the device's design specifications and industry standards, verified through objective measurements and validated test methods.

4. Adjudication Method for the Test Set

• N/A: As "ground truth" from human experts is not established for this device type, there is no adjudication method among experts. Performance is measured against predefined objective standards.

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

• No: An MRMC comparative effectiveness study is typically conducted for diagnostic devices (especially AI-powered ones) to assess the impact of the device on human reader performance. This is a physical breast pump, not a diagnostic device, so such a study is not applicable.

6. If a Standalone Performance Study (Algorithm Only) was done

• Yes, in essence. The performance testing (e.g., vacuum level verification, cycle speed, backflow protection, battery life) are "standalone" tests of the device's inherent functional capabilities against its specifications. The software evaluation was also a standalone assessment of the embedded control program. There isn't an "algorithm-only" performance in the sense of an AI model's output being compared to ground truth, but the physical and software functionalities were tested independently of human interaction for their core performance.

7. The Type of Ground Truth Used

• Objective Engineering Specifications and International/National Standards: The "ground truth" for this device's performance acceptance is based on its own design specifications (e.g., stated vacuum ranges and cycle speeds), and adherence to recognized electrical safety (e.g., IEC 60601 series), EMC, and biocompatibility (e.g., ISO 10993-1) standards. For instance, a stated vacuum level of -160 mmHg is verified by direct measurement using calibrated equipment; the "ground truth" is the measurement itself, compared to the specification.

8. The Sample Size for the Training Set

• N/A: This is a physical breast pump with embedded control software, not a machine learning/AI model that requires a "training set" of data in the common sense (e.g., for image classification or prediction). The software is a "fixed function" embedded control program.

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

• N/A: As there is no "training set" in the context of machine learning, this question does not apply. The "ground truth" for the device's design and functionality is derived from engineering principles and regulatory requirements for powered breast pumps.

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The AURA 10 PET/CT system is a cabinet diagnostic imaging device that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The AURA 10 PET/CT system images harvested specimens from various anatomical regions in order to provide rapid verfication that the correct tissue has been excised during the surgical procedure. Images can be obtained as CT only, or a combination of both by surgeon's discretion.

The AURA 10 cabinet PET/CT system provides an image of extent and degree of intensity radiopharmaceutical uptake in the specimen by PET and the anatomical information by CT, which will help the surgeon with further patient management.

The AURA 10 PET/CT system is not validated for margin detection.

The AURA 10 PET/CT is a mobile, vertical-bore PET/CT system with a Field of View (FOV) suitable for small pathology specimens. It is intended to be used in both the operating room (OR) as well as the pathology department to image pathology specimens from various anatomical regions in order to provide rapid pathology imaging. The AURA 10 PET/CT is intended to image pathology specimens for a wide range of patient types, sizes, and extent of diseases. It is designed as a mobile cart so that it is easily portable by one person and can be moved to different surgical suites or between departments as needed.

The provided text describes the regulatory clearance for the AURA 10 PET/CT system, which is a cabinet diagnostic imaging device for imaging harvested specimens. However, it explicitly states, "Not applicable. Clinical studies are not necessary to establish the substantial equivalence of this device." This means that the submission does not include information about clinical performance data or a study proving the device meets acceptance criteria derived from clinical studies.

The document focuses on demonstrating substantial equivalence to a predicate device (Vereos PET/CT) and a reference device (Faxitron VisionCT) through non-clinical performance data, primarily bench testing, electrical safety, EMC, and software verification/validation.

Therefore, it is not possible to provide the requested information regarding acceptance criteria and a study that proves the device meets those criteria from a clinical performance perspective. The clearance is based on technological characteristics and non-clinical testing demonstrating equivalency to existing cleared devices, not on a new clinical performance study.

Here's an explanation based on the provided text's limitations:

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

• Acceptance Criteria: No specific clinical acceptance criteria (e.g., sensitivity, specificity, accuracy against a clinical ground truth) are provided in the document. The acceptance for this device is based on meeting safety and performance standards through non-clinical testing and demonstrating technological equivalence to predicate devices.
• Reported Device Performance (Non-Clinical):
  • Electrical Safety & EMC: "The device passed all tests" for IEC 61010-1, IEC 61010-2-091, IEC 61010-2-101, and IEC 61326-2-6.
  • Software Verification & Validation: "Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance... The software for this device was considered as a moderate level of concern." "The AURA 10 PET/CT was tested in accordance with IEC 62304:2006 + A1:2015...".
  • Bench Testing:
    • Analytical performance testing: "The AURA 10 PET/CT was tested in accordance with NEMA NU 4-2008 - Performance measurements of small animal positron emission tomographs (PETs)." (Specific performance numbers from this test, like spatial resolution or peak NEC rate, are listed in the "Technological characteristics" table, but it's not explicitly stated that these are the "acceptance criteria" for clearance, rather they are characteristics measured against the predicate.)
    • Usability testing: "The AURA 10 PET/CT was tested in accordance with IEC 62366-1:2015... Usability testing was conducted and documentation provided as recommended by FDA's Guidance...".

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

• Since no clinical studies were performed, there is no "test set" in the context of clinical data. The non-clinical tests involved hardware and software evaluations.

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

• Not applicable, as no clinical ground truth was established by experts for a clinical test set.

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

• Not applicable, as no clinical test set requiring adjudication was used.

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

• No MRMC study was done, as explicitly stated, "Clinical studies are not necessary to establish the substantial equivalence of this device." This device is an imaging system, not an AI-assisted diagnostic tool for human readers in the traditional sense of improving reader performance. Its purpose is to provide images for verification.

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

• The device is a medical imaging system (PET/CT), not an algorithm that produces a diagnostic output on its own. Its "performance" is in image generation and quality, which was evaluated through bench testing.

7. The type of ground truth used:

• For the non-clinical bench testing, the "ground truth" would be the known physical properties and performance characteristics of phantoms and test setups used in accordance with standards like NEMA NU 4-2008.

8. The sample size for the training set:

• Not applicable, as this documentation does not describe an AI/ML model that would require a "training set" of data for its primary function. It's a hardware imaging system.

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

• Not applicable.

In summary: The provided FDA 510(k) clearance letter and summary for the AURA 10 PET/CT system indicate that its clearance was based on demonstrating "substantial equivalence" to existing, legally marketed predicate devices through non-clinical testing (electrical safety, EMC, software V&V, and bench testing against industry standards like NEMA NU 4-2008) and a comparison of technological characteristics. No clinical performance studies, human reader studies, or AI algorithm performance studies were deemed necessary for this clearance.

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The Xstrahl Photoelectric Therapy System is a low energy X-Ray system intended for superficial radiotherapy and surface electronic brachytherapy treatment of primary malignant epithelial neoplasms of the skin and keloids.

Typical applications include treatment for Basal Cell Carcinoma, Squamous Cell Carcinoma, Metatypic Carcinoma, Cutaneous Appendage Carcinoma, Karposi's Sarcoma, Merkel Cell Carcinoma, Lentigo Maligna, Lentigo Maligna Melanoma, Cutaneous Lymphomas (B and T cell) and Keloids.

The X80 / RADiant / Photoelectric Therapy System (hereafter referred to as the RADiant System) is a compact and ergonomic superficial X-Ray therapy system operating in the 10kV to 80kV range intended for superficial radiotherapy and surface electronic brachytherapy treatment of primary malignant epithelial neoplasms of the skin and keloids.

The RADiant System is a standalone X-Ray radiation therapy system consisting of the X-Ray Therapy Unit, a TP2 Central Control Unit (CCU), a Control POD (Control POD), and a PC on which user interface software is loaded. The system has a time-based control system used with treatment filters and applicators. A range of bespoke treatment applicators and beam filters are available for use with the RADiant System.

The system is freestanding, self-contained, unobtrusive, compact and ergonomic in design, which helps to ensure a reassuring and stress-free patient experience. The system is floor mounted in order to accommodate almost any clinical space, and features ergonomically designed controls ensuring smooth adjustment and safe, simple patient set-up. The system requires connection to the clinical facilities electrical supply and room interlocks.

The Xstrahl Photoelectric Therapy System (RADiant Aura) is a low energy X-Ray system intended for superficial radiotherapy and surface electronic brachytherapy treatment of primary malignant epithelial neoplasms of the skin and keloids.

Here’s an analysis of the provided information regarding its acceptance criteria and the study:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific acceptance criteria for performance metrics in a clinical study. The "acceptance criteria" here are generally understood as meeting design requirements, mitigating risks, and conforming to relevant standards, which are evaluated through non-clinical testing.

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

• Sample Size for Test Set: Not explicitly stated as a "test set" in the context of clinical data. The testing described largely involves non-clinical (engineering and technical) verification and validation. This means the "sample size" would refer to the number of devices or components tested. The document mentions "Twenty Six independent verification tests and 18 independent validation tests were executed on the RADiant Aura systems." This implies that at least one, but likely a limited number (e.g., prototype or production units), of RADiant Aura systems were subjected to these tests.
• Data Provenance: This information refers to the origin of the data. Since the testing is non-clinical, the data provenance is primarily from internal testing conducted by Xstrahl Ltd. and independent testing by the National Physics Laboratory UK (NPL). The context is purely technical performance evaluation, not clinical outcomes from human patients. The data is prospective in the sense that it was generated specifically for this submission to verify the new design. There is no mention of country of origin of clinical data, as no clinical data is presented.

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

This section is not applicable as the document describes non-clinical performance and safety testing, not a clinical study requiring expert-established ground truth for a test set (e.g., image interpretation or disease diagnosis). The "ground truth" here is adherence to engineering specifications, safety standards, and physical laws, verified by technical measurements and evaluations.

4. Adjudication Method for the Test Set

This is not applicable as the document describes non-clinical performance and safety testing. Adjudication methods are typically used in clinical studies when multiple human readers evaluate data, and their assessments need to be reconciled to establish a ground truth.

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 an X-Ray radiation therapy system, not an AI diagnostic or assistance tool. The submission focuses on the safety and performance of the hardware and software for delivering radiation therapy, not on interpreting medical images or assisting human readers in diagnosis.

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

This question is not directly applicable in the context of this device. The "algorithm" in this case refers to the embedded software and control systems of the radiation therapy device. The non-clinical testing described (e.g., software run-through functionality test, dose reproducibility) effectively evaluates the "standalone" performance of these systems in meeting their intended technical specifications, without direct human intervention in the treatment delivery process once programmed. However, the device itself is a treatment device, not a diagnostic algorithm.

7. The Type of Ground Truth Used

For the non-clinical testing, the "ground truth" used was based on:

• Engineering specifications and design requirements: The device was tested against its defined operational parameters and expected performance.
• International and national standards: Compliance with standards like BS EN 60601-2-8, IEC 60601-1, etc., served as the ground truth for safety, electrical performance, usability, and software lifecycle.
• Recognized codes of practice: For output measurements, protocols from AAPM (2001) and IPEMB (1996) were used as the benchmark for accurate dose delivery.

8. The Sample Size for the Training Set

There is no mention of a training set in the document. This is because the device is not an AI/ML-based diagnostic or predictive algorithm that typically requires large datasets for training. The software components mentioned (Concerto, Fisica, TP2) appear to be control software and firmware for the device's operation, not machine learning models.

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

This is not applicable as there is no training set for an AI/ML model mentioned in the context of this device.

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The Aura Storm air purifier is a device intended for medical purposes that is used to capture and destroy bacteria and viruses in the air through the multi-stage filtration system and exposure to ultraviolet radiation.
The Aura Storm air purifier has been demonstrated to destroy the following bacteria: Staphylococcus albicans, Staphylococcus aureus, and Escherichia Coli, and virus: A/PR8/34 HIN1 virus entrained on the filter of the subject device under the following exposure conditions:
Average Maximum log reduction / entrainment time (minutes) at Fan Speed 4. Room Temperature test: Log 4 (99.99%) / 60 minutes.
Average Maximum log reduction / entrainment time (minutes) at Fan Speed 1. Room Temperature test: Log 4 (99.99%) / 120 minutes.

The Aura Storm is a multi-stage UV-C air purifier that delivers air purification for rooms up to 2700 square feet (*52ft x 52ft). The Storm inactivates and eliminates bacteria and viruses in the Aura Storm may be used for medical purposes which can include hospitals, medical facilities, medical clinics, nursing facilities, and dental facilities. The Aura Storm is a standalone device that is controlled via buttons on the top of the unit.
The Aura Storm is a dual-sided system with each side consisting of four-stage is a prefilter. The second stage is a HEPA H13+ filter. The third stage is a TiO2 cold photo-catalyst filter. Finally, the UV-C sterilization lamp emits a 253.7mm designed to activate the photo-catalyst filter and eliminate bacteria and viruses. The anion generator is used strictly to increase the size of the particulate molecules to increase the ability to capture and eliminate the bacteria and viruses. This designed system delivers a third-party tested 99.99% (4-log) sterilization in 60 minutes at the highest fan speed. The Aura storm was also tested at the lowest fan speed and delivered a 99.99% (4-log) sterilization in 120 minutes. The air flow diagram has been submitted in the 510(k) submission.
There is an internal fan which draws in air from both sides of the unit, filters it through the multi-stage system and outputs the filtered air through the top of the unit features a capacitive touch button control to operate the On/Off, fan speed (4 speeds), Auto mode, UV lamp, Anion generator, Child lock, timer, and filter reset. There is also a particulate matter sensor and color bar to indicate the level of clean air.

The Invictus Aura Storm Air Purifier (K212644) has been tested for its ability to reduce bacteria and inactivate viruses, and for its filtration efficiency.

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided document does not explicitly state the country of origin for the data or whether the studies were retrospective or prospective.

• Bacteria Reduction Test: For each of the three bacteria (Staphylococcus albicans, Staphylococcus aureus, and Escherichia Coli), three separate tests were conducted. Each test involved a control group and a test group, indicating a total of 3 samples per bacteria type, or 9 samples for bacteria reduction.
• Virus Inactivation Test: Three separate tests were conducted for the A/PR8/34 H1N1 virus.
• Filtration Efficiency Testing: The sample size for this test is not specified, but it was conducted by a 3rd party accredited laboratory.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. The ground truth for these tests (bacterial/viral counts, filtration efficiency) is established through laboratory measurements and standardized protocols, not by expert consensus or interpretation of images.

4. Adjudication Method

Not applicable for these types of laboratory tests. The results are quantitative measurements obtained through direct testing, rather than subjective assessments requiring adjudication.

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

Not applicable. The device is an air purifier, and its performance is measured through direct laboratory tests for microbial reduction and filtration efficiency, not through human reader interpretation or clinical assessment that would require an MRMC study.

6. Standalone Performance

Yes, a standalone (algorithm only without human-in-the-loop performance) study was done. The reported performance metrics (log reduction, elimination rates, filtration efficiency) are direct measurements of the device's capability without human intervention in its operation or performance assessment.

7. Type of Ground Truth Used

The ground truth used is based on controlled laboratory measurements of:

• Bacterial colony-forming units (CFU/m3) for bacteria reduction tests.
• Viral activation/reduction measurements for virus inactivation tests.
• Particle counts for filtration efficiency tests.

These measurements are considered objective and quantitative.

8. Sample Size for the Training Set

Not applicable. The Invictus Aura Storm Air Purifier is a physical device, not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning.

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

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

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The A123 is used for aspiration, harvesting, filtering and transferring of autologous adipose tissue for aesthetic body contouring. The system should be used with a legally marketed vacuum or aspirator apparatus as a source of suction. If harvested fat is to be re-implanted, the harvested fat is to be used without any additional manipulation.

The A123 is intended for use in the following surgical specialties when aspiration of soft tissue is desired: plastic and reconstructive surgery, neurosurgery, gastrointestinal and affiliated organ surgery, urological surgery, general surgery, orthopedic surgery, gynecological surgery, thoracic surgery, and laparoscopic surgery.

The A123 is a suction lipoplasty system designed to be used in the operating room in conjunction with, and attached to, a user-provided liposuction cannula, a vacuum source, and a waste canister. The A123 allows the surgeon to conveniently and accurately harvest, wash, filter, concentrate, and transfer autologous adipose tissue for reinjection into the same patient for body contouring in cosmetic and reconstructive surgery applications during the same procedure in which autologous adipose tissue is collected. The system is a sterile, disposable unit for single patient use.

The A123 consists of the following components:

• Collection chamber
• Collection mesh basket
• Concentration chamber with fluid-absorbing pads
• AuraClens™ powder packets
• Outlet tube and drain valve with tube clamp
• Mixing spatula

The A123 is to be used together with FDA-cleared devices (such as a lipoplasty device [Product Code MUU, Requlation Number 21 CFR 878.50401, liposuction cannula, high vacuum tubing, waste container, syringes [e.g. 60 cc Toomev-tip svringes, Luer-Lock, Product Code KYZ1, and roomtemperature, sterile 0.9% normal saline solution, all provided by the user.

The provided text describes the 510(k) summary for the AuraGen 123™ Suction Lipoplasty System (A123). This device is a Class II medical device used for aspirating, harvesting, filtering, and transferring autologous adipose tissue for aesthetic body contouring. The summary details bench testing conducted to demonstrate substantial equivalence to a predicate device.

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

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

The document mentions that "The A123 meets the acceptance criteria for all tests," but it does not provide a table detailing the specific acceptance criteria for each test nor the quantitative reported device performance values. It lists the bench tests performed but not the specific thresholds for "meeting" the criteria.

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

The document mentions "A123 units were tested" for various bench tests, but it does not specify the sample size (number of units) used for each test.
The data provenance is not explicitly stated in terms of country of origin. The study appears to be retrospective in the sense that it's bench testing on manufactured units, rather than a prospective clinical trial.

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

This information is not applicable to this type of submission. The ground truth for bench testing of a lipoplasty system involves quantifiable physical measurements and material properties, rather than expert interpretation of medical images or conditions.

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

This is not applicable. Adjudication methods are typically used in studies involving subjective human interpretation (e.g., reading medical images) to resolve discrepancies. For bench testing, the results are typically objective measurements.

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. This submission is for a medical device used for tissue processing, not an AI-assisted diagnostic tool that supports human readers/interpreters.

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

This is not applicable. The device is a physical system, not an algorithm.

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

The "ground truth" for this device's performance evaluation is based on objective, quantitative measurements obtained through standardized bench testing methods (e.g., centrifugation for fat volume, time measurement for TTG, force measurement for tensile strength, and established ISO standards for sterility, biocompatibility, implosion, collapse, and leak tests).

8. The sample size for the training set:

This is not applicable. The device is a physical product and not an AI algorithm that requires a training set.

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

This is not applicable. As stated above, the device is not an AI algorithm.

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The Branchpoint AURA™ ICP Monitoring System is intended for use by a qualified neurosurgeon in the direct monitoring of intracranial pressure in intraparenchymal applications.

The Branchpoint AURA™ ICP Monitoring System is a device intended for monitoring intracranial pressure (ICP). The Branchpoint AURA™ ICP Monitoring System is composed of the following three packages:
Package 1) AURA™ Sensor Tray (Model SP101-A)

• AURA™ Sensor (Model 10025G)
• Disposable Scalp Retractor (Model OS0001B)
• Disposable Drill Bit with Collar (Model 10008C)
• Disposable Torque Wrench (Model OS0004C)
• Disposable Antenna Holster (Model 10007A)
  Package 2) AURA™ Monitor Pack (Model TK101-A)
• AURA™ Monitor (Model T0011B)
• AURA™ Antenna (Model T0010A)
• 2x Lithium-Ion 11v Rechargeable Batteries (Model T0032A)
• Two-bay battery charger (Model T0014A)
  Package 3) AURA™ Data Receiver Pack (Model DG101-A)
• AURA™ Data Receiver (Model D0004B)

Here's a breakdown of the acceptance criteria and the study information for the AURA™ ICP Monitoring System, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA 510(k) summary provides a list of non-clinical bench tests performed to support substantial equivalence and demonstrate device performance. For the direct ICP measurement, the relevant standard is ANSI/AAMI NS28:1988(r)2010. While specific numerical acceptance criteria and precise reported device performance values for ICP measurement itself are not detailed in the provided text beyond meeting the standard, the document states:

For Biocompatibility, specific results are provided:

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AcceleDent® Aura is intended for use during orthodontic treatment. It is used in conjunction with brackets and wires or aligners and helps facilitate minor anterior tooth movement.

The AcceleDent® Aura is an orthodontic accessory for the treatment of tooth malocclusion. AcceleDent® Aura should be used by patients for twenty minutes per day in conjunction with standard orthodontic treatment.

The provided text describes a 510(k) premarket notification for a modified medical device, the AcceleDent® Aura, which is an orthodontic accessory. The submission focuses on expanding the indications for use to include patients undergoing orthodontic treatment with aligners.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state "acceptance criteria" in the traditional sense of a pass/fail threshold for a specific performance metric. Instead, it relies on demonstrating substantial equivalence to predicate devices, particularly regarding clinical outcomes with aligners. The key "performance" aspect is the demonstration of facilitation of tooth movement.

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The AURA DR 43C-AG detector is indicated for digital imaging solution designed for general radiographic system for human anatomy. It is intended to replace film or screen based radiographic system in all general-purpose diagnostic procedures. It is not to be used for mammography.

AURA DR 43C-AG is a digital X-ray flat panel detector which has 43cm x 43cm imaging area and communicates with a wired communication feature, Giga-bit Ethernet communication method through connecting a tether cable. The device intercepts x-ray photons and the scintillator (Gadox:Tb) and emits visible spectrum photons that illuminate an array of photo (a-SI) detector that creates electrical signals. After the electrical signals are generated, it is converted to digital values, and the images will be displayed on the monitor. This device should be integrated with an operating PC and an X-Ray generator. It can digitalize x-ray images and transfer them for radiography diagnostics. Advanced digital image processing allows considerably efficient diagnosis, all kinds of information management, and sharing of image information on network.

The provided text is a 510(k) summary for a medical device (AURA DR 43C-AG Digital Flat Panel X-ray Detector) and focuses on establishing substantial equivalence to a predicate device, rather than presenting a study demonstrating the device meets a specific set of acceptance criteria in the way one might for an AI/ML clinical study.

Therefore, many of the requested categories for a study proving acceptance criteria cannot be directly extracted from this document, as the submission takes a different approach to demonstrating safety and effectiveness.

Here's an analysis based on the provided text:

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

The document doesn't define explicit acceptance criteria in the typical "pass/fail" numerical sense for clinical performance. Instead, it demonstrates performance by showing the proposed device is equivalent or superior to a predicate device based on specific technical characteristics and non-clinical tests.

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

• Sample Size: The document does not mention a "test set" in the context of clinical images or patient data. The non-clinical performance testing involved measurements of physical values (DQE, MTF NPS) usually conducted on a device itself or phantoms, not a patient sample. No clinical studies were conducted for this 510(k) submission.
• Data Provenance: Not applicable as no clinical data was used for 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 no clinical studies were performed, and thus no expert ground truth was established for a test set of images.

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

• Not applicable as no clinical studies were performed.

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

• No MRMC study was done, as this is an X-ray detector, not an AI-powered diagnostic tool. The submission focuses on device characteristics and substantial equivalence to a predicate, not on human reader performance with or without AI assistance.

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

• Not applicable. This is an imaging hardware device, not an algorithm.

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

• Not applicable as no clinical images or patient data requiring ground truth were used in the testing described in this 510(k) summary. The "ground truth" for the non-clinical performance relied on standardized measurement methods for DQE, MTF, and NPS.

8. The sample size for the training set

• Not applicable, as this is an X-ray detector and not an AI/ML device that requires a training set of data.

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

• Not applicable, as no training set was used.

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To be used for temporary relief of pain associated with sore and aching muscles in the upper and lower back due to strain from exercise or normal household work activities choose Manual modes 1, 2, 3, 4, 5, 6 or Auto 4.

To be used for temporary relief of pain associated with sore and aching muscles in the upper extremities (arm) due to strain from exercise or normal household work activities choose Manual modes 1, 2, 3, 4, 5, 6 or Auto 1 or Auto 3.

To be used for temporary relief of pain associated with sore and aching muscles in the lower extremities (leg) due to strain from exercise or normal household work activities choose Manual modes 1, 2, 6 or Auto1 or Auto1 or Auto 4.

To be used for symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis, choose Manual modes 1 and 3 or Auto 1, Auto 2, Auto 3, or Auto 4.

Used to stimulate healthy muscles in order to improve and facilitate muscle performance choose Manual Mode 1 or Auto Mode 2.

Not Found

The provided document is a 510(k) premarket notification letter from the FDA for the T1040 aka Aurawave device, which is a Transcutaneous Electrical Nerve Stimulator (TENS) for pain relief.

The letter does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth methodologies. It is a regulatory approval document confirming that the device is substantially equivalent to legally marketed predicate devices.

Therefore, I cannot provide the requested information from the given text. The document is strictly a regulatory approval and does not detail the technical performance studies or the clinical trial data that would contain the requested information.

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AcceleDent® Aura is intended for use during orthodontic treatment. It is used in conjunction with orthodontic appliances such as braces and helps facilitate minor anterior tooth movement.

AcceleDent® Aura is an orthodontic accessory for the treatment of tooth malocclusion. It is used as an adjunctive therapy for patients with orthodontic appliances such as braces to help facilitate tooth movement. AcceleDent® Aura should be used by patients for twenty minutes per day in conjunction with standard orthodontic treatment.

AcceleDent® Aura includes the Activator, Mouthpiece and Travel Case. The Activator and connected Mouthpiece are used by patients to provide a light vibration to the teeth – the Activator vibrates at a 0.25 N (25 grams) force level and 30 Hz frequency for 20 minutes when turned-on; the vibration is transmitted from the Activator through the Mouthpiece to the patient's teeth as they lightly bite down on the Mouthpiece.

The Activator and Mouthpiece assembly is light, comfortable, hands-free, and can be used while multi-tasking or while engaged in a variety of other daily activities. The Travel Case is an enclosure that may be used to conceal, protect, and keep the AcceleDent® Aura Activator and Mouthpiece clean while not in use. The device includes a USB port, which can connect directly into a computer or power supply to recharge the battery. The USB port can also be connected to a computer to display usage data. A USB Cable and Power Adaptor are included to complete the system.

The provided document is a 510(k) premarket notification for the AcceleDent Aura, an orthodontic accessory. It explicitly states: "No further clinical data were collected for AcceleDent® Aura." This means there isn't a new study demonstrating the device meets acceptance criteria as typically understood for new medical devices requiring clinical trials.

Instead, the submission relies on the concept of substantial equivalence to a previously cleared predicate device (AcceleDent, K110661). The acceptance criteria and "proof" in this context refer to engineering and performance testing comparing the new device (AcceleDent Aura) to the predicate device to ensure it performs safely and as intended, without significant differences in safety or effectiveness.

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

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly that the AcceleDent Aura performs functionally equivalently to the predicate AcceleDent, particularly regarding the therapeutic vibration parameters and intended use. The performance data presented is primarily a comparison table that shows identical specifications for the core therapeutic elements.

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

• Sample Size: Not applicable in the context of clinical testing for this 510(k) submission. The changes were evaluated through design control review, risk analysis (ISO 14971), and verification testing (IEC 60601 and device specifications), rather than a sample of patient data.
• Data Provenance: Not applicable for clinical data. The engineering and performance testing would have been conducted by the manufacturer, OrthoAccel Technologies, Inc., based in Bellaire, TX, USA. These are laboratory/bench tests, not patient-derived data.
• Retrospective/Prospective: Not applicable.

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 there was no clinical test set for which ground truth needed to be established by experts. The "ground truth" for this 510(k) is the performance of the predicate device.

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

• Not applicable as there was no clinical test set requiring adjudication.

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

• Not applicable. This device is an orthodontic vibrating accessory, 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.

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

• For this 510(k), the "ground truth" for performance is the established safety and effectiveness of the predicate device (AcceleDent, K110661), which was presumably demonstrated through its own testing and clinical data at the time of its 510(k) clearance. The AcceleDent Aura is deemed substantially equivalent because its modifications do not alter its fundamental scientific technology, intended use, or therapeutic parameters (output force, frequency).

8. The sample size for the training set

• Not applicable, as no clinical training set was used for this 510(k) submission for the AcceleDent Aura device.

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

• Not applicable, as no clinical training set was used.

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