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Reloadable Cutters

The ClearMedical Reprocessed Reloadable Cutters are intended for transection, resection, and creation of anastomoses in gastrointestinal, gynecologic, thoracic, and pediatric surgery.

Reloadable Staplers

The ClearMedical Reprocessed Reloadable Staplers are intended for the resection of tissues in the alimentary tract and in thoracic surgery.

The Reprocessed Reloadable Cutters deliver two double-staggered rows of titanium staples while dividing the tissue between the rows. The reloadable cutters may be reloaded during a single procedure, up to a maximum number of firings per instrument as stated in the product insert.

The Reprocessed Reloadable Staplers deliver two double-staggered rows of titanium staples to approximate internal tissues. The reloadable cutters may be reloaded during a single procedure, up to a maximum number of firings per instrument as stated in the product insert.

The provided text is a 510(k) Summary for a medical device called "ClearMedical Reprocessed Reloadable Linear Cutters and Staplers" (K033579) and a subsequent FDA clearance letter for a related product with similar name (K033578). The documents essentially state that the reprocessed devices are substantially equivalent to their predicate devices. However, the text does NOT contain information about specific acceptance criteria or a detailed study proving the device meets those criteria.

The 510(k) Summary states: "Validation of cleaning, performance, packaging, and sterilization together with biocompatibility testing demonstrate reprocessed clip reloadable cutters and staplers perform as intended and are safe and effective." This is a high-level statement and does not provide the specifics requested in your prompt.

Therefore, I cannot fill out the requested table and answer the study-related questions based on the provided input because the required detailed information is not present. The document focuses on establishing substantial equivalence based on the technological characteristics being unchanged and relying on general validation of various aspects rather than a specific comparative performance study with defined acceptance criteria and statistical analysis.

If this information were present, it would typically be found in dedicated sections detailing performance testing methodologies, results, and statistical analyses, which are absent here.

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Reprocessed multiple clip appliers are intended for the ligation of vessels or other tubular structures.

The reprocessed multiple clip applier is an automatic ligating clip applier. The device is preloaded with a minimum of 10 titanium ligating clips that individually advance after each clip application.

Acceptance Criteria and Study Details for ClearMedical Reprocessed Multiple Clip Appliers

The provided documents describe the 510(k) summary for the ClearMedical Reprocessed Multiple Clip Appliers, which are reprocessed versions of the Ethicon Ligaclip Multiple Clip Appliers. The submission focuses on demonstrating substantial equivalence to the predicate device through validation of reprocessing procedures, rather than a de novo clinical study with specific performance metrics for the reprocessed device's function in a surgical setting.

Therefore, the "acceptance criteria" and "reported device performance" are primarily related to the successful validation of the reprocessing process and the maintenance of equivalence to the predicate device in terms of function and safety.

1. Table of Acceptance Criteria and Reported Device Performance

Study Details:

The provided 510(k) summary is for a reprocessed medical device. The "study" described is primarily a series of validation tests for the reprocessing procedures and comparison to the predicate device. It is not a clinical study evaluating the surgical or diagnostic performance of the device in patients in the same way an AI/software device would be.

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

• Test Set Sample Size: The document does not specify the exact sample sizes used for each validation test (e.g., cleaning, performance, packaging, sterilization, biocompatibility).
• Data Provenance: The data would have been generated internally by ClearMedical, Inc. during their reprocessing validation activities. This would be prospective testing conducted to support the 510(k) submission. No information on country of origin for this testing is provided, but it is implicit that it was conducted by or for ClearMedical, Inc. in the context of a US regulatory submission.

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

This type of information is generally not applicable to a reprocessing validation study for a manual surgical instrument. Ground truth would be defined by validated testing methods and specifications (e.g., cleanliness levels, sterility assurance levels, mechanical performance thresholds) rather than expert consensus on clinical findings or images. The "experts" would be individuals with expertise in:
* Reprocessing validation (cleaning, sterilization)
* Materials science and biocompatibility
* Mechanical engineering and functional testing of surgical instruments

The document does not detail the specific number or qualifications of these individuals.

4. Adjudication Method for the Test Set:

Not applicable. Adjudication methods (like 2+1 or 3+1) are typically used in clinical studies or studies involving human interpretation of data where there might be disagreement among experts. Here, the "truth" is determined by objective physical and chemical testing against pre-defined 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:

This is not applicable. The device is a reprocessed manual surgical instrument, not an AI or imaging diagnostic device. Therefore, no MRMC study, human reader improvement, or AI assistance is relevant.

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

This is not applicable. The device is a reprocessed manual surgical instrument, not an algorithm.

7. The Type of Ground Truth Used:

The "ground truth" for this device's validation is based on:

• Engineering specifications and performance standards: For mechanical function (e.g., clip apposition, jaw closure, clip retention, tensile strength, fatigue resistance).
• Microbiological standards: For sterility assurance and cleanliness levels.
• Chemical standards: For residual levels of cleaning agents or material degradation products.
• Biocompatibility standards: (e.g., ISO 10993 series) for material safety.

Essentially, the ground truth is "the device successfully meets its pre-defined engineering, performance, safety, and regulatory specifications after reprocessing, demonstrating equivalence to the new predicate."

8. The Sample Size for the Training Set:

This is not applicable. The device is a reprocessed manual surgical instrument, not an AI or machine learning model that requires a training set. The validation involves testing samples of the reprocessed physical device.

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

This is not applicable for the same reason as #8.

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The ClearMedical Reprocessed Endopath® Tristar® Blunt Tip Surgical Trocar, ClearMedical Reprocessed Endopath® Tristar® Surgical Trocar, and ClearMedical Reprocessed Endopath® Dilating Tip Trocar have application in thoracic, gynecologic laparoscopy, and other abdominal procedures to establish a path of entry for minimally invasive instruments.

Reprocessed endoscopic trocars consist of an obturator and sleeve. The trocar sleeve has a stopcock valve for gas insufflation and a desufflation lever for gas evacuation. The trocar obturator are either flat bladed, pyramidal, or blunt tip. Bladed and dilating tip obturators have a safety shield that exposes the blade during insertion and retract over the tip after the operative cavity has been penetrated.

The provided text is a 510(k) summary for ClearMedical Reprocessed Trocars. It focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance, rather than reporting on a clinical or performance study of an AI/algorithm-driven device. Therefore, much of the requested information regarding acceptance criteria for an AI device, sample sizes for training/test sets, expert ground truth, MRMC studies, or standalone algorithm performance is not applicable or cannot be extracted from this document.

However, I can extract the general acceptance criteria and the type of information provided to "prove" the device meets them in the context of this 510(k) submission.

Acceptance Criteria and Device Performance (based on the provided 510(k) summary):

Study Information (Based on the provided document):

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

   • Not applicable / Not specified. This document describes a 510(k) submission for reprocessed medical devices, not an AI or algorithm-driven device that would typically involve a "test set" in the computational sense. The "test data" mentioned refers to validation of cleaning, performance, packaging, sterilization, and biocompatibility, which are laboratory/engineering tests on the reprocessed devices themselves. The specific sample sizes for these validation tests are not detailed in this summary.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

   • Not applicable / Not specified. Ground truth, in the context of AI/algorithm performance, is not relevant to this submission. The "truth" for reprocessed devices is assessed through engineering and biological safety tests.

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

   • Not applicable / Not specified.

4. 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, not applicable. This is not an AI-assisted device.

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

   • No, not applicable. This is not an algorithm.

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

   • Not applicable in the typical AI sense. For this device, the "ground truth" equivalent would be the objective standards and specifications for the original predicate devices, and the established regulatory requirements for reprocessing, cleaning, sterilization, and biocompatibility. The performance (e.g., integrity, functionality) of the reprocessed devices is compared against these engineering and safety benchmarks.

7. The sample size for the training set:

   • Not applicable / Not specified. This is not an AI/machine learning device.

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

   • Not applicable / Not specified.

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The ClearMedical Reprocessed Used, Disposable Endoscopic Scissors and Graspers have application in a variety of minimally invasive procedures to facilitate grasping, mobilization, dissection, and transaction of tissue.

The Reprocessed SUD (Reprocessed Used, Disposable Endoscopic Scissors and Graspers) is a sterilized SUD. The reprocessed Endopath endoscopic instruments are sterile, single patient use instruments that have a rotating insulated shaft and are designed for use through appropriate surgical trocars. The rotation knob located on the handle rotates the shaft 360 degrees in either direction. Some instruments have a monopolar cautery connector extending from the top of the handle and can be used for electosurgery when properly attached to standard cautery cables and appropriate generators. Other instruments have rachet handles, which allow the instrument jaws to be locked in place. The instrument jaws or scissor blades are activated by compression and release of the ring handles. See instructions for complete mode of operation details. The Reprocessed SUD (Reprocessed Used, Disposable Endoscopic details. The Reprosesses Coasted using EtO sterilization.

The provided text is a 510(k) summary for a reprocessed medical device, the "Reprocessed Used, Disposable Endoscopic Scissors and Graspers." It focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific acceptance criteria and a study to prove meeting those criteria in the way a new device would.

Therefore, much of the requested information regarding acceptance criteria, device performance tables, sample sizes for test/training sets, expert qualifications, ground truth establishment, adjudication methods, and MRMC studies is not present in this document. This document is a regulatory submission for substantial equivalence based on similarity to an existing device.

Here's an analysis of what can be extracted and what is missing:

Description of Acceptance Criteria and Study to Prove the Device Meets Them:

The document does not describe specific acceptance criteria and a detailed study designed to quantitatively prove the reprocessed device meets those criteria with performance metrics (e.g., accuracy, sensitivity, specificity, mechanical performance thresholds). Instead, the submission argues for substantial equivalence to a predicate device based on similar design, materials, intended use, and technological characteristics. The "study" here is implicitly the comparison made to the predicate device to satisfy the FDA's regulatory requirements for substantial equivalence.

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

• Not provided. The document does not contain a table of acceptance criteria or quantitative performance metrics for the reprocessed device. The submission relies on the concept that if the reprocessed device is substantially equivalent to a legally marketed predicate device, its performance is implicitly acceptable for its intended use.

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

• Not specified. The document does not describe a "test set" in the context of performance evaluation with a specific sample size. The substantial equivalence argument is based on a comparison to a predicate device's characteristics, not an independent performance study on a separate dataset of reprocessed devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable/Not specified. This type of information is pertinent to performance studies involving expert review (e.g., for image analysis algorithms). For a reprocessed surgical instrument, "ground truth" would typically relate to functional performance, sterility, and material integrity, which are assessed through engineering and quality control tests, not expert interpretation of data. The document does not detail such specific testing experts.

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

• Not applicable/Not specified. Adjudication methods are typically used in clinical or imaging studies where multiple readers interpret data and discrepancies need to be resolved. This is not relevant to the type of substantial equivalence argument presented for a reprocessed surgical instrument.

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 such study was done or reported. MRMC studies are relevant for evaluating the impact of AI or new diagnostic tools on human reader performance. This device is a surgical instrument, not an AI-powered diagnostic tool, so an MRMC study is inapplicable here.

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

• Not applicable. This device is a manual surgical instrument. It does not operate as a standalone algorithm.

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

• Implied Regulatory Ground Truth: The "ground truth" for this submission is the legally marketed predicate device (Ethicon Endoscopic Surgical Instruments, K930933). The substantial equivalence argument posits that the reprocessed device is functionally equivalent to this predicate, thus implicitly sharing its established "ground truth" performance and safety profile from its original approval. Specific, independent "ground truth" data for the reprocessed device's performance, as would be generated for a novel device, is not described.

8. The sample size for the training set

• Not applicable. This is not an AI/machine learning device, so there is no training set in that context. The "training" for the reprocessed device would be in the quality control processes and procedures established for reprocessing, but this is not discussed in terms of a "training set" for statistical analysis.

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

• Not applicable. See point 8.

Summary of available information from the document:

• Device Name: Reprocessed Used, Disposable Endoscopic Scissors and Graspers
• Predicate Device: Ethicon Endoscopic Surgical Instruments (K930933), cleared June 22, 2003.
• Basis for Equivalence: Similarities in intended use, material, design, performance, and physical characteristics to the predicate device.
• Reprocessing Method: Ethylene Oxide (EtO) sterilization.
• Intended Use: "indicated for use in a variety of minimally invasive procedures to facilitate grasping, mobilization, dissection, and transaction of tissue."

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Clear Medical, Inc. reprocessed Microvasive, single use, electric and mechanical biopsy forceps are intended to be used during GI procedures for endoscopic tissue sample acquisition.

Cold biopsy forceps are intended to be used through an endoscope to remove polyps and/or tissue specimens throughout the alimentary tract.

Hot Biopsy Forceps are intended to be used through an endoscope to cauterize and remove polyps and/or tissue specimens throughout the alimentary tract.

Reprocessed Used Disposable Biopsy Forceps. Reprocessing Biopsy Forceps is performed by Clear Medical to Clear Medical protocol Number 40003. "Reprocessed," means all operations performed to render a contaminated single-use device patient ready. Clear Medical is a "third party reprocessor" and reprocesses used, single-use medical devices. Clear Medical, Inc. reprocessed Microvasive, single use, electric and mechanical biopsy forceps. CMI intends to reprocess used disposable hot and cold biopsy forceps manufactured by Micovasive. CMI reprocessed biopsy forceps are disposable unless reprocessed again by Clear Medical, Inc.

This document is a 510(k) summary for Reprocessed Used Disposable Biopsy Forceps by Clear Medical, Inc. It mainly focuses on the substantial equivalence of the reprocessed devices to new predicate devices. It does not contain information about specific acceptance criteria or an analytical study proving the device meets those criteria in the way a clinical study would for efficacy/performance claims.

Here's an analysis based on the provided text, focusing on what can be extracted or inferred about acceptance criteria directly related to the reprocessing and substantial equivalence, rather than a clinical performance study.

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

Based on the nature of this 510(k) submission, "performance" here refers to the ability of the reprocessed device to meet the functional and safety characteristics of the original device after reprocessing, demonstrating substantial equivalence. The document doesn't provide a table of precise quantitative acceptance criteria with reported numerical performance values from a study. However, it implicitly states the requirement for the reprocessed device to perform equivalently to the new predicate device.

The acceptance criteria for "reprocessed" devices, as stated by Clear Medical, are defined by the FDA's Compliance Policy Guide #7124.16 related to "reusable - by Clear Medical" devices:

• Ability to withstand necessary cleaning and sterilization processes.
• Physical characteristics or quality of the device will not be adversely affected.
• The device remains safe and effective for its intended use.

The document states that Clear Medical believes these conditions are met, and the FDA's 510(k) clearance implies that the provided data (though not detailed here) was sufficient to demonstrate this belief as valid for substantial equivalence.

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 size, data provenance, or study design (retrospective/prospective) for any specific testing related to establishing substantial equivalence. The submission is for "Reprocessed Used Disposable Biopsy Forceps," indicating that the "test set" would be reprocessed devices. The original disposable biopsy forceps were manufactured by Microvasive.

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 510(k) summary does not mention the use of experts to establish a "ground truth" in the context of a clinical performance study. The primary focus is on the substantial equivalence of the reprocessed device to the predicate device, which would typically involve engineering and sterilization validation rather than expert clinical assessment of patient outcomes for a test set.

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

Not applicable, as a clinical test set requiring adjudication by experts is not described in this document.

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

Not applicable. This document pertains to the reprocessing of medical devices (biopsy forceps), not an AI-assisted diagnostic tool or a study involving human readers.

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

Not applicable. This document pertains to the reprocessing of medical devices (biopsy forceps), not an algorithm.

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

For this type of device, the "ground truth" for substantial equivalence would likely revolve around:

• Functional equivalence: Demonstrating that the reprocessed device performs the biopsy function (e.g., tissue sample acquisition) comparably to new devices. This might involve mechanical testing, tissue grip tests, cutting performance.
• Sterility: Proving that the device is sterile after reprocessing.
• Material integrity: Ensuring the device materials do not degrade and no toxic residues remain after reprocessing. This would involve chemical analysis, material compatibility testing, and biocompatibility.
• Biocompatibility: Demonstrating that the reprocessed materials are still biocompatible.

The document does not provide details on which specific "ground truth" methods were employed, but these are typical for reprocessing validations.

8. The sample size for the training set

Not applicable. There is no mention of a "training set" as this device is not an algorithm based on machine learning.

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

Not applicable, as there is no training set for an algorithm.

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The ClearMedical Blood Pressure Cuff is indicated for use in manual measurement and automatic non-invasive blood pressure (BP) monitoring by properly trained personnel. Complete inflation systems are designed for use with manometers during manual BP measurement The ClearMedical Blood Pressure Cuff is intended as a single patient use item.

Not Found

This is a medical device clearance letter from the FDA for the ClearMedical Blood Pressure Cuff (K031416). It states that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain any information regarding acceptance criteria or a study that proves the device meets those criteria.

Medical device clearance letters like this one typically confirm substantial equivalence based on comparisons to existing devices, review of design specifications, and performance data provided by the manufacturer. They summarize the FDA's decision but do not usually include the detailed study results or the specific acceptance criteria themselves. These details would be found in the manufacturer's 510(k) submission to the FDA.

Therefore, I cannot provide the requested information from the given text.

To be clear, the sections of your request that cannot be answered from this document are:

1. A table of acceptance criteria and the reported device performance
2. Sample sized used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
4. Adjudication method
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, and its effect size
6. If a standalone performance study was done
7. The type of ground truth used
8. The sample size for the training set
9. How the ground truth for the training set was established

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The neonatal/adult Oxisensor, model N-25, is Indicated for single patient use when continuous noninvasive arterial oxygen saturation and pulse rate monitoring are required for patients weighing less than 3 kg or more than 40 kg.

The reprocessed ClearMedical/Nellcor N-25 Oxisensor is intended as a single patient use O₂ transducer/accessory sensor to a Nellcor Oximeter system. The role of the sensor the acquisition of patient data which is used by the oximeter in the determination of functional oxygen saturation and pulse rate of neonatal and adult patients. The N-25 oxisensor is used in conjunction with the Nellcor oximeter in a hospital environment where non-invasive monitoring of pulse oxygen hemoglobin saturation (SpO2) and pulse rate (PR) are required for patients with potentially abnormal pulmonary/circulatory function.

The ClearMedical/Nellcor Oxisensor is an accessory device to an oximeter monitoring system. The oximeter system is designed for the determination of functional oxygen saturation and pulse rate. The oxisensor is designed as a transducer for the transmission of electrical signals from the oximeter to the patient and the return of patient modified signals back to the oximeter for analysis and display of patient information.

The sensor contains three optical components: two light emitting diodes (LEDs) that serve as light sources and one photodiode that acts as a light detector. Both the LEDs and photodiode are contained within a laminated envelope with an adhesive bandage for attachment to a patient. Attached to the laminated envelope is a sensor cable, which terminates in a connector element that connects to the oximeter.

The provided document is a 510(k) summary for the ClearMedical/Nellcor Oxisensor II, Neonatal/Adult O2 Transducer, Model N-25, which is a reprocessed single-use device. This document primarily focuses on establishing "substantial equivalence" to a predicate device rather than presenting a performance study with explicit acceptance criteria for a new device's performance. Therefore, much of the requested information regarding acceptance criteria, study design, and specific performance metrics for the device itself is not explicitly detailed in this type of submission.

However, I can extract information related to the basis for establishing substantial equivalence, which serves as the "study" proving the device meets its regulatory acceptance criteria (i.e., substantial equivalence to a legally marketed predicate device).

Here's an analysis based on the provided text, addressing the points where information is available or inferable:

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

Since this is a 510(k) submission for a reprocessed device, the "acceptance criteria" are primarily framed around demonstrating substantial equivalence to the predicate device. The performance data presented is comparative, showing that the reprocessed device performs equivalently to the original. Explicit numerical acceptance criteria for clinical performance are not provided in this summary.

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

The summary states that "specific bench and non-invasive clinical testing" was performed. However, it does not specify:

• The exact sample size for the test set (number of patients or reprocessed devices tested).
• The country of origin of the data.
• Whether the study was retrospective or prospective.

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 information is not provided in the summary. For an oximeter, "ground truth" for oxygen saturation is typically established by arterial blood gas analysis (Co-Oximetry), not by expert consensus. The summary mentions "comparative non-invasive Co-Oximetry and Oximetry data," suggesting a comparison against a more accurate measurement method (Co-Oximetry), which would serve as the ground truth. However, details on how this was conducted or expert involvement in establishing ground truth are not present.

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

This information is not provided in the summary. Given the nature of oximetry, it's unlikely a multi-reader adjudication method would be directly relevant to the core SpO2 measurement, which tends to be an objective numerical value.

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

An MRMC study is not applicable here. This device is an oximeter transducer, an accessory device, not an AI-powered diagnostic tool requiring human interpretation. The "study" focuses on the equivalence of the reprocessed hardware's performance.

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

The device itself is a transducer, a hardware component that, in conjunction with an oximeter system, acquires data. It's not an algorithm that operates "standalone" in the way AI algorithms are evaluated. The "performance" refers to the sensor's ability to accurately transmit patient-modified signals to the oximeter, and thus its accuracy in contributing to SpO2 and pulse rate determination. The evaluation would have been of the device in its intended use, effectively "standalone" from human interpretation of raw signals, but in conjunction with the oximeter system.

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

The summary mentions "comparative non-invasive Co-Oximetry and Oximetry data." This strongly suggests that Co-Oximetry (a more accurate, usually invasive, measurement of arterial oxygen saturation) was used as the ground truth for evaluating the accuracy of the reprocessed oxisensor in contributing to SpO2 determination.

8. The sample size for the training set

This information is not relevant or provided as there is no "training set" in the context of this traditional medical device (a reprocessed oximeter transducer). The device is not an AI algorithm that learns from data.

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

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

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The adult Oxisensor, model D-25 and D-25L, is indicated for single patient use when continuous noninvasive artertal oxygen saturation and pulse rate monitoring are required for patients weighing more than 30 kg.

The reprocessed ClearMedical/Nellcor D-25/ D-25L Oxisensor is intended as a single patient use transducer/accessory sensor to a Nellcor Oximeter system. The role of the sensor is the acquisition of patient data which is used by the oximeter in the determination of functional oxygen saturation and pulse rate of adult patients. The D-25/D-25L oxisensor is used in conjunction with the Nellcor oximeter in a hospital environment where non-invasive monitoring of pulse oxygen hemoglobin saturation (SpO2) and pulse rate (PR) are required for patients with potentially abnormal pulmonary/circulatory function.

The ClearMedical/Nellcor Oxisensor is an accessory device to an oximeter monitoring system. The oximeter system is designed for the determination of functional oxygen saturation and pulse rate. The oxisens of the a the a transmission of functional oxygen saturation and and from the oximeter to the patient and the return of patient modified signals back to the oximeter for analysis and display of patient information.

The sensor contains three optical components: two light emitting diodes (LEDs) that serve as light sources and one photodiode that acts as a light detector. Both the LEDs and photodiode are contained within a laminated envelope with an adhesive bandage for attachment to a patient. Attached to the laminated envelope is a sensor cable, which terminates in a connector element that connects to the oximeter.

The provided document is a 510(k) summary for the ClearMedical/Nellcor Oxisensor II O2 Transducer. It describes the device, its intended use, and claims substantial equivalence to a predicate device. However, it does not contain the detailed study information required to fully answer the request. Specifically, it lacks comprehensive acceptance criteria with specific thresholds, detailed methodology of a study proving those criteria are met, and information about the training set.

Therefore, many of the requested fields cannot be filled from the provided text.

Here's what can be extracted and what is missing:

Acceptance Criteria and Device Performance

Study Details

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

   • Sample Size: Not specified. The document mentions "clinical and/or non-clinical performance data" but does not give specific numbers for human subjects or test cases.
   • Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).

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

   • Not specified. The document does not describe how ground truth was established, or if experts were involved in a capacity to establish ground truth for a test set.

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

   • Not specified.

4. 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 involving AI or human readers is not mentioned. The device is an O2 Transducer, not an AI diagnostic tool.

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

   • The device is a hardware sensor, not an algorithm. Standalone performance for a sensor would typically refer to its accuracy against a gold standard; however, details of such a test are not provided. The comparison is against another physical device (the predicate).

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

   • Not explicitly stated. The comparison is based on "comparative non-invasive Co-Oximetry and Oximetry data" against a predicate device. This suggests the predicate device's readings or an external reference oximetry method might have served as a de facto "ground truth" for comparison, but this is not clearly defined.

7. The sample size for the training set:

   • Not applicable as this is a hardware device, not an AI algorithm requiring a training set.

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

   • Not applicable.

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The pediatric Oxisensor, model D-20, is indicated for single patient use when continuous noninvasive arterial oxygen saturation and pulse rate monitoring are required for patients weighing between 10 and 50 kg.

The reprocessed ClearMedical/Nellcor D-20 Oxisensor is intended as a single patient use O transducer/accessory sensor to a Nellcor Oximeter system. The role of the sensor the acquisition of patient data which is used by the oximeter in the determination of functional oxygen saturation and pulse rate of pediatric patients. The D-20 oxisensor is used in conjunction with the Nellcor oximeter in a hospital environment where non-invasive monitoring of pulse oxygen hemoglobin saturation (SpO2) and pulse rate (PR) are required for patients with potentially abnormal pulmonary/circulatory function.

The ClearMedical/Nellcor Oxisensor is an accessory device to an oximeter monitoring system. The oximeter system is designed for the determination of functional oxygen saturering and pulse rate. The oxisensor is designed as a transducer for the transmission of electrical signals from the oximeter to the patient and the return of patient modified signals back to the oximeter for analysis and display of patient information.

The sensor contains three optical components: two light emitting diodes (LEDs) that serve as light sources and one photodiode that acts as a light detector. Both the LED's and photodiode are contained within a laminated envelope with an adhesive bandage for attachment to a patient. Attached to the laminated envelope is a sensor cable, which terminates in a connector element that connects to the oximeter.

Here's a breakdown of the acceptance criteria and study information based on the provided text, categorized as you requested. Please note that the document is a 510(k) summary, which often provides general statements of equivalence rather than a full, detailed study report. Therefore, some information, especially regarding specific statistical outcomes or detailed methodologies, might be inferred or not explicitly present.

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

The document doesn't explicitly state quantitative acceptance criteria in a pass/fail format with exact numerical targets for all aspects. Instead, it emphasizes substantial equivalence to the predicate device in terms of safety and performance. The performance is reported as meeting this substantial equivalence.

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

• Sample size for test set: Not explicitly stated. The document refers to "specific bench and non-invasive clinical testing" but does not provide details on the number of subjects or cases included in these tests.
• Data provenance: Not explicitly stated. Clinical testing implies prospective data collection, but the location (country of origin) is not mentioned.

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 information is not provided in the document. For oximeters, ground truth for SpO2 is typically established via arterial blood gas (Co-Oximetry) measurements, but the specifics of how this was performed (number of experts, their qualifications, or who performed the reference measurements) are not detailed.

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

• This information is not provided in the document. Adjudication methods are more common in studies involving subjective interpretation (e.g., radiology reads). For objective measurements like oximetry, statistical comparison to a reference standard is typically used rather than adjudication.

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 is not applicable (N/A). The device is an oximeter sensor, which provides objective physiological measurements (SpO2 and pulse rate) and does not involve human "readers" interpreting images or data that could be augmented by AI. The device functions as a transducer for an oximeter system.

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

• This is not applicable (N/A). The device itself is a sensor (hardware component), not an algorithm. Its performance is measured in conjunction with an oximeter system. The "algorithm" here would be inherent in the oximeter's processing of the sensor's signals, not a standalone AI application. The document describes the sensor's function as "transmission of electrical signals from the oximeter to the patient and the return of patient modified signals back to the oximeter for analysis and display of patient information."

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

• The document mentions "Comparative non-invasive Co-Oximetry and Oximetry data." For oximeters, the gold standard for measuring arterial oxygen saturation is arterial blood gas analysis (Co-Oximetry). Therefore, it is highly likely that this was the type of ground truth used for the "non-invasive clinical testing" to validate SpO2 accuracy. Pulse rate ground truth would typically come from an ECG or manual palpation.

8. The sample size for the training set

• This information is not provided and is likely not relevant in the context of this device. The device is a reprocessed hardware sensor. Its "performance" is based on its physical and electrical properties, and its ability to produce signals comparable to the predicate device. It is not an AI/ML algorithm that requires a distinct "training set" in the conventional sense. The "training" here would be the quality control and reprocessing procedures, and the "validation" would be the bench and clinical testing described.

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

• This is not applicable (N/A) for the reasons stated in point 8. There is no "training set" in the AI/ML context for this hardware device.

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To reduce the incidence of deep vein thrombosis, reduce pain and swelling after injury or surgery and increase arterial blood flow.

The ClearMedical/Kendall SCDs are an accessory device to a SCD System which is used for the prevention of deep vein thrombosis and pulmonary embolism. The SCD Sleeve is designed with inflatable bladders that fill with air to provide compression to the legs. A connector tubing system attaches the SCD to the Controller system. The SCD Sleeves are latex-free, made of a polyester-cotton fabric. They are designed with velcro hook straps, three bladders and molded polyethylene tubing with a polypropylene snap-lock connector. Kendall has recently changed the device from the color blue to white. ClearMedical will designate the white SCDs with a "w" after the part number (i.e. 5330W).

This 510(k) summary describes a reprocessed medical device, the ClearMedical/Kendall Sequential Compression Device (SCD) Sleeves, which are intended to be substantially equivalent to the Kendall SCD Sleeves. The submission focuses on demonstrating that the reprocessed devices maintain the same safety and performance characteristics as the original, legally marketed predicate devices.

Here's an analysis of the provided information, focusing on your requested categories:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly present a table of numerical acceptance criteria with corresponding performance data in the typical format of a clinical study report. Instead, it relies on a qualitative assessment of "technological indicators of substantial equivalence" and bench testing results. The acceptance criterion is essentially "equality in safety and performance" compared to the predicate device.

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

• Sample Size: Not explicitly stated. The document refers to "bench tests" and "non-clinical performance data" but does not quantify the number of reprocessed sleeves or components tested.
• Data Provenance: The data is generated from bench testing and "non-clinical performance data" conducted by ClearMedical, Inc. This is internal company data. The country of origin of the data is the USA (Bellevue, WA, where ClearMedical is located). The data is retrospective in the sense that it evaluates the reprocessed devices against the established characteristics of the predicate device.

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified. The submission appears to rely on internal engineering and quality control expertise within ClearMedical for evaluating the bench test results against the predicate device's characteristics. There is no mention of independent clinical experts or a consensus panel.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable or specified. Given the nature of bench testing for substantial equivalence, there isn't a "ground truth" to be adjudicated by multiple readers in the traditional sense of a diagnostic medical device. The comparison is against engineering specifications and the known characteristics of the predicate device.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

• MRMC Study: No, an MRMC comparative effectiveness study was not done. The device is a physical, accessory compression sleeve, not an imaging or diagnostic device that would typically involve human readers interpreting cases.
• Effect Size: Not applicable.

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

• Standalone Performance: Not applicable. This is a physical, non-electronic device. There is no algorithm involved. "Standalone" performance would refer to the device's physical function by itself, which is what the bench tests were designed to assess.

7. The Type of Ground Truth Used

• Ground Truth: The "ground truth" for this substantial equivalence determination is the established characteristics and performance of the legally marketed predicate device (Kendall SCD Sleeves). This includes its technical labeling, promotional materials, and assumed baseline performance for safety and efficacy. The reprocessed device's performance benchmarks were derived from the predicate device's specifications and behavior.

8. The Sample Size for the Training Set

• Training Set Sample Size: Not applicable. This device is not an AI/ML algorithm that requires a "training set." It is a reprocessed physical medical device.

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

• Ground Truth for Training Set: Not applicable, as there is no training set for an AI/ML algorithm.

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