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The Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensor Model MAXNAR is indicated for single patient use when continuous non-invasive arterial oxygen saturation and pulse rate monitoring is required for adult patients as indicated in the sensor directions for use. This device is for prescription use only.

The Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensor, model MAXNAR is designed for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate in conjunction with a Nellcor Pulse Oximeter. The Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensor, model MAXNAR, is intended for prescription use with adult patients in hospitals, hospital-type facilities, and intra-hospital transport. The proposed device is not provided sterile

The provided document describes a 510(k) premarket notification for a reprocessed medical device, the Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensor, Model MAXNAR. This is not an AI/ML device, but a reprocessed physical sensor. Therefore, many of the typical acceptance criteria and study components for an AI/ML device (like an algorithm's performance, human reader improvement, expert consensus for ground truth on images, training sets, etc.) are not applicable here.

Instead, the study focuses on demonstrating substantial equivalence to an existing predicate device by showing that the reprocessed sensor meets performance specifications and safety standards similar to a new device. The "ground truth" here is the actual arterial oxygen saturation measured by a co-oximeter, and the "device performance" refers to the accuracy of the SpO2 sensor against this gold standard.

Here's an attempt to extract and reframe the information based on the prompt's requirements, noting where AI/ML specific criteria do not apply:

Device: Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensor, Model MAXNAR
Device Type: Reprocessed pulse oximeter sensor (physical hardware, not an AI/ML algorithm)

Acceptance Criteria and Reported Device Performance

The core acceptance criterion for this device, as a pulse oximeter, is its accuracy in measuring SpO2. This is evaluated against an established standard (ISO 80601-2-61:2011).

Note: "Arms" refers to the "Accuracy Root Mean Square" deviation, which is a statistical measure of accuracy for pulse oximeters.

Study Details

1. Sample Size and Data Provenance:

   • Test Set Sample Size: 10 healthy adult volunteer subjects.
   • Data Provenance: The study was conducted in a laboratory setting on healthy volunteers. The exact country of origin is not specified, but the context implies it's within the US, given the FDA submission. It was a prospective clinical trial.
   • Subject Demographics: Ages 25 to 36 years; weight 105 - 220 lb.; height 60 – 72 in.; BMI of 20.0 – 33.4.

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

   • Not applicable in the typical AI/ML sense where human experts label images.
   • The ground truth for SpO2 was established invasively using a co-oximeter (arterial blood gas analysis), which is the gold standard for measuring arterial oxygen saturation. This does not involve human expert interpretation of images. The study followed "ISO 80601-2-61:2011 Procedure for invasive laboratory testing on healthy volunteers applicable sections."

3. Adjudication Method for the Test Set:

   • Not applicable. This study is a direct comparison of the device reading against an objective, invasive gold standard (co-oximetry), not an interpretation that requires adjudication by multiple experts.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   • No. An MRMC study is relevant for AI/ML systems that assist human interpretation of medical images. This device is a sensor that directly measures a physiological parameter. The study focuses on the sensor's accuracy, not its impact on human reader performance.

5. Standalone (Algorithm Only) Performance:

   • Yes, but framed differently. This is a hardware device, not an algorithm. The "standalone performance" is the accuracy of the reprocessed sensor itself (Model MAXNAR) in measuring SpO2 and pulse rate against the co-oximeter standard, without further human interpretation other than reading the display. The reported performance of 2% SpO2 accuracy is this standalone performance.

6. Type of Ground Truth Used:

   • Outcomes Data/Physiological Measurement (Invasive Gold Standard): Arterial oxygen saturation (SpO2) measurements obtained via co-oximetry on arterial blood samples from healthy volunteers. This is considered the true physiological value.

7. Sample Size for the Training Set:

   • Not applicable. This isn't an AI/ML algorithm that requires a training set. The "training" for a reprocessed device involves the manufacturing and reprocessing procedures themselves, ensuring they meet the original equipment manufacturer's specifications and performance.

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

   • Not applicable. As above, no training set in the AI/ML context. The closest analogy would be the validation of the reprocessing methods to ensure the sensor performs "as new." This involves non-clinical tests (biocompatibility, disinfection, shelf life, electrical, tissue heating, pulse rate accuracy, active element assessment, adhesive peel, environmental testing, visual inspection, cleaning efficacy) to establish that the reprocessed device meets specifications. The clinical study mentioned verifies the final performance.

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The Medline ReNewal Reprocessed Versaport V2 Bladeless Optical Trocar is intended for use in a variety of gynecologic, general, thoracic and urologic endoscopic procedures to create and maintain a port of entry. The trocar may be used with or without visualization for primary and secondary insertions.

The Medline ReNewal Reprocessed Versaport V2 Bladeless Optical Trocar 5-mm, 11-mm and 12-mm, with transparent cannula and obturator, allows optical entry for visualization of tissue layers during insertion. It is available in standard (100 mm), short (70 mm) and long (150 mm) cannula lengths. The obturator housing contains a scope retention mechanism and the trocar housing contains internal seals to prevent loss of pneumoperitoneum when instruments are inserted into a port or withdrawn completely from a port. The 5-mm, 11-mm and 12-mm Versaport seal system accommodate instruments indicated as 5-mm up to 11-mm and 12-mm respectively.

The provided text is a 510(k) Summary for a reprocessed medical device, the Medline ReNewal Reprocessed Versaport V2 Bladeless Optical Trocar. It asserts substantial equivalence to a predicate device based on functional performance studies, cleaning performance, biocompatibility, and sterilization and packaging validations. However, it does not contain the specific acceptance criteria (thresholds) for each performance test, nor does it present detailed "device performance" in a comparative table against those criteria. It also does not describe a "study that proves the device meets the acceptance criteria" in terms of clinical trials or multi-reader multi-case studies, but rather product verification and validation testing.

Therefore, much of the requested information regarding detailed acceptance criteria, specific performance numbers, sample sizes for test sets (beyond the implied "models included in clearance"), data provenance, expert ground truth, adjudication methods, or MRMC studies is not available in the provided document. The document describes a technical testing scheme for reprocessing rather than a study evaluating diagnostic AI performance.

Here's a breakdown of what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Not explicitly stated as numerical thresholds in this document)
The document states that the functional characteristics were "evaluated and were found to be substantially equivalent to the predicate device based on the following tests." This implies that the acceptance criteria for the reprocessed device were to perform comparably to the original predicate device on these tests. Actual numerical or qualitative thresholds for "passing" these tests are not provided.

Reported Device Performance:
The document does not provide specific numerical or qualitative performance results for the reprocessed device. It only states that the device was "found to be substantially equivalent" based on the described tests.

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

• Sample Size for Test Set: The document lists 15 specific reprocessed device models (combinations of diameter, length, and fixation/smooth cannula) that were included in the clearance. For each of these models, it implies that representative samples were tested across the various performance evaluations. However, the exact number of units tested for each specific test (e.g., how many devices were tested for seal leakage) is not provided.
• Data Provenance: The studies are described as "Performance Testing" conducted by the submitter, Medline ReNewal. This implies the data were generated prospectively as part of this 510(k) submission process for the reprocessed device. The country of origin for the data is not explicitly stated, but Medline ReNewal is based in Redmond, Oregon, USA, suggesting the testing was likely conducted in the USA or supervised by their US-based QA/RA department.

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. The device is a surgical trocar, not an AI/diagnostic imaging device where "ground truth" would typically be established by expert readers or pathology. The "ground truth" for this device's performance relies on engineering and biological safety standards for reprocessing and functional equivalence to the original device.

4. Adjudication method for the test set

• This information is not applicable and not provided. Adjudication methods like 2+1 or 3+1 typically refer to expert consensus in interpreting images or clinical data, which is not relevant to the described performance testing of a 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

• This information is not applicable and not provided. This is not an AI-assisted diagnostic device, but a reprocessed surgical instrument. Therefore, MRMC studies and the concept of human reader improvement with AI are not relevant.

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 not an algorithm or AI device.

7. The type of ground truth used

• As mentioned, the concept of "ground truth" in the context of expert consensus or pathology is not applicable. The "ground truth" for this device's substantial equivalence is based on meeting engineering performance specifications, cleaning efficacy, biocompatibility standards, and sterilization validation results, all benchmarked against the original (predicate) device's validated performance and relevant regulatory standards (e.g., ISO standards for biocompatibility).

8. The sample size for the training set

• This information is not applicable and not provided. This is not an AI/machine learning device that requires a training set. The "training" for this device would refer to the validated reprocessing procedures, not data used for an algorithm.

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

• This information is not applicable and not provided for the reasons stated in point 8.

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Medline ReNewal Reprocessed Harmonic ACE+ Shears without Adaptive Tissue Technology are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instruments can be used as an adjunct to or substitute for electrosurgery, lasers and steel scalpels in general, plastic, gynecologic, urologic, exposure to orthopedic structures (such as spine and joint space) and other open and endoscopic procedures.

Medline ReNewal Reprocessed Harmonic ACE+ Shears without Adaptive Tissue Technology (originally manufactured by Ethicon Endo-Surgery) are cleaned, refurbished, tested, inspected, packaged, and sterilized for an additional clinical use.

The provided text describes the substantial equivalence of a reprocessed surgical device, not an AI or diagnostic device, so many of the requested categories (like number of experts for ground truth, MRMC study effect size, sample size for training set, etc.) are not applicable and cannot be answered from the provided document.

However, I can extract the relevant acceptance criteria and performance information:

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

The document does not explicitly present a table of acceptance criteria with specific numerical thresholds matched to reported performance data for each criterion. Instead, it describes various performance tests conducted to demonstrate equivalence to the predicate device. The general acceptance criterion is that the reprocessed device performs equivalently to the original predicate device across these tests.

2. Sample size used for the test set and the data provenance
The document does not specify exact sample sizes for each test set. It describes types of tests performed (e.g., simulated use, grasping/pulling force, cutting effectiveness). The "data provenance" is implied to be from laboratory testing conducted on the reprocessed devices, comparing them to the predicate devices. The document does not specify country of origin or whether the data was retrospective or prospective, though performance testing is inherently prospective for the reprocessed device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable to a reprocessed surgical instrument. The "ground truth" for these tests relates to measurable physical and functional properties, as well as biological safety, compared against the predicate device and established standards, rather than expert interpretation of images or clinical data.

4. Adjudication method for the test set
Not applicable for this type of device and testing. Test results are based on objective measurement against established specifications or predicate device performance.

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 is for a surgical instrument, not an AI or diagnostic tool involving human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is for a surgical instrument.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" implicitly refers to the established performance characteristics and safety profile of the legally marketed predicate device, as well as recognized industry standards for safety (e.g., electrical safety, biocompatibility, sterilization efficacy) and functionality. For example, "cutting effectiveness" would be compared to a benchmark established by the new predicate device, and "vessel burst pressure" would have a defined acceptable range.

8. The sample size for the training set
Not applicable. This is a reprocessed surgical instrument, not a machine learning algorithm.

9. How the ground truth for the training set was established
Not applicable, as there is no training set mentioned for this type of device submission.

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Medline ReNewal Reprocessed Compression Limb Sleeves are designed to be used with a pump system to apply sequential compression to the lower limbs to prevent deep vein thrombosis.

Medline ReNewal Reprocessed Compression Limb Sleeves are used with a pump system to apply sequential compression to the lower limbs (leg and foot). They are made of a variety of materials and come in various sizes. They are originally manufactured as single use devices.

I am sorry, but the provided text is a 510(k) summary for a medical device and does not contain the detailed information required to describe the acceptance criteria and the comprehensive study that proves the device meets those criteria. The document explicitly states:

• "The functional characteristics of the proposed devices have been evaluated and found to be equivalent to the predicate devices after the specified number of reprocessing cycles."
• "Testing included: bioburden testing; biocompatibility testing (cytotoxicity, irritation, sensitization); cleaning process validation; equipment qualification; and visual inspection."

While these are types of tests performed, the document does not provide:

1. A table of acceptance criteria and reported device performance: It lists types of tests but not specific criteria (e.g., "bioburden must be

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Medline ReNewal Reprocessed Gyrus-Diego Sinus Application Blades are designed for use in limited sinus applications involving soft tissue and thin bone such as lamina papyracea.

Medline ReNewal Reprocessed Gyrus-Diego Sinus Application Blades are sterile single use devices that have been cleaned, disinfected, inspected, refurbished, tested, packaged, labeled, and sterilized. The Medline ReNewal Reprocessed Gyrus-Diego Sinus Application Blades are originally manufactured by OLYMPUS/Gyrus ACMI.

This document is a 510(k) premarket notification for Medline ReNewal Reprocessed Gyrus-Diego Sinus Application Blades. It focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study that defines and proves acceptance criteria for a novel device or AI algorithm.

Therefore, most of the requested information regarding acceptance criteria, specific performance metrics, sample sizes for test and training sets, expert involvement, and ground truth establishment is not present in this document. This document primarily describes the regulatory process for reprocessed medical devices.

Here's an attempt to answer the questions based on the available information:

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

The document does not explicitly present a table of quantitative acceptance criteria with corresponding performance results. Instead, it states that "The functional characteristics of the proposed devices have been evaluated and found to be equivalent to the predicate devices after the specified number of reprocessing cycles." The "acceptance criteria" appear to be that the reprocessed blades perform equivalently to the new predicate devices.

2. Sample sizes 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 the various tests (biocompatibility, cleaning validation, product stability, product performance). The data provenance is not mentioned, but given it's a 510(k) submission to the US FDA, the testing would typically be conducted to US regulatory standards. It would be considered prospective for the reprocessed device, as tests are conducted on the reprocessed products.

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. The testing described (biocompatibility, cleaning validation, bench tests for device function) does not typically involve "experts establishing ground truth" in the same way an AI algorithm for medical imaging would. It involves laboratory testing and comparison to manufacturing specifications or predicate device performance.

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

This is not applicable and not provided. Adjudication methods are typically used in clinical studies or studies involving human interpretation of data where consensus among multiple reviewers is needed to establish ground truth or evaluate performance. The tests described are laboratory-based and objective performance measurements.

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 and not provided. This device is a reprocessed surgical blade, not an AI-assisted diagnostic tool. Therefore, an MRMC study related to human readers and AI assistance would not be relevant.

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

This is not applicable. This device is a physical surgical tool and does not involve any algorithms.

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

The "ground truth" in this context is the performance specifications of a new, original equipment manufacturer (OEM) device (the predicate device) and accepted industry standards (e.g., ISO 10993-1 for biocompatibility). The reprocessed device's performance is compared against these established benchmarks.

8. The sample size for the training set

This is not applicable. There is no "training set" as this is not an AI/machine learning device.

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

This is not applicable. There is no "training set."

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