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The FIT Pro Breast Pump is a single-user, powered breast pump intended to express and collect milk from the breasts of lactating women.

The FIT Pro Breast Pump is an electric breast pump powered by an external AC-DC power supply or by an internal rechargeable lithium-ion battery. The device is provided non-sterile. The device is intended to be used by lactating women to express and collect milk from their breasts. Pumping can be performed on either one breast (single pumping) or both breasts at the same time (double pumping). The FIT Pro Breast Pump utilizes a DC-powered motor driving a diaphragmtype vacuum pump and an electromechanical solenoid which are controlled electronically to provide a range of user-selectable vacuum (suction) levels at various pre-determined cycle frequencies. The FIT Pro Breast Pump has a backlit LCD display, which shows pumping mode, suction level, timer, and battery level. The device also has four softtouch buttons allowing the user to power the device on/off, switch between stimulation and expression pumping modes, and control vacuum strength within each mode (6 levels of vacuum strength in stimulation mode and 12 levels in expression mode). The FIT Pro Breast Pump is intended for a single user in the home environment. When properly connected, the Hygeia PAS pumping kit transfers the vacuum generated by the powered pump to the breast, enabling expression and collection of milk. A diaphragm in the backflow protection assembly physically isolates pump and tubing from the space where milk is expressed and collected, protecting the breast milk from contamination. The base model of the FIT Pro Breast Pump contains a pump, pumping kit, AC adapter with detachable USB-C cable, and a lanyard.

This document is a 510(k) summary for the FIT Pro Breast Pump, a medical device. It does not describe an AI medical device or software. Therefore, the requested information about acceptance criteria and study details for an AI/software device cannot be extracted from this document, as it does not pertain to such a device. This document focuses on the substantial equivalence of the breast pump to a predicate device, based on non-clinical performance testing.

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The Fit & Brilliant Dental Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. The Fit &Brilliant Dental Implant System is for single and two stage surgical procedures. It is intended for delayed loading.

This medical product is for dental implant that is a surgical component that interfaces with the bone of the jaw to support a dental prosthesis such as a crown, bridge, denture. It is inserted in the jaw to support and maintain the prosthodontic restorative tooth or denture when the tooth is partially or totally lost. It is made of titanium material (ASTM F136 Ti 6Al-4V ELI) that is a widely used in the market. The surface of the produce is treated with powder for CaP, and it is designed to connect with the superstructure that abutment by internal fastening method. This is disposable product sterilized by gamma sterilization method and it prevents re-sterilization or reuse.

The provided document is a 510(k) summary for the "Fit & Brilliant Dental Implant System". This document focuses on demonstrating substantial equivalence to a predicate device (U fit Dental Implant System K132956) based on technological characteristics and performance testing to ensure safety and effectiveness. It is not an AI/ML device, and therefore the requested information regarding AI-specific criteria (like MRMC study, stand-alone algorithm performance, training set details, ground truth for AI) is not applicable or present in this document.

Here's the available information relevant to your request, formatted as closely as possible, and noting where information is not applicable (NA) for this type of device submission.

Acceptance Criteria and Device Performance

The acceptance criteria for this medical device are based on demonstrating substantial equivalence to a predicate device through conformity to recognized standards and comparative characteristics. The "reported device performance" refers to the results of non-clinical studies conducted according to these standards.

Table of Acceptance Criteria and Reported Device Performance

Note: The document states "To demonstrate substantial equivalence, the following studies have been performed on the new device (K190637) in accordance with these standards." and concludes that the "New device (K190637) is substantially equivalent to the predicate device K132956." This implies that the device met the requirements of these standards.

Additional Requested Information:

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 explicitly stated as a separate "test set" in the context of an AI/ML device. For dental implant testing, samples would refer to the number of implants/components tested according to each ISO/ASTM standard. This information (specific number of units tested for fatigue, biocompatibility, etc.) is typically found in the detailed study reports, which are not included in this 510(k) summary.
• Data Provenance: Not applicable in the context of clinical data for AI/ML. The studies are non-clinical, laboratory-based tests. The manufacturer is F&B Technology Co., Ltd. from Busan, Korea.

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. This is not an AI/ML device requiring human expert ground truth for classification or diagnosis. The "ground truth" for non-clinical studies is defined by the objective pass/fail criteria of the scientific standards (ISO, ASTM, USP).

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

• Not applicable. This concept applies to human interpretation of data for ground truth establishment in AI/ML studies, not to objective non-clinical performance testing of a physical medical device.

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

• Not applicable. This is a physical dental implant device, not an AI/ML diagnostic or assistive tool.

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

• Not applicable. This is not an AI/ML algorithm.

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

• Not applicable in the context of human-labeled data for AI/ML. For this device, the "ground truth" is established by the objective, quantifiable endpoints and criteria defined within the referenced international (ISO) and national (ASTM, USP) standards for medical device performance and safety (e.g., cytotoxicity levels, fatigue limits, sterility assurance levels).

8. The sample size for the training set

• Not applicable. This is not an AI/ML device.

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

• Not applicable. This is not an AI/ML device.

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• Class III and Class V restorations
• Small Class I restoration
• Base/Liner

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The provided text from the FDA 510(k) clearance letter for the Shofu Dental Corporation's "FIT SA" device does not contain the detailed information necessary to fully answer all the questions about acceptance criteria and a study proving the device meets them. This document is a clearance letter, which means the FDA has reviewed the manufacturer's submission and found the device substantially equivalent to a legally marketed predicate. However, it typically does not include the specifics of the performance studies themselves.

The information provided only states the indications for use and general regulatory information. It does not describe any specific acceptance criteria for a performance study, nor does it detail a study that proves the device meets those criteria.

Therefore, for almost all of the requested information, the answer is "Information not provided in the input text."

Here's a breakdown of what can be inferred or stated based on the provided text, and what is missing:

Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

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

• Information not provided in the input text. The clearance letter does not list specific performance metrics or acceptance criteria for the FIT SA device. It only states the device's indications for use.

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

• Information not provided in the input text. The letter does not mention any sample sizes, types of data (retrospective/prospective), or data provenance for any 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)

• Information not provided in the input text. This detail would typically be part of a clinical or performance study report, which is not included in the FDA clearance letter.

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

• Information not provided in the input text. Adjudication methods are specific to how discrepancies in ground truth establishment are resolved, which is not mentioned here.

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

• Information not provided in the input text. This type of study is typically for AI-assisted diagnostic devices. FIT SA is a dental restorative material, so an MRMC study related to AI assistance would not be applicable. The letter does not mention any MRMC studies.

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

• Information not provided in the input text. Similar to point 5, this is not applicable to a restorative dental material. The device itself is not an algorithm.

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

• Information not provided in the input text. As there's no mention of a performance study with a test set, there's no information on how ground truth would have been established. For dental restorative materials, performance is typically assessed through physical, mechanical, and biocompatibility testing, potentially in vitro or in vivo studies, but not in the way an AI diagnostic device uses "ground truth."

8. The sample size for the training set

• Information not provided in the input text. As the device is a material and not an AI algorithm, the concept of a "training set" in this context is not applicable.

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

• Information not provided in the input text. (Not applicable for this type of device.)

Summary regarding the provided text:

The provided FDA 510(k) clearance letter for the Shofu Dental Corporation's FIT SA device is a regulatory document confirming clearance based on substantial equivalence. It does not contain the detailed technical or clinical study results, acceptance criteria, or ground truth establishment methods that would be typically found in a clinical study report or the technical sections of a 510(k) submission. Therefore, the specific information requested in the questions cannot be extracted from this document.

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The SM9065 Fitness Belt is indicated for the improvement of muscle tone, for strengthening of muscles and for the development of firmer muscles.

• The big belt is intended for use on the muscles in abdomen.
• The small belt is intended for use on the muscles in arms and thighs areas.
  Contraindicated use on injured or otherwise impaired muscles.
  Not intended for use in any therapy or for the treatment of any medical conditions or diseases.

SM9065 Fitness Belt is a two channels battery operated muscle stimulation system to achieve the purpose of exercise and relaxation. It is comprised of a main device for signal generation, four belts for fixation, and series electrodes.
The big belt is intended for use on muscles in abdomen. The two small belts are intended for use on muscles in arms and thigh areas.
Power is derived from 2 "AAA" batteries located in a compartment protected by a removable battery cover. The stimulator sends gentle electrical current to targeted muscle group through the electrodes placed on the skin. The parameters of the unit are controlled by the buttons. Its intensity level and frequency level can be adjusted by user.

This document is a 510(k) summary for the SM9065 Fitness Belt, a powered muscle stimulator. It focuses on demonstrating substantial equivalence to already marketed predicate devices rather than presenting a standalone study with acceptance criteria in the typical sense for clinical performance.

Here's a breakdown of the requested information based on the provided text, recognizing the nature of a 510(k) submission for this type of device:

1. Table of Acceptance Criteria and Reported Device Performance

For this specific device (a powered muscle stimulator for muscle toning), direct clinical acceptance criteria like sensitivity/specificity are not presented. Instead, the "acceptance criteria" are compliance with established electrical safety, EMC, and biocompatibility standards, and demonstrating waveform parameters are within acceptable ranges and comparable to 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)

The document describes bench testing against standards, not a clinical trial with a "test set" of patient data. Therefore, the concept of sample size and data provenance in a clinical context does not apply here. The "test set" refers to the device itself being tested according to engineering and safety standards. The document does not specify the number of units tested, but standard compliance typically involves testing representative samples. Data provenance is not applicable for this type of 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)

This is not applicable. For a 510(k) submission regarding a powered muscle stimulator, and specifically for bench testing against established engineering and safety standards, "ground truth" is defined by the requirements of those standards (e.g., a certain voltage must be output, a certain current limit must not be exceeded). The tests are performed by qualified engineers or technicians in testing facilities, but the "ground truth" itself is the standard's specification, not expert consensus on medical images or clinical outcomes.

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

Not applicable. This type of device does not involve expert adjudication as one would find in studies assessing diagnostic accuracy where ground truth is challenging to establish.

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

Not applicable. This is a powered muscle stimulator, not an AI diagnostic or assistance device. No MRMC study was mentioned or would be relevant for this type of device.

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

This refers to the performance of the device's hardware and software alone as an electrical stimulator. The document states that bench tests were conducted to verify that the subject device meets all design specifications. These include:

• Electrical safety tests (IEC 60601-1, IEC 60601-2-10)
• Electromagnetic compatibility tests (IEC 60601-1-2)
• Software verification and validation tests
• Waveform tests (verifying output parameters according to FDA guidance)
• Biocompatibility tests (ISO 10993-5, ISO 10993-10)

These tests evaluate the device's inherent performance characteristics, without human interaction other than operating the device for the purpose of testing.

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

The "ground truth" for this submission is adherence to recognized electrical safety, biocompatibility, and performance standards (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10, ISO 10993 series, and FDA guidance documents for powered muscle stimulators). The device's measured parameters (voltage, current, frequency, etc.) are compared against the limits and specifications defined by these standards and guidance.

8. The sample size for the training set

Not applicable. This device is not an algorithm trained on a dataset. It's a hardware device evaluated against engineering standards.

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

Not applicable. There is no training set for this device.

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GC Fit Checker Advanced is a silicone impression material intended to check fit by detecting the high spots and pressure points of crowns, bridges, veneers, inlays and dentures.
Checking fit of crowns, bridges, veneers, inlays and dentures.

GC Fit Checker Advanced is a silicone impression material intended to check fit by detecting the high spots and pressure points of crowns, bridges, veneers, inlays and dentures. GC Fit Checker Advanced has two types of packaging/delivery systems in which the base silicone paste and the catalyst silicone are filled. One is in tubes and the other is a cartidge device, similar to silicone impression material. Fit Checker Advanced was developed combining the technology of Fit Checker and vinyl polyether silicone impression material, EXA'lence, to achieve higher hydrophilicity. Due to the improved hydrophilicity, the material easily and uniformly spreads and sets sharply under moist oral environment. The optimal translucency enables the users to examine the thickness with ease.

Here's an analysis of the provided 510(k) summary regarding the GC Fit Checker Advanced device:

Acceptance Criteria and Device Performance Study for GC Fit Checker Advanced

This 510(k) summary focuses on demonstrating that the GC Fit Checker Advanced, a dental impression material, is substantially equivalent to existing predicate devices. The study conducted is a bench study evaluating physical properties directly related to the material's function.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document does not explicitly state the numerical sample size (n) for each test. However, for "Detail reproduction," three measurements are reported (20, 20, 20), suggesting at least 3 samples were tested. For "Elastic recovery" and "Strain in compression," ranges are provided, which typically come from multiple measurements but the exact number isn't quantified.
• Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective. Given it's a bench test of a newly developed material by GC America Inc., it's implied to be prospective and likely conducted in-house or by a contracted lab.

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

This type of information is not applicable to this study. The "ground truth" for these physical property tests is based on objective, quantifiable measurements using standardized test methods (ISO 4823), not on expert subjective assessment. Therefore, no human experts were involved in establishing the "ground truth" for the test set.

4. Adjudication Method for the Test Set

This information is not applicable to this study. Since the ground truth is established through objective physical measurements as per ISO standards, there is no need for an adjudication method by human experts.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. This is a bench study on the physical properties of a material, not a clinical study involving human readers or cases.

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

This concept is not applicable to this device. GC Fit Checker Advanced is a physical dental impression material, not an AI algorithm or software device. The performance evaluation is entirely standalone, as it's the material itself performing under predefined conditions.

7. The Type of Ground Truth Used

The ground truth used for this study is based on objective measurements derived from standardized international testing methods (ISO 4823). These standards define how to quantitatively measure properties like detail reproduction, elastic recovery, and strain in compression, providing a clear, reproducible ground truth.

8. The Sample Size for the Training Set

This concept is not applicable to this device. GC Fit Checker Advanced is a physical material, not a machine learning model. Therefore, there is no "training set." The product's development likely involved iterative formulation and testing, but not in the context of an AI training set.

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

This concept is not applicable as there is no training set for a physical dental material.

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Fit Test C&B is intended for the following applications: Control of precise fit, marginal tightness and marginal gap of - full or partial crowns - bridges - inlays/onlays - cast post cores/post crowns - metal bases - implant-supported crowns and bridges - attachments and other secondary parts of dentures

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I am sorry, but based on the provided document, I cannot answer your request. The document is a letter from the FDA regarding a 510(k) premarket notification for a dental impression material named "Fit Test C&B." It primarily discusses regulatory classification and general controls.

The document does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.

Therefore, I cannot extract the information you requested about the study that proves the device meets acceptance criteria.

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Silicone fit examining material used to detect high spots and pressure points of crowns, bridges, veneers, inlays and dentures.

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The provided text is a Letter of Substantial Equivalence from the FDA for a device named "FIT CHECKER II." This document does not contain information about acceptance criteria, device performance, sample sizes, ground truth establishment, or study designs (such as MRMC or standalone studies).

It is a regulatory approval letter based on the device's substantial equivalence to a legally marketed predicate device, rather than a detailed study report demonstrating performance against specific acceptance criteria.

Therefore, I cannot provide the requested information from the given text.

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