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Found 8 results
510(k) Data Aggregation
(103 days)
The touchTymp tympanometer is an electroacoustic test instrument that produces controlled levels of test tones and signals intended for use in conducting diagnostic hearing evaluations and assisting in the diagnosis of possible otologic disorders. It features tympanometry and acoustic reflex audiometry.
The touchTymp is an auditory impedance analyser. The device is intended to change the air pressure in the external auditory canal and measure and graph the mobility characteristics of the tympanic membrane to evaluate the functional condition of the middle ear. The device is used to determine abnormalities in the mobility of the tympanic membrane due to stiffness, flaccidity, or the presence of middle ear pathologies. The device is also used to measure the acoustic reflex threshold which occurs due to contractions of the stapedial muscle following exposure to a strong stimulus. This test allow to assess between central and peripheral pathologies and to identify where the patients uncomfortable loudness level may reside. The instrument is software controlled. The software controls the probe (tone and pressure) stimuli, measures the result and presents the result on a built in display. All functions are set and interpreted by the operator. The technological characteristics are substantially equivalent with predicate device. All technological characteristics are in compliance with the consensus standard ANSI S3.39 for auditory impedance testers.
The provided text details a 510(k) premarket notification for the "touchTymp" device, an auditory impedance tester. The FDA determined the device is substantially equivalent to legally marketed predicate devices.
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state specific quantitative acceptance criteria or a detailed "reported device performance" table in the way one might expect for a study comparing a new algorithm's performance against a gold standard. Instead, it relies on demonstrating compliance with existing standards and substantial equivalence to a predicate device.
The closest we can get to implied "acceptance criteria" and "performance" from this document are:
| Acceptance Criteria (Implied from the document) | Reported Device Performance (Implied from the document) |
|---|---|
| Technological Characteristics Equivalence: The device's technological characteristics must be substantially equivalent to the predicate device. This includes its ability to change air pressure, measure and graph tympanic membrane mobility, evaluate middle ear function, and measure acoustic reflex thresholds. It also implies compliance with the consensus standard ANSI S3.39 for auditory impedance testers. Safety and EMC Compliance: The device must comply with current standards for medical device safety and electromagnetic compatibility (EMC). Performance Equivalence: The device must perform as safely and effectively as the predicate device for its claimed purposes (conducting diagnostic hearing evaluations and assisting in the diagnosis of possible otologic disorders, featuring tympanometry and acoustic reflex audiometry). Software Control and Interpretation: The software must effectively control probe stimuli, measure results, and present them on a display, with all functions interpretable by the operator. | Technological Characteristics Equivalence: The document explicitly states: "The technological characteristics are substantially equivalent with predicate device. All technological characteristics are in compliance with the consensus standard ANSI S3.39 for auditory impedance testers." Safety and EMC Compliance: "The device was found in compliance with current standards [for medical device safety and EMC]." Performance Equivalence: "The verification and validation activities show substantial equivalence with the predicate device and that the modified touchTymp is as safe and effective as the predicate device for its claimed purpose." Software Control and Interpretation: "The instrument is software controlled. The software controls the probe (tone and pressure) stimuli, measures the result and presents the result on a built in display. All functions are set and interpreted by the operator." |
2. Sample Size Used for the Test Set and Data Provenance
The document states "Clinical tests None applicable" (page 5), indicating that no clinical test set was used for this 510(k) submission. The determination of substantial equivalence was based on nonclinical tests verifying compliance with standards and technological similarity to the predicate device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not applicable, as no clinical test set was used to establish a ground truth.
4. Adjudication Method for the Test Set
Not applicable, as no clinical test set was used.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
No. The document explicitly states "Clinical tests None applicable." This type of study would fall under clinical testing.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
Yes, in a way. The "Nonclinical tests summary" discusses "design verification and validation" performed "according to current standards for medical device safety and EMC and performance of impedance tester." This implies standalone testing of the device's functional performance against engineering specifications and industry standards, without human interpretation as part of a clinical study. However, this is not performance in the sense of an AI algorithm's diagnostic accuracy.
7. The Type of Ground Truth Used
For the nonclinical tests mentioned:
- Compliance with standards: The "ground truth" was the specifications and requirements outlined in standards like ANSI S3.39 for auditory impedance testers, and general medical device safety and EMC standards.
- Equivalence to predicate device: The "ground truth" was the established performance and characteristics of the predicate device (MI 24, K905704).
8. The Sample Size for the Training Set
Not applicable. This device is not an AI/ML algorithm that undergoes a "training set." Its functionality is based on established electroacoustic principles.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
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(100 days)
Ultrasound scanner and transducers for B, Tissue and Contrast Harmonic Imaging, M, PWD, CWD, Color Doppler, Vector Flow Imaging and combined mode imaging and Elastography.
Signal Analysis.
Guidance of biopsy needles, geometrical measurements and calculation of parameters. And optimal 3-D unit can reconstruct a series of 2-D images into a single 3-D volume and display this on the screen.
An optional Vector Flow Imaging (VFI) module: Color Flow Mapping (CFM) imaging mode with the ability to visualize both the axial and the transverse velocity.
Clinical Applications:
- Fetal (Sometimes called Obstetrics)
- Abdominal
- Intra-operative
- Intra-operative (Neuro) (sometimes called Neuro Surgical)
- Pediatrics
- Small Organ (Sometimes called Small Parts)
- Neonatal Cephalic (Cephalic is sometimes called trans-cranial)
- Adult Cephalic (Cephalic is sometimes called trans-cranial)
- Trans-rectal
- Trans-vaqinal
- Trans-urethral
- Musculo-skeletal (Conventional)
- Musculo-skel. (Superficial)
- Cardiac Adult
- Peripheral Vessel (Sometimes called Peripheral Vascular)
Diagnostic ultrasound imaging or fluid flow analysis of the human body.
Ultrasound scanner and transducers for B, Tissue and Contrast Harmonic Imaging, M, PWD, CWD, Color Doppler, Smart Flow Imaging, combined mode imaging, and Elastography.
Signal Analysis.
Guidance of biopsy needles, geometrical measurements and calculation of parameters. A 3-D unit that can reconstruct a series of 2-D images into a single 3-D volume and display this on the screen.
An optional Smart Flow Imaqinq module: Color Flow Mapping (CFM) imaqinq mode with the ability to visualize both the axial and the transverse velocity.
The provided document is a 510(k) Pre-market Notification from Carestream Health, Inc. for their "Touch Ultrasound" device. It outlines the device's indications for use and compares its technological characteristics to predicate devices. However, it does not contain a specific study demonstrating that the device meets explicit acceptance criteria in terms of performance metrics like sensitivity, specificity, accuracy, or other quantitative measures.
The document focuses on demonstrating substantial equivalence to legally marketed predicate devices, which is the primary requirement for a 510(k) submission. This is achieved by showing that the new device has the same intended use and similar technological characteristics, or if there are differences, that these differences do not raise new questions of safety and effectiveness.
Therefore, I cannot extract the specific details you requested regarding acceptance criteria and a study that proves the device meets them, because such information is not present in this type of regulatory submission. The document explicitly states: "FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements..."
However, I can extract information regarding the device's characteristics and the non-clinical tests performed to ensure safety and equivalence.
Here's a breakdown of what the document does provide, addressing your numbered points where possible, and noting where information is absent:
1. A table of acceptance criteria and the reported device performance
This information is not provided in the document. The 510(k) submission establishes substantial equivalence to predicate devices, not direct performance against specific numerical acceptance criteria (e.g., sensitivity, specificity for diagnostic accuracy). The performance is implied to be equivalent to the predicate devices.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This information is not provided in the document. The submission focuses on non-clinical tests (acoustic output, safety, etc.) and comparison to predicate devices, not on a clinical test set with human subjects to evaluate diagnostic performance.
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 provided in the document, as there is no described clinical test set for diagnostic performance.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not provided in the document, as there is no described clinical test set for diagnostic performance.
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 information is not provided in the document. The device described is an ultrasound system, not an AI-powered diagnostic assistance tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not provided in the document. The device is a diagnostic ultrasound system, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not provided in the document, as there is no described clinical test set for diagnostic performance.
8. The sample size for the training set
This information is not provided in the document, as the submission does not describe an AI/algorithm that requires a training set.
9. How the ground truth for the training set was established
This information is not provided in the document, as the submission does not describe an AI/algorithm that requires a training set.
Information that is available in the document regarding the device and its testing:
- Device Name: Touch Ultrasound
- Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body.
- New Modes Added in this Submission: Elastography, Smart Flow Imaging (also referred to as Vector Flow Imaging [VFI]), Continuous Wave Doppler (CWD/CW), Contrast Harmonic Imaging (CHI or Ci).
- Non-Clinical Tests Performed (to ensure safety and equivalence):
- Acoustic output (conforming to AIUM/NEMA UD-2 & UD-3 standards; Ispta 720 mW/cm² and MI 1.9, TI ≤ 6.0)
- Thermal safety (conforming to IEC 60601-1, IEC 60601-2-37, IEC 62359)
- Electrical safety (conforming to IEC 60601-1, IEC 60601-2-37)
- Electromagnetic safety (conforming to IEC 60601-1-2)
- Mechanical safety (conforming to IEC 60601-1, IEC 60601-2-37)
- Biocompatibility (conforming to EN ISO 10993-1)
- Software lifecycle processes (conforming to IEC 62304)
- Risk Management (conforming to ISO 14971)
- Comparison to Predicate Devices: The document extensively compares the "Touch Ultrasound" (modified device) to several predicate devices (e.g., K150342 Carestream Health Touch Ultrasound, K140428 bk2300, K043524 Pro Focus 2202, K100919 Pro Focus 2202, K130619 Acuson S1000) in terms of imaging modes (B, THI, M, PWD, CFM, CHI, CWD, VFI, Elastography) and clinical applications (Fetal, Abdominal, Intraoperative, Neurosurgery, Pediatrics, Small Parts, Adult Cephalic, Neonatal Cephalic, Transrectal, Transvaginal, Transurethral, Musculo-skeletal, Cardiac, Peripheral Vessel). The modified device incorporates certain modes that were previously present in one or more of the predicate devices.
- Transducers: All transducers in the submission were previously cleared by FDA. No changes to physical design or patient contact materials. All patient contact materials are biocompatible. All transducers are "Track 3" transducers.
In summary, this document demonstrates the safety and substantial equivalence of the "Touch Ultrasound" device based on engineering and non-clinical performance standards, and comparison of technological characteristics and intended uses with predicate devices already on the market. It does not present clinical study data for diagnostic performance with acceptance criteria.
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(86 days)
The system is intended for use by qualified physicians for ultrasound evaluation. Specific clinical applications and exam types include: Fetal (including Obstetrics), Abdominal, Intraoperative, Intraoperative Neuro (also known as Neurosugery), Pediatric, Small Organ (also known as Small Parts), Neonatal Cephalic (also known as Neonatal Transcranial), Adult Cephalic (also known as Adult Transcranial), Transrectal, Transvaginal, Transurethral, Musculoskeletal (Conventional and Superficial), Cardiac Adult, Peripheral Vessel (also known as Peripheral Vascular). Indicated uses are different for different transducers. The Product Data sheet for the system contains a table listing the indicated uses for each transducer that can be used with the system. The bk3000 ultrasound system is not intended for ophthalmic use or any use causing the acoustic beam to pass through the eye. The Cardiac Adult application is not intended for direct use on the heart.
Touch Ultrasound supports the following scanning modes and combinations thereof: B-mode (incl. Tissue Harmonic Imaging), M-mode, CFM mode, Amplitude (Power) Doppler mode. The system can perform simple geometric measurements, and perform calculations in the areas of Vascular, Urology, Cardiology and OB/GYN applications. The system can guide biopsy- and puncture needles. An optional 3-D module can reconstruct a series of 2-D images into a single 3-D volume and display this on the screen. Transducers are linear arrays, convex arrays, and phased arrays. The patient contact materials are biocompatible. All transducers used together with bk 2300 are Track 3 transducers.
The provided text is a 510(k) Summary for the "Touch Ultrasound" device. It describes the device, its intended use, and compares it to a predicate device to establish substantial equivalence. However, it does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria in the context of diagnostic performance or clinical effectiveness.
The document focuses on regulatory compliance, safety, and technological equivalence. It mentions:
- Acoustic output limits: Ispta ≤ 720 mW/cm² and MI ≤ 1.9 (Track 3, non-ophthalmic), and Thermal Index (TI) ≤ 6.0. These are safety limits, not diagnostic performance acceptance criteria.
- Clinical measurement accuracy: Stated as being "described and accuracies are provided in the User Information." However, the actual criteria and reported performance are not provided in this document.
- Safety standards compliance: Lists several IEC and ISO standards related to acoustic output measurement, thermal/mechanical indices, electrical safety, electromagnetic compatibility, risk management, biocompatibility, and software lifecycle processes. These are general safety and quality assurance standards, not diagnostic performance studies.
Therefore, I cannot populate the requested table or answer most of the questions about acceptance criteria and performance studies because that information is not present in the provided text.
Here is a summary of what can be extracted from the text regarding acceptance criteria and the study (related to safety and equivalence, not diagnostic performance):
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Criteria (from document) | Reported Device Performance (from document) |
|---|---|---|
| Acoustic Output (Safety) | Spatial-Peak Temporal-Average Intensity (Ispta) | ≤ 720 mW/cm² (Track 3, non-ophthalmic) |
| Acoustic Output (Safety) | Mechanical Index (MI) | ≤ 1.9 (Track 3, non-ophthalmic) |
| Acoustic Output (Safety) | Thermal Index (TI) | ≤ 6.0 |
| Clinical Measurement Accuracy | Not specified in document | "described and accuracies are provided in the User Information" (details not in this document) |
| Thermal, Mechanical, Electrical Safety | Conformance to applicable medical device safety standards (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, ISO 14971, EN ISO 10993-1, IEC 62304, IEC 62359) | "has been tested by a recognized Certified Body" and "found to conform with applicable medical device safety standards." "Thermal, electrical, electromagnetic and mechanical safety is unchanged" (compared to predicate). |
| Biocompatibility | Conformance to EN ISO 10993-1 | Patient contact materials are biocompatible. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not provided. The document does not describe any clinical test sets or diagnostic performance studies. The "testing" mentioned is related to safety and engineering standards.
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 / Not provided. No diagnostic performance test set or ground truth establishment is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Not provided. No diagnostic performance test set is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This device is a diagnostic ultrasound system, not an AI-based system, and no MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an AI-based algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable / Not provided. No diagnostic performance ground truth is mentioned. The ground truth for safety testing would be compliance with specified technical standards.
8. The sample size for the training set
- Not applicable / Not provided. This is not an AI-based device that would require a "training set" in the machine learning sense.
9. How the ground truth for the training set was established
- Not applicable / Not provided.
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(177 days)
The TouchPACS Suite software system is a picture archiving and communications system (PACS) intended to be used as a networked Digital Imaging and Communications in Medicine (DICOM) and non- DICOM information and data management system. The TouchPACS Suite PACS & DICOM Viewer Software is comprised of modular software programs that run on standard "off-the-shell" personal computers, business computers, and servers running standard operating systems. TouchPACS TouchMGR Suite DICOM Viewer Software system is an image, data storage and display software that accepts DICOM data from any OEM modality which support DICOM standard imaging data. The system provides the capability to organize images generated by OEM vendor equipment, perform digital manipulation, create graphical representations of anatomical areas, and perform quantitative measurements.
The TouchPACS Suite software is not for mammographic use.
The TMS TouchPACS Suite is a collection of software applications coded in the Microsoft C# application language, using the Windows Presentation Foundation (WPF) libraries for user interface, that run on "off-the-shelf" Microsoft Windows-based personal or business computers to provide diagnostic imaging workstation capabilities. The system is designed to provide an environment for radiological diagnosticians which is "easy on the eyes"; so that the user can use the system for 10-12 hours per day without undue strain.
The core of the system is the database, which is a relational design, using Microsoft SQL Server 2008 Enterprise edition as the Relational Database Management System (RDBMS). The database server provides a dedicated, central place to provide disaster recovery servicing (via standard SQL Server replication), as well as the large multiterabyte storage required for a PACS system.
Attached to the RDBMS are TouchPACS client workstations, TouchMGR client workstations, and servers required for system operations: TMS DICOM SCP Server and Microsoft SQL Server. All of the aforementioned software modules, except for Microsoft SQL Server, are TMS software products.
The TouchPACS Suite PACS client workstation is intended to be a desktop computer replacement product, with the interface dominating the screen space on a workstation computer.
The TouchMGR client workstation represents the nerve center of the TouchPACS Suite, providing services for securing the TMS network, maintaining users, allowing paperless workflow, and other such critical day-to-day system maintenance tasks.
The TMS DICOM SCP Server provides multi-threaded DICOM v3 server capabilities of the TouchPACS system.
The provided text describes a 510(k) summary for the "TouchPACS Suite," a medical imaging workstation. It focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a dedicated study. As such, much of the requested information regarding acceptance criteria, study details, and ground truth establishment is not present in the provided document.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state acceptance criteria in a quantitative form (e.g., specific accuracy, sensitivity, or specificity thresholds). Instead, it relies on demonstrating that the TouchPACS Suite has similar intended use and technical features to its predicate devices. The "Predicate Device Comparison" table highlights feature parity rather than performance metrics.
| Feature / Criteria | TouchPACS | Predicate Devices (STAIR, RamSoft, Fuji, EZPACS) |
|---|---|---|
| Communications | TCP/IP | TCP/IP |
| Image Archive | Yes | Yes |
| Image Processing | Yes | Yes |
| Image Edit | Yes | Yes |
| Edit Patient Demographics | Yes | Yes |
| Add and remove images | Yes | Yes |
| Combine studies | Yes | Yes |
| Edit Patient Orientation information | Yes | Yes |
| Set and Edit Routing Information | Yes | Yes |
| JPEG Lossy/Lossless Compression | Display = Yes, Apply = LOSSLESS | Yes |
| JPEG 2000 Lossy/Lossless Compression | Display = Yes, Apply = LOSSLESS | Yes |
| Image Processing (image scaling) | Yes | Yes |
| Image Processing (Window Level, Pan, Zoom, Cine Display) | Yes | Yes |
| DICOM Print | Yes | Yes |
2. Sample size used for the test set and the data provenance
Not applicable. The document describes a comparison to predicate devices based on features and functionality, not a performance study on a test set of medical images.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth establishment for a diagnostic performance study is not described.
4. Adjudication method for the test set
Not applicable. No test set adjudication method is described.
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 or any study on human reader improvement with AI assistance is mentioned. The device is a PACS system, not an AI-assisted diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. The device is a PACS system and viewer, not a standalone algorithm with diagnostic performance metrics. Its functionality is to store, display, and manipulate images for human interpretation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. No ground truth is mentioned as this is not a diagnostic performance study. The focus is on DICOM compliance, feature parity with predicate devices, and general software functionality.
8. The sample size for the training set
Not applicable. There is no mention of a training set as the device is a PACS system, not a machine learning model.
9. How the ground truth for the training set was established
Not applicable. No training set or associated ground truth establishment is mentioned.
Summary of Acceptance Criteria and Study Details (Based on the Provided Text):
The "acceptance criteria" for the TouchPACS Suite, as presented in this 510(k) summary, are primarily based on achieving substantial equivalence to existing legally marketed predicate devices. This is demonstrated by showing that the device has:
- Similar intended use: A networked DICOM and non-DICOM information and data management system for image storage, display, manipulation, and quantitative measurements (excluding mammographic use).
- Similar technological characteristics/features: As detailed in the predicate device comparison table, the TouchPACS Suite provides identical or comparable functionalities (e.g., TCP/IP communication, image archiving, processing, editing, patient demographic editing, DICOM print, various compression methods).
- No new safety and efficacy issues: A hazard analysis was conducted, and the device is deemed a "minor level of concern."
The "study" that proves the device meets these "acceptance criteria" is the comparison to predicate devices and the internal verification and validation testing of the software. The document states:
- "The TMS TouchPACS Suite has similar intended use and technical features of the predicate devices listed above."
- "A comparison of the labeling, substantial equivalence table, and verification and validation testing has established that the device meets its intended use and design specifications."
- "Potential hazards are identified through risk analysis and managed through the software development process and verification/validation testing."
The document also highlights compliance with relevant standards like ACR/NEMA DICOM Version 3.0, IEC60950, and IEC/CISPR 22 as part of its safety and design verification.
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(306 days)
The TouchSoft™ Coagulator is used to provide therapeutic hemostasis and tissue ablation in the gastrointestinal tract through a flexible endoscope by a trained physician or clinician.
Not Found
I am sorry, but the provided text does not contain information about acceptance criteria, device performance, study details, or ground truth establishment. The document is an FDA 510(k) clearance letter for the TouchSoft™ Coagulator, primarily focusing on its regulatory status and intended use. Therefore, I cannot generate the requested table and study description based on the given input.
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(56 days)
This material is indicated for the following:
- A dentin bonding agent used with direct filling materials that include but may not be limited to, composite resins, resin modified glass ionomers or compomers, etc.
- A dentin bonding agent used with resin cements or composite luting agents to retain indirect tooth-colored and cast alloy restorations that include but may not be limited to indirect composite or porcelain inlays and onlays, laminate veneers, either resin or porcelain, porcelain-fused-to-metal crowns, etc.
- Treatment of hypersensitive areas of exposed root surfaces.
- A cavity sealant and desensitizer applied to exposed dentin that has been prepared to receive a laboratory fabricated restoration such as porcelain-fused-to-metal crowns, cast alloy or tooth-colored inlays or onlays, veneers, etc.
Single bottle, self-etching, self-priming, light-cured bonding system that contains 4-META. Does not require acid etching of tooth surfaces, and can be polymerized with any available light-cure device. For use as the adhesive agent for direct or indirect restorations, and can be used as a sealant/desensitizer to minimize post-operative sensitivity.
This 510(k) premarket notification (K020239) for Parkell, Inc.'s Touch&Bond-Plus device does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria.
The provided documents are a 510(k) summary and the FDA's clearance letter. These documents primarily focus on:
- Device identification: Trade name, common name, classification, and predicate devices.
- Description/Intended Use: What the device is and what it's used for.
- Substantial Equivalence determination: The FDA's finding that the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed.
- Regulatory information: Applicable regulations and general controls.
The 510(k) summary (Section {0}) briefly describes the device as a "Single bottle, self-etching, self-priming, light-cured bonding system that contains 4-META" and lists its intended uses. However, it does not include any performance data, acceptance criteria, study methodologies, or results.
Therefore, I cannot populate the table or provide the detailed study information you requested based on the given input. This type of detailed study information is typically found in the full 510(k) submission, not necessarily in the publicly available 510(k) summary or the FDA clearance letter.
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(112 days)
The TOUCH TEAR IGE MICROASSAY KIT™ is an in vitro diagnostic device which is used for the quantitative determination of Immunoglobulin E (IgE) concentration in human tears. This can be used as an aid in the diagnosis of ocular Type 1 allergic conjunctivitis or the allergic component of ocular inflammatory responses.
Not Found
The provided text is a 510(k) clearance letter from the FDA for a device called "Touch Tear IgE Microassay Kit." It establishes substantial equivalence to a predicate device and provides regulatory information. However, it does not contain the detailed study information, acceptance criteria, or performance data that would be used to describe the acceptance criteria and the study that proves the device meets them, as requested in your prompt.
The document states: "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (...) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976." This indicates that the device was cleared based on demonstrating equivalence, not necessarily on a novel clinical study with specific acceptance criteria that are detailed in this letter.
Therefore, I cannot extract the following information from the provided text:
- A table of acceptance criteria and the reported device performance: This document does not present any performance data or acceptance criteria.
- Sample size used for the test set and the data provenance: Not mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
- Adjudication method: Not mentioned.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: Not mentioned.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This is an in vitro diagnostic kit, not an AI algorithm.
- The type of ground truth used: Not mentioned.
- The sample size for the training set: Not mentioned.
- How the ground truth for the training set was established: Not mentioned.
Conclusion: The provided document is a regulatory clearance letter and does not contain the technical study details, acceptance criteria, or performance data required to answer your prompt. To get this information, you would need to refer to the actual 510(k) submission documentation, which is generally more extensive and includes the study reports.
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(69 days)
The intended use of the device is to provide continuous heat at the tip of a dental instrument, the Hot Pulp Test Tip, to test tooth response to thermal stimulus.
The device, which is battery-operated (Model 5001 and 5004) or powered by a wall adapter (Model 5002), is designed to provide continuous heat at the tip of a dental instrument, the Hot Pulp Test Tip, to test tooth response to thermal stimulus. The battery operated models are fully rechargeable through the use of the plug-in charge adapter. The Hot Pulp Test Tip is heated to the desired temperature. A medium, such as a ball of softened gutta percha, is used to transfer the heat from the Hot Pulp Test Tip to the tooth. The gutta percha ball is dipped into talcum powder or Vaseline to prevent it from sticking to the tooth. The Hot Pulp Test Tip is placed in firm contact with the tooth, ensuring that a good contact is established. The patient's response to the heat is evaluated by the clinician to determine whether the pulp is healthy or inflamed.
The provided text describes a "Touch n' Heat" dental instrument heater and its intended use as a thermal pulp tester. However, it does not contain any information regarding acceptance criteria, device performance metrics, study details (sample sizes, ground truth, expert qualifications, adjudication methods), or any comparative effectiveness studies.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study proving the device meets them because the necessary information is absent from the input.
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