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The Bio Fluff System is intended for colon cleansing to remove fecal residues when medically indicated, such as before radiological or endoscopic examination.

The Bio Fluff System is intended to instill water through a disposable speculum into the colon. Intestinal Cleansing is carried out by inserting water in the patient's rectum at controlled temperature and pressure through the disposable specula. This action allows the cleaning of the lower tract of the colon. The Bio Fluff System comprises:

• different models of the Bio Fluff device:
• HT model, for professional use,
• HTP model, portable version of HT model,
• associated components:
• disposable HT specula for both Bio Fluff model HT and Bio Fluff model HTP.

The provided document is a 510(k) summary for the Bio Fluff System, a colonic irrigation system. Unlike submissions for AI/ML-based medical devices, which typically describe acceptance criteria based on metrics like sensitivity, specificity, or accuracy derived from clinical performance studies, this document focuses on demonstrating substantial equivalence to a predicate device through non-clinical bench testing and biocompatibility.

Therefore, this document does not contain the specific information requested regarding acceptance criteria related to AI/ML device performance, such as:

• A table of acceptance criteria and reported device performance based on AI/ML metrics.
• Sample sizes used for test sets in the context of AI/ML performance evaluation.
• Number of experts and their qualifications for ground truth establishment for AI/ML data.
• Adjudication methods for AI/ML test sets.
• Multi-reader multi-case (MRMC) comparative effectiveness studies for AI assistance.
• Standalone (algorithm-only) performance evaluations relevant to AI/ML.
• Specific types of ground truth (e.g., pathology, outcomes data) for AI/ML algorithm training or testing.
• Sample sizes for training sets of AI/ML algorithms.
• Methods for establishing ground truth for training sets of AI/ML algorithms.

Instead, the document focuses on:

• Biocompatibility Testing:
  • Acceptance Criteria (Implied): Compliance with ISO 10993-5 (Cytotoxicity), ISO 10993-10 (Sensitization), and ISO 10993-10 (Irritation).
  • Reported Performance: "The devices do not arise any issues of biocompatibility for their intended use." This indicates the tests were passed.
• Bench Tests:
  • Acceptance Criteria (Implied): Correct operation for Pressure Safety, Flow Control, Temperature Safety, and Leak Resistance.
  • Reported Performance: "Functional testing showed correct operation of the Bio Fluff System as per its intended use." This indicates the tests were passed.

The core of the submission is a comparison to a predicate device (Aqua Cleanse, K150381) to establish substantial equivalence based on:

• Indications for Use: Substantially equivalent.
• Classification, Product Code, Intended User, Insertion Point, Antibacterial Filters, Flow Regulator, Temperature Gauge, Timer, Outgoing Waste Material Observation, Circuit Cleaning System, Biocompatibility: All deemed substantially equivalent or same.
• Temperature Safety, Flow Control, Pressure Control: Deemed substantially equivalent despite minor technical differences.
• Electrical Components and Performance Test (Electrical Safety): Not present in the subject device, which the submission argues does not affect safety or effectiveness, thus still leading to substantial equivalence.

In summary, this document describes the acceptance criteria and study findings for a traditional medical device (colonic irrigation system) based on non-clinical testing and comparison to a predicate device, not an AI/ML-based medical device. Therefore, it cannot provide the detailed information requested about AI/ML device validation.

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The use of this device is restricted to colon cleansing when medically indicated, such as before radiological or endoscopic examination.

The Colonic Plus Regular, Small and Straight shape Hydrokits is a plastic, non-sterile, single use product colonic irrigation system that is used as an accessory with lower bowel Colonic irrigation systems intended to instill water into the colon through a nozzle inserted 2" 3" into the rectum to evacuate the contents of the lower colon.

The provided text is a 510(k) premarket notification for a medical device called "Colonic Plus Regular, Small, and Straight Shape Hydrokits." Based on the content, it's a submission for a colonic irrigation system accessory, asserting substantial equivalence to a predicate device.

Crucially, this document focuses on demonstrating physical and functional equivalence of a medical device (a hydrokit for colonic irrigation) to a legally marketed predicate device, as required for a 510(k) submission to the FDA. It is not a clinical study report for an AI/ML-based medical device addressing a specific disease or condition.

Therefore, I cannot extract the information required to answer your questions regarding acceptance criteria and study proving device performance for an AI/ML device. The provided text discusses:

• Device Description: A plastic, non-sterile, single-use product colonic irrigation system accessory.
• Comparison to Predicate Device: Detailed comparison of design, materials, and intended use to the Transcom Hydrokit (K131852).
• Non-Clinical Data: Water pressure leakage, tensile & compression tests, and biocompatibility testing (cytotoxicity, irritation, sensitization). These are engineering and material safety tests, not performance metrics related to diagnostic accuracy or clinical outcomes.
• Clinical Data: Explicitly states, "No clinical studies are submitted to support this premarket notification."

Since the device in question is a physical medical device and not an AI/ML algorithm, and no clinical studies were submitted, the requested information (performance metrics, test set details, expert involvement, MRMC studies, standalone algorithm performance, training set details) related to AI/ML device validation does not apply to this document.

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The device is intended for colon cleansing when medically indicated, such as before radiological or endoscopic examinations.

The disposable rectal speculum is a non-metal (Polypropylene) device used to introduce water into the colon and dispose waste from the colon during a colonic irrigation procedure.

I apologize, but the provided text does not contain the information required to answer your request regarding the acceptance criteria and the study that proves the device meets those criteria.

The document is a 510(k) premarket notification for a colonic irrigation system. It details the device's indications for use, technological characteristics, and claims substantial equivalence to predicate devices. However, it does not describe any specific performance acceptance criteria or a study that directly tests and proves the device meets such criteria.

Instead, the document focuses on:

• Substantial Equivalence: The primary argument for market clearance is that the device is substantially equivalent to legally marketed predicate devices in terms of intended use, indications for use, design, and materials.
• Biocompatibility Testing: It mentions that the finished colonkit was tested for biocompatibility, indicating one type of non-clinical testing performed.

Therefore, I cannot populate the requested table or provide details on the study's methodology, sample size, expert involvement, or ground truth establishment because this information is not present in the provided text.

To answer your question, information about specific performance metrics (e.g., flow rate, safety pressure limits, material strength, etc.), the criteria set for these metrics, and the results of tests designed to meet these criteria would be needed. This depth of information is typically found in design verification and validation reports, which are part of the larger 510(k) submission but are not fully detailed in this summary letter.

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THIS DEVICE IS INTENDED FOR COLON CLEANSING WHEN MEDICALLY INDICATED. SUCH AS BEFORE RADIOLOGICAL OR ENDOSCOPIC EXAMINATION.

The proposed device "Aqua Cleanse" is for colon cleansing when medically indicated such as before radiological or endoscopic examination. It introduces water at a comfortable temperature into the large intestine. It fills and empties water into and out of the colon thus cleansing it of its contents. The device is equipped with a pressure regulated safety system; a self-contained cleaning system, and flow regulator. lt is used with the accessory, disposable rectal speculum kits.

The associated disposable kit is intended to introduce water into the colon through a speculum inserted into the rectum to assist with the evacuation of the contents of the lower colon. This is a single-use only kit.

The provided document is a 510(k) premarket notification for the "Aqua Cleanse" colonic irrigation system. As such, it does not contain the acceptance criteria or results from a study proving device performance in the manner typically associated with clinical trials of diagnostic or therapeutic devices.

Instead, this document focuses on demonstrating substantial equivalence to a predicate device (HC-1 Classic, K131852) through non-clinical testing and comparison of technological characteristics.

Therefore, many of the requested sections about clinical study design (sample size, ground truth, expert adjudication, MRMC studies) are not applicable to this submission.

Here's a breakdown based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states that "Bench test results proved safety and effectiveness when testing for accurate pressure and temperature range." The specific numerical acceptance criteria (e.g., pressure range, temperature range) are not explicitly detailed in the summary provided.

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

• Sample Size: Not applicable. The document refers to "bench testing," which typically involves testing a limited number of manufactured units or prototypes to verify engineering specifications, not a clinical "test set" of patients.
• Data Provenance: Not applicable. The data comes from the manufacturer's internal bench testing. No country of origin for clinical data is relevant as no clinical data was used.
• Retrospective/Prospective: Not applicable, as no clinical study was performed.

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

• Not applicable. Ground truth as typically understood for clinical studies (e.g., disease diagnosis) was not established for this non-clinical bench testing. The "ground truth" here would be adherence to engineering specifications and safety standards.

4. Adjudication Method for the Test Set

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

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

• No, an MRMC comparative effectiveness study was not done. The document explicitly states: "No animal or clinical testing was performed on the proposed device."
• Effect Size: Not applicable, as no such study was conducted.

6. Standalone (Algorithm Only) Performance Study

• Not applicable. This device is a physical medical device (colonic irrigation system), not an AI algorithm. Its performance is evaluated through bench testing of its mechanical and electrical functions, not algorithmic accuracy.

7. Type of Ground Truth Used

• For the bench testing, the "ground truth" was adherence to established engineering and safety specifications, and proper mechanical/electrical function.
• For the accessory kits, material biocompatibility was assessed against ANSI/AAMI/ISO 10993-5 standards by Nelson Laboratories ("certified to ANSI/AAMI/ISO 10993-5").

8. Sample Size for the Training Set

• Not applicable. There is no "training set" in the context of a physical device like this. The device is not based on a machine learning algorithm that requires training data.

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

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

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The use of this device is restricted to colon cleansing when medically indicated, such as before radiological or endoscopic examination.

The HC-1 and HC-1 Classic proposed device is a device for colon cleaning. It introduces water at a comfortable temperature into the large intestine. It automatically fills and empties water into and out of the colon thus cleansing it of its contents when medically indicated such as before radiological or endoscopic examination. It is hygienic, painless and odorless. The device is equipped with an automatic pressure safety system; integrated disinfectant container, flow regulator and a 3-way manifold. It is supplied with disposable probe/hose assemblies for single-use during colonic hydrotherapy.

The HYDROKIT is a colonic irrigation system intended to instill water into the colon through a nozzle inserted into the rectum to evacuate the contents of the lower colon.

Here's an analysis of the provided documentation regarding the acceptance criteria and study for the TRANSCOM COLON HYDROTHERAPY MODELS HC-1 and HC-1 Classic, and HYDROKITS:

This device did not undergo a study to prove it met specific quantitative acceptance criteria related to its clinical efficacy or performance in a traditional sense. Instead, the FDA clearance via a 510(k) pathway was based on demonstrating substantial equivalence to a predicate device. This means the manufacturer argued the new device is as safe and effective as a legally marketed device (the predicate).

Therefore, many of the typical study-related questions (sample size, ground truth, MRMC, etc.) are not applicable in this context.

Here's the information based on your request:

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

Since this was a substantial equivalence submission, there aren't explicit quantitative "acceptance criteria" for clinical performance in the document beyond meeting the functional specifications of a colon irrigation system comparable to the predicate. The "performance" is implicitly deemed equivalent to the predicate device.

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

• Test Set Sample Size: Not applicable. No clinical test set data was provided.
• Data Provenance: Not applicable for clinical testing. Bench testing was performed but details on sample size for components or systems are not specified in this summary.

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. No establishment of ground truth by experts in a clinical study was performed or documented here.

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

Not applicable. No clinical test set.

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. No MRMC study was performed as this is a medical device (colon irrigation system), not an AI diagnostic tool involving human readers.

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. Functional laboratory bench testing was performed to ensure correct operation of the device.

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

Not applicable for clinical ground truth. For the device itself, the "ground truth" for demonstrating substantial equivalence rested on:

• Bench testing: Verifying electrical safety, electromagnetic compatibility, and delivery of colon hydrotherapy according to specifications.
• Biocompatibility testing: For the Hydrokits (cytotoxicity, sensitization, irritation/intracutaneous toxicity).
• Mechanical testing: For the Hydrokits (tensile, compression).
• Comparison to Predicate Device: Architectural and functional similarities to the legally marketed predicates.

8. The sample size for the training set

Not applicable. This device does not use an "algorithm" in a machine learning sense, so there is no training set.

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

Not applicable. See above.

Summary of the Study:

The "study" presented here is a pre-market notification (510(k)) for substantial equivalence.

• For the HC-1 and HC-1 Classic colon hydrotherapy units: The study primarily involved a comparison of technological characteristics and features to a previously cleared predicate device (TRANSCOM COLON HYDROTHERAPY MODEL HC-2000, K970482). Bench testing confirmed basic functional aspects like electrical safety, EMC, and operational specifications. No animal or clinical testing was performed. The conclusion was that the new devices' intended use, indications for use, functionality, and operation are essentially the same as the predicate, making them substantially equivalent.
• For the HYDROKITS (disposable speculums and associated components): The study involved a comparison to a predicate device (SPO1 and SP02 disposable speculums, K000388). Bench testing included biocompatibility tests (cytotoxicity, sensitization, irritation or intracutaneous toxicity) and mechanical tests (tensile, compression) of the material (SASOL HNR100 polypropylene copolymer). No clinical data was submitted. The conclusion was substantial equivalence to the predicate disposable speculums.

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The Water Lily The is indicated for colon cleansing when medically indicated, such as before radiological or endoscopic examination.

The Water Lily 10 is a professional colon hydrotherapy system for use when medically indicated. It introduces filtered water at a comfortable temperature into the large intestine, thus cleansing the colon of its contents. Water temperature is controlled by means of a mixing valve; flow is controlled by one switch operated by the user. The system is manually sanitized prior to each use with a suitable broad spectrum disinfectant (not included). The system includes disposable tubing and a sterile, disposable rectal nozzle intended for single use only (ConMed Corporation K050992).

The provided document describes the K094022 510(k) submission for the Water Lily™ Colon Hydrotherapy System. This device is a colonic irrigation system and its acceptance criteria and the study proving it meets them are detailed primarily through a comparison to a predicate device, the Angel of Water™ Colon Hydrotherapy System (K003720), and non-clinical testing.

1. Table of Acceptance Criteria and Reported Device Performance

This device is cleared based on demonstrating substantial equivalence to a predicate device. The acceptance criteria are implicitly met by showing similar technical characteristics and performance to the predicate. The "reported device performance" below refers to the results of non-clinical testing for specific safety parameters.

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

The document does not detail a "test set" in the traditional sense involving human subjects or clinical data for evaluating the device's performance against the acceptance criteria. Instead, the evaluation is based on:

• Non-clinical bench testing: This was used to verify specific safety parameters (pressure, temperature shutdown, electrical safety). There is no "sample size" indicated for these tests, as they are typically performed on a limited number of manufactured units to confirm design specifications.
• Comparison to a predicate device: The Water Lily™ was compared to the Angel of Water™ (K003720) based on shared technical characteristics. This is a design and functional comparison, not a data-driven clinical comparison.
• Data provenance: Not applicable in the context of clinical trials as no clinical trials were performed. The testing described is bench testing.

Therefore, there is no explicit sample size for a "test set" or data provenance information (country of origin, retrospective/prospective) because the submission focuses on substantial equivalence through design and non-clinical engineering verification rather than clinical studies.

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

Not applicable. This device's clearance is based on substantial equivalence to a predicate device and non-clinical bench testing. There was no "ground truth" derived from expert consensus for a test set as would be found in a clinical study for diagnostic accuracy or efficacy.

4. Adjudication method for the test set

Not applicable. As no clinical "test set" was described requiring expert assessment or ground truth establishment, no adjudication method was used.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done

No. The document does not mention any clinical studies, including MRMC comparative effectiveness studies, demonstrating how human readers (or users in this context) improve with or without AI assistance. This device is a physical medical device, not an AI-driven diagnostic or assistive tool.

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

No. This device is a colon hydrotherapy system and does not involve any algorithms or AI, thus rendering "standalone performance" (in the context of AI) irrelevant.

7. The type of ground truth used

Not applicable in the sense of clinical "ground truth." For the non-clinical tests, the "ground truth" equates to engineering specifications and safety standards (e.g., pressure not exceeding 2 psi, temperature shutdown at 104°F, UL/CSA electrical safety approvals). The primary ground for clearance is substantial equivalence to the legally marketed predicate device.

8. The sample size for the training set

Not applicable. This device does not involve machine learning or AI, so there is no concept of a "training set."

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

Not applicable, as no training set was used.

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The Libbe Colonic Nozzle is to be used as the Device/Nozzle inserted into the rectum when used with the LIBBE Lower Bowel Evacuation System. The Device/Nozzle is intended for colon cleansing when medically indicated, such as before radiological or endoscopic examination.

The LIBBE Colonic Nozzle device is a plastic, non-sterile, single use product for use as an accessory with lower bowel evacuation systems or enema kits. The Device/Nozzle is intended to be inserted two to three inches into the rectum for instilling water into the colon region. The LIBBE Colonic Nozzle is designed as a one-piece, injection molded, medical grade plastic accessory. The nozzle has an open tip with a slight bulb shape that has two small holes in its wall. The proximal end of the nozzle has a barbed fitting for attachment to plastic tubing from the colonic irrigation, or enema, system.

This document describes a 510(k) submission for the LIBBE Colonic Nozzle, a device that is substantially equivalent to a previously cleared device. Therefore, a comprehensive study proving the device meets acceptance criteria as would be expected for a novel device is not presented. The information provided focuses on demonstrating substantial equivalence rather than independent performance testing against predefined acceptance criteria.

Here's an analysis of the provided text in relation to your request:

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

The document does not explicitly define acceptance criteria in terms of specific performance metrics for the LIBBE Colonic Nozzle. Instead, it argues for substantial equivalence to a predicate device, the Libbe Rectal Tube (K962259).

The performance "reported" is primarily a comparison of the new device's characteristics to the predicate device, implying that equivalence in these characteristics constitutes meeting the necessary "performance."

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

No separate test set with a defined sample size for performance evaluation is mentioned. The submission relies on a comparison to a predicate device and biocompatibility testing. The data provenance for the biocompatibility testing (ISO 10993) is not specified in terms of country of origin or whether it was retrospective/prospective outside of the standard testing protocol.

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)

No experts were used to establish ground truth for a test set in the context of device performance, as no such test set is described. The “ground truth” related to safety and effectiveness is largely based on the predicate device's prior clearance and the existing regulatory framework for colonic irrigation systems.

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

Not applicable. There was no test set requiring expert adjudication for performance evaluation.

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 medical device (a nozzle), not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study related to human reader performance or AI assistance is irrelevant.

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

Not applicable. This device is not an algorithm.

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

The document relies on the "ground truth" established by the prior clearance of the predicate device (Libbe Rectal Tube K962259) and generally accepted standards for medical device safety and performance, specifically:

• Substantial Equivalence: The primary ground truth is that the predicate device is safe and effective when used as intended.
• Biocompatibility Standards: The device meets ISO 10993, which serves as a recognized standard for evaluating biological effects of medical devices.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that requires a training set.

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

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

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The Colonic Nozzle is to be used as an attachment to gravity fed colonic systems for cleansing when medically indicated such as before radiological or endoscopic examination.

This Colonic nozzle is made of medical grade tubing, has an opening on one end. The other end is sealed with a small hole in the middle and has two holes on the sides at the same end.

This document is a 510(k) premarket notification for a medical device called a "Colonic Nozzle." The information provided in the document focuses on establishing substantial equivalence to a predicate device, rather than presenting a performance study with acceptance criteria.

Therefore, I cannot provide the requested information about acceptance criteria or a study proving the device meets them, because this type of information is not typically included in a 510(k) summary for a Class II device seeking substantial equivalence. A 510(k) typically demonstrates that the new device is as safe and effective as a legally marketed predicate device, rather than establishing de novo performance criteria.

The document states: "Technological characteristics of our device compared to the predicate device, Ultimate Professional Continuous Flow colonic System, K033149, are exactly the same except for material used and the addition of a hole at one end. The new material is still medical grade and therefore equivalent. The hole at the end is equivalent to the design of the Jimmy John nozzle, K973256." This explicitly indicates that the basis for approval is equivalence to existing devices, not a new performance study against defined acceptance criteria.

If this were a de novo submission or a device with new indications requiring clinical validation against performance criteria, the information you requested would be relevant. However, for a 510(k) claiming substantial equivalence for this type of device, the primary "proof" is the comparison to the predicate device.

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The ConMed Irrigation Nozzle is intended for colon cleansing when medically indicated, such as before radiological or endoscopic examinations.

The device is sterile, for single-use and is intended for use as an accessory with The device is stome, for clingie nomercial distribution and acts as a nozzle when inserted into a patient's recturn to direct water into and cleanse the lower colon when medically indicated, such as before radiological or endoscopic examination. The nozzle is designed as a one-piece, injection molded plastic handpiece having a slight curvature at the end intended for insertion into the rectum. At the opposite end the device has a barbed fitting for attachment to the tubing from the colonic irrigation system. Several tip configurations are made available to provide options for the clinician.

The provided text is a 510(k) Premarket Notification for a non-AI medical device (ConMed Irrigation Nozzle). As such, it does not contain information typically found in submissions for AI/ML-powered medical devices regarding acceptance criteria, performance studies, sample sizes, ground truth establishment, or expert involvement as requested in your prompt.

Therefore, I cannot extract the requested information.

The document discusses the device's substantial equivalence to predicate devices (Jimmy John III Rectal Nozzle and GC Irrigator) for its intended use in colon cleansing. It mentions that all devices are for similar use, made of similar materials, and have a similar design. This is a common approach for non-AI devices to demonstrate safety and effectiveness without needing extensive clinical trials in the same way an AI-powered device would.

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The indication for use of this device must be restricted to colon cleansing when medically indicated, such as before radiological or endoscopic examination.

The Pro-Fit™ disposable rectal speculum is a non-metal (Polyethelene) device used to introduce water into the colon and dispose waste from the colon during a colonic irrigation procedure.

This document is a 510(k) Summary for the Pro-Fit™ Disposable Speculum. A 510(k) submission is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed predicate device. This type of submission does not typically include detailed studies proving acceptance criteria in the same way clinical trials for novel devices would.

Therefore, the requested information points (acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set details) are not applicable and are not found in this document.

Instead, the document focuses on demonstrating substantial equivalence to existing predicate devices.

Here's a breakdown of what is provided and why the requested information isn't present:

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

• Not applicable / Not present. This document is a 510(k) summary, which establishes substantial equivalence, not novel performance claims against specific acceptance criteria.

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 / Not present. No clinical or performance test set data beyond biocompatibility is discussed for comparison to specific acceptance criteria. The document relies on the existing safety and effectiveness of the predicate devices.

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 present. Ground truth determination by experts for a test set is not part of a substantial equivalence claim for this type of device.

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

• Not applicable / Not present. No test set requiring expert adjudication 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 / Not present. This device is a manual, non-AI medical device (a rectal speculum). MRMC studies are completely irrelevant to its function or regulatory pathway.

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

• Not applicable / Not present. This is a physical, non-AI medical device. Standalone algorithmic performance is not relevant.

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

• Not applicable / Not present. Ground truth, in the context of diagnostic accuracy, is not relevant for a physical medical device like a speculum in a 510(k) submission.

8. The sample size for the training set:

• Not applicable / Not present. This device does not involve any machine learning algorithms, so there's no training set.

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

• Not applicable / Not present. As there is no training set, there's no ground truth to establish for it.

What the document DOES provide, relevant to its 510(k) purpose:

• Device Description: The Pro-Fit™ disposable rectal speculum is a non-metal (Polyethelene) device used for colonic irrigation.
• Intended Use: To be used for colon cleansing when medically indicated (e.g., before radiological or endoscopic examination).
• Predicate Devices: The document identifies three predicate devices (Clearwater Colon Hydrotherapy, Inc. Disposable Speculum; Specialty Health Products Inc. Disposable Speculum; Dotolo Research Corp. Disposable Speculum). The primary comparison is made to the SP01 and SP02 disposable speculums (K000388) by Clearwater Colon Hydrotherapy Inc.
• Substantial Equivalence Claim: The Pro-Fit™ disposable speculums have the "same technological characteristics as, and are substantially equivalent to" the specified predicate devices.
• Key Difference from Predicate: The only difference noted is the "insertion stopper present on the Pro-Fit™ Disposable Speculum." The document implies this difference does not raise new questions of safety or effectiveness.
• Materials: Fortiflex® HDPE T50-2000 polyethylene copolymer, which meets FDA requirements 21CFR 177.1520.
• Biocompatibility: The finished Pro-Fit™ Speculum was tested for biocompatibility by North American Science Associates, Inc. (NAMSA). This is a type of acceptance criteria (safety), but specific numerical criteria and results are not detailed in this summary.
• Kit Components: Other components (water line, waste hose, surgical lubricant) are also claimed to be substantially equivalent to those included with predicate devices.
• Regulatory Conclusion: The FDA reviewed the submission and determined the device is substantially equivalent to predicate devices, allowing it to be marketed. They also noted that the surgical lubricant is regulated as a drug and requires separate review by the Center for Drug Evaluation and Research.

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