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The surgical patties and surgical strips are indicated for the use including brain and other tissues of the central nervous system, during surgery.

The Codman Surgical Patties and Strips are single use, sterile devices indicated for the use in protection of tissue, including brain and other tissues of the central nervous system, during surgery.

The Surgical Patties are comprised of 3 main components: Cottonoid Material, String and X-ray detectable monofilament.

The Strips are comprised of 2 main parts: Cottonoid Material and X-ray detectable monofilament.

This document describes the acceptance criteria and study results for the Integra LifeSciences Corporation's Codman Surgical Pattie & Strip (K193346).

1. Table of Acceptance Criteria and Reported Device Performance:

2. X-ray weld strength
3. X-ray flash
   (Demonstrates that proposed patties meet the same performance specification as the predicate device) | All samples passed the acceptance criteria. |
   | Visual Inspection (Strips) | 1. X-ray weld strength
4. X-ray flash
   (Demonstrates that proposed strips meet the same specifications as the predicate strips and that the performance of the proposed device with a non-phthalate PVC Resin is substantially equivalent to that of the predicate device) | All samples passed the acceptance criteria. |
   | Radiopacity (Patties and Strips) | Qualitative acceptance criteria (as per FDA recognized standard ASTM F640-12).
   (Supports that the performance of the proposed device with a non-phthalate PVC Resin is substantially equivalent to that of the predicate device) | All samples passed the qualitative acceptance criteria. |
   | Sterilization Validation | Achieve a 10⁻⁶ sterility assurance level (SAL) using the overkill process per FDA recognized standard, ISO 11135:2014, with a reference product load that included "worst case" product, and meet EO/ECH residual and bioburden acceptance criteria.
   (Same as predicate device, supporting substantial equivalence) | Test results met the EO/ECH residual and bioburden acceptance criteria and achieved a sterility assurance level of 10⁻⁶. |
   | Shelf-Life (2-years) | • X-ray shall not protrude
   • Meets ASTM F640
   • X-ray shall exhibit adequate adherence
   • X-ray shall not overlap string.
   (Within the current shelf life claim for the predicate device, does not raise new questions of safety and effectiveness as per FDA recognized standard ASTM F640) | All product tested passed the acceptance criteria. |
   | Biocompatibility - Cytotoxicity | Less than or equal to grade 2 reactivity on the 0 to 4 reactivity scale (per ISO 10993-5).
   (Demonstrates biocompatibility and substantial equivalence to predicate device) | All product tested passed the acceptance criteria. |
   | Biocompatibility - Intracutaneous Study | Difference between test article extract overall mean score and control group score is 1.0 or less (per ISO 10993-10).
   (Demonstrates biocompatibility and substantial equivalence to predicate device) | All product tested passed the acceptance criteria. |
   | Biocompatibility - USP Rabbit Pyrogen Study | No single animal shows a rise of 0.5 °C above its baseline temperature (per ISO 10993-11).
   (Demonstrates biocompatibility and substantial equivalence to predicate device) | All product tested passed the acceptance criteria. |
   | Biocompatibility - Acute Systemic Toxicity | No single animal treated with the individual test extract exhibits a significantly greater reaction than the control animals; no more than two animal deaths; no abnormal behavior such as convulsions or prostration occurs in two or more animals; no final body weight loss greater than 10% occurred in three or more animals (per ISO 10993-11).
   (Demonstrates biocompatibility and substantial equivalence to predicate device) | All product tested passed the acceptance criteria. |
   | Biocompatibility - Guinea Pig Maximization Sensitization Test | A grade of 0 on a patch test reaction scale of 0-3 (per ISO 10993-10).
   (Demonstrates biocompatibility and substantial equivalence to predicate device) | All product tested passed the acceptance criteria. |
   | Biocompatibility - ASTM Hemolysis Study | Hemolytic index for the test article extract to be 0.1% and non-hemolytic (as per ASTM F756 and ISO 10993-4).
   (Demonstrates biocompatibility and substantial equivalence to predicate device) | All product tested passed the acceptance criteria. |

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

The document does not explicitly state the exact sample size for each test. However, it indicates "All samples" passed the acceptance criteria for most tests, suggesting an appropriate number of samples were tested to demonstrate substantial equivalence. The data provenance is derived from bench testing conducted by Integra LifeSciences Corporation, as stated under "Bench Testing" and "Performance Data." This is prospective data generation for the purpose of demonstrating substantial equivalence. The country of origin for the data is not specified, but the submission is to the U.S. FDA.

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

Not applicable. This device is a physical medical instrument (surgical pattie and strip), not an AI/imaging device requiring expert interpretation for ground truth establishment. The performance evaluation relies on objective physical, chemical, and biological tests.

4. Adjudication method for the test set:

Not applicable. As described in point 3, this is not an AI/imaging device subject to expert adjudication of results.

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

Not applicable. This device is a physical medical instrument and does not involve AI assistance or human readers.

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

Not applicable. This device is a physical medical instrument.

7. The type of ground truth used:

The "ground truth" for this device's performance evaluation is established through adherence to recognized industry standards (e.g., ASTM, ISO standards) and meeting predefined objective specifications for physical, chemical, and biological properties. This includes measurements of weld strength, X-ray visibility, sterility assurance levels, and biocompatibility endpoints.

8. The sample size for the training set:

Not applicable. This device is a physical medical instrument and does not involve AI models or training sets.

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

Not applicable. As described in point 8, this device does not involve AI models or training sets.

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The device is intended to be used by trained physicians in neurosurgical procedures to protect nervous tissue, absorb fluids and stop bleeding.

Not Found

This looks like a 510(k) clearance letter from the FDA for a medical device called "Medline Neuro Sponge". This document is an approval letter, not a scientific study report or clinical trial summary.

Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria and performance studies.

Here's why and what kind of information is present:

• 510(k) Clearance: This is a premarket submission made to the FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed predicate device. It typically relies on demonstrating equivalence to an existing device, rather than proving novel performance against specific acceptance criteria through a new study.
• Content of this Document:
  • It confirms that the FDA has reviewed the 510(k) premarket notification (K140369) for the "Medline Neuro Sponge".
  • It states that the device is "substantially equivalent" to legally marketed predicate devices.
  • It outlines the regulatory classification (Class II, Product Code: HBA) and regulation number (21 CFR 882.4700 - Neurosurgical Paddle).
  • It lists the general controls provisions of the Act that apply to the device.
  • It includes the "Indications for Use" for the device, which state it is "intended to be used by trained physicians in neurosurgical procedures to protect nervous tissue, absorb fluids and stop bleeding."

To answer your prompt, you would need a different type of document, such as:

• A clinical study report.
• A summary of safety and effectiveness data (such as an SSED for a PMA device, though this is a 510(k)).
• A scientific publication describing the device's performance.

Since none of the requested information (acceptance criteria table, sample sizes, expert qualifications, adjudication, MRMC, standalone performance, training set details) is present in this FDA clearance letter, I cannot populate your table or answer your specific questions based on this input.

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The device is intended to be used by trained physicians during neurosurgical procedures to protect neural tissues from drying, abrasion, or contamination and to absorb fluids.

The device is indicated for use by trained physicians during neurosurgical procedures to protect neural tissues from drying, abrasion, or contamination and to absorb fluids:

The device is a non-adherent, strung, x-ray detectable surgical sponge that is sterile and disposable. The American Surgical Sponges (brand) product line is made from cotton, polyester, or rayon in various sizes and shapes and has been first marketed since 1985. The current cleared product line includes the Telfa® Sponges, which are cotton surgical sponges covered on both sides with polyethylene terephthalate. The Telfa® Sponges provide additional stiffness to the neurosurgical sponges. The new proposed addition to the product line includes neurosurgical sponges (cotton, polyester, or rayon) covered on one side with a thin single layer of polytetrafluoroethylene (PTFE) to enhance the material stiffness and non-adherence properties while maintaining flexibility of the sponge. The polytetrafluoroethylene (PTFE) layer will be provided in a choice of three thicknesses, 0.001", 0.003" or 0.005". The sponges range in size from 6mm × 76mm × 76mm.

The presented text describes a 510(k) summary for the American Surgical Company's Neurosurgical Sponges, specifically focusing on the addition of a polytetrafluoroethylene (PTFE) layer to the sponges. The document details the product description, intended use, indications for use, and a comparison to a predicate device to establish substantial equivalence.

However, this document does not contain information about acceptance criteria for device performance, nor does it describe a study that proves the device meets such criteria in the way typically expected for an AI/ML medical device.

Here's why and what information is present:

• Type of Device: The device described is a physical medical device (neurosurgical sponges), not a software or AI/ML algorithm. Therefore, the typical "acceptance criteria" and "performance study" inquiries relevant to AI/ML (like sensitivity, specificity, AUC, etc., and studies involving human reader performance or standalone algorithm performance) are not applicable in this context.
• Regulatory Pathway: This is a 510(k) submission, which focuses on demonstrating substantial equivalence to a legally marketed predicate device. The primary evidence presented is that the modified device has the "same indications for use and intended use," "same principle of operation," "same basic design," "equivalent materials," "same shelf life," and "packaged and sterilized using the same materials and processes."

Given this, I cannot fulfill most of your request as the information is not present in the provided text. I will address the points that can be inferred or directly stated from the document, acknowledging where information is missing due to the nature of the device and submission.

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

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

• Test Set Sample Size: Not applicable/not specified for the type of device. The biocompatibility tests would have involved specific animal models or in-vitro cell cultures, but these details are not provided. Peel testing would involve a sample of the sponges.
• Data Provenance: The biocompatibility studies were conducted in compliance with U.S. Food and Drug Administration Good Laboratory Practice (GLP) regulations, implying the testing was performed in the US or under US GLP standards. Details on retrospective/prospective are not applicable for material testing.

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

• Not applicable. This device is a physical sponge, not an AI/ML algorithm requiring expert opinion for ground truth. Biocompatibility and mechanical testing do not involve expert consensus on medical images or diagnoses.

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

• Not applicable. This refers to adjudication of ground truth for AI/ML performance studies, which is not relevant here.

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. This is a physical medical device, not an AI/ML algorithm. An MRMC study is not relevant.

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

• No. This is a physical medical device, not an AI/ML algorithm. A "standalone performance" study in the context of AI is not relevant.

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

• The "ground truth" for the biocompatibility testing would be the established biological responses to the materials (e.g., absence of cytotoxicity, irritation, sensitization) as defined by ISO 10993 standards.
• For the peel testing, the "ground truth" would be the measured force required to delaminate the layers.

8. The sample size for the training set

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

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

• Not applicable. There is no AI/ML algorithm involved, so there is no training set or ground truth for one.

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The device is a neurosurgical pad used during surgery to protect nervous tissue, absorb fluids, or stop bleeding.

The device is a non-adherent, strung, x-ray detectable surgical sponge that is sterile and disposable. The Delicot product line is made from lyocell, a manmade fiber derived from cellulose, better known under the brand name of Tencel - a type of rayon; it is supplied in various lengths and widths and has been marketed since 1990. The Delicot product line is one of three rayon-based sponges. The Delicot sponges are manufactured using Dupont Style 8623 consisting of 100% lyocell. Dupont has discontinued the manufacture of Style 8623. Dupont Style 8471 consisting of 58% polyester and 42% lyocell is our proposed replacement.

The provided text is a 510(k) summary for a medical device (Delicot Neurosurgical Sponge) seeking substantial equivalence to a predicate device. It does not describe a study proving the device meets specific acceptance criteria in the way a diagnostic AI device or a device with measurable performance metrics would. Instead, the submission focuses on demonstrating equivalence through material and process changes.

Therefore, many of the requested categories are not applicable to this type of submission.

Here's an analysis based on the provided text:

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

The core "acceptance criteria" in this 510(k) submission is to demonstrate substantial equivalence to a previously cleared predicate device. The study to prove this involves comparing the modified device (using a new material) to the predicate device across various aspects.

The specific "acceptance criteria" are implied by the points of comparison for substantial equivalence:

• Same indications for use and intended use.
• Same principle of operation.
• Same basic design.
• Equivalent materials.
• Same shelf life.
• Packaged and sterilized using the same materials and processes.

The study conducted to prove this focused on Biocompatibility Testing and Comparability Testing.

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: The document does not specify the sample size for the biocompatibility testing or the comparability testing.
• Data Provenance: Not explicitly stated, but typically, such testing is conducted in a laboratory setting, either internally or at a contract research organization. The biocompatibility testing was conducted "in compliance with U.S. Food and Drug Administration Good Laboratory Practice (GLP) regulations set forth in 21 CFR Part 58." This implies a systematic, controlled study. It is prospective for the device under review.

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

• Not applicable. This is not a study involving human interpretation of data where "ground truth" would be established by experts (e.g., radiologists reading images). Biocompatibility and comparability testing relies on objective laboratory assays and measurements.

4. Adjudication Method for the Test Set:

• Not applicable. There is no human interpretation or adjudication described for these materials and biocompatibility tests.

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 a submission for a physical medical device (surgical sponge), not an AI/diagnostic software device.

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

• Not applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used:

• Biocompatibility: The "ground truth" is defined by established international standards (ISO-10993) and regulatory guidelines (FDA's Blue Book Guidance G95-1) for evaluating biological response and toxicity. The test results (e.g., cell viability in cytotoxicity assays) are compared against these predetermined thresholds for what constitutes a safe response.
• Comparability: The "ground truth" for evaluating the "equivalence" of the new material for mechanical or functional properties (which are not detailed in this summary but would be part of a comparability study) would be the performance characteristics of the predicate device. The new device's performance would need to fall within an acceptable range of the predicate's performance.

8. The Sample Size for the Training Set:

• Not applicable. This is not a machine learning or AI device that requires a training set.

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

• Not applicable. This is not a machine learning or AI device.

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The neurological sponge is a cotton or rayon pattie used to keep exposed tissue from drying out during surgery. It is used to absorb excess fluids and to protect the tissue from trauma during surgery. It is also used to assist in the gentle suction of fluids.

Neurosurgical Paddies are used to keep exposed tissue from drying out or to absorb excess fluids and to protect the tissue from trauma during surgery. They are manufactured from either cotton or viscose fibers cut into rectangular pads of various sizes with a suture string attached for ease in count verification and with an x-ray detectable marker sewn to it as an extra precaution. The paddies are normally packaged 10 per count card of a single size and may be sterilized for end use or sold non sterile for kit packers. They are single use items that can be ETO sterilized twice or E-beam sterilized once.
HE, Inc.'s product will be made from cotton and/or or rayon in sizes and shapes similar to the predicate devices as they have been since 2005 under a 510(k) license. The most commonly used sizes are ½' x ½', ½' x 1", ½" x 3", 1" x 1" and 1" x 3".

The provided document is a 510(k) summary for a medical device called "Neuro Patties and/or Neurosponges" by HE, Inc. This submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a de novo study with acceptance criteria and performance data in the typical AI/CADe sense. Therefore, many of the requested elements (like "reported device performance," "sample sizes," "number of experts," "adjudication method," "MRMC study," "stand-alone study," "ground truth type," and "training set size") are not applicable to this type of regulatory submission.

The document primarily states that the device is substantially equivalent to a legally marketed predicate device (McNeil Healthcare, Inc. under K935883). Substantial equivalence means that the new device has the same intended use and the same technological characteristics as the predicate, or if it has different technological characteristics, the differences do not raise different questions of safety and effectiveness and the device is as safe and effective as the predicate.

Here's a breakdown of the available information in relation to your request:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria:
The "acceptance criteria" in this context is the FDA's determination that the device is substantially equivalent to a predicate device and therefore can be marketed. There are no specific quantitative performance metrics like sensitivity, specificity, or AUC mentioned. Instead, the acceptance is based on demonstrating:

• Same intended use.
• Identical technological characteristics (materials, manufacturing process, design) OR
• If technological characteristics differ, these differences do not raise new safety or effectiveness concerns, and the device is as safe and effective as the predicate.

Reported Device Performance:
The document does not provide quantitative "performance" data in terms of accuracy, precision, etc., for the HE, Inc. device. Its performance is implicitly deemed acceptable because it is identical to the predicate device in terms of materials, intended use, and manufacturing process.

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

• Not Applicable. This is a substantial equivalence submission based on direct comparison to a predicate device's existing regulatory approval, not a performance study involving a test set of data. The "test" is the comparison of device characteristics against those of the predicate.
• The data provenance mentioned relates to the predicate device's prior approval (K935883 from McNeil Healthcare, Inc.) and the history of HE, Inc. manufacturing the same product under license since 2005.

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

• Not Applicable. There was no "test set" or "ground truth" establishment in the context of image analysis or diagnostic performance for this type of device (neurosurgical paddies). The "ground truth" for the regulatory approval is that the predicate device was already approved as safe and effective.

4. Adjudication Method for the Test Set

• Not Applicable. No test set or expert adjudication was performed as part of this substantial equivalence submission.

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

• No. An MRMC study is not relevant for this type of device (neurosurgical paddies). This device is a surgical aid, not a diagnostic imaging or AI tool.

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

• Not Applicable. This device is a physical medical product, not an algorithm, and does not have a "standalone" performance apart from its physical use in surgery.

7. The Type of Ground Truth Used

• The "ground truth" for this submission is that the predicate device (McNeil Healthcare, Inc.'s Neurological Sponges under K935883) was previously determined by the FDA to be safe and effective. The argument of the 510(k) is that the HE, Inc. device is identical or sufficiently similar to this already-approved device.

8. The Sample Size for the Training Set

• Not Applicable. This submission does not involve an AI algorithm with a training set.

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

• Not Applicable. There is no training set for an AI algorithm in this context.

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Aesculap's Neuro Patties are intended for use during surgery to protect nervous tissue, absorb fluids, or stop bleeding during neurological and other general procedures.

Aesculap's Neuro Patties are rectanqular fluid absorption pads for use during neurological and/or general procedures. The devices are available in a variety of dimensions and sizes. The neuro patties are manufactured from either a cotton or viscose fibers. All patties have a suture string attached for ease in count verification, they are also available with x-ray detectable markers if desired. The patties are packaged 10 per card in either single size sets or in procedure (indication) sets with a variety of sizes. These devices are provided sterile or non-sterile (for kit packager), single use only, and should not be resterilized.

The provided document K062406 describes a 510(k) premarket notification for "Aesculap Neuro Patties" (Neurosorb Premium). This device is a neurosurgical paddie, and the submission primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting extensive performance studies against specific acceptance criteria.

Therefore, many of the requested categories (e.g., acceptance criteria, detailed study results, sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for training) are not applicable or not explicitly detailed in this type of submission.

Here's an analysis based on the provided text, acknowledging the limitations for a 510(k) submission for a cottonoid paddie:

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

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

• Sample Size for Test Set: Not applicable or not specified. This submission is for establishing substantial equivalence for a Class II medical device (Neurosurgical paddie) based on comparison to a predicate device, rather than a clinical performance study with a test set.
• Data Provenance: Not applicable. Performance data from a clinical test set is not explicitly provided or referenced as the basis for this 510(k) clearance. The provenance of the predicate device (Aesculap Neuro Patties K031008) is that it was legally marketed.

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

• Not applicable. No clinical test set requiring expert ground truth establishment is described in this submission.

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

• Not applicable. No clinical test set requiring adjudication is described.

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

• Not applicable. This device is a physical medical device (neurosurgical paddie), not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study and AI performance improvement are not relevant.

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

• Not applicable. This device is a physical medical device, not an algorithm.

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

• Not applicable. For this type of 510(k) submission, the "ground truth" is primarily based on the equivalence to the legally marketed predicate device and compliance with general controls and recognized safety/performance attributes for such devices (e.g., material biocompatibility, sterility, absorption capacity, which would have been established during the development and clearance of the predicate).
  • The "study" that proves the device meets (implicit) acceptance criteria is the comparison to the predicate device. The claim is that the "Neurosorb Premium Pattie will be offered in similar in shapes and sized as the predicate devices. The Neurosorb Premium Paddie is manufactured from viscose, which is the same material as the existing predicate device."

8. The sample size for the training set

• Not applicable. No training set is described for this device.

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

• Not applicable. No training set or associated ground truth establishment is described.

Summary of the "Study" for this K062406 Submission:

The provided document describes a substantial equivalence claim rather than a "study" in the typical sense of a clinical trial or performance evaluation. The "study" that proves the device meets the (implied) acceptance criteria is the comparison to the predicate device, Aesculap Neuro Patties (K031008).

The basis for this substantial equivalence is stated as:

• The material (viscose) is the same as the predicate.
• The shapes and sizes will be similar to the predicate.
• The indications for use are identical to the predicate: "Aesculap's Neuro Patties are intended for use during surgery to protect nervous tissue, absorb fluids, or stop bleeding during neurological and other general procedures."

Therefore, the "acceptance criteria" are implicitly met by demonstrating that the new device shares the fundamental technological characteristics and indications for use with a previously cleared device, implying similar safety and effectiveness. No new clinical performance or efficacy studies are detailed in this 510(k) summary because the device is a simple, well-understood product type with a clear predicate.

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Aesculap's Neuro Patties are intended for use during surgery to protect nervous tissue, absorb fluids, or stop bleeding during neurological and other general procedures.

Aesculap's Neuro Patties are rectangular fluid absorption pads for use during neurological and/or general procedures. The devices are available in a variety of dimensions, with widths from 4mm to 70mm and lengths from 6mm to 150mm. The material used for the patties is natural woven cotton fiber, this material is available in either a tight weave (neurosorb 4 or 6) or a more open gauze-like weave (neurosorb 75). The neurosorb 4 material consists of 4 layers while neurosorb 6 is constructed with 6 layers, the layers provide different levels of absorbency for surgeon preference. All pattles have a suture string attached for ease in count verification, they are also available with x-ray detectable markers if desired. The patties are packaged 10 per card in either single size sets or in procedure (indication) sets with a variety of sizes. These devices are for single use only and should not be resterilized.

The provided text is a 510(k) Premarket Notification for the Aesculap Neuro Patties, a medical device. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a study.

Therefore, the input does not contain the information needed to fill out all the requested sections of your query. This device is a cottonoid pattie, which is a low-risk device where performance is typically assessed by material properties and comparison to existing similar devices, not through a clinical trial with performance metrics like sensitivity, specificity, etc.

Here's a breakdown of what can be extracted or inferred from the provided text, and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: Not explicitly stated as quantitative performance metrics. The implicit "acceptance criteria" here is substantial equivalence to the predicate devices.
• Reported Device Performance: No quantitative performance metrics (like sensitivity, specificity, F1-score, etc.) are reported. The document describes the device's physical characteristics and 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 applicable. This document describes a medical device for surgical use, not an AI/software device that undergoes testing on a "test set" of data in the typical sense. There is no mention of a test set, data provenance, or a study that uses such a set.

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

• Not applicable. No test set or ground truth in the context of AI/ML evaluation is mentioned.

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

• Not applicable. No test set or related adjudication process is mentioned.

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

• No. This is a physical medical device (cottonoid patties), not an AI-assisted diagnostic or therapeutic tool. Therefore, an MRMC study is irrelevant and not mentioned.

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

• Not applicable. This is a physical medical device, not an algorithm.

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

• Not applicable. There is no "ground truth" as a reference standard for performance evaluation in the context of this type of device submission. The assessment is based on material properties, manufacturing controls, and comparison to legally marketed predicate devices.

8. The sample size for the training set:

• Not applicable. No training set is mentioned as this is not an AI/ML device.

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

• Not applicable. No training set or ground truth for it is mentioned.

In summary: The provided 510(k) document is for a Class II physical medical device (Aesculap Neuro Patties) and focuses on demonstrating substantial equivalence to existing predicate devices. It does not contain information about acceptance criteria or studies in the context of AI/ML or diagnostic performance (e.g., sensitivity, specificity, test sets, ground truth establishment, MRMC studies) because such evaluations are not typically required or relevant for this type of device.

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To be used in surgery to protect nervous tissue, absorb fluids, or stop bleeding.

Not Found

The provided text is a 510(k) clearance letter from the FDA for the "Traatek Cottonoid Patties." This document describes the regulatory approval of a medical device, specifically traditional cottonoid patties, based on its "substantial equivalence" to legally marketed predicate devices.

Critical Note: The information provided is for a traditional, physical medical device (cottonoid patties) and does not contain any details about an AI/ML-based device or a study proving its performance against specific acceptance criteria in the manner requested by the prompt. The prompt's questions are tailored for AI/ML device evaluations (e.g., sample sizes for training/test sets, ground truth establishment, expert adjudication, MRMC studies, standalone performance).

Therefore, I cannot provide the requested information from the given text. The FDA letter is a regulatory approval for a conventional medical product, not an AI/ML diagnostic or therapeutic system.

To answer your prompt, I would need a regulatory document or scientific publication detailing the development and validation of an AI/ML device, including performance metrics, study design, and ground truth methodologies.

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Intended for neurosurgical procedures to protect tissue, absorb fluids and stop bleeding. They are Supplied to the user in sterile packages. These patties are X-ray detectable and are provided in a variety of sizes necessary to meet clinical needs.

Not Found

The provided document is a 510(k) summary for a medical device (Norapad Cottonoid) and does not contain information regarding an AI/ML study. It is a premarket notification for a traditional medical device, comparing it to a predicate device for substantial equivalence, focusing on its intended use, materials, and manufacturing.

Therefore, I cannot provide the requested information about acceptance criteria, device performance, study details (sample size, data provenance, experts, adjudication, MRMC, standalone), or ground truth, as these concepts are not applicable to the content of this 510(k) submission.

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This device is intended to be used by trained physicians during neurosurgical procedures to protect neural tissues from drying, abrasion, or contamination and to absorb fluids.

The device is a non-adherent, strung, x-ray detectable surgical sponge that is sterile and disposable.

This document is a 510(k) summary for a neurological surgical sponge, and it explicitly states that "Performance evaluations (comparisons with the predicate) were not conducted as there are no significant technological differences between the devices."

Therefore, a study demonstrating that the device meets specific acceptance criteria, as requested in the prompt, was not performed, nor was it required for this submission. The basis for clearance is substantial equivalence to a legally marketed predicate device (K904519), and since no significant technological differences were identified, performance testing was deemed unnecessary by the manufacturer for this submission.

As a result, I cannot populate the table or answer the subsequent questions regarding acceptance criteria, study details, sample sizes, ground truth, or expert involvement, as such information is not present in the provided text.

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