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The CooperSurgical IRC is indicated for the treatment of hemorrhoids, especially bleeding, non-prolapsed internal hemorrhoids, as a means of hemostasis in the treatment of hemorrhoids by routine excision, or to coagulate external thrombotic hemorrhoids that have been removed ("collectively referred to as hemorrhoids") through the coagulative necrosis of the mucosa proximal to the base of the hemorrhoid.

The Cooper IRC delivers short pulses of visible and infrared light through a small contact tip applicator that is applied to the tissue. This light causes thermal coagulation that results in tissue necrosis. The user sets the pulse duration control knob depending on the depth of the tissue necrosis required. The depth of coagulation is directly related to the pulse length delivered to a given area of tissue. The area(s) to be treated may be locally anesthetized at the physician's discretion.

The CooperSurgical IRC consists of the following main components: (1) a console unit; (2) a hand piece; (3) a removable light guide; and (4) a disposable contact tip.

This document is a 510(k) summary for CooperSurgical, Inc.'s Infrared Coagulator (IRC), seeking clearance for the treatment of hemorrhoids. It details the device's intended use, principles of operation, technical characteristics, and the basis for its substantial equivalence to previously cleared devices.

Here's an analysis of the provided information, specifically addressing the questions about acceptance criteria and supporting studies:

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

   The document does not explicitly state specific acceptance criteria in terms of numerical performance metrics (e.g., sensitivity, specificity, accuracy, or a specific success rate for treatment). Instead, the basis for clearance is substantial equivalence to predicate devices. This means the device is deemed safe and effective because it is essentially the same as a device already on the market.

   Acceptance Criteria	Reported Device Performance
   Implicit Criterion: Substantial Equivalence to Predicate Devices for the Treatment of Hemorrhoids. (This implies it must perform similarly in safety and effectiveness as the predicate devices for the same indication.)	The CooperSurgical IRC is "essentially the same device" as Redfield Corporation's Infrared Coagulator already cleared for hemorrhoid treatment. It is also "identical" (with the exception of four features which are not specified as relevant to hemorrhoid treatment or the PVC tips) to CooperSurgical's own IRC cleared for genital condylomas and general warts. The safety and effectiveness for hemorrhoid treatment are based on the FDA's prior clearance of these predicate devices and "CooperSurgical's testing of the PVC contact tips."
   Implicit Criterion: The device's technical characteristics (console unit, hand piece, removable light guide, disposable contact tip) must be comparable to the predicate devices and suitable for its intended use.	The technical characteristics are described as: "The CooperSurgical IRC consists of the following main components: (1) a console unit; (2) a hand piece; (3) a removable light guide; and (4) a disposable contact tip. The CooperSurgical IRC is essentially the same device as Redfield Corporation's Infrared Coagulator that has already been cleared by FDA for the treatment of hemorrhoids. With the exception of four features, the CooperSurgical IRC is identical to the CooperSurgical IRC that is cleared for the treatment of genital condylomas and general warts." The functioning principle (delivery of short pulses of visible and infrared light, causing thermal coagulation and tissue necrosis) is also described, aligning with known IRC technology. The user can set pulse duration based on desired depth of tissue necrosis.
   Implicit Criterion: The PVC contact tips used with the device must be safe and effective.	"CooperSurgical's testing of the PVC contact tips" was performed. (No details on the nature or results of this testing are provided in the summary.)

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

   The document does not report any clinical study data from a "test set" in the traditional sense (i.e., a clinical trial comparing the device's performance against a reference standard or control group). The basis for clearance is substantial equivalence. Therefore, there is no sample size, data provenance, or information on retrospective/prospective studies mentioned that specifically tested this version of the CooperSurgical IRC for hemorrhoids. The "testing of the PVC contact tips" is mentioned, but no details regarding sample size or nature of testing are provided.

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. As noted above, there is no disclosed "test set" and thus no mention of experts establishing ground truth for performance metrics.

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

   Not applicable. No "test set" or clinical performance study for this specific device for this indication is described.

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

   Not applicable. This device is an Infrared Coagulator, a treatment device, not an AI-assisted diagnostic or interpretation device. Therefore, no MRMC study or AI assistance is relevant.

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

   Not applicable. This device is a manual medical instrument, not an algorithm.

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

   Not applicable. The clearance is based on substantial equivalence, not on a de novo clinical trial with explicit ground truth determination for performance evaluation. The "ground truth" for the predicate devices' clearance would have established their safety and effectiveness, but those details are not provided here.

8. The sample size for the training set

   Not applicable. This device is not an AI/ML-based device that requires a training set.

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

   Not applicable. This device is not an AI/ML-based device.

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The CooperSurgical InfraRed Coagulator ("IRC") is indicated for the treatment of chronic rhinitis through the coagulative necrosis of the submucosal tissue of the inferior turbinate.

The Cooper IRC delivers short pulses of visible and infrared light through a small contact tip applicator that is applied to the tissue. This light causes thermal coagulation that results in tissue necrosis. The user sets the pulse duration control knob depending on the depth of the tissue necrosis required. The depth of coagulation is directly related to the pulse length delivered to a given area of tissue. The area(s) to be treated may be locally anesthetized at the physician's discretion. Contact photocoagulation requires direct contact of the entire optical window of the disposable contact tip. The physician applies light mechanical pressure to the optical window against the tissue to be treated before depressing the activation trigger of the hand piece. To achieve coagulation, the user depresses the activation trigger. A built-in digital timer deactivates the lamp automatically according to the pulse duration setting preselected by the physician. If the desired treatment site is larger than the optical window, the physician may use overlapping exposures until the entire area is coagulated. waiting at least five seconds between exposures. The CooperSurgical IRC consists of the following main components: (1) a console unit: (2) a hand piece: (3) a removable light guide; and (4) a disposable contact tip.

Here's an analysis of the provided text regarding the CooperSurgical InfraRed Coagulator, focusing on acceptance criteria and the supporting study information.

Executive Summary:

The provided document (a 510(k) Summary) for the CooperSurgical InfraRed Coagulator (IRC) does not describe an independent study to establish specific acceptance criteria for performance metrics or to directly prove device performance against such criteria. Instead, the basis for finding substantial equivalence – and thus, acceptance – is primarily reliance on previously cleared predicate devices and bench testing demonstrating similar performance in photocoagulation and non-stick characteristics.

Here’s a breakdown of the requested information, highlighting what is (and isn't) present in the text:

Acceptance Criteria and Device Performance

Explanation: The document states that the CooperSurgical IRC is "essentially the same device" as the Redfield Corporation's InfraRed Coagulator and "identical" to a previously cleared CooperSurgical IRC for other indications, with minor differences. The "performance" is implicitly deemed acceptable because it is considered equivalent to devices already found safe and effective. No specific numeric thresholds for depth of coagulation, tissue necrosis, or other functional metrics are provided as acceptance criteria, nor are corresponding quantitative results from a study.

Study Details

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 explicitly states the "safety and effectiveness of the CooperSurgical IRC for the treatment of chronic rhinitis is based on: (1) Redfield IRC's premarket clearances for the treatment of chronic rhinitis; and (2) CooperSurgical IRC's clearance for the treatment of genital condylomas and general warts." It also mentions bench testing for photocoagulation and non-stick characteristics. This means no clinical "test set" (e.g., patient data) was used in a new clinical study described in this 510(k) summary for the indication of chronic rhinitis. The data provenance would be from the predicate device clearances.

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 new clinical study with a "test set" requiring expert ground truth establishment is described.

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

• Not Applicable. As no new clinical test set was used, no adjudication method is relevant here.

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

• No. This device is an infrared coagulator, not an AI or imaging device. Therefore, a MRMC study is not relevant.

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

• Not Applicable. This is a physical medical device, not an algorithm.

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

• Implicitly: The "ground truth" for the device's safety and effectiveness relies on the prior FDA clearances of the predicate devices. These clearances would have been based on clinical data, performance data, and potentially pathology or outcomes data from the predicate devices. For the CooperSurgical IRC itself, the bench testing provides "ground truth" on its physical performance characteristics (photocoagulation and non-stick) in comparison to the predicate.

8. The sample size for the training set

• Not Applicable. No machine learning or AI model is described, thus no "training set."

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

• Not Applicable. As there is no training set mentioned.

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The CooperSurgical Infrared Coagulator ("IRC") is intended for coagulative necrosis of tissue. It is indicated for the treatment of genital condylomas (condyloma accuminata) and general warts.

The Cooper IRC delivers short pulses of visible and infrared light through a small contact tip applicator that is applied to the tissue. This light causes thermal coagulation that results in tissue necrosis. The user sets the pulse duration control knob depending on the depth of the tissue necrosis required. The depth of coagulation is directly related to the pulse length delivered to a given area of tissue. The area(s) to be treated may be locally anesthetized at the physician's discretion. Contact photocoagulation requires direct contact of the entire optical window of the disposable contact tip. The physician applies light mechanical pressure to the optical window against the tissue to be treated before depressing the activation trigger of the hand piece. To achieve coagulation, the user depresses the activation trigger. A built-in digital timer deactivates the lamp automatically according to the pulse duration setting preselected by the physician. If the desired treatment site is larger than the optical window, the physician may use overlapping exposures until the entire lesion is coagulated, waiting at least five seconds between exposures. The CooperSurgical IRC consists of the following main components: (1) a control unit; (2) a hand piece; (3) a removable light guide; and (4) a disposable contact tip.

The provided text describes a 510(k) premarket notification for the CooperSurgical Infrared Coagulator. It focuses on demonstrating substantial equivalence to predicate devices and does not contain detailed acceptance criteria, a specific study design to prove acceptance criteria, or most of the requested information about sample sizes, ground truth establishment, or expert involvement for the current device.

However, the document does state that the safety and effectiveness are based on:

1. Redfield IRC's premarket clearances for the treatment of hemorrhoids and chronic rhinitis, and for tattoo removal.
2. The long history of use of lasers for the treatment of genital condylomas and general warts.
3. Two recent clinical studies demonstrating that the IRC is equivalent to its predicate devices for the treatment of genital condylomas and general warts.

Without the actual study reports for these "two recent clinical studies," it's impossible to extract the specific acceptance criteria and detailed study information as requested. The available document only provides a high-level summary of the basis for substantial equivalence.

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

Here's an attempt to answer what can be inferred from the document, with caveats:

1. Table of Acceptance Criteria and Reported Device Performance

• The document does not explicitly state specific quantitative acceptance criteria (e.g., a specific percentage of lesion clearance, a recurrence rate threshold, or a specific safety metric) for the CooperSurgical Infrared Coagulator or its performance in the context of acceptance criteria.
• It states that "two recent clinical studies demonstrating that the IRC is equivalent to its predicate devices for the treatment of genital condylomas and general warts" were performed.
• Inference: The "acceptance criteria" for the CooperSurgical IRC was likely demonstrating equivalence (non-inferiority) to the established safety and efficacy profiles of the predicate devices for the new indicated uses (genital condylomas and general warts), rather than meeting predefined numerical thresholds reported in this summary. The performance would then be interpreted as "equivalent to predicate devices."

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

• The document mentions "two recent clinical studies," but does not provide any details on the sample size used for the test set (patients/cases) or the data provenance (e.g., country of origin, retrospective or prospective nature) for these studies.

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

• The document does not specify the number or qualifications of experts used to establish ground truth in the clinical studies. Given the context (treatment of condylomas and warts), it is highly probable that clinicians (e.g., dermatologists, gynecologists, urologists) would have been involved in diagnosing and assessing treatment outcomes, but no details are provided.

4. Adjudication method for the test set

• The document does not describe any adjudication method used in the clinical studies.

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 device is an infrared coagulator, not an AI-powered diagnostic or treatment assistance tool. Therefore, an MRMC comparative effectiveness study involving AI assistance is not applicable and was not performed.

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

• This device is a hardware medical device for tissue coagulation, not an algorithm. Therefore, a standalone algorithm-only performance study is not applicable and was not performed.

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

• For the "two recent clinical studies," the ground truth for efficacy would likely be based on clinical assessment of lesion clearance/resolution and possibly recurrence rates as determined by treating physicians (outcomes data). For safety, it would involve monitoring adverse events. The document does not explicitly state the type of ground truth beyond "demonstrating that the IRC is equivalent."

8. The sample size for the training set

• As this is a hardware device cleared based on substantial equivalence and clinical studies, rather than an AI/ML algorithm requiring a training set, the concept of a "training set" in the AI sense is not applicable here. The design and parameters of the device were developed through engineering and pre-clinical testing, not a "training set" of data.

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

• Again, as this is not an AI/ML device, the concept of establishing ground truth for a training set is not applicable. Device design is typically based on engineering principles, material science, and pre-clinical/bench testing, as well as prior knowledge from predicate devices.

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