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The Midwest Reprocessing Center (MRC) Reprocessed Cerebral-Somatic Oximetry Sensors are indicated for use when continuous noninvasive trending of regional hemoglobin oxygen saturation of blood in the brain or in other tissue beneath the sensor is required.

Midwestern Reprocessing Center (MRC) Reprocessed Cerebral-Somatic Oximetry Sensors (CSS) are optical devices which use dual-wavelength light to determine a patient's current regional oxygen saturation level. Once a sensor has been applied to the patient, a light source in the sensor sends red and near-infrared light through the skin surface and photodiodes measure the reflected light. This signal is sent back to a monitor which calculates the patient's trending oxygenation levels.

The provided document is a 510(k) Summary for a reprocessed medical device, the Midwestern Reprocessing Center (MRC) Reprocessed Cerebral-Somatic Oximetry Sensors. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting a de novo study with acceptance criteria and clinical performance goals typical of novel devices.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria in the traditional sense of a new medical device approval. The submission relies on establishing that the reprocessed device performs identically and safely as the original predicate devices.

However, I can extract information related to the functional testing and the basis for the equivalence claim, which is the closest approximation to "performance data" in this context.

Here's a breakdown of what is and isn't present in the document:

1. Table of acceptance criteria and reported device performance:
* Not explicitly provided in the form of a table with specific quantitative acceptance criteria or numerical performance metrics.
* The document states: "Functional testing, cleaning validation, and biocompatibility data demonstrates that the reprocessed oximetry sensors perform as intended, and are safe and effective." This implies the "acceptance criteria" were that the reprocessed sensors demonstrated performance equivalent to the original OEM devices ("perform as intended").

2. Sample size used for the test set and the data provenance:
* Not specified. The document mentions "functional testing," "cleaning validation," and "biocompatibility data" without details on sample sizes or data provenance (e.g., country of origin, retrospective/prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
* Not applicable/Not mentioned. Since this is a reprocessing of an existing device, the "ground truth" performance is generally established by the original device's cleared performance. This submission focuses on ensuring the reprocessing process does not degrade that performance. There's no mention of experts establishing ground truth for a test set for this reprocessed device.

4. Adjudication method for the test set:
* Not applicable/Not mentioned. See point 3.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done:
* No. This type of study is not relevant for a reprocessed oximetry sensor that claims identical technological characteristics and intended use.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
* Not applicable directly. Oximetry sensors are hardware devices. The "algorithm" here is the underlying principle of dual-wavelength light measurement, which is identical to the OEM device. The focus is on the hardware's functionality after reprocessing, not on a standalone algorithmic performance test.

7. The type of ground truth used:
* Implicitly, the ground truth is the performance characteristics of the original, legally marketed OEM Somanetics oximetry sensors. The claim is that the reprocessed sensors are "identical to the original OEM devices in reference to the technological characteristics" and "perform as intended" (i.e., like the OEM).

8. The sample size for the training set:
* Not applicable/Not mentioned. There is no "training set" in the context of this device. It's a reprocessed medical device, not an AI or machine learning model.

9. How the ground truth for the training set was established:
* Not applicable/Not mentioned. See point 8.

Summary of what can be inferred about "acceptance criteria" and "study" from the document:

• Acceptance Criteria (Implied): The reprocessed sensors must:

  1. Perform identically to the original OEM devices in terms of technological characteristics and functional output (regional oxygen saturation measurements).
  2. Be safe for patient use (demonstrated by biocompatibility data).
  3. Be effectively cleaned and sterilized (demonstrated by cleaning validation).
  4. Meet the same intended use as the predicate devices.

• "Study" (referred to as Performance Data):

  • The study comprised "Functional testing, cleaning validation, and biocompatibility data."
  • The purpose of this testing was to demonstrate that the reprocessed sensors meet the implied acceptance criteria (perform as intended, safe, effective).
  • No details on methodologies, quantitative results, sample sizes, or specific metrics are provided in this summary. The conclusion simply states that this data demonstrates the required performance.

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The MRC Reprocessed Pulse Oximeter sensors are used as a noninvasive method to provide continuous SpO2 monitoring and pulse rate monitoring. These devices are intended for prescription use.

The Midwestern Reprocessing Center reprocessed pulse oximeter sensors are non-invasive sensors used to provide continuous SpO2 monitoring and pulse rate. The sensors contain a dual wavelength light emitting diode (LED), and an optical photodiode sensor which are housed in a pad which attaches to the patient using adhesive material. The LED emits red and infrared light in alternate pulses, governed by the Oximeter instrument. The photodiode sensor responds to the light and generates a current that is interpreted by the Oximeter instrument. The Oximeter instrument interprets the different amounts of each light type (red and infrared) from the output of the photodiode and interprets the information and displays a reading. The sensor operates without any type of tissue penetration, electrical contact, or heat transfer to the patient. The sensors use optical means to determine the light absorption of functional arterial hemoglobin. The sensor is indicated for use as a non-invasive method to provide continuous SpO2 monitoring and pulse rate.

{
  "acceptance_criteria_and_performance_table": null,
  "study_summary": {
    "sample_size_test_set": null,
    "data_provenance": null,
    "number_of_experts_ground_truth_test_set": null,
    "qualifications_experts_ground_truth_test_set": null,
    "adjudication_method_test_set": null,
    "mrmc_comparative_effectiveness_study": false,
    "effect_size_human_readers_mrmc": null,
    "standalone_performance_study": true,
    "type_of_ground_truth": "clinical testing and non-clinical functional testing (such as performance/functional testing, cleaning validation, and biocompatibility testing)",
    "sample_size_training_set": null,
    "ground_truth_establishment_training_set": null
  },
  "additional_notes": "The provided text indicates that 'Clinical Testing demonstrated that the reprocessed devices used with its compatible pulse oximeter perform as intended and are safe and effective' and 'Based on the assessment of clinical testing, non-clinical functional testing, cleaning validation, and biocompatibility testing performed, Midwestern Reprocessing Center concludes that the Midwestern Reprocessing Center reprocessed pulse Oximeter sensors are substantially equivalent to their predicate devices'. However, no specific acceptance criteria or quantitative performance metrics are provided to be presented in a table. The document focuses on demonstrating substantial equivalence through various tests rather than specific performance against numerical acceptance criteria. Therefore, a table of acceptance criteria and reported device performance cannot be generated from the given text."
}

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The Midwestern Reprocessing Center reprocessed sleeves/foot garments are intended to be used in the same manner as the predicated devices. They are designed to apply intermittent pneumatic compression to the lower limbs to help prevent deep vein thrombosis in patients at risk. The devices are intended to be used in both the home and institutional settings on patient populations for which these devices are applicable.

The Midwest Reprocessing Center Reprocessed Aircast Sleeves/Foot Cuffs are used in the treatment of venous leg/foot ulcers and edema which are disorders associated with venous insufficiency. The Midwest Reprocessing Center Reprocessed Aircast Sleeves/Foot Cuffs are also a noninvasive therapeutic method for prevention of deep vein thrombosis.

The Midwest Reprocessing Center Reprocessed ALP® DVT Sleeve is used as a non-invasive therapeutic method to prevent deep vein thrombosis, and treat venous leg ulcers and edema that result from venous insufficiency.

The Midwest Reprocessing Center Reprocessed Kendall SCD Express® Sleeves/Foot Cuffs are used in the treatment of venous leg/foot ulcers and edema which are disorders associated with venous insufficiency. The Midwest Reprocessing Center Reprocessed Kendall SCD Express® Sleeves/Foot Cuffs are also a noninvasive therapeutic method for prevention of deep vein thrombosis.

The Midwest Reprocessing Center Reprocessed Kendall SCD™ Sleeve is used in the treatment of venous leg/foot ulcers and edema which are disorders associated with venous insufficiency. The Midwest Reprocessing Center Reprocessed Kendall SCD™ Sleeve is also a non-invasive therapeutic method for prevention of deep vein thrombosis.

The Midwest Reprocessing Center Reprocessed Novamedix ImPad® is designed to enhance circulation of blood in the venules and arterioles. It is to be used by patients in both the home and institutional settings as a non-invasive therapeutic method to: Prevent deep vein thrombosis, Reduce wound healing time, Treat and assist healing of venous leg ulcers, Reduce edema caused by venous insufficiency in the lower extremities.

The Midwest Reprocessing Center Reprocessed Venodyne Sleeves are used in the treatment of venous leg ulcers and edema which are disorders associated with venous insufficiency. The Midwest Reprocessing Center Reprocessed Venodyne Sleeves are also a noninvasive therapeutic method for prevention of deep vein thrombosis.

The Midwest Reprocessing Center Reprocessed Venodyne Foot Cuffs are used in the treatment of venous leg/foot ulcers and edema which are disorders associated with venous insufficiency. The Midwest Reprocessing Center Reprocessed Venodyne Foot Cuffs are also a noninvasive therapeutic method for prevention of deep vein thrombosis.

The Midwest Reprocessing Center Reprocessed CTC VasoPress Compression Sleeves are used as a noninvasive therapeutic method to prevent deep vein thrombosis, and treat venous leg ulcers and edema that result from venous insufficiency.

The Midwest Reprocessing Center Reprocessed Nutech® Combo is used as a non-invasive therapeutic method by patients in the home or institutional setting in order to: Prevent deep vein thrombosis, Reduce wound healing time, Treat and assist healing of venous leg ulcers, Reduce edema caused by venous insufficiency in the lower extremities.

The Midwest Reprocessing Center Reprocessed Nutech® Calf Wrap is used as a non-invasive therapeutic method to be used by patients in the home or institutional setting in order to: Prevent deep vein thrombosis, Reduce wound healing time, Treat and assist healing of venous leg ulcers, Reduce edema caused by venous insufficiency in the lower extremities.

The Midwest Reprocessing Center Reprocessed Nutech® Foot Wrap is designed to enhance circulation of blood in the venules and arterioles. It is to be used by patients in both the home and institutional settings as a non-invasive therapeutic method to prevent: Deep vein thrombosis, Reduce wound healing time, Treat and assist healing of venous leg ulcers, Reduce edema caused by venous insufficiency in the lower extremities, Decrease compartmental pressures.

The Midwest Reprocessing Center Reprocessed Huntleigh Flowtron® Single Pulse DVT Sleve is used as a non-invasive therapeutic method to prevent deep vein thrombosis, and treat venous leg ulcers and edema that result from venous insufficiency.

The Midwest Reprocessing Center Reprocessed Huntleigh Foot Wrap is designed to enhance circulation of blood in the venules and arterioles. It is to be used by patients in both the home and institutional settings as a non-invasive therapeutic method to prevent: Deep vein thrombosis, Reduce wound healing time, Treat and assist healing of venous leg ulcers, Reduce edema caused by venous insufficiency in the lower extremities, Decrease compartmental pressures.

The Midwestern Reprocessing Center reprocessed sleeves/foot garments are compression devices that, when attached to an approved controller, provide intermittent, sequentially gradient pressure to a patient's leg/foot for the prevention of Deep Vein Thrombosis (DVT). As the sleeves/cuffs compress the legs/feet, veins collapse, forcing the blood to move upward towards the heart. After compression, the sleeves/cuffs deflate which allows the veins to reopen and bring oxygenated blood to the region. The inflation and deflation sequence is predetermined by the product's specific controller. The pressure of compression is determined by the controller.

The provided 510(k) summary describes the Midwestern Reprocessing Center Reprocessed Sleeves/Foot Cuffs, which are medical devices intended for the prevention of Deep Vein Thrombosis (DVT) and the treatment of venous leg/foot ulcers and edema. The submission aims to establish substantial equivalence to predicate devices, which are also compression sleeves/foot cuffs.

Here's an analysis of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly state specific numerical acceptance criteria (e.g., pressure ranges, durability metrics with defined pass/fail thresholds) for the reprocessed sleeves/foot cuffs. Instead, it makes a general claim of equivalence to original equipment manufacturer (OEM) devices and relies on functional, cleaning, and biocompatibility testing to demonstrate this.

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

The document does not specify a sample size for any functional, cleaning, or biocompatibility testing. It also does not provide information on data provenance (e.g., country of origin, retrospective or prospective nature) for these tests. The submission mentions "Performance Data" but elaborates neither on the methodology nor the data itself.

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

This information is not provided in the given text. Establishing ground truth typically applies to diagnostic or prognostic devices where expert review (e.g., radiologists, pathologists) is used to classify or evaluate cases. The device in question is a therapeutic, reprocessed medical device, and the evaluation relies on functional and material testing rather than expert-derived ground truth for diagnostic accuracy.

4. Adjudication Method for the Test Set

This information is not applicable/provided in the context of this device and the type of testing described. Adjudication methods like 2+1 or 3+1 are relevant for studies involving human readers and interpretations, particularly in diagnostic imaging. The submission focuses on physical and biological performance rather than interpretative tasks.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size.

An MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI on diagnostic performance of human readers. The device presented is a reprocessed compression sleeve, not an AI-powered diagnostic or interpretive tool.

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

A standalone study (in the context of an algorithm's performance) was not done. As mentioned, the product is a physical reprocessed medical device, not an algorithm. The "functional testing, cleaning validation, and biocompatibility testing" could be considered "standalone" in the sense that they assess the device's inherent properties and performance, but not in the AI/algorithm context.

7. The Type of Ground Truth Used

The concept of "ground truth" as typically used in AI/diagnostic studies (e.g., pathology, outcomes data, expert consensus) is not directly applicable here. For this reprocessed device, the "ground truth" for performance is implicitly defined by the characteristics and performance expected of the original, new OEM devices.

• Functional Testing: The ground truth would be the expected pressure profiles, inflation/deflation cycles, and durability characteristics matching the original, new sleeves.
• Cleaning Validation: The ground truth would be the absence of contaminants and residues below specified safe levels, and effective sterilization (if applicable).
• Biocompatibility Testing: The ground truth would be the absence of toxic or allergenic reactions, corresponding to established biocompatibility standards for medical devices and matching the performance of the original devices' materials.

8. The Sample Size for the Training Set

The concept of a "training set" is not applicable to this submission. This is a reprocessed physical medical device, not an AI algorithm that undergoes training.

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

This question is not applicable as there is no training set for an AI algorithm.

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The Midwestern Reprocessing Center reprocessed sleeves/foot garments are intended to be used in the same manner as the predicated devices. They are designed to apply intermittent pneumatic compression to the lower limbs to help prevent deep vein thrombosis in patients at risk. The devices are intended to be used in both the home and institutional settings on patient populations for which these devices are applicable.

The Midwest Reprocessing Center Reprocessed Venodyne Sleeves are used in the treatment of venous leg ulcers and edema which are disorders associated with venous insufficiency. The Midwest Reprocessing Center Reprocessed Venodyne Sleeves are also a non-invasive therapeutic method for prevention of deep vein thrombosis.

The Midwest Reprocessing Center Reprocessed Venodyne Foot Cuffs are used in the treatment of venous leg / foot ulcers and edema which are disorders associated with venous insufficiency. The Midwest Reprocessing Center Reprocessed Venodyne Foot Cuffs are also a noninvasive therapeutic method for prevention of deep vein thrombosis.

The Midwest Reprocessing Center Reprocessed CTC VasoPress Compression Sleeves are used as a non-invasive therapeutic method to prevent deep vein thrombosis, and treat vanous leg ulcers and edema that result from venous insufficiency.

The Midwest Reprocessing Center Reprocessed NuTech® Combo is used as a non-invasive therapeutic method by patients in the home or institutional setting in order to: Prevent deep vein thrombosis, Reduce wound healing time, Treat and assist healing of venous leg ulcers, Reduce edema caused by venous insufficiency in the lower extremities.

The Midwest Reprocessing Center Reprocessed NuTech® Calf Wrap is used as a noninvasive therapeutic method to be used by patients in the home or institutional so thiosi order to: Prevent deep vein thrombosis, Reduce wound healing time, Treat and assist healing of venous leg ulcers, Reduce edema caused by venous insufficiency in the lower extremities.

The Midwest Reprocessing Center Reprocessed NuTech® Foot Wrap is designed to enhance circulation of blood in the venules and arterioles. It to be used by patient's in both the home and institutional settings as a non-invasive therapeutic method to prevent: Deep vein thrombosis, Reduce wound healing time, Treat and assist healing of venous leg ulcers, Reduce edema caused by venous insufficiency in the lower extremities, Decrease compartmental pressures.

The Midwest Reprocessing Center Reprocessed Huntleigh Flowtron® Single Pulse DVT Sleeve is used as a non-invasive therapeutic method to prevent deep vein thrombosis, and treat venous leg ulcers and edema that result from venous insufficiency.

The Midwest Reprocessing Center Reprocessed Huntleigh Foot Wrap is designed to enhance circulation of blood in the venules and arterioles. It is to be used by patient's in both the home and institutional settings as a non-invasive therapeutic method to prevent: Deep vein thrombosis, Reduce wound healing time, Treat and assist healing of venous leg ulcers, Reduce edema caused by venous insufficiency in the lower extremities, Decrease compartmental pressures.

The Midwestern Reprocessing Center reprocessed sleeves/foot garments are compression devices that, when attached to an approved controller, provide intermittent, sequentially gradient pressure to a patient's leg/foot for the prevention of Deep Vein Thrombosis (DVT). As the sleeves/cuffs compress the legs/feet, veins collapse, forcing the blood to move upward towards the heart. After compression, the sleeves/cuffs deflate which allows the veins to reopen and bring oxygenated blood to the region. The inflation and deflation sequence is predetermined by the product's specific controller. The pressure of compression is determined by the controller.

This is a 510(k) summary for the reprocessing of various compression sleeves and foot cuffs. The document focuses on demonstrating substantial equivalence to already marketed predicate devices, rather than establishing performance criteria for a novel AI/ML device or providing a detailed study methodology with acceptance criteria and results in the format requested.

Therefore, many of the requested points are not applicable or cannot be extracted from the provided text.

Here is a summary of what can be gleaned:

Acceptance Criteria and Reported Device Performance

Breakdown of Study Information:

1. Sample size used for the test set and the data provenance: Not specified. The document mentions "Functional Testing, cleaning validation, and biocompatibility testing" but does not provide details on the sample sizes or data provenance (e.g., country of origin, retrospective/prospective nature) for these tests. This is typical for a 510(k) where the focus is on substantial equivalence, and detailed study protocols and results are usually submitted as part of the full 510(k) rather than summarized in the public-facing summary.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This document does not describe the establishment of ground truth for an AI/ML or diagnostic device. The evaluation is based on standard engineering and biological testing (functional, cleaning, biocompatibility).

3. Adjudication method for the test set: Not applicable. There is no mention of expert adjudication as this is not a diagnostic device or an AI/ML performance study.

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: Not applicable. This is not an AI/ML device.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML device.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the context of diagnostic "ground truth." The ground truth for this device's performance would be established by objective measurements in functional testing, sterility/cleanliness assays for cleaning validation, and standard biological tests for biocompatibility, compared against specifications or predicate device performance.

7. The sample size for the training set: Not applicable. This is not an AI/ML device.

8. How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.

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