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A percutaneous guide wire introducer for vascular and non-vascular procedures with activating safety shield to reduce needle stick injury during use and disposal.

A needle and hub device for the percutaneous introduction of a guide wire, with a hub modification to allow one-handed activation of a sheath to cover the needle and help prevent accidental needle sticks during use and disposal.

The provided document is a 510(k) Premarket Notification for the "SafetyNET Guidewire Introducer". It contains administrative information, an intended use statement, and a declaration of compliance with ISO 10993-1. However, it does not include specific acceptance criteria, performance data, or details of studies typically found in a clinical or performance study report.

Therefore, most of the requested information cannot be extracted from this document.

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

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

• Cannot be provided. The document states "Product and materials meet all applicable test requirement per ISO 10993-1" under the "Testing" section, which refers to biocompatibility testing. It implies that these requirements were met, but it does not specify what those "applicable test requirements" or their acceptance criteria were, nor does it provide the results of those tests or any other performance metrics for the device itself (e.g., success rate of guidewire introduction, effectiveness of the safety shield in preventing needle sticks, etc.).

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

• Cannot be provided. The document does not describe any specific performance or clinical studies, and therefore no information on sample sizes or data provenance for a test set.

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)

• Cannot be provided. There is no mention of a test set requiring ground truth establishment by experts.

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

• Cannot be provided. There is no mention of a test set or any adjudication process.

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

• Cannot be provided. This device is a manual surgical instrument (a guidewire introducer with a safety mechanism), not an AI-powered diagnostic or interpretive tool. Therefore, an MRMC study is not applicable and not mentioned.

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

• Cannot be provided. This device is a manual surgical instrument, not an algorithm. Standalone algorithm performance is not applicable.

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

• Cannot be provided. There is no mention of any ground truth being established as no such study is described.

8. The sample size for the training set

• Cannot be provided. There is no mention of a training set, as the device is not an AI/ML algorithm.

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

• Cannot be provided. There is no mention of a training set or ground truth establishment.

Summary of available information related to testing:

The document briefly mentions "Testing" and states:

• "Product and materials meet all applicable test requirement per ISO 10993-1"
  • ISO 10993-1 refers to "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process." This standard guides the evaluation of biocompatibility but does not define specific performance criteria for the function of a device. It indicates that the materials used in the SafetyNET Guidewire Introducer have been assessed for their biological safety in accordance with this standard. No specific data or acceptance criteria for this testing are provided in this document.

For this type of device (a manual surgical instrument), the "study" demonstrating its safety and effectiveness for a 510(k) submission typically relies on substantial equivalence to existing predicate devices and in vitro/bench testing (like biocompatibility, sterility, strength, dimensions, and the function of the safety mechanism) rather than large clinical trials or AI performance evaluations. The document does not elaborate on these specific tests or their results, instead summarizing them with the ISO 10993-1 compliance statement.

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The device is intended to pierce the epidermal layer of the human skin for the collection of a small volume of blood sample.

Not Found

This looks like a 510(k) clearance letter for a medical device (FUTUMEDS™ SAFETY LANCET WITH PALS SYSTEM). However, the provided document does not contain the kind of detailed study information (acceptance criteria, reported performance, sample sizes, ground truth methodology, expert qualifications, etc.) that would typically be found in a clinical study report or a more comprehensive summary of safety and effectiveness data.

The FDA 510(k) clearance process primarily evaluates substantial equivalence to a predicate device, rather than requiring extensive clinical trials for all devices, especially Class I devices like this one (manual surgical instrument for general use).

Therefore, based only on the provided text, I cannot extract the detailed information requested in your prompt. The document primarily states:

• Device Name: FUTUMEDS™ SAFETY LANCET WITH PALS SYSTEM
• Regulation Number/Name: 21 CFR 878.4800, Manual surgical instrument for general use (Class I)
• Intended Use/Indications for Use: To pierce the epidermal layer of the human skin for the collection of a small volume of blood sample.
• Clearance: FDA finding of "substantial equivalence" to legally marketed predicate devices.

What is missing from the document to answer your questions:

• No specific acceptance criteria for device performance are mentioned. For a Class I device like a lancet, acceptance usually revolves around safe design, manufacturing quality, and meeting basic functional requirements (e.g., proper puncture, sterility, ease of use). These wouldn't typically be expressed as statistical performance metrics like sensitivity/specificity for a diagnostic AI.
• No study details: There is no mention of a formal clinical study, sample sizes, data provenance, ground truth establishment, expert adjudication, MRMC studies, or standalone algorithm performance. This type of detail is generally not included in the 510(k) clearance letter itself.
• No AI component: The device is a "SAFETY LANCET." There is no indication that it includes any artificial intelligence (AI) component, which is a prerequisite for many of your questions (e.g., "human readers improve with AI," "standalone algorithm performance").

Conclusion based on provided text:

I cannot fulfill your request as the provided FDA clearance letter for the FUTUMEDS™ SAFETY LANCET WITH PALS SYSTEM does not contain information about acceptance criteria, study details, or AI performance metrics. This type of information would be found in the manufacturer's more detailed 510(k) submission summary or a separate clinical study report, neither of which is present here.

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FOR USE IN INSTALLING SURGICAL DRAINS

The EuTrochar is a trocar used for the installation of surgical drains. The EuTrochar has a handle, the "Deployer" to facilitate gripping, to improve accuracy of drain placement and to keep fingers away from the sharp point. Trocars have been used for more than a hundred years to create an incision in soft tissue for surgical drain tubing. Like other drain installation trocars, this instrument is a highly polished stainless steel rod of small diameter, normally 4 to 6mm in diameter and about 160mm long. One end of the rod is very sharply pointed and the other end has a hose barb for affixing tying. The rod is curved between the two ends so that it looks like a giant sailmaker's needle.

Here's an analysis of the provided text regarding the acceptance criteria and study for the EuTrochar device:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Description: "Many drain installations were performed on dead animal tissue." and "Employing plastic sheet as ersatz tissue, a series of EuTrochars and several Deployers were used in trials."
• Sample Size:
  • Animal Tissue: Not explicitly stated, but described as "Many." This indicates a qualitative assessment rather than a statistically robust sample size.
  • Plastic Sheet ("Bench Trial"): Not explicitly stated how many "series of EuTrochars" or "several Deployers" were used, nor the number of trials total.
• Data Provenance:
  • Country of Origin: United States (based on the company address and FDA submission).
  • Retrospective or Prospective: The "bench trial" and tests on animal tissue were conducted prospectively by the device manufacturer.

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

• Number of Experts: Not explicitly stated. The text mentions "Technicians in Special Devices" and later "outside surgeons and support personnel" for the "bench trial." It's unclear how many individuals constituted "technicians" or "outside surgeons."
• Qualifications of Experts:
  • Technicians: "Technicians in Special Devices performed exhaustive tests..." - No specific qualifications (e.g., years of experience, specific medical expertise) are provided beyond being "technicians."
  • Outside Surgeons: "ascertain that the hardware could be used successfully by outside surgeons and support personnel..." - No specific qualifications are provided for the "outside surgeons."

4. Adjudication Method for the Test Set

• Adjudication Method: Not explicitly stated. The phrase "The conclusions of each tester were that there had been no failure..." suggests individual assessments by "each tester" rather than a formal adjudication process (like 2+1 or 3+1 consensus). It appears to be based on direct observation and qualitative assessment by the individuals performing the tests.

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

• No, an MRMC comparative effectiveness study was not done. The studies described are focused on the safety and basic functionality of the EuTrochar in a standalone context, not on its comparative effectiveness in improving human reader performance.

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

• Yes, a standalone performance assessment was effectively done. The EuTrochar is a manual surgical instrument, not an algorithm. The "tests with prototype hardware using both plastic tissue and animal tissue" and the "bench trial" evaluate the device's standalone mechanical safety and functionality, without comparing its performance to human (surgeon) performance or evaluating human performance with and without the device. The device itself is the "standalone" element being tested.

7. The Type of Ground Truth Used

• Ground Truth Type:
  • Qualitative Observation/Expert Assessment: The "ground truth" for the tests appears to have been based on direct observation of the device's function, ease of use, and whether "failures were experienced" or if it "presented a hazard" by the "technicians" and "outside surgeons" involved in the trials.
  • Functionality/Safety Outcomes: The primary outcomes were successful installation of drains, lack of failures, and absence of hazards.

8. The Sample Size for the Training Set

• Not applicable. The EuTrochar is a mechanical surgical instrument, not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning. The "prototype hardware" and "series of EuTrochars and several Deployers" used in testing would represent the specific instances of the device being evaluated, not a training set for an algorithm.

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

• Not applicable. As stated above, this is not an AI/ML device, so there is no training set or associated ground truth establishment for a training set.

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The Andrews Introducer™ is specifically designed for the insertion of intercostal chest tubes.

The Andrews Introducer™ is a reusable surgical forceps made of surgical steel that is specifically designed for the insertion of chest tubes. The Andrews Introducer™ is a three-limbed forceps and has three major features:

1. A pivot joint at the fulcrum that opens the tips when the handles are closed using the stronger gripping force of the hand. The extent to which the tips open has been limited so as to reduce the trauma to the intercostal muscle.
2. A vertical extension on each blade that creates a circular channel which is more accurately and appropriately shaped to allow easy passage of the chest tube. The distance between the vertical blades at the fulcrum is 10.7 millimetres, sufficient-to accommodate the diameter of a 32 gauge chest tube, expanding to 22mm at the.
3. A third limb that is attached to the two main limbs through the pivot joint. It is held equidistant from the two main limbs by two leaf springs, which also close the tips when force is relieved from the handles. There is also a grip on the distal end of the third limb to hold the chest tube in position on the instrument for more rapid insertion once the channel has been created.

Here's a breakdown of the acceptance criteria and the study details for the Andrews Introducer™, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Important Note: The document does not explicitly state pre-defined quantitative acceptance criteria (e.g., "95% successful placement rate"). Instead, it presents the results of the feasibility study as evidence that the device meets the intended use and offers improvements over predicate devices. The "acceptance criteria" here are inferred from the study's endpoints and reported outcomes.

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

• Sample Size: 30 patients
• Data Provenance:
  • Country of Origin: Not explicitly stated, but the applicant's address is in Dublin, Ireland, which suggests the study may have been conducted there.
  • Retrospective or Prospective: Prospective. The study was a "clinical feasibility study of the use of the Andrews Introducer™ in an elective surgical setting" where tubes "were instead inserted using the Andrews Introducer™." This indicates a planned intervention for data collection.

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

• The document does not explicitly state the "number of experts" or their "qualifications" involved in establishing ground truth for the test set.
• Instead, the assessment of "successful and accurate placement" and the questionnaire ratings were completed by the "operators" who inserted the chest tubes. These operators would be medical professionals (likely surgeons or cardiothoracic surgeons) trained in chest tube insertion.
• The document doesn't specify any independent review or external expert consensus on the "ground truth" of successful placement; it implicitly relies on the operator's assessment during the procedure.

4. Adjudication Method for the Test Set

• An explicit adjudication method (e.g., 2+1, 3+1) is not described in the provided text.
• The determination of "successful and accurate placement" appears to have been made by the operating physician(s) at the time of the procedure without a described independent adjudication process.

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

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted in the traditional sense involving multiple human readers assessing cases with and without AI assistance.
• The study was a clinical feasibility study comparing the device (Andrews Introducer™) to previous experience with a different device (Roberts forceps), not an AI algorithm assisting human readers.
• The comparison was qualitative based on operator experience ("rated as significantly easier relative to experience of use of the Roberts forceps").

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)

• Yes, in a manner of speaking, the study was a "standalone" performance study for the device itself.
• The Andrews Introducer™ is a surgical tool, not an AI algorithm. Therefore, the "standalone" performance here refers to its direct application in surgery by a human operator, without any AI component or "human-in-the-loop" interaction in the context of an AI algorithm. The device's performance was evaluated based on its use by the operators.

7. Type of Ground Truth Used

• The ground truth for the test set was primarily based on clinical outcome and operator assessment:
  • "Successful and accurate placement of the chest tube" as assessed by the operating physician/team.
  • Absence of complications.
  • Subjective ratings of ease of use by the operators.

8. Sample Size for the Training Set

• Not applicable / Not explicitly stated. This device is a manual surgical instrument, not an AI algorithm. Therefore, there is no "training set" in the context of machine learning. The device design and refinement would have involved engineering principles and potentially pre-clinical testing, but not a data-driven "training set."

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

• Not applicable. As a manual surgical instrument, there is no "training set" for which ground truth would be established in the context of AI. The design and manufacturing would adhere to established surgical instrument standards and engineering specifications.

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The Pulmonary Guidewire is indicated for use to provide access to the tracheobronchial tree.

The Pulmonary Guidewire is constructed of a core wire, outer jacket and a tip. The guidewire is designed to provide access to the tracheobronchial tree.

This is a marketing document for a medical device (Pulmonary Guidewire). It is not an AI/ML device, and therefore the requested information for acceptance criteria and study data related to AI/ML device performance is not applicable.

The document describes a medical device, the Pulmonary Guidewire, which is "constructed of a core wire, outer jacket and a tip" and "designed to provide access to the tracheobronchial tree." The document states that the device successfully met biocompatibility assessment requirements.

Here's a breakdown of why the requested information isn't present in this document:

1. AI/ML Device: The Pulmonary Guidewire is a physical medical instrument, not an artificial intelligence or machine learning device. Therefore, the concepts of "acceptance criteria" for algorithms, "performance metrics" like sensitivity/specificity, or "ground truth" derived from expert consensus for image analysis are not relevant to this product.

2. Study Type: The "study" mentioned is a biocompatibility assessment, which is standard for medical devices that come into contact with the body. This is distinct from clinical trials or performance studies relevant to AI/ML diagnostic or prognostic tools.

3. Regulatory Pathway: This device is a Class I device and went through the 510(k) premarket notification pathway based on substantial equivalence to predicate devices (Boston Scientific Corporation currently marketed Microvasive® Guidewires). This pathway generally focuses on demonstrating that a new device is as safe and effective as a legally marketed predicate device, rather than requiring elaborate de novo clinical trials with specific performance endpoints often seen with novel AI/ML technologies.

Therefore, I cannot provide the requested information because it does not exist within the provided document, as the device is not an AI/ML product.

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Intended Use: A single use disposable introducer needle/cannula intended for A single use disposuble wires in non-vascular procedures.
Indications for Use: For use with the Dual Radiation Targeting System (ie: DRTS) to improve the accuracy of the needle placement.

The Light Saber Introducer Needle consists of a needle, a collimator, to which The fight Saber Introducer Neves enclosed in a cannula/hub assembly with a a soyieving tip. The female Luer of the cannula hub, for attachment to the mateling op. The 10to comply with ISO-594 for "Conical fittings with a 6% Syringe, is debigited to ossings of ther medical equipment." The Light (Duer) tor by inges) installer are provided in gauges of 17, 18, and 19 and in Daber - Invodated 11 Sinches. The tip design for these needles will provide icities of 27x, I all a point. Depth markings are standard on the cannula at 1cm intervals.

The provided text, K013040 for the MINRAD, INC. Light Saber™ Introducer Needle, is a 510(k) summary and FDA clearance letter. It does not contain information typically found in a clinical study report that would detail acceptance criteria and a study proving a device meets those criteria, particularly for a device that relies on complex performance metrics like an AI/ML algorithm.

The Light Saber™ Introducer Needle is a physical medical device designed to gain percutaneous access for surgical procedures, and specifically to be used with a Dual Radiation Targeting System (DRTS) to improve needle placement accuracy.

Therefore, the requested information elements (acceptance criteria, study details, sample sizes, ground truth establishment, MRMC studies, standalone performance, etc.) are not applicable in the context of this 510(k) submission for this type of device. The FDA clearance for this device, as indicated in the provided documents, is based on substantial equivalence to predicate devices, not on a clinical study demonstrating performance against specific numerical acceptance criteria for an AI/ML algorithm.

However, I can still extract relevant information about the device and its clearance process:

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

• Acceptance Criteria: Not explicitly defined in terms of measurable performance thresholds. For substantial equivalence, the "acceptance criteria" revolve around demonstrating that the new device has the same intended use, similar technological characteristics, and raises no new issues of safety or effectiveness compared to predicate devices.
• Reported Device Performance: No specific numerical performance metrics (e.g., accuracy, sensitivity, specificity) akin to those for AI/ML algorithms are reported. The document states:
  • "The Light Saber Introducer Needle is identical to a combination of its predicate devices."
  • "These minor differences raise no new issues of safety or effectiveness."
  • "Thus, the MINRAD, INC. Light Saber™ Introducer Needle is substantially equivalent to its predicate devices."

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. This submission does not describe a clinical test set of real-world cases with associated data for an AI/ML algorithm. The equivalence is based on design comparison and intended use, not statistical performance on a dataset.

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. Ground truth establishment by experts for a test set is not part of a substantial equivalence submission for a physical introducer needle.

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

• Not applicable. No test set or adjudication process as described for AI/ML algorithms 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. No MRMC study was conducted or reported for this device. The device itself is an introducer needle, not an AI-assisted diagnostic tool.

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

• Not applicable. The device is a physical introducer needle; there is no standalone algorithm performance to evaluate.

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

• Not applicable. The concept of "ground truth" as it applies to AI/ML performance evaluation is not relevant to this submission. The "ground truth" for substantial equivalence is the existing regulatory classification and safety/effectiveness profile of the predicate devices.

8. The sample size for the training set

• Not applicable. There is no AI/ML algorithm involved, so no training set.

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

• Not applicable. No training set or ground truth establishment process as described for AI/ML algorithms is mentioned.

In summary: The provided 510(k) summary for the MINRAD, INC. Light Saber™ Introducer Needle focuses on demonstrating substantial equivalence to existing predicate devices based on design, intended use, and technological characteristics. It does not involve performance studies or data analysis in the way modern AI/ML medical devices require, as it is a physical surgical tool.

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The SAPHLIFT is a holding and manipulating arm for use in surgery which allows the operating team to hold surgical instruments in a given position and to change that position immediately with one hand.
The SAPHLIFT is a holding and manipulating arm for use in surgery which allows the operating team to hold manual surgical instruments and the SaphLite Retractor in a given position and to change that position immediately with one hand.

The SAPHLIFT consists of three main components: an articulated arm that clamps to the rail of the surgical bed, an instrument holder, and a compressed gas supply to maintain the pneumatic pressure to hold the instrument in place. Ball joints in the articulated arm and instrument holder allow for a wide variety of instrument positions. Repositioning of the instrument is by means of a control lever that releases the pneumatic pressure when pressed and locks the instrument in place when released. The SAPHLIFT is reusable and is sterilized by steam autoclave.

The provided document is a 510(k) summary for a surgical instrument holder called SAPHLIFT. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, this document does not contain any information about acceptance criteria or a study proving that the device meets such criteria.

Therefore, I cannot provide the requested information. The document focuses on regulatory approval based on substantial equivalence rather than performance studies with defined acceptance criteria.

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ENDOPOUCH PRO Specimen Retrieval Bag is intended for use during general laparoscopic surgical procedures as well as the collection and extraction of tissue specimens such as the appendix, gall bladder, ovaries, fibroid tumors, other tissues and calculi.

ENDOPOUCH PRO Specimen Retrieval Bag is a disposable device used as a receptacle for the collection and extraction of tissue specimens such as the appendix, gall bladder, ovaries, fibroid tumors, other tissues and calculi during laparoscopic surgical procedures.

The ENDOPOUCH PRO device is comprised of a flexible plastic bag with a large, easily accessible opening, a push rod handle and an introducer tube. The push rod and handle allow for single hand deployment.

The provided text describes a 510(k) summary for a medical device called the ENDOPOUCH PRO Specimen Retrieval Bag. It outlines its intended use, technological characteristics, and a brief summary of performance data. However, the document does NOT contain the detailed information required to answer all the questions in your request, particularly those related to specific acceptance criteria, sample sizes, ground truth establishment, or multi-reader multi-case studies, as this device is not an AI/ML algorithm.

Here's an analysis of what can and cannot be answered based on the provided text:

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

• Explanation: The document states that "Pre-clinical in vivo as well as bench top testing has been performed to verify that the product meets the performance requirements described." However, it does not explicitly list the acceptance criteria (e.g., "bag strength must be X Newtons") nor provides quantitative reported device performance other than the qualitative statement about greater bag strength.

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

• Information Not Provided: The document mentions "Pre-clinical in vivo as well as bench top testing," but it does not specify the sample size for these tests, the type of data (e.g., if it involved human subjects or materials), or the provenance of any 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)

• Information Not Provided: This question is more relevant to studies involving interpretation by human experts, such as medical image analysis. For a specimen retrieval bag, the "ground truth" would likely relate to objective physical properties or functional performance, not expert consensus on interpretations.

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

• Information Not Provided: Adjudication methods are typically associated with resolving disagreements in expert interpretations, which is not applicable to the type of testing described for this device.

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 study was not done.
• Explanation: An MRMC study is relevant for AI/ML-based diagnostic devices that assist human readers (e.g., radiologists interpreting images). The ENDOPOUCH PRO is a surgical instrument, not an AI/ML diagnostic aid. The document does not describe any such study.

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

• No, a standalone algorithm performance study was not done.
• Explanation: This question also pertains to AI/ML algorithms. The ENDOPOUCH PRO is a physical medical device, not an algorithm.

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

• Implied Ground Truth: For the "bag strength" testing, the ground truth would likely be established through objective physical measurements (e.g., tensile strength testing) rather than expert consensus, pathology, or outcomes data, as it's a mechanical property. The document doesn't specify the exact metrics or methods for establishing this.

8. The sample size for the training set

• Information Not Applicable/Provided: As this device is not an AI/ML algorithm, there is no "training set."

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

• Information Not Applicable/Provided: As this device is not an AI/ML algorithm, there is no "training set" and thus no ground truth established for one.

Summary of Study (as described for the ENDOPOUCH PRO Specimen Retrieval Bag):

The study referenced is "Pre-clinical in vivo as well as bench top testing." The purpose of this testing was to "verify that the product meets the performance requirements described." The key finding reported is that the device "has greater bag strength than either predicate device."

This documentation focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and functional performance testing, which is typical for a 510(k) submission of a conventional medical device. It does not involve AI/ML components or associated study methodologies like MRMC, standalone algorithm performance, or extensive details on ground truth establishment relevant to AI.

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