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Instalief is a single use device for the treatment of hemorrhoids by applying it directly to the swollen hemorrhoidal tissues. By applying cold to the tissue, the inflammation is reduced. The device can be used for the treatment of external hemorrhoids and internal hemorrhoids. The device is for adults only.

Instalief™ is a device designed for the treatment of internal and external hemorrhoids by the application of cold directly to the swollen hemorrhoidal tissue. The device consists of an outer bag which houses an endothermic salt, a smaller water-containing frangible bag, an insertion tip with an attached compliant balloon, as well as a separate component that aids in the usage of the device, known as the squeezer. To use the device, the user first bursts the frangible bag by pressing on it, initiating an endothermic process between the water and endothermic salt. The user then inserts the shaft of the device into the anal canal (for internal hemorrhoids) or applies to the outer tissues (for external hemorrhoids), and squeezes the bag with the aid of the squeezer. This action transfers the cold fluid generated into the balloon, which provides targeted cold therapy to the hemorrhoids. Instalief™ is meant to be used for 6 - 8 minutes.

This document describes information about the Instalife Hemorrhoidal Cooling Device, based on the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample sizes used for each non-clinical test (e.g., number of devices tested for balloon burst or cold duration). The data provenance is derived from these non-clinical tests performed by the manufacturer, Privi Medical Pte Ltd. It is a retrospective evaluation of the device's performance against established test protocols. The country of origin for the data (where the tests were conducted) is not specified, but the company is located in Singapore.

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

Not applicable. The "ground truth" for the non-clinical tests was established by objective performance metrics derived from laboratory testing, not expert consensus on medical images or patient outcomes.

4. Adjudication Method for the Test Set

Not applicable. As the tests were non-clinical performance and safety evaluations, there was no adjudication method involving human interpretation. The results were objectively determined based on test protocol criteria.

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

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical testing is not applicable for establishing substantial equivalence of Instalief™."

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done

This question is not applicable as the device is a physical medical device (a hemorrhoid cooling device), not an algorithm or AI software. Therefore, there is no "standalone algorithm" performance to report.

7. The Type of Ground Truth Used

The ground truth used for demonstrating substantial equivalence was primarily based on:

• Performance Documentation (Test Protocols): Objective criteria for structural integrity, functional performance (like cold duration), and biocompatibility detailed in specific test protocols (e.g., VV0001P, VV0002P).
• Comparison to Predicate Device: Direct comparison of physical characteristics and functional performance against the predicate device (Anuice) also served as a "ground truth" for showing similar safety and effectiveness.

8. The Sample Size for the Training Set

Not applicable. The Instalief™ device is a physical medical device, not an AI or machine learning model that requires a training set.

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

Not applicable. As there is no training set, there is no ground truth establishment for it.

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The device use is the treatment of hemorrhoids by applying it directly to the swollen Hemorrhoidal tissues. By applying cold to the tissue, the inflammation is reduced. The cap section is used for the treatment of external hemorrhoids and the tube section for the treatment of internal hemorrhoids. The lubricant is used to ease the introduction of the tube into the rectum.

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The provided text is an FDA 510(k) clearance letter for a device called "anucure," which is intended for the treatment of hemorrhoids by applying cold to the tissue.

This document does not contain any information regarding acceptance criteria, device performance, study design, sample sizes, ground truth establishment, or expert qualifications. It is a regulatory approval letter based on substantial equivalence to predicate devices, not a study report.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance or other study-related details based solely on the provided text.

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The device is for the treatment of external hemorrhoids by applying cold therapy (cryotherapy) directly to swollen hemorrhoidal veins. By applying the device to the tissue, the inflammation is reduced. The direct application of cold provides prompt relief of/extinguishes itching, burning, pain, and swelling. In addition, the device is beneficial for the treatment of perianal fissures due to the vasoconstriction and analgesia properties of the device.

The Cryostat Cold Therapy Pack device consists of a combination of water and chemicals in an anatomically designed sealed plastic bag, enclosed in a cloth outer wrapper for comfort. Six Cold Therapy Packs are packaged in one carton. An individual cold pack is 95mm long and 25mm wide and 26mm in depth. A cold pack consists of a series of inner plastic containers, one of which contains water and FDA food grade dye (to distinguish it from the other fluid), inside a second container which contains a secondary fluid, consisting of water, USP Food grade Kosher propylene glycol as well as a different color FDA food grade dye. The freezing temperature of the first fluid is higher than that of the second fluid. This allows a time released cooling process which delivers high performance cold therapy because of conduction and convection following the phase change of the primary fluid from solid to liquid. The containers are made of formable film common in the food and medical packaging industry. The film is a multi-layer extrusion with one layer being Nylon to add strength and act as a vapor barrier. Visual inspection is performed to verify seal integrity and the dye in the fluids facilitates quality control. Since the intended use of the device is to treat a specific ailment which requires comfort, the miniature cold pack is then wrapped in a heat sealable fabric for comfort to the affected area. The material chosen is white, so that the device, once used can be seen as soiled and therefore is disposed of.

The provided text is a 510(k) Premarket Notification Submission for the Lil' Drug Store Products, Inc. Cryostat™, a device for treating external hemorrhoids with cold therapy. This document focuses on demonstrating substantial equivalence to a predicate device, not on conducting a study with specific acceptance criteria related to a new device performance metric for diagnosis or treatment effectiveness that would involve clinical trials, expert adjudication, or AI.

Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" are not applicable in this context. The "study" here refers to a battery of technical tests, not a clinical study involving human participants in the way the questions imply.

Here's an analysis based on the provided text, addressing the applicable points and explaining why others are not present:

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

   The document does not explicitly state "acceptance criteria" in the format of specific thresholds for clinical performance metrics (like sensitivity, specificity, accuracy). Instead, it lists technical tests performed to demonstrate safety and effectiveness, and implicitly, the device "met" these tests for the FDA to issue a substantial equivalence determination.

   Test Performed	Reported Device Performance (Implicitly Met for Substantial Equivalence)
   Temperature longevity	Demonstrated adequate duration of cold therapy.
   Flammability	Met safety standards for flammability.
   Burst strength	Met safety standards for burst strength.
   Tensile strength	Met safety standards for tensile strength.
   Tear strength	Met safety standards for tear strength.
   Safety/toxicological	Demonstrated safety regarding materials and potential toxicity.
   Irritation	Demonstrated no or acceptable irritation.
   Sensitization	Demonstrated no or acceptable sensitization.
   Cytotoxicity	Demonstrated no cytotoxicity.

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

   Not applicable. The document describes engineering and materials testing, not a clinical test set with human subjects. The "tests performed" (temperature longevity, flammability, etc.) would be conducted on samples of the device itself. Specific sample sizes for these engineering tests are not mentioned in this summary. Data provenance is not relevant in this context.

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 a study requiring expert ground truth for diagnostic or clinical evaluation. The "ground truth" for the engineering tests would be established by standard engineering and safety protocols and measurements.

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

   Not applicable. This is not a study requiring expert adjudication of clinical outcomes or interpretations.

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

   Not applicable. This document pertains to a physical medical device (cold therapy pack), not an AI algorithm or a diagnostic tool that involves human readers/interpreters.

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

   Not applicable. This is not an AI algorithm.

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

   For the technical tests (flammability, burst strength, etc.), the "ground truth" is defined by established engineering standards, material science properties, and safety thresholds. For example, flammability testing would have a pass/fail criterion based on material burning characteristics. For the toxicological assessment, it would be based on established toxicology protocols.

8. The sample size for the training set

   Not applicable. There is no "training set" in the context of this device and its regulatory submission. This is not an AI/machine learning device.

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

   Not applicable. There is no "training set."

Summary of the Device's "Study" and Basis for Acceptance:

The "study" described in this 510(k) submission is a "rigorous risk assessment and performance test regimen" designed to demonstrate the safety and effectiveness of the Cryostat device. The submission’s primary goal is to prove substantial equivalence to a previously legally marketed predicate device (Hemor-Rite Cryotherapy, K042564).

The tests performed were:

• Temperature longevity
• Flammability
• Burst strength
• Tensile strength
• Tear strength
• Safety/toxicological assessment
• Irritation
• Sensitization
• Cytotoxicity

The device "met" these performance criteria implicitly, as "The FDA finding of substantial equivalence of your device... permits your device to proceed to the market." The detailed results or specific thresholds for these tests are not provided in this summary but would have been part of the full 510(k) submission reviewed by the FDA. The "acceptance criteria" here are inherent to meeting relevant safety and performance standards for a medical device of this type, allowing the FDA to determine it is "safe and effective for its proposed indications" and "substantially equivalent" to predicate devices.

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The device use is for the treatment of hemorrhoids by applying it directly to the swollen hemorrhoidal tissues. By applying the device to the tissue, the inflammation is reduced. The base section is used for the treatment of external hemorrhoids and the neck/probe section is used for the treatment of internal hemorrhoids. The lubricant is used to ease the introduction of the probe into the rectum.

Hemor-Rite Cryotherapy is an anatomically designed device for applying cold therapy (Cryotherapy) directly to the swollen hemorrhoidal veins of external hemorrhoids and the internal hemorrhoids within the rectal cavity. The direct application of cold provides prompt relief of itching, pain, and swelling. In addition, Hemor~Rite Cryotherapy is beneficial for the treatment of anal and perianal fissures due to the vasoconstriction and analgesia properties of the device. Hemor-Rite Cryotherapy has been designed taking the following factors into consideration: human anatomy and the medical concepts for treating the ailment.

Hemor-Rite Cryotherapy is an anatomically designed medical device ergonamicly shaped for application of cold therapy (Cryotherapy) directly to swollen hemorroidal veins of external hemorrhoids and internal hemorthoids within the rectal canal. The direct application of cold provides prompt relief of itching, pain, and swelling. The device consists of a sealed applicator containing a coolant formula. The HemorRite device is placed into the user's freezer until frozen. After the Hemor-Rite Cryotherapy device is frozen, the user inserts the device to te affected hemorrhoidal area. The probe is maintained in the area for 6-8 minutes, until the probe reaches body temperature, or up to a maximum of 10 minutes. The HemorRite Cryotherapy device is a reusable device.

Hemor~Rite is comprised of two pieces of plastic; the crown and the base.

The provided text describes the Hemor~Rite Cryotherapy device and a study to demonstrate its substantial equivalence to a predicate device (ANUICE). However, the document does not contain a comprehensive algorithm performance study with specific acceptance criteria, test set details, ground truth establishment for AI/ML devices, as would be expected for a submission for an AI-powered medical device. Instead, the study focuses on hardware and biological compatibility assessments.

Here's a breakdown of the information that can be extracted, acknowledging the limitations regarding AI/ML-specific criteria:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a "test set" in the context of an AI/ML algorithm. The studies listed (Accelerated Aging, Compression Strength, Cytotoxicity, Intracutaneous, Maximization Sensitization) are typical for medical device material and physical property testing. The sample sizes for these tests are not provided, nor is the data provenance (e.g., country of origin, retrospective/prospective). These are laboratory-based tests on the device materials themselves.

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

This information is not applicable to the type of studies described. The "ground truth" for these tests would be established by standardized testing protocols and analytical methods, not by expert consensus on clinical cases.

4. Adjudication Method for the Test Set

This is not applicable as the studies are not clinical trials or expert review processes.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the Effect Size of Human Improvement with AI vs. Without AI Assistance

No, an MRMC comparative effectiveness study was not conducted as this is not an AI/ML powered device. The device is a physical cryotherapy device.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study was done

No, a standalone algorithm performance study was not done for the same reason as above.

7. The Type of Ground Truth Used

The "ground truth" for the tests performed relates to the adherence of the device's materials and design to established safety and performance standards (e.g., ISO 10993 for biocompatibility), and its physical characteristics compared to the predicate device. It is based on laboratory testing and standardized analytical methods, not clinical outcomes or expert consensus on patient data.

8. The Sample Size for the Training Set

This is not applicable as there is no AI/ML algorithm being trained.

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

This is not applicable as there is no AI/ML algorithm being trained.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The study proving the device meets the acceptance criteria is a benchtop and biocompatibility testing program. The listed tests include:

• Accelerated Aging and Integrity: Likely to assess the device's durability and material stability over time under simulated aging conditions.
• Investigation of Compression Strength: To evaluate the device's mechanical robustness and ability to withstand forces during use.
• Cytotoxicity (ISO 10993): To determine if the device's materials release substances that are harmful to cells.
• ISO Intracutaneous (ISO 10993): To assess local skin irritation effects from the device materials.
• Maximization Sensitization (ISO 10993): To determine the potential for the device materials to cause allergic sensitization.

The conclusion of these tests was that "Hemor~Rite is substantially equivalent to ANUICE and is safe, as effective, and performs as well as or better than the predicate device." This implies that the device successfully passed these tests and demonstrated comparable or superior characteristics to the predicate device, thereby fulfilling the safety and performance requirements for marketing. The basis for substantial equivalence for this device is primarily its technological characteristics and the results of these non-clinical performance assessments.

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The Ice Baton is intended to provide relief from pain and discomfort due to hemorrhoids

The Ice Baton is a suppository-shaped medical device designed to provide relief from the pain and discomfort due to hemorrhoids. The Ice Baton consists of an applicator cover and applicator. During use, the cover is removed and the Ice Baton applicator is filled with bottled or drinking water. The applicator cover is placed back on the Ice Baton and excess water is removed. The Ice Baton is placed in the user's freezer until frozen. After the Ice Baton is removed from the freezer, the applicator cover is removed and the Ice Baton is applied to the target hemorrhoid area. It is maintained on that area until the ice has melted or relief is felt. The Ice Baton is a disposable device.

This 510(k) submission for the Behive Ltd Ice Baton does not contain the information required to populate the requested table and answer the study-related questions.

The provided documents focus on establishing substantial equivalence to a predicate device based on intended use and technological characteristics. They do not describe acceptance criteria, performance metrics, or any clinical or technical study data to demonstrate the device meets specific performance standards.

Here's why the information is missing:

• Type of Device: The Ice Baton is a simple, non-powered, topical device for symptomatic relief. For such devices, the FDA's 510(k) pathway often relies heavily on demonstrating substantial equivalence to a legally marketed predicate device rather than extensive performance testing against defined acceptance criteria.
• 510(k) Pathway: The 510(k) process is primarily a premarket notification to establish that a new device is as safe and effective as a legally marketed predicate device. It usually doesn't require new clinical studies if substantial equivalence can be demonstrated through other means (e.g., comparison of technical characteristics, materials, intended use).

Therefore, I cannot provide the requested table or answer the study-specific questions based on the provided text.

If this were a more complex or novel device (e.g., an AI-powered diagnostic tool, an implantable device, or a device with new technology), the 510(k) submission would typically include detailed performance data, acceptance criteria, and study information.

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The device use is the treatment of hemorrhoids by applying it directly to the swollen hemorrhoidal Tissues. By applying cold to the tissue, the INFLAMMATION IS REDUCED -THE CAP SECTION IS USED FOR THE TREATMENT OF EXTERNAL HEMORRHOIDS AND THE TUBE SECTION FOR THE TREATMENT OF INTERNAL HEMORRHOIDS. THE LUBRICANT IS USED TO EASE THE INTRODUCTION. OF THE TUBE INTO THE RECTUM.

ANUICE -COLD PACK, PLASTIC APPLICATO MEDICAL GRADE - NON-CHOMICA

The provided text is a 510(k) clearance letter from the FDA for a device called "ANUICE -COLD PACK, PLASTIC APPLICATOR, MEDICAL GRADE - NON-CHEMICAL". It details the regulatory approval process but does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes and data provenance for the test set.
3. Number and qualifications of experts for ground truth.
4. Adjudication method for the test set.
5. MRMC comparative effectiveness study results.
6. Standalone performance study details.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

This document is a regulatory approval notice, not a study report.

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The Hemorrelief device is intended to provide treatment for the relief of pain, itching, inflammation and bleeding of hemorrhoids by means of cryotherapy (controlled cold treatment).

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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 a device called "Hemorrelief" and its corresponding Indications for Use statement. It confirms the device's substantial equivalence to a predicate device but does not include the specifics of a study or performance metrics. Therefore, I cannot generate the requested information based on the input.

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