Search Results

A device intended to temporarily relieve minor muscle aches and for temporary increase in circulation to the treated areas in people who are in good health.

This product is an Intermittent Pneumatic Compression system to temporarily relieve minor muscle aches and pains and for temporary increase in circulation to the treated areas in people who are in good health. The operating principle is that the air from the device will be delivered to the sleeve with 4 air chambers and the air pressurizes sequentially the chambers from 1st to 4th.

The provided document is a 510(k) summary for the LX9max device, which is a powered inflatable tube massager. The document aims to demonstrate that the LX9max is substantially equivalent to a legally marketed predicate device (Rapid Reboot Compression Therapy System) and a reference device (Rapid Reboot REGEN+).

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

1. Table of acceptance criteria and the reported device performance

The document does not explicitly present a table of "acceptance criteria" in the sense of performance metrics or thresholds for clinical efficacy. Instead, it focuses on demonstrating substantial equivalence to predicate devices. This typically involves showing that the new device has similar indications for use, technological characteristics, and safety and effectiveness profiles as the cleared predicate.

The table provided (Table 1: Comparison of Proposed Device to Predicate / Reference Devices) compares various characteristics:

The "reported device performance" for the LX9max is implicitly that it meets the safety and effectiveness standards of the predicate devices because its technological characteristics are similar, and any differences (pressure range, time range, sleeve type) do not raise new questions of safety or effectiveness. The justification for these minor differences is presented on page 7.

The document also states that the LX9max complies with several voluntary standards for electrical safety, electromagnetic compatibility, and use in the home healthcare environment (listed on page 8). These standards serve as technical acceptance criteria for safety.

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

The document explicitly states: "Clinical Testing was not required to demonstrate the substantial equivalence of the LX9max to its predicate / reference device." (page 8).

Therefore, there

• was no clinical test set used for this submission to prove substantial equivalence.
• no observational data provenance (country, retrospective/prospective) is applicable.

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 testing was performed for substantial equivalence.

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

Not applicable, as no clinical testing was performed for substantial equivalence.

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 physical therapy device (massager), not an AI-assisted diagnostic or therapeutic tool. No MRMC study was conducted.

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

Not applicable. This is not an algorithm-based device.

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

Not applicable. No clinical ground truth was established as no clinical testing was performed. The basis for substantial equivalence relies on comparison of technical characteristics and compliance with safety standards.

8. The sample size for the training set

Not applicable. This is not a machine learning/AI device, so there is no "training set."

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

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

Ask a specific question about this device

A device intended to prevent Deep Vein Thrombosis/Pulmonary Embolism (DVT/PE) by increasing venous blood flow to a patient who has a risk of DVT/PE.

A device intended to prevent DVT/PE by increasing venous blood flow to a patient who has a risk of DVT/PE.

Operating principal of this device is that the air output from the air motor is delivered to a sleeve composed of four air chambers are sequentially inflated from the first air chamber to the third chamber through solenoid valve.

The provided document is a 510(k) Pre-Market Notification for the DVT-4000S device. It does not contain a study demonstrating acceptance criteria for the device's performance in terms of its intended use (preventing DVT/PE by increasing venous blood flow).

Instead, the document focuses on demonstrating substantial equivalence to a predicate device (DVT-2600) based on technological characteristics and compliance with electrical safety and electromagnetic compatibility standards.

Therefore, many of the requested details about acceptance criteria, device performance against those criteria, sample sizes, expert involvement, and ground truth establishment are not present in this document.

Here's what can be extracted from the document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state acceptance criteria for DVT/PE prevention or venous blood flow increase, nor does it report performance metrics against such criteria. The "specifications" listed are more about the device's operational parameters rather than clinical outcomes.

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

• Clinical Test Set: The document explicitly states: "Clinical testing was not required to demonstrate the substantial equivalence of the DVT-4000S to its predicate device." Therefore, there is no clinical test set mentioned, and thus no sample size or data provenance for such a test.
• Non-Clinical Test Set: For electrical safety, EMC, and biocompatibility, the sample size is not specified, but these are typically tested on a representative number of devices (e.g., a small batch) during product development and regulatory submission. The provenance would be from laboratory testing performed by the manufacturer or a certified testing facility.

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 test set requiring ground truth establishment by experts was conducted or reported.

4. Adjudication method for the test set:

Not applicable, as no clinical test set requiring adjudication was conducted or reported.

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 mechanical compression device, not an AI-powered diagnostic or assistive 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 mechanical compression device, not an algorithm.

7. The type of ground truth used:

Not applicable, as no clinical test involving ground truth for disease detection/prevention was performed. The ground truth for electrical safety or biocompatibility would be defined by the standards themselves (e.g., does it conduct electricity safely, does it cause cell death).

8. The sample size for the training set:

Not applicable, as this is a non-AI device; therefore, there is no training set mentioned.

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

Not applicable, as this is a non-AI device; therefore, there is no training set mentioned.

Summary of Study (as presented in the document):

The "study" presented is a substantial equivalence comparison to a legally marketed predicate device (DVT-2600). The manufacturer asserts that the DVT-4000S is substantially equivalent to the DVT-2600 based on:

• Identical Indications for Use: Both devices are intended to prevent DVT/PE by increasing venous blood flow.
• Similar Technological Characteristics: The operating principle (sequential inflation of air chambers) is the same. Key specifications like pressure range and number of chambers are identical.
• Minor Differences Justified: The differences (power consumption and inclusion of a battery in DVT-4000S) were deemed not to raise new questions of safety or effectiveness. Performance tests confirmed that the device functions equivalently when using AC power or battery.
• Compliance with Voluntary Standards: The DVT-4000S complies with recognized standards for electrical safety (IEC 60601-1:2012), electromagnetic compatibility (IEC 60601-1-2:2014), and biocompatibility (ISO 10993-5:2009, ISO 10993-10:2010).

The basis for market clearance, in this case, is not a clinical study demonstrating performance against specific clinical acceptance criteria, but rather a demonstration of substantial equivalence to an already cleared device and compliance with relevant safety and performance standards.

Ask a specific question about this device

DVT-Pro is a system to prevent DVT (Deep Vein Thrombosis) by improving the blood velocity of patients. DVT-Pro is Circulation Enhancement, Deep Vein Thrombosis Prophylaxis, Edema - Chronic, Extremity Pain Incident to Trauma or Surgery, Leg Ulcers, Venous Stasis / Venous Insufficiency.

DVT-Pro device is a specialized intermittent pneumatic compression (IPC) system to prevent DVT (Deep Vein Thrombosis) and PE (Pulmonary Embolism) by improving the venous blood flow in at risk patients. The basic set of The Venous Assist System(DVT-PRO) consists of the main body, which includes the air pump that generates air pressure and control panel, air hose that transfers air pressure and sleeve (cuff) for calf and foot.

The provided document is a 510(k) Summary for a medical device called "DVT-Pro," a compressible limb sleeve system used to prevent Deep Vein Thrombosis (DVT). The document outlines the device's characteristics and compares it to a predicate device (DVT-2600) to demonstrate substantial equivalence, but it does not contain information on acceptance criteria or a study proving the device meets specific performance metrics in the way typically expected for an AI/ML device (e.g., sensitivity, specificity, or reader studies). The "performance data" section primarily refers to safety and software validation testing, not clinical performance for its stated indications.

Therefore, I cannot provide the detailed information requested in the prompt, especially points related to:

• A table of acceptance criteria and reported device performance (in terms of clinical efficacy metrics like accuracy, sensitivity, specificity).
• Sample size used for the test set or training set for clinical performance evaluation.
• Data provenance, number of experts, adjudication methods, or ground truth types for clinical performance.
• MRMC comparative effectiveness study or standalone performance.

The document focuses on demonstrating that the DVT-Pro device is substantially equivalent to an existing device (DVT-2600) based on:

• Intended Use: Both devices are for "Circulation Enhancement, Deep Vein Thrombosis Prophylaxis, Edema - Acute, Edema - Chronic, Extremity Pain Incident to Trauma or Surgery, Leg Ulcers, Venous Stasis / Venous Insufficiency." The DVT-Pro explicitly states it's for DVT prevention by improving blood velocity.
• Technological Characteristics Comparison (See the table on page 8-9): This table highlights similarities in mechanical and electrical specifications, such as mode of compression (sequential), pressure ranges (with slight differences in maximums for leg/foot), and general design.
• Safety and Software Validation:
  • Biocompatibility testing: ISO10993-5, ISO10993-10 were performed.
  • Electrical safety and performance testing: Conducted according to IEC 60601-1:2005 + CORR.1(2006) + CORR(2007).
  • EMC testing: Conducted according to IEC 60601-1-2:2007.
  • Software Verification and Validation Testing: Documented as per FDA's "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software was classified as "minor" level of concern. All test results were satisfactory.

Key Missing Information (as per your prompt):

The document does not detail any clinical performance study (e.g., to measure the device's effectiveness in preventing DVT) with specific acceptance criteria like accuracy, sensitivity, or specificity. The "performance data" discussed is related to engineering and software validation for safety and proper functioning, not clinical outcomes directly demonstrating DVT prevention efficacy against a defined ground truth.

Therefore, I cannot populate the table or answer the specific questions regarding clinical performance studies, test set/training set sizes, expert involvement, or adjudication methods, as this information is not present in the provided text.

Ask a specific question about this device

LF-400 is intended for use by medical professionals and patients at home, who are under medical supervision, in treating many conditions, such as : Primary lymphedema, Edema following trauma and sport injuries, Postimmobilization edema, Venous insufficiencies. Lymphedema.

LF400 is the pressurization system helping to relieve the symptom of lymphedema and prevent aggravation of symptoms by applying the air pressure to limbs. LF400 comprises 4-step sleeves which move the body fluids through the limbs by evenly applying pressure to the limbs. The basic set of Air Compression Therapy System consists of the main body, which includes the air pump that generates air pressure and control panel, air hose that transfers air pressure and cutoff sleeve (cuff) for leg and its accessories include overlapping sleeve (cuff) for leg, cutoff sleeve (cuff) for arm, overlapping sleeve (cuff) for arm, cutoff sleeve (cuff) for waist and pants sleeve (cuff). The device consists of 4 parts-PCB, control panel, air pump (AC motor pump) and distributor (solenoid).

The provided text describes a 510(k) premarket notification for the LF-400 Compressible Limb Therapy System, which is a medical device for treating various lymphedema and edema conditions. The document focuses on demonstrating substantial equivalence to a predicate device, the LX7 (V7), rather than presenting a study specifically designed to establish acceptance criteria and prove the device meets them in the way clinical trials or AI performance evaluations usually do.

Based on the nature of this 510(k) submission, the "acceptance criteria" discussed are primarily related to safety, electrical performance, biocompatibility, and software validation, rather than clinical efficacy metrics like sensitivity or specificity. The "reported device performance" refers to the results of these technical tests, which found the device to be satisfactory and substantially equivalent to the predicate.

Here's an analysis of the requested information based on the provided text:

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

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

The document does not describe a "test set" in the context of clinical data (e.g., patient cases). The performance data cited are from technical tests (biocompatibility, electrical safety, EMC, software). These types of tests typically use specific numbers of samples of the device components or the device itself, rather than a "sample size" of patients or data from medical records. The text does not specify the exact number of units or materials tested for these engineering and materials assessments.

Regarding data provenance:

• The submitter, DaeSung Maref Co., Ltd., is located in the Republic of Korea.
• The standards (ISO, IEC, FDA guidance) are international and US-based.
• The tests are implied to be conducted as part of the device development and regulatory submission process, which would typically be prospective for these types of technical evaluations.

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 to the type of performance data presented. The "ground truth" for technical standards is the standard itself, and the performance is measured against objective criteria within that standard by qualified test engineers/labs, not by a panel of medical experts establishing consensus on patient-specific data.

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

This is not applicable. Adjudication methods are used for expert review of clinical results or imaging data, which are not part of this document's performance section.

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. The LF-400 is a physical medical device (compressible limb therapy system), not an AI/imaging diagnostic tool that involves "human readers" or AI assistance in interpretation.

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

This is not applicable as the device is not an AI algorithm. Its software validation ensures its control functions operate correctly, but it does not perform diagnostic interpretation or AI-driven decision-making in a "standalone" algorithmic sense.

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

For the technical performance data, the "ground truth" is adherence to established international and national standards (ISO, IEC) for biocompatibility, electrical safety, EMC, and FDA guidance for software. These standards define the acceptable parameters and test methodologies.

8. The sample size for the training set

This is not applicable. This device does not use machine learning or AI that would require a "training set" of data. The software components are for control and user interface, verified through traditional software validation methods.

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

Not applicable, as there is no training set for an AI/ML model for this device.

Ask a specific question about this device

MK300L is intended for use by medical professionals and patients at home, who are under medical supervision, in treating many conditions, such as : Primary lymphedema, Edema following trauma and sport injuries, Postimmobilization edema, Venous insufficiencies, Lymphedema.

MK300L is used with four chamber garments for full leg, and period has its own variable duration,pressure, cycle time and gradient setting. Power unit features visual operation statusand fault indicators.

The provided text is a 510(k) summary for the Compressible Limb Therapy System MK300L, which is a medical device and not an AI/ML device. Therefore, the questions related to AI/ML device performance metrics, such as sample sizes for test and training sets, ground truth establishment, expert qualifications, and MRMC studies, are not applicable to this document.

The document focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed performance studies or acceptance criteria in the context of AI/ML evaluation.

However, based on the provided text, I can extract information relevant to the device's regulatory review and intended use:

1. Acceptance Criteria and Reported Device Performance:

The document does not explicitly state quantitative acceptance criteria in terms of performance metrics (e.g., accuracy, sensitivity, specificity) for the device. Instead, it relies on demonstrating substantial equivalence to predicate devices. The "reported device performance" is implicitly that it meets the safety and effectiveness standards comparable to the predicate devices.

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

The document mentions "bench as well as laboratory testing to applicable standards" but does not specify sample sizes for any test sets in terms of patient data or data provenance (e.g., country of origin, retrospective/prospective). This type of detail is typically not included in a 510(k) summary focused on substantial equivalence for a non-AI/ML device.

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

Not applicable. This question pertains to AI/ML device evaluation where expert consensus is often used for ground truth. For a physical medical device like a massager, ground truth would typically relate to physical measurements, engineering standards, or clinical outcomes, not expert interpretation of data.

4. Adjudication Method for the Test Set:

Not applicable. This question is relevant to AI/ML evaluations where disagreements between experts need to be resolved. For a non-AI device, adjudication methods in this context are not described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done or described. MRMC studies are specific to evaluating how human readers' performance changes with or without AI assistance, which is not applicable to this device.

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

Not applicable. This device is a physical massager and does not involve an algorithm or AI component in the sense of a software-as-a-medical-device (SaMD) evaluated for standalone performance.

7. The Type of Ground Truth Used:

The "ground truth" for this device's evaluation is based on compliance with established medical device standards (e.g., electrical safety, quality management, risk management, clinical investigation general requirements) and demonstrating that its performance is comparable to legally marketed predicate devices through "bench as well as laboratory testing." Clinical outcomes data might be inferred from the predicate devices' long-standing safety and effectiveness, but it's not explicitly stated as the ground truth for this specific device's evaluation.

8. The Sample Size for the Training Set:

Not applicable. This device does not use a training set as it is not an AI/ML device.

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

Not applicable. This device does not have a training set.

Ask a specific question about this device

DVT-2600 is a system to prevent DVT (Deep Vein Thrombosis) by improving the blood velocity of patients. DVT-2600 is Circulation Enhancement, Deep Vein Thrombosis Prophylaxis, Edema - Acute, Edema - Chronic, Extremity Pain Incident to Trauma or Surgery, Leg Ulcers, Venous Stasis / Venous Insufficiency.

DVT-2600 device is a specialized intermittent pneumatic compression (IPC) system to prevent DVT (Deep Vein Thrombosis) and PE (Pulmonary Embolism) by improving the venous blood flow in at risk patients. The system consists of the controller, the tubing sets and 3 types(Non-woven, Fabric, Oxford) garments. The system offers Sequential inflation promoting venous blood movement and metabolism and then has sufficient interval time to refill with blood sufficiently after deflation. The operation of the inflation and deflation is repeated until the stop button is activated.

The provided 510(k) summary for K112677, "The Venous Assist System DVT-2600", does not contain details about specific acceptance criteria or a study that definitively proves the device meets such criteria in terms of performance metrics like sensitivity, specificity, or reader improvement.

Instead, the document focuses on demonstrating substantial equivalence to a predicate device (SCD Express™4 system, K040511) through:

• Comparison of Intended Use: Stating that the DVT-2600 has "substantial equivalent intended use" to the predicate.
• Comparison of Technological and Performance Characteristics: Claiming "substantial equivalent technological and performance characteristics," and that it is "as safe and effective as the predicate devices, has few technological differences, but there are no new indications for use and without raising any new safety and/or effectiveness concerns."
• Adherence to Standards: Listing several international standards (IEC, ISO) that the device complies with, which are general safety and quality management standards rather than specific performance metrics for DVT prevention efficacy. These include:
  • Council Directive 93/42/EEC
  • IEC 980:2003
  • IEC1041:1998
  • ISO 13485:2003
  • ISO 14155-1:2003
  • ISO 14971:2007
  • IEC 60601-1
  • IEC 60601-1-2

The document explicitly states "After analyzing both bench as well as laboratory testing to applicable standards," but does not provide any specific results or data from these tests, nor does it describe a clinical study measuring performance against acceptance criteria for DVT prevention efficacy. This is typical for a 510(k) submission seeking substantial equivalence for devices of this type, where performance often relies on demonstrating similar operational principles and safety to already-cleared devices, rather than a new clinical efficacy trial with detailed performance metrics.

Therefore, most of the requested information cannot be extracted from the provided text.

Here is a summary of what can be inferred or is stated, and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Missing: Specific quantitative acceptance criteria (e.g., target increase in blood velocity, DVT incidence reduction, specific pressure ranges, cycle times, etc.) and direct performance data to demonstrate meeting these criteria.

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

Missing. The document does not describe a clinical "test set" involving human subjects or data that would typically have a sample size for performance evaluation. The "bench as well as laboratory testing" mentioned likely refers to engineering tests and basic safety assessments, not a clinical study on patient outcomes or diagnostic performance.

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

Missing. No information on experts or ground truth establishment is provided, as no clinical performance study akin to a diagnostic device trial is detailed.

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

Missing. No adjudication method is mentioned.

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

Missing. This device is an intermittent pneumatic compression system for DVT prophylaxis, not an AI-powered diagnostic or decision support tool for human readers. Therefore, an MRMC study is not applicable to its function.

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

Missing. This is not an algorithm-only device. It is a physical medical device.

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

Missing. As no clinical performance study is described with detailed results, no ground truth type is specified. For a device like this, clinical ground truth would typically be DVT incidence or objective measures of blood flow.

8. The sample size for the training set

Missing. This device is not an AI/ML model that would have a "training set."

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

Missing. Not applicable, as this is not an AI/ML model.

In summary: The provided 510(k) emphasizes substantial equivalence to a predicate device and adherence to general medical device safety and quality standards (e.g., ISO, IEC). It does not detail a specific clinical study with quantitative performance acceptance criteria, sample sizes, or ground truth establishment for measuring the device's efficacy in preventing DVT. This approach is common for devices demonstrating substantial equivalence where the predicate has already established clinical effectiveness.

Ask a specific question about this device

LX7(V7) is intended for use by medical professionals and patients at home, who are under medical supervision, in treating many conditions, such as : Primary lymphedema, Edema following trauma and sport injuries, Postimmobilization edema, Venous insufficiencies, Lymphedema.

LX7(V7) is used with four chamber garments for full leg, and period has its own variable duration,pressure, cycle time and gradient setting. Power unit features visual operation statusand fault indicators.

The provided text describes a 510(k) premarket notification for a medical device called the "Compressible Limb Therapy System LX7(V7)". This submission focuses on establishing substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a clinical study with statistical endpoints. Therefore, a direct table of acceptance criteria and reported device performance, as typically seen in efficacy studies, is not applicable or present in this document.

The core of this submission is a comparison of the new device (LX7(V7)) to two predicate devices (Lympha Press Plus and WHF-324 (POWER-Q1000 Plus)) to demonstrate that it is "as safe and effective". The "Performance Characteristics" section lists various standards the device applied and conducted tests to, which are related to safety and quality management, but it does not detail specific performance metrics or their acceptance thresholds.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

As mentioned, the document does not present quantitative acceptance criteria or numerical performance data of the LX7(V7) in the way one would expect from an efficacy study. Instead, substantial equivalence is established by comparing the new device's features, intended use, and adherence to safety standards with those of legally marketed predicate devices.

The table below summarizes the comparison between the LX7(V7) and its predicate devices, which serves as the basis for the substantial equivalence determination rather than a direct performance acceptance criteria table.

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

The document does not describe a clinical study with a "test set" in the context of evaluating diagnostic or predictive performance. Instead, it relies on bench and laboratory testing against established safety and quality standards to demonstrate the device's characteristics. Therefore, information on sample size and data provenance for a test set in a performance study is not applicable. The data provenance for the device is from Korea (manufacturer Daesung Maref Co., Ltd.). The study described is a premarket notification for substantial equivalence, not a clinical trial.

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

This information is not provided because the submission is not based on a clinical study where expert-established ground truth would be necessary for a test set.

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

Not applicable, as no test set data requiring adjudication is presented.

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. The device is a 'Powered Inflatable Tube Massager' without AI components or diagnostic capabilities that would involve human readers interpreting images or data.

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

Not applicable, as this is a physical medical device, not an algorithm.

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

The "ground truth" in this context refers to compliance with recognized international and national standards for medical device safety and quality. The device demonstrated conformance to standards such as:

• Council Directive 93/42/EEC (medical devices)
• IEC 980:2003 (graphical symbols)
• IEC1041:1998 (information supplied by manufacturer)
• ISO 13485:2003 (quality management systems)
• ISO 14155-1:2003 (clinical investigation, Part 1: General requirements - this standard specifies requirements for the design, conduct, recording, and reporting of clinical investigations performed on human subjects to assess the clinical performance or safety of medical devices. Its mention here suggests the potential for clinical investigations, but the document itself doesn't detail one.)
• ISO 14971:2007 (risk management)
• IEC 60601-1 (general requirements for safety)
• IEC 60601-2-10 (safety of nerve and muscle stimulators)
• IEC 60601-1-2 (electromagnetic compatibility)

The "ground truth" for the substantial equivalence claim is that the device's characteristics and performance are comparable to (i.e., "as safe and effective as") the predicate devices, which have already been cleared by the FDA.

8. The sample size for the training set

Not applicable, as there is no mention of an algorithm or machine learning model that would require a training set.

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

Not applicable for the same reason as above.

Ask a specific question about this device