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The Medline General Surgery Tray contains a single-use sterile surgical drape intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination. The drape is packaged and sterilized with disposable devices intended for professional use/used by licensed physicians in preparing the operating environment for, and performing procedures and surgeries. The intended products assembled in these kits will not be changed from the manufacturer's original intended use.

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I am sorry, but the provided text from the FDA 510(k) clearance letter for the "Medline General Surgery Tray" does not contain information about acceptance criteria or a study proving the device meets specific performance criteria.

The 510(k) letter is a regulatory document indicating that the FDA has reviewed the premarket notification and determined the device is substantially equivalent to legally marketed predicate devices. It focuses on regulatory requirements, classification, and general controls, rather than detailed performance study results or acceptance criteria.

The "Indications for Use" section describes how the device is intended to be used (as a single-use sterile surgical drape to isolate a surgical site) but does not provide details of any studies or performance metrics.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes, data provenance, number of experts, adjudication methods for test sets.
3. Information on MRMC studies or human reader improvement.
4. Stand-alone algorithm performance.
5. Type of ground truth used.
6. Sample size for the training set or how ground truth was established for the training set.

This type of information is typically found in the full 510(k) submission, not in the public clearance letter.

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The Medline Cardiovascular Procedure Kit contains a single-use sterile surgical drape intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination. The drape is packaged and sterilized with disposable devices intended for professional use/used by licensed physicians in preparing the operating environment for, and performing cardiovascular procedures and surgeries. The intended use of the medical products assembled in these kits will not be changed from the manufacturer's original intended use.

The Medline Cardiovascular Procedure Kit is customized to meet requirements of the hospitals and health care professionals utilizing them. The kit is provided sterile, single-use and includes a range of components dependent upon the specific procedure. These kits are assembled for customer convenience using Medline and other manufacturer's currently manufactured/marketed components. Customers specify the kit contents, quantity, and placement of individual components in the kit. A component listing is provided within this submission, which includes the name and regulatory status of components that can be selected for placement in various configurations of the final Medline Cardiovascular Kits. The BOM provides the corresponding FDA product codes, and reference to respective marketing clearances (as applicable). These included components are standard for cardiovascular procedures.

The intended use of the products assembled in the final Medline Cardiovascular Procedure Kit will not be changed. These components are all legally marketed drug products, and/or medical devices that are either: (1) pre-amendment devices; (2) 510(k)-cleared devices; or (3) 510(k) exempt devices. Commodity products, not regulated by FDA, are additionally included in the proposed kit. The customer may also specify a certain brand of similar items or minor variations of items. If additional components and/or manufacturers must be added to this list, we certify the regulatory compliance of the added components and maintain the information in our internal Device Master Record.

This document is a 510(k) Premarket Notification for a Medline Cardiovascular Procedure Kit. It is a regulatory submission to the FDA, and as such, it does not contain a study that proves the device meets acceptance criteria in the way described in the request (e.g., performance metrics, sample sizes for test sets, expert adjudication methods).

Instead, this submission is built on the principle of Substantial Equivalence (SE) to a legally marketed predicate device. The core argument is that the new device has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness compared to the predicate.

Here's a breakdown based on your request, explicitly stating when the information is not present in the document:

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

   • Not applicable in the provided document for this type of device. This document is for a "convenience kit" which is essentially a collection of existing, already-cleared medical devices (and some non-regulated items) bundled together for convenience. The performance of the individual components is assumed to be established by their original clearances or regulatory status (e.g., pre-amendment devices).
   • The "acceptance criteria" for a 510(k) for a convenience kit revolve around demonstrating that the kit itself does not alter the intended use or safety/effectiveness of its components, and that the chosen sterilization method is appropriate.

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

   • Not applicable. No test set with patient data (e.g., images for AI) was used or described. The "testing" primarily refers to non-clinical evaluations related to biocompatibility and sterilization of the kit assembly.

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. No external experts were used to establish ground truth in the context of device performance testing in this submission.

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

   • Not applicable. No test set with adjudication was performed.

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 surgical procedure kit, not an AI-powered diagnostic or assistive device that would involve human readers or AI assistance.

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

   • Not applicable. This is not an algorithm-based or AI device.

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

   • Not applicable in the context of performance testing. The "ground truth" for this submission concerns the regulatory status and intended use of the individual components within the kit, and the validation of the sterilization process.

8. The sample size for the training set

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

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

   • Not applicable.

Information that is present in the document relevant to a regulatory acceptance:

• Predicate Device: K962826 - Medline Radiology-Diagnostic Kits. This is the primary "proof" for substantial equivalence.
• Non-Clinical Testing: The safety and performance evaluation was conducted based on a risk assessment and evaluated in accordance with applicable recognized standards and FDA guidance documents. These include:
  • ISO 10993-1 Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a Risk Management Process
  • AAMI/ANSI/ISO 10993-7, Biological Evaluation of Medical Devices Part 7: Ethylene Oxide Sterilization Residuals.
  • FDA's Convenience Kits, Interim Regulatory Guidance: 20 May 1997
  • FDA's Sterilized Convenience Kits for Clinical and Surgical Use: 7 January 2002
• Sterilization: The kit is terminally sterilized by ethylene oxide (EO) to deliver a minimum sterility assurance level of 10-6. Medline ensures sterility of components and no adverse impact from sterilization on functionality.
• Components: The device consists of legally marketed drug products and/or medical devices that are either pre-amendment, 510(k)-cleared, or 510(k) exempt devices, along with commodity products not regulated by FDA. The intended use of these products is not changed.

In summary, this document is a regulatory submission for a convenience kit, not a performance study for a novel diagnostic or therapeutic device. The "acceptance criteria" are interpreted by the FDA as meeting the requirements for Substantial Equivalence to the predicate device, primarily through demonstrating similar intended use, technological characteristics, and compliance with relevant non-clinical and sterilization standards.

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The D.I.R.R.A. surgical drape device kit is composed of natural or synthetic materials and intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial or other contamination.

The DIRRA surgical drape device kit is composed of natural or synthetic materials and intended to be used as protective patient covering, such as to isolate a site of surgical incision from microbial or other contamination. The DIRRA surgical drape device kit is to be used by medical and dental professionals when performing surgical procedures.

The DIRRA surqical drape device kit consists of the following components: Gown w/ paper towel (2), Mayo stand cover (1), Sterile sheet (1), Patient drape (1), Transparent drape (1), Adhesive strip (4), Tube holder (1), Cord drape (2), Suction tubing w/tip (1), Flat gauze (20), Round gauze sponge (5), Plastic tray (1), Transparent adhesive film (3), Connector for suction tubing (1), Kit wrapping drape (1).

All the components are wrapped in the DIRRA surgical drape device kit wrapping drape which is closed with a label.

The final measurement of the kit (not enveloped) is approximately cm.30x30x10. The kit is then enveloped in sequence and in accordance with the instructions for use. The pack is then inserted in the Sterilization plastic/tyvek pouch and the pouch is sealed. 2 Kits are put into one cardboard box along with instructions for use,. The box is then closed and sterilized by Bioster. A sterilization batch number is applied on the box after the sterilization process has been completed.

The provided document (K041080) is a 510(k) summary for a Surgical Drape Kit. It is a premarket notification for a medical device seeking clearance from the FDA by demonstrating substantial equivalence to a legally marketed predicate device.

For such a device (Class II, Surgical Drape and Drape Accessories, Product Code: LRO), direct performance studies to establish detailed acceptance criteria and prove performance as one would for a diagnostic or AI-driven device are typically not required in the same manner. The basis of clearance is substantial equivalence to a predicate device, meaning it has the same intended use and similar technological characteristics, and any differences do not affect safety or effectiveness.

Therefore, the detailed information requested regarding acceptance criteria, study design (sample sizes, experts, adjudication, MRMC, standalone performance), and ground truth establishment is not applicable to this type of 510(k) submission for a surgical drape kit.

Here's how to address each point based on the information provided in this 510(k) summary:

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

The document explicitly states: "The determination of substantial equivalence is not based on an assessment of performance data." (Section: Comparison to predicate devices). Therefore, there are no specific performance acceptance criteria or reported device performance metrics in the format typically seen for a diagnostic device validation. The "acceptance criteria" here relate to demonstrating substantial equivalence to the predicate device in terms of intended use, technological characteristics (materials, sterility, dimensions), and showing that any differences do not raise new questions of safety or effectiveness.

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. No performance data or test set was used for this 510(k) clearance, as explicitly stated that the determination of substantial equivalence is not based on an assessment of performance data.

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

Not applicable. No test set or ground truth was established for this submission.

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

Not applicable. No test set requiring adjudication was used.

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 surgical drape kit, not an AI-driven diagnostic or assistive device that would involve human readers or AI assistance.

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

Not applicable. This device is a surgical drape kit, not an algorithm or AI system.

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

Not applicable. No ground truth was established as performance data was not used for the determination of substantial equivalence. The "ground truth" for this submission would essentially be the predicate device's established safety and effectiveness, to which the new device is compared.

8. The sample size for the training set

Not applicable. This device is a physical product (surgical drape kit), not a machine learning model that requires a training set.

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

Not applicable. As there is no training set for a physical surgical drape kit, no ground truth needed to be established for it.

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The Quick-Tap® Paracentesis Kit, Tray and Needle are indicated to relieve pressure by draining fluid from the peritoneal space. The fluid may be undergo diagnostic testing to assess for chemistries, infection or abnormal cells.

Abdominal paracentesis is a procedure used to remove bodily fluid from the peritoneal cavity. Fluid can be the result of liver disease, congestive heart failure or other disease that result in "ascites" fluid. Fluid may also be in the form of blood from perforated organs due to trauma. The fluid is susceptible to infection.

Abdominal paracentesis provides therapeutic relief to patients who experience bloating and difficult breathing. The procedure serves a diagnostic purpose, as well. Typically, fluid specimens are sent to a laboratory for microbiological, chemical and histological analysis.

Abdominal paracentesis can be performed at bedside or in a treatment center. The patient is prepped using sterile technique and local anesthetic. The sitting position is preferred so that gravity can assist. If preferred, a skin nick is performed with a scalpel and a large bore outer cannula is introduced into the peritoneal cavity midline between the umbilicus and pubis. A syringe can be used to collect the first sample of fluid from the patient confirming a suitable puncture site. The inner needle is withdrawn and disposed of leaving the outer cannula in place. Specimen tubes stand ready for specimen collection. The large majority of fluid is drained into bags or large containers and disposed of. There are no guidelines or standard of care that define the amount or rate of ascites fluid evacuation other than to monitor for signs of hypovolemic shock. One to two liters can be evacuated at one session. After paracentesis the cannula is removed and an adhesive bandage is placed over the puncture site. The patient is then monitored briefly for signs of distress such as persistent bleeding from the puncture site, faintness, anxiety, abnormal pulse, temperature etc.

Complications are rare but can include hemorrhage, perforation of abdominal organs, wound infection and hypovolemic shock.

There are a variety of disposable instruments used for paracentesis. These include generic angio-introducer catheters and specific needle/cannula combinations for paracentesis. Figure A-I illustrates the Ballard, Caldwell® Paracentesis Needle/Cannula.

Our proposed paracentesis needles (and thus trays and kits) are substantially equivalent in design, composition, technology and function to our present paracentesis trays (see predicate devices).

The provided text describes the 510(k) Premarket Notification Summary for the Quick-Tap® Paracentesis Kit, Tray and Needle. It focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study that proves the device meets specific acceptance criteria in the way a clinical trial for a novel drug or a new AI diagnostic would.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a quantitative, measurable sense for a new device's performance. Instead, it asserts substantial equivalence to predicate devices based on design, composition, technology, function, and a limited set of non-clinical tests.

Note: The acceptance criteria are largely implied by the substantial equivalence framework, meaning the device should perform similarly to its predicates regarding safety and efficacy for the stated intended use. Specific quantitative thresholds for tensile strength, flow rate, or visual inspection are not provided in this summary.

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

The document describes non-clinical data through direct performance testing of the device components (needles), rather than a "test set" of patient data.

• Sample Size: Not specified for the Tensile test, Flow rate, or Visual inspection. It's common for such tests to use a statistically representative sample size, but the exact number isn't mentioned in this summary.
• Data Provenance: Non-clinical (laboratory testing of the device itself), not human or animal data.

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

N/A. This is a medical device for a procedure, and its safety and efficacy are evaluated through functional and material testing, and comparison to legally marketed predicate devices, not through a diagnostic assessment requiring expert ground truth on a test set.

4. Adjudication Method for the Test Set

N/A. As there's no clinical "test set" requiring expert ground truth or diagnostic assessment, no adjudication method is applicable.

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

No. This document describes a 510(k) submission for a medical device (paracentesis kit, tray, and needle), not an AI-assisted diagnostic tool. Therefore, an MRMC comparative effectiveness study regarding human readers with or without AI assistance is not applicable and was not performed.

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

N/A. This is a physical medical device. The concept of an "algorithm only" or "standalone" performance without human interaction does not apply.

7. The Type of Ground Truth Used

The "ground truth" here is the functional integrity and material properties of the device components, relative to established engineering standards and the performance of predicate devices. This is established through:

• Engineering/Material Testing: Tensile strength, flow rate, visual inspection.
• Comparison to Predicate Devices: Demonstrating similar design, composition, technology, and function to previously cleared devices.

8. The Sample Size for the Training Set

N/A. There is no machine learning "training set" involved as this is a physical medical device.

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

N/A. Same as above, no machine learning training set applies.

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The AMSINO TRACHEOSTOMY CARE TRAY is intended for use in the cleaning and maintenance of Tracheostomy sites.

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The provided text is a 510(k) clearance letter from the FDA for a medical device (Amsino Tracheostomy Care Tray). This type of document is a regulatory approval, not a scientific study describing the performance of a device against acceptance criteria. It primarily focuses on establishing "substantial equivalence" to a legally marketed predicate device rather than detailing specific performance metrics from a technical study.

Therefore, the input document does not contain the information requested in your prompt regarding acceptance criteria, study details, sample sizes, ground truth establishment, or expert involvement. The letter simply states that the device is "substantially equivalent" to predicate devices for its intended use.

To answer your request, I would need a different type of document, such as a summary of safety and effectiveness data, a design verification report, or a clinical study report that outlines the device's technical specifications, performance goals, and the results of tests conducted to meet those goals.

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THE INTENDED USE OF THE WORLDWIDE MEDICAL MODELOW FOR BONE MARROG OF THE BONE MARROW For PATHOLOGICAL IS TO OBTAIN A SAMPLE BIDPSY TRAY EXAMINATION IN THE DIALNOSIS + TREATIMENT OF VARIOUS DISEASES

Bone Marrow Biopsy Procedure Tray

This FDA 510(k) letter for the "Worldwide Medical Technologies Bone Marrow Biopsy Procedure Tray" does not contain the detailed information necessary to describe acceptance criteria or a study proving the device meets specific performance metrics.

Here's why and what information is missing:

• Substantial Equivalence (SE) vs. Performance Data: This letter grants "substantial equivalence." This means the FDA has determined the device is as safe and effective as a legally marketed predicate device, not that it has passed specific, quantitative performance acceptance criteria in a study. A 510(k) submission typically relies heavily on comparison to a predicate device, rather than extensive new clinical or performance studies demonstrating novel performance claims.
• Device Type: A bone marrow biopsy tray is a collection of instruments and materials used to obtain a sample. The performance of the tray itself isn't typically measured by statistical metrics like sensitivity or specificity, but rather by its ability to facilitate the procedure (e.g., sterility, strength of components, ease of use, ability to obtain an adequate sample). The diagnostic performance (e.g., accuracy of diagnosis) is related to the subsequent pathological examination of the sample, not the tray itself.

Therefore, I cannot provide the requested information because it is not present in the provided document. The letter focuses on regulatory approval based on substantial equivalence, not on a detailed performance study with acceptance criteria.

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Opportunity Inc.'s Bone Marrow and Aspiration Tray is intended for use by a licensed professional or other medical personnel as deemed appropriate by the using facility. The intended use of the medical products assembled in these kits will not change from the manufacturers original intended use. This kit is used for performing or assisting in performing bone marrow surgical procedures.

Bone Marrow Biopsy and Aspiration Tray

I am sorry, but the provided text does not contain information about acceptance criteria, device performance, validation studies, sample sizes, expert qualifications, or ground truth establishment. The document is an FDA 510(k) clearance letter for a "Bone Marrow Biopsy and Aspiration Tray," which states that the device is substantially equivalent to legally marketed predicate devices. It discusses regulatory matters, such as good manufacturing practices, labeling, and drug components within the kit, but it does not detail performance metrics or studies performed to prove the device meets specific acceptance criteria.

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Opportunity Inc.'s General Purpose Tray is intended for use by a licensed professional or other medical personnel as deemed appropriate by the using facility. The intended use of the medical products assembled in these kits will not change from the manufacturers original intended use. This kit is used for performing or assisting in performing general surgical procedures.

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The provided document is an FDA 510(k) clearance letter for a "General Purpose Tray" and does not contain information about the acceptance criteria, device performance, or study details as outlined in the request. The letter only states that the device is substantially equivalent to legally marketed predicate devices and addresses regulatory aspects such as labeling, drug components, and general controls.

Therefore, I cannot provide the requested information based on the given input.

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Presbyterian Linen Services Surgical Packs are intended to be used in various surgical procedures. The packs provide sterile gowns, drapes and towels to be used during procedures to protect both the surgical patient and the operating room personnel from transfer of microbial and other contamination. Surgical towels provide additional absorption of blood and body fluids when used to square off a surgical site, or may be used by operating room personnel for drying of hands after scrubbing.

Presbyterian Linen Services Surgical Packs are packs composed of reusable gowns, drapes, and toweling, the specifics of which are tailored to the customer's specifications for that procedure.

I'm sorry, but based on the provided document, I cannot generate the requested information about device acceptance criteria and a study proving those criteria.

Here's why:

• The document is a "Summary of Safety and Effectiveness" for a surgical procedure pack, which is a sterile medical device. It focuses on establishing substantial equivalence to previously cleared devices (K932522, K935199, K930700) based on material and construction similarities, rather than presenting a performance study with detailed acceptance criteria and results as typically found for diagnostic or interventional devices with quantitative performance metrics.
• The document describes reusable gowns, drapes, and toweling. These types of devices generally have different regulatory pathways and "performance" is often related to sterility, material integrity, and barrier properties, which are typically assessed through recognized standards and testing, not clinical studies with "test sets," "ground truth," or "expert readers" in the way described in your prompt.
• The request specifically asks for details relevant to diagnostic/AI-assisted devices, such as "reported device performance," "sample sizes," "data provenance," "number of experts," "adjudication method," "MRMC study," "standalone performance," and "type of ground truth" for a study proving the device meets acceptance criteria. These concepts are not applicable to the type of device and regulatory submission presented in the input.

Therefore, the provided document does not contain the information necessary to fulfill your request.

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