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Used to endoscopically ligate esophageal varices at or above the gastroesophageal junction or to ligate internal hemorrhoids.

Multi-band ligator inculding control handle (rotation handle, shaft and joint), loading catheter, irrigation adapter (irrigation pipe and base), barrel, trigger cord (cord and pellets) and loop.The barrel preloaded with 4~9 loops. This device is designed for attachment to the end of an endoscope for ligating esophageal varices or hemorrhoids. Once assembled and attached the endoscope is advanced to the desired banding site and individual bands are deployed via manipulation of the deployment handle and trigger cord. The multi-band feature allows for serial ligations, which reduces the need to remove the endoscope for reloading. This device is supplied non-sterile and is intended for single use only.

The provided document is a 510(k) summary for a medical device called "Multi-Band Ligator." It outlines the device's characteristics, intended use, and a comparison to a predicate device to demonstrate substantial equivalence to legally marketed devices.

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

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

The document does not explicitly state "acceptance criteria" in a quantitative format for each test. Instead, it describes the purpose or goal of each test and then generally states that the device "meets the related requirements" or "complied with the Indication for Use."

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

The document does not specify the sample sizes used for any of the bench tests (e.g., how many units were tested for appearance, functional performance, chemical properties, etc.).

The data provenance is from China, as the submitter, Beijing ZKSK Technology Co., Ltd., is located in Beijing, China, and the designated submission correspondent is in Shanghai, China. The testing described is prospective in nature, as it involves testing new units of the device against predefined requirements.

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 section is not applicable as the document describes bench testing for a mechanical device, not an AI/imaging device where expert ground truth establishment for a test set would be relevant. The "ground truth" for these tests comes from engineering specifications and industry standards.

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

This is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or for establishing ground truth from multiple expert opinions, which is not the type of testing described here. The testing involves objective measurements and compliance with engineering specifications.

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, an MRMC comparative effectiveness study was not done. This device is a mechanical multi-band ligator and not an AI-assisted diagnostic tool or an imaging device involving human readers.

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

No, a standalone (algorithm-only) performance study was not done. This is a mechanical medical device, not an algorithm or software.

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

The "ground truth" for the bench tests described is based on:

• Engineering specifications and design requirements: For functional and mechanical performance, appearance, and physical properties.
• International standards: Such as ASTM F 1980-16 for shelf life and ISO 10993 for biocompatibility.
• Company's technical requirements: For specific mechanical properties of the loop.

8. The sample size for the training set

This is not applicable. The document describes a medical device, not an AI/machine learning model that requires a training set.

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

This is not applicable, as there is no training set for this device.

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The device is designed to be used with an Endoscope to deliver a Ligation Loop designed to control bleeding following polypectomy of pedunculated polyps.

The Ligation Device is sterile and single-use, which consists of two main components, ligation loop and delivery system. And these two components provided in different sizes to consist different specifications of ligation device.

The document provided is a 510(k) premarket notification for a medical device called "Ligation Device." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving clinical efficacy or diagnostic accuracy through extensive clinical trials. Therefore, much of the requested information regarding clinical study setup, acceptance criteria, multi-reader multi-case studies, and ground truth establishment, which are typical for AI/ML-driven diagnostic devices, is not applicable or not present in this regulatory submission.

However, I can extract information related to non-clinical testing and performance comparisons.

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

The submission does not specify numerical "acceptance criteria" for the non-clinical tests in the usual sense (e.g., a specific threshold for release force). Instead, it states that "Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device." The "reported device performance" is implicitly that it passed these tests and was comparable 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)

The document explicitly states: "No clinical study is included in this submission." Therefore, there is no clinical test set, sample size, or data provenance information provided in this regulatory document. The evaluations were non-clinical (benchtop and biocompatibility).

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

Not applicable. No clinical test set or ground truth established by experts is mentioned in this non-clinical submission.

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

Not applicable. No clinical test set or adjudication process 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

Not applicable. This device is a mechanical ligation device, not an AI-assisted diagnostic 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 device is a mechanical ligation device, not an algorithm.

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

Not applicable. For the non-clinical tests, "ground truth" would be the direct measurement results (e.g., force values, cytotoxicity assays) compared against predefined specifications or predicate device performance.

8. The sample size for the training set

Not applicable. This is a mechanical device, not an AI/ML model requiring a training set.

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

Not applicable. This is a mechanical device, not an AI/ML model requiring a training set and associated ground truth.

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The Wi-3 HAL-RAR System is a Bluetooth-enabled, pulsed Doppler, ultrasound system intended to be used for detecting hemorrhoidal arteries, manually ligating these arteries, and subsequently carrying out a mucopexy of hemorrhoidal prolapse if necessary.

The Wi-3 HAL-RAR System is a Bluetooth-enabled, pulsed Doppler, ultrasound system intended to be used for detecting hemorrhoidal arteries, manually ligating these arteries, and subsequently carrying out a mucopexy of hemorrhoidal prolapse if necessary. "HAL" is an acronym referring to "Hemorrhoidal Arteries Ligation", and "RAR" is an acronym referring to "Recto Anal Repair." The Wi-3 HAL-RAR System is designed for use in a surgical suite or operating room.

The Wi-3 HAL-RAR System includes components that come in contact with the patient during use. The RAR Probes (made of acrylic-based multipolymer) and Sleeve (PBT) are external communicating devices having limited contact duration (

This document is a 510(k) premarket notification for the Wi-3 HAL-RAR System and primarily focuses on establishing substantial equivalence to predicate devices, rather than presenting a detailed study proving the device meets specific acceptance criteria in the manner requested. The document outlines non-clinical testing performed, but does not provide specific acceptance criteria or performance results in a quantifiable way for clinical efficacy.

Therefore, many of the requested elements for describing acceptance criteria and a study proving device performance cannot be extracted from this document.

Here's what can be extracted:

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

This information is not provided in the document. The document states that "non-clinical testing" was performed, but does not specify acceptance criteria or quantitative performance results for clinical efficacy. The types of non-clinical tests mentioned are:

• Biocompatibility: Compliant to ISO 10993-1.
• Software Verification: Compliant to IEC 60601-1 and IEC 60601-1-4.
• Electromagnetic Compatibility and Electrical Safety: Compliant to IEC 60601-1-2 and IEC 60601-2-37.

For these non-clinical tests, the "reported device performance" is simply that the device was found to be "in compliance" or "tested in compliance" with the stated standards. No specific performance metrics or quantitative results are given.

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

Not applicable. The document discusses non-clinical testing of the device itself (biocompatibility, software, electrical safety) rather than clinical performance data from a test set of patient data.

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 document does not describe a study involving expert review for ground truth establishment.

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

Not applicable. This document does not describe a study involving adjudication of a 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. The device described, the Wi-3 HAL-RAR System, is a surgical tool for detecting and ligating hemorrhoidal arteries. It is not an AI-based diagnostic tool, and therefore, an MRMC study comparing human reader performance with and without AI assistance is not relevant to this device or document.

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

Not applicable. The Wi-3 HAL-RAR System is a physical medical device (ultrasound system for surgery) used by a human operator, not a standalone algorithm.

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

Not applicable. As noted, the testing described is non-clinical and related to device safety and compliance with standards, not diagnostic or therapeutic efficacy requiring ground truth from clinical data.

8. The sample size for the training set

Not applicable. This document does not describe the development or training of an algorithm using a training set.

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

Not applicable. This document does not describe the development or training of an algorithm using a training set.

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The inx Medical Nexus™ Hemorrhoid Ligator includes suction and ligation capabilities. The ligator is used to cut off the blood flow to hemorrhoidal tissue by means of a ligature or ring placed around the hemorrhoid base.

It is for use only by trained medical personnel in hospitals, clinics, and doctors' offices.

The inx Medical Nexus™ Hemorrhoid Ligator is a simple handheld device which allows the user to hold the hemorrhoid tissue with an applied suction while slipping a ligation band around the tissue.

The inx Medical Nexus™ Hemorrhoid Ligator is a disposable device for the rubber band ligation of hemorrhoids. It is for single use only and is supplied with preloaded non-latex rubber bands.

The provided document is a 510(k) Premarket Notification for the Nexus™ Hemorrhoid Ligator. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through clinical trials with defined acceptance criteria and statistical endpoints as might be found for a PMA device.

Therefore, the study design and acceptance criteria information as typically requested for performance evaluation of a novel medical device (especially AI/ML-driven) are not available in this document. The provided text outlines non-clinical performance testing against the predicate devices for features like drop resistance, environmental exposure, and suction generation, and asserts substantial equivalence rather than reporting on specific clinical performance metrics.

Specifically, the document does not include:

• A table of acceptance criteria and reported device performance related to diagnostic accuracy or clinical outcomes.
• Information on sample sizes for test sets, data provenance, or ground truth establishment by experts for clinical performance.
• Adjudication methods or multi-reader multi-case comparative effectiveness studies.
• Details on standalone algorithm performance for an AI component.
• Training set details.

The focus is on demonstrating that the Nexus™ Hemorrhoid Ligator is substantially equivalent to existing predicate devices (Haemoband Multi-Ligator and O'Regan Ligator) in terms of indications for use, technology, mode of operation, materials, and environment of use, and that no new safety or efficacy considerations are raised.

However, here's an overview of the non-clinical testing conducted to support substantial equivalence, presented in a format that aligns with parts of your request for "acceptance criteria" where applicable to non-clinical tests:

Non-Clinical Performance Testing and Reported Device Performance

The "acceptance criteria" here are framed as pass/fail criteria for non-clinical engineering and material tests, demonstrating that the device functions as intended and is comparable to predicates.

Further Details (as per request, but information is limited/not applicable to clinical performance)

2. Sample size used for the test set and the data provenance: Not applicable. This was non-clinical engineering and material testing, not a clinical study involving patients or data sets. The "test set" would be the specific units of the device subjected to the environmental, drop, and suction tests. The document doesn't specify the number of units tested.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth in this context refers to engineering specifications and comparison to predicate device characteristics, not expert clinical interpretation.
4. Adjudication method for the test set: Not applicable. This was engineering testing, not a study requiring adjudication of expert 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 device is a mechanical ligator, not an AI/ML 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 is not an AI/ML algorithm-driven device.
7. The type of ground truth used: For the non-clinical tests, the "ground truth" was based on established engineering standards (e.g., ISO, MIL-STD) for performance and direct comparison of material identity and functional equivalence (suction strength) to legally marketed predicate devices.
8. The sample size for the training set: Not applicable. This device does not involve a training set as it is not an AI/ML device.
9. How the ground truth for the training set was established: Not applicable.

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The THD Bandy is used to cut off the blood flow to hemorrhoidal tissue by means of a ligature or ring placed around the hemorrhoid base. The THD Bandy is to be used for exclusive use by medical personnel trained in a proctology procedures.

The THD Bandy is an hemorthoidal ligator intended for pinching off hemorrhoidal nodule. The device is to be used in combination with a suction device, mounted on the basis of the THD Bandy. The THD Bandy consists of a ligation unit, a pusher and a cone. The ligation unit consists of a cylindrical housing connected with a trigger for the release of the elastic band or of the ligature. The hemorrhoidal nodule, trapped on the distal portion of the device, receive an elastic ring or a ligature in order to cut off the blood flow. The pusher and the cylindrical cone are provided in order to assist in the loading of the bands.

The provided text does not contain information about acceptance criteria or a study that proves the device meets those criteria in the context of device performance metrics (e.g., sensitivity, specificity, accuracy) or comparative effectiveness. The available documents are a 510(k) summary and the FDA's clearance letter for the THD Bandy hemorrhoidal ligator.

Instead, the documents indicate that the device (THD Bandy) was determined to be "substantially equivalent" to predicate devices based on similarities in intended use, design characteristics, materials, and labeling information. The performance data section refers to compliance with international standards for biocompatibility (ISO 10993-1:2003), graphical symbols in labeling (CEN EN 980:1996+A1:1999+A2:2001), and risk management (ISO 14971:2007). These are general safety and procedural standards, not performance criteria for diagnostic or clinical effectiveness as one might expect for a study proving device performance in the sense of AI/reader studies.

Therefore, I cannot populate the requested table or provide information for points 2 through 9 based on the provided text. The device's "performance" in this context refers to its adherence to established safety and quality standards, and its equivalence to legally marketed predicate devices, rather than a clinical performance study with defined metrics.

Here's a breakdown of what can be extracted or deduced from the provided documents:

• Same intended use as predicate devices.
• Similar design characteristics to predicate devices.
• Similar materials to predicate devices.
• Compliant labeling information.
• Adherence to biocompatibility standards (ISO 10993-1:2003).
• Adherence to graphical symbol standards for labeling (CEN EN 980:1996+A1:1999+A2:2001).
• Adherence to risk management standards (ISO 14971:2007).

Reported Device Performance (from K093497):

• "The THD Bandy is substantially equivalent to the predicate devices."
• "The intended use of THD Bandy is the same as Sapimed LEM (K070881)."
• "Both THD Bandy and Sapimed LEM (K070881) are manufacture in plastic material, are designed with similar dimensions and are single use devices."
• "The THD Bandy is equivalent to the Sapimed LEM (K070881) and to the Haemoband Multi Ligator Device (K091519) and to the THD Disposable Anoscope/Proctoscope (K080132) concerning the labeling information."
• The device has "been developed and tested according to the following international standards": ISO 10993-1:2003, CEN EN 980:1996+A1:1999+A2:2001, ISO 14971:2007. |
  | 2 | Sample size used for the test set and data provenance | Not applicable. No "test set" in the context of clinical performance data is mentioned. The submission focuses on substantial equivalence and compliance with general standards. |
  | 3 | Number of experts used to establish ground truth and qualifications | Not applicable. No clinical ground truth establishment or expert review process (outside of FDA's regulatory review) is described in relation to performance data. |
  | 4 | Adjudication method for the test set | Not applicable. No test set requiring adjudication is mentioned. |
  | 5 | MRMC comparative effectiveness study and effect size | Not applicable. No MRMC study or AI assistance is mentioned. This device is a mechanical ligator, not an AI or diagnostic tool. |
  | 6 | Standalone (algorithm only) performance study | Not applicable. This is a medical device, not an algorithm. |
  | 7 | Type of ground truth used | Not applicable in the context of clinical performance metrics. The "ground truth" for substantial equivalence is the characteristics of the predicate devices and the relevant international standards. |
  | 8 | Sample size for the training set | Not applicable. No training set for an algorithm is mentioned. |
  | 9 | How ground truth for training set was established | Not applicable. No training set for an algorithm is mentioned. |

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The Haemoband Multi-Ligator includes suction and ligation capabilities. The ligator is used to cut off the blood flow to hemorrhoidal tissue by means of a ligature or ring placed around the hemorrhoid base. It is for use only by trained medical personnel.

The Haemoband Multi-Ligator is a simple handheld device which allows the user to hold the hemorrhoid tissue with an applied suction while slipping a ligation band around the tissue. The Haemoband Multi-Ligator is a disposable device for the rubber band ligation of hemorrhoids. It is for single use only and is supplied with 4 preloaded non-latex rubber bands.

The provided text is a 510(k) Premarket Notification for the Haemoband Multi-Ligator. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than on proving device performance against specific acceptance criteria through a clinical study. Therefore, the document does not contain the detailed information requested regarding acceptance criteria, a specific study proving device performance, sample sizes for test/training sets, expert consensus details, or MRMC studies.

The document primarily details the device description, indications for use, comparison with predicate devices to establish substantial equivalence in terms of technology, materials, and intended use.

Here's a breakdown of what can be extracted and what is missing based on the provided text:

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

• Missing. The 510(k) summary does not define specific performance acceptance criteria or report device performance against them. It focuses on establishing substantial equivalence to predicate devices, implying that if it is equivalent, its performance is acceptable.

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

• Missing. No specific test set or clinical study data is mentioned in this 510(k) summary. The submission relies on a comparison to 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)

• Missing. Ground truth establishment is not relevant as no test set or clinical study is described.

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

• Missing. Not applicable; no test set 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

• Missing. This device is a mechanical ligator, not an AI-assisted diagnostic tool. Therefore, an MRMC study and AI-related effects are not applicable.

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

• Missing. Not applicable; this is a mechanical device, not an algorithm.

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

• Missing. Not applicable; no ground truth is established for device performance in the context of this 510(k) submission.

8. The sample size for the training set

• Missing. Not applicable; no training set for an algorithm is mentioned.

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

• Missing. Not applicable; no training set is mentioned.

Summary based on available information:

The Haemoband Multi-Ligator obtained 510(k) clearance based on demonstrating substantial equivalence to existing predicate devices (K0000297 - Erchinger Medizintechnik - Ligator and K070881 - SAPI MED S.p.a. - LEM ligator). The "study" for this submission is implicitly the comparison presented in the "Summary of substantial equivalence" table.

Table of Acceptance Criteria and Reported Device Performance:

Key takeaway: This 510(k) submission does not include a clinical study with acceptance criteria and measured performance in the way a robust device performance study or AI algorithm validation would. Instead, it demonstrates that the Haemoband Multi-Ligator is "substantially equivalent" to already legally marketed devices, implying that its safety and effectiveness are comparable.

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The LEM Hemorrhoidal ligators are used to cut off the blood flow to hemorrhoidal tissue by means of a ligature or ring placed around the hemorrhoid base. Hemorrhoidal ligators are intended for exclusive use by medical personnel trained in proctology procedures.

The Sapimed LEM Disposable hemorrhoidal ligators are used to apply a ligature or elastic ring around the base of the hemorrhoidal nodule in order to cut off the blood flow to hemorrhoidal tissue. The lack of blood supply will result in shrinkage, desiccation and elimination of the hemorrhoid. It is supplied in two models Model numbers A.5650 and A 5660. They are both manufactured from plastic and designed for single patient use. Both variants are supplied with a separable cylindrical cone (0 10mm) to assist in loading the bands, an angled distal cylinder to contain the nodule, and an ergonomicallydesigned pistol handgrip,with trigger to release the banding ring. The LEM has an angled design that allows the operator a clear view of the procedure.

The provided submission does not contain specific acceptance criteria or a detailed study proving the device meets these criteria. Instead, it is a 510(k) summary focused on establishing substantial equivalence to predicate devices. The document outlines the intended use, device description, and a comparison table with predicate devices, but lacks quantitative performance metrics or a formal study design for evaluating the LEM Hemorrhoidal Ligators' performance against predefined acceptance criteria.

The core of this submission is a comparison of the new device (LEM Hemorrhoidal Ligators) to existing, legally marketed devices (O'Regan Ligator and Erchinger Hemorrhoidal Ligator) to demonstrate that it is "substantially equivalent." This means that the device is as safe and effective as the predicate devices.

Here's an analysis of the provided text in relation to your request, with explicit mention of what information is not present:

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information:

• Specific numerical or qualitative performance targets that the device had to meet (e.g., success rate of banding, complication rates, force required, band retention force, etc.).
• Actual performance data from a study against such criteria. The document only describes the device's features and its similarity to predicate devices.

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

• Sample Size for Test Set: Not applicable / Not reported.
• Data Provenance: Not applicable / Not reported.

Explanation: This 510(k) summary does not describe a clinical performance study with a "test set" in the sense of patient data. The evaluation is based on a comparison to predicate devices, focusing on design, materials, and intended use. There is no mention of country of origin for any (non-existent) test data or whether it was retrospective or prospective.

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

• Not applicable. There is no mention of a "test set" requiring ground truth established by experts.

4. Adjudication Method for the Test Set

• Not applicable. No test set requiring adjudication is mentioned.

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

• No. The document does not describe an MRMC study or any study comparing human readers' performance with or without AI assistance. This device is a mechanical ligator, not an AI-assisted diagnostic tool.

6. Standalone Performance Study (Algorithm Only)

• Not applicable. This device is a mechanical medical instrument, not an algorithm. Therefore, a standalone (algorithm only) performance study is irrelevant.

7. Type of Ground Truth Used

• Not applicable. As there is no test set or clinical study described in detail, the concept of "ground truth" (e.g., pathology, outcomes data) for evaluation is not presented. The "ground truth" equivalent in a 510(k) is often the established safety and effectiveness of the predicate devices against which the new device is compared.

8. Sample Size for the Training Set

• Not applicable. This device is not an AI/ML algorithm 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 algorithm that requires a "training set" with established ground truth.

Overall Conclusion:

The provided document is a 510(k) premarket notification summary. For such submissions, the primary "study" is often a comparison to predicate devices, demonstrating substantial equivalence rather than conducting a de novo clinical trial with specific performance acceptance criteria. The document focuses on demonstrating that the LEM Hemorrhoidal Ligators have the "same intended use" and "similar technological characteristics" to legally marketed predicate devices, and that any differences do not raise new questions of safety or effectiveness. Therefore, many of the detailed study-related questions you posed are not applicable to the content of this specific regulatory submission.

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The Speedband™ Superview Super7 is indicated for use in endoscopic ligation of esophageal varices and anorectal hemorrhoids.

The Injection Speedband™ Superview Super 7 is indicated for endoscopic treatment of esophageal varices utilizing combination ligation therapy. The Injection Speedband™ Superview Super7 is also indicated for band ligation treatment of anorectal hemorrhoids.

The Speedband Superview Super7 and Injection Speedband Superview Super7 consist of two main components; a ligating unit and a handle assembly. The ligating unit consists of a cylindrical housing with a flexible silicone endoscope adapter, and seven elastic ligating bands. Suture is threaded around each band and passes through suture slots around the perimeter of the housing. The suture enters the endoscope through the working channel of an endoscope and is secured the tripwire on the handle assembly durning set-up.

The handle assembly consists of a handle knob and plastic spool mounted on a bracket with a stem. A tripwire is attached to the spool and passes through the septum and into the stem. The stem fits into the working channel of the endoscope. The septum seals the channel so suction can be maintained. On the Injection models, the septum has a port for insertion of an injection therapy needle.

The provided text is a 510(k) Summary for a medical device (Speedband™ Superview Super7 and Injection Speedband™ Superview Super7) and an FDA clearance letter. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, this document does not contain specific acceptance criteria, detailed study protocols, or performance data in the format requested.

Here's a breakdown based on the information available in the provided text, and where it falls short for your request:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: Not explicitly stated in the document. The document focuses on demonstrating "substantial equivalence" to predicate devices.
• Reported Device Performance: The document only states "Bench testing was conducted to aid with the establishment of substantial equivalence of the proposed devices to the predicate device." No specific performance metrics (e.g., success rate, band deployment force, durability) or their results are provided.

Therefore, a table cannot be constructed from the provided text.

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

• Sample Size: Not specified. "Bench testing" is mentioned, but the number of units tested is not provided.
• Data Provenance: Not specified. Bench testing generally implies laboratory conditions, but the country of origin of the data or whether it was retrospective/prospective is not mentioned.

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

• This information is not applicable and not present in the document. Bench testing for a device like a ligator likely involves engineering or quality control personnel assessing mechanical properties, not clinical experts establishing ground truth in a diagnostic context.

4. Adjudication Method for the Test Set:

• Not applicable/Not mentioned. Adjudication methods are typically relevant for clinical studies or studies involving human assessment of data (e.g., image interpretation), which is not described here.

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

• No, an MRMC study was not done. This type of study focuses on improving human reader performance with AI assistance, which is outside the scope of this device (a mechanical ligator) and the type of performance testing described.

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

• Not applicable. This device is a manual medical instrument, not an AI algorithm. Therefore, "standalone" algorithm performance is not relevant.

7. The Type of Ground Truth Used:

• The document implies that the "ground truth" for "substantial equivalence" was established by comparing the proposed devices' characteristics (intended use, materials, number of bands, handle design) and bench testing results against those of the predicate devices. The specific metrics used for "bench testing" are not detailed. It's essentially a comparison against established performance/design of the predicate.

8. The Sample Size for the Training Set:

• Not applicable. This device is a mechanical instrument, not an AI/ML algorithm that requires a "training set."

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

• Not applicable for the same reason as above.

In summary, the provided document describes a 510(k) submission for a medical device focusing on "substantial equivalence" through bench testing. It does not provide the detailed performance study information, acceptance criteria, or ground truth establishment methods typically associated with AI/ML device evaluations as requested in your prompt.

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Used to ligate internal hemorrhoids.

The Wilson-Cook Modified Multiple Band Ligator is used to ligate internal hemorrhoids. This device is supplied non-sterile and intended for single use only. The modification of the predicate Wilson-Cook Multiple Band Ligator (K944220/A) consists of a change to the handle in order to accommodate single-hand operation through an anoscope. In addition, the modified device comes preloaded with the barrel attached to the tip of the handle. The predicate device is designed for attachment to the end of an endoscope, while the modified Multiple Band Ligator is used in conjunction with an anoscope. The barrel and bands of the modified device are identical to the barrel and bands of the Wilson-Cook Multiple Band Ligator in the choice of the production and the specifications of each. The trigger cord is comprised of the same materials, however the trigger cord is slightly shorter in length for the modified devices, as the modified device comes preloaded and is used with an anoscope. Loading catheter and irrigation adapter are not needed.

The provided text does not contain detailed information about specific acceptance criteria or a dedicated study with performance metrics for the Wilson-Cook Modified Multiple Band Ligator. Instead, it focuses on the device's substantial equivalence to a predicate device and the process of design control, risk analysis, and design verification.

However, based on the provided text, we can infer some general information about design verification and what the acceptance criteria would have been for a device like this, even if the specific outcomes aren't quantified.

Here's a breakdown of what can be extracted and what cannot:

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

The document states: "All results obtained during our Design Verification met our predetermined acceptance criteria for this product line." This implies that acceptance criteria were established and met, but the specific criteria and the reported performance values are not provided in the text.

We can infer the types of criteria that would have been evaluated based on the description of the device modification and its function:

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

• Sample Size: Not specified. The document only mentions "Design Verification" and "dimensional and functional testing" without detailing the number of units tested.
• Data Provenance: Not specified, but generally, design verification testing for medical devices is conducted by the manufacturer (Wilson-Cook Medical Inc.) in a controlled environment. It is not a clinical study in this context, so concepts like "country of origin" for data are not applicable in the same way. The testing would be prospective in the sense that it's performed on the manufactured device models to ensure they meet specifications.

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

This information is not applicable and not provided. "Ground truth" and expert consensus are terms typically used in clinical studies or studies evaluating diagnostic accuracy, especially for AI/ML devices. This document describes a modification to a physical medical device (a ligator) and its engineering-based design verification testing. The "ground truth" here is adherence to engineering specifications and functional performance.

4. Adjudication method for the test set:

This information is not applicable and not provided. Adjudication methods (like 2+1, 3+1) are for resolving discrepancies in expert opinions, typically in clinical evaluations or image interpretation studies. For design verification of a physical device, the "adjudication" is essentially the comparison of test results against predefined engineering acceptance criteria by qualified technicians or engineers.

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 information is not applicable and not provided. This device is a manual surgical tool, not an AI-assisted diagnostic or therapeutic device. Therefore, MRMC studies and concepts of human reader improvement with AI assistance are irrelevant to this submission.

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

This information is not applicable and not provided. This is a physical, manually operated medical device. There is no "algorithm" to be evaluated in a standalone manner.

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

The "ground truth" for this device's verification is engineering specifications, functional requirements, and material properties. The device is tested to ensure it meets these predefined criteria. This is not derived from clinical outcomes, pathology, or expert consensus in the typical sense.

8. The sample size for the training set:

This information is not applicable and not provided. There is no "training set" as this is not an AI/ML device.

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

This information is not applicable and not provided. As there is no training set, this question is not relevant.

Summary of the Study that Proves the Device Meets Acceptance Criteria (as described in the document):

The document states that a Design Verification process was conducted. This involved:

• Risk Analysis: Identifying risks relative to performance requirements, including failure modes, effects, severity, potential causes, and rates of occurrence, along with design control elements to eliminate them.
• Dimensional Testing: Measuring the physical properties of the modified device (e.g., barrel, bands, trigger cord length) to ensure they conform to specifications.
• Functional Testing: Assessing the operational performance of the device, likely including its ability to ligate, the functionality of the trigger cord, and its compatibility with an anoscope for single-hand operation.
• Biocompatibility Assurance: Establishing biocompatibility through a history of patient-contacting materials and/or specific biocompatibility test results.

The key statement is: "All results obtained during our Design Verification met our predetermined acceptance criteria for this product line." This indicates that a study (the Design Verification process) was performed, and the device successfully fulfilled the established criteria, although the specific details of those criteria and quantitative performance results are not openly provided in this 510(k) summary. The study essentially confirmed that the modified device's design (including changes to the handle, preloaded barrel, and trigger cord length) maintained the same safety and effectiveness profile as the predicate device.

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