Search Results

Busse Extension Sets are intended to be used with a vascular access device for administrative and withdrawals of fluids.

Busse Extension Set consists of PVC tubing with or without connectors. The tubing accessories include; 3-way connectors, clamps, male and female luer lock, luer slip fitting, and valves. The Extension Set will be provided as sterile, single use only and will be packaged individually and in medical convenience kits. The Extension Sets will be available in a variety of lengths, starting from 6" to 36".

This document describes a 510(k) premarket notification for the "Busse Extension Set," which is an intravascular administration set. The provided text, however, focuses on demonstrating substantial equivalence to a predicate device rather than detailing acceptance criteria and the study proving direct performance against those criteria in the way one might expect for a novel AI/software device.

Instead, the document primarily lists standard tests performed on medical devices of this type to ensure safety and performance compared to existing, legally marketed devices. It does not contain information about an AI/software component, nor does it present the study design typical for evaluating an AI's diagnostic or predictive performance against specific metrics like sensitivity, specificity, or AUC, as would be common in the context of the requested information.

Therefore, many of the requested fields cannot be directly answered because the document describes a physical medical device (an extension set) and not an AI or software-based medical device.

Based on the provided text, here is the information that can be extracted, and where relevant, why other information is not present:

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

The document does not explicitly present "acceptance criteria" in a numerical or statistical format often seen for AI/software performance. Instead, it describes various tests and states that the materials and tests "met the testing requirements and were found to be acceptable for the 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)

This information is not provided in the document. The testing appears to be on physical samples of the device, not a "test set" of data in the AI/software context.

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

This information is not applicable and not provided. "Ground truth" in the traditional sense, as it relates to expert consensus for diagnostic tasks, is not relevant to the evaluation of a physical medical device like an extension set. The "ground truth" here would be objective physical measurements and chemical/biological assays.

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

This information is not applicable and not provided.

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

This information is not applicable and not provided. The device is a physical medical extension set, not an AI or software for diagnostic assistance.

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

This information is not applicable and not provided. The device is a physical medical extension set.

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

The document implies that the "ground truth" for the device's acceptable performance is based on established industry standards and regulatory requirements (e.g., ISO 10993-1 for biocompatibility, ISO 11135-1 for sterilization, ISO 11607-2 for packaging) as well as established physical and biological testing protocols (e.g., specific liquid leakage, pull tests, durometer tests, and various biocompatibility assays). The success of these tests (e.g., no leakage, non-hemolytic, apyrogenic, meeting specified strength) confirms the "ground truth" of the device's functional and safety characteristics.

8. The sample size for the training set

This information is not applicable and not provided. This document refers to the evaluation of a physical medical device, not a machine learning model.

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

This information is not applicable and not provided.

Ask a specific question about this device

The I-Style Bone Marrow Aspiration Needle with T-Handle is intended for aspiration of bone marrow.

The I-Style Bone Marrow Aspiration Needle with T-Handle consists of a 15G and 18G needle with a triple sharpened atraumatic tip stylet of corresponding size all made of AISI 304 Stainless steel. The needle has an ergonomic grip at whose base a Luer-Lock cone in fitted. The innovative element of the needle is a removable spacer, which indicates the depths the tip can reach. Using a depth stopper, easy adjustment of the needle length, making it easier to reach the tissue to be examined.

The provided document is a 510(k) summary for a medical device (I-Style Bone Marrow Aspiration Needle with T-Handle) seeking clearance for market, not a study report detailing performance against acceptance criteria with patient data. Therefore, many of the requested elements about clinical studies, sample sizes, expert ground truth, and comparative effectiveness (MRMC) cannot be found in this document.

However, I can extract information related to the device's technical characteristics and the types of verification and validation testing performed.

Here's the breakdown of what can be extracted and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Not provided. This document details engineering and biocompatibility testing, not a clinical study involving a "test set" of patient data.

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

• Not applicable/provided. The tests described are laboratory-based and do not involve human experts establishing ground truth for patient data.

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

• Not applicable/provided. No clinical test set.

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, an MRMC study was not done. This describes a medical device (needle), not an AI algorithm for diagnosis or interpretation that would involve human readers.

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

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

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

• For the biocompatibility tests: Likely validated laboratory standards for cytotoxicity and intracutaneous reactivity.
• For the performance tests: Likely engineering specifications and functional requirements for features like stylet fastening, insertion ease, handle capacity, spacer adjustability, Luer-Lock adequacy, and sample collection inspection. The "ground truth" would be whether the device performed as designed and met the pre-defined engineering and safety specifications.
• No clinical ground truth (like pathology or outcomes data) was used in the context of a patient-based study.

8. The sample size for the training set:

• Not applicable/provided. This document does not describe an AI/ML device with a "training set."

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

• Not applicable/provided. As above, no training set.

Summary based on the document:

This 510(k) summary focuses on demonstrating the substantial equivalence of the I-Style Bone Marrow Aspiration Needle with T-Handle to existing predicate devices. This is achieved through:

• Technological Characteristics Comparison: Showing the new device has similar characteristics to the predicate, with minor design changes (T-Handle vs. Quick Stylet locking handle).
• Biocompatibility Testing: Materials used were evaluated and found acceptable.
• Performance Testing: Several functional aspects of the needle were tested (e.g., stylet fastening, insertion ease, handle capacity, spacer manageability, Luer-Lock adequacy, sample inspection) and found acceptable against unstated internal requirements.

The document states that "All materials used... were evaluated through biological qualification safety tests" and "I-Style Bone Marrow Aspiration Needle with T-Handle has been tested for the following performance tests." It concludes that the materials "have met the testing requirements and were found to be acceptable for the intended use," leading to the overall conclusion of substantial equivalence.

Ask a specific question about this device

This Biopsy Instrument is used for drawing of osteomedullary substance or for explantation of bone marrow with a Snare-It Acquisition Cannula intended to contain the specimen during withdrawal from the needle's cannula.

The J-Style Bone Marrow Biopsy / Aspiration Needle with Snare-It Marrow Acquisition Cannula consists of a J-style Bone Marrow Biopsy / Aspiration Needle with cap, providing the physician with greater torque than similar instruments, an ABS Ergonomic grip handle, which increases accuracy and speeds biopsy operation. It comes in 3 sizes; 8G x 4", 11G X 4", and 13G x 4". A Stylet, consisting of a locking mechanism to secure position in Biopsy needle, as well as a stainless steel cannula with a trocar tip for easier penetration into bone tissue. The Snare-it Marrow Acquisition Cannula is designed to allow the tissue to remain intact during removal. This allows for accurate analysis. It also allows additional sample collection without having to re-insert needle into the patient. A stainless steel, sample extractor, allows for convenient sample removal from the cannula. And finally, an extractor Cap.

The provided text does not contain information about acceptance criteria for a device's performance, nor does it describe a study proving the device meets such criteria. Instead, it details a 510(k) premarket notification for a medical device (J-Style Bone Marrow Biopsy / Aspiration Needle with Snare-It Acquisition Cannula).

The document focuses on demonstrating substantial equivalence to a predicate device, as required for 510(k) clearance by the FDA. The "Summary of Testing" section (Page 1) mentions:

• Biological qualification safety tests: Specifically, "Cytotoxicity Test" and "Intracutaneous Reactivity Test" were performed on materials used in the device.
• Acceptance: "These materials have met the testing requirements and were found to be acceptable for the intended use."

This indicates that biocompatibility was evaluated, and the materials met the necessary safety standards for their intended use. However, these are general material safety tests, not performance-based acceptance criteria for the device itself (e.g., accuracy, success rate of bone marrow acquisition, torque resistance, etc.). The document explicitly states the "subject device has the same Technological Characteristics as a legally marketed predicate device," implying that performance is assumed to be equivalent rather than independently proven against new, quantitative acceptance criteria.

Therefore, I cannot provide a table of acceptance criteria or details about a study demonstrating performance in the way described in your request (e.g., sample size for test set, expert qualifications, MRMC study, etc.) because this information is not present in the provided text.

Ask a specific question about this device

The epidural catheter is intended for administration of local anesthetics into epidural space. Busse recommends the removal and/or replacement of the catheter every 72 hours.

The Epidural Catheter kit consists of clear tubing with a black radiopaque stripe, a Thread assist guide, a Connector Gasket, and a Tuohy Borst adapter catheter connection. All inserted in a Polvethylene bag. The catheter is marked at 5 cm from the tip with 1 cm increments up to 20 cm. The 10 cm mark is indicated by two marks, the 15 cm by three marks, and the 20 cm by four marks. The Catheter will be available 20 Gauge, with a nominal length of 36 inches. It will be available in open tip or closed tip with 3 eyes. As an extra safety feature, the tip of the catheter is incorporated with a marking to assure the completed catheter has been removed.

The provided text describes a 510(k) premarket notification for a medical device, the Busse Epidural Catheter Kit. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving that the device meets specific acceptance criteria through a clinical trial or a deep learning algorithm's performance study.

Therefore, the information typically requested in your prompt (e.g., acceptance criteria tables, sample sizes for test sets, expert-driven ground truth, MRMC studies, standalone algorithm performance) is not applicable or present in this 510(k) summary.

Here's why and what information is available:

• 510(k) Submissions are about Substantial Equivalence: The primary goal of a 510(k) is to show that a new device is as safe and effective as a legally marketed predicate device, not necessarily to prove it meets a set of predefined performance "acceptance criteria" in the way a novel AI algorithm might.
• Focus on Bench Testing and Biocompatibility: The "study" here consists of bench tests and biocompatibility evaluations, demonstrating that the device materials and physical performance are acceptable and comparable to the predicate.

Information provided in the text that is relevant to your request (though not directly "acceptance criteria" for an AI or clinical study):

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

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

• Sample Size: Not specified for the bench tests or biocompatibility tests. These are typically laboratory tests on manufactured units or material samples, not patient data.
• Data Provenance: Not applicable in the sense of patient data. The "data" comes from laboratory testing of the device materials and components.

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: "Ground truth" in the context of expert consensus on medical images or clinical outcomes is not relevant for this type of device submission. The "truth" is established by adherence to recognized testing standards for material biocompatibility and physical performance characteristics.

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

• Not Applicable: Adjudication methods are for resolving discrepancies in expert interpretations, which is not part of this submission. The tests performed have clear pass/fail criteria based on established laboratory protocols.

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, not done: This is a submission for a physical medical device (an epidural catheter kit), not an AI-powered diagnostic tool. MRMC studies are not relevant here.

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

• No, not done: This is a physical device, not an algorithm.

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

• Laboratory Standard Compliance: The "ground truth" or "reference standard" for this submission is compliance with established biocompatibility testing standards (e.g., ISO 10993 series, though not explicitly stated that exact standard, it's implied for such tests) and engineering performance specifications for devices of this type.

8. The sample size for the training set

• Not Applicable: There is no "training set" as this is not an AI/machine learning device.

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

• Not Applicable: There is no "training set."

Summary of the "Study" mentioned:

The "study" referenced in the 510(k) summary is a series of laboratory-based biocompatibility tests and performance tests conducted on the Busse Epidural Catheter and its materials. The purpose of these tests was to demonstrate that the device materials are safe for patient contact and that the device performs functionally as expected, showing substantial equivalence to the predicate device. The document explicitly states: "All materials used in the fabrication of the epidural catheter were evaluated through biological qualification safety tests" and "These materials have met the testing requirements and were found to be acceptable for the intended use."

Ask a specific question about this device

Busse Surgical Drape IV is intended to be used as a protective patient covering, such as to isolate a site of surgical incisions from microbial and other contamination. They are provided sterile using Ethylene Oxide.

Surgical drapes described in this submission are one piece, single use, designed to provide an absorbent sterile barrier & protection from microbial and other contamination. There are various sizes, with & without fenestration, and with & without adhesive strip/patch.

The provided document is a 510(k) premarket notification for a medical device, specifically Busse Surgical Drape IV. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving clinical effectiveness through extensive studies with detailed acceptance criteria and performance metrics typically associated with AI/software devices.

Therefore, many of the requested categories related to AI/software performance studies, such as sample sizes for test sets, number of experts, adjudication methods, MRMC studies, standalone performance, and training set details, are not applicable to this document. The document describes a comparison to a predicate device based on material characteristics and safety testing.

Here's an attempt to answer the questions based only on the provided text, indicating when information is not present or not applicable for this type of submission:

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

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

• Sample Size for Test Set: Not specified in the document. The testing refers to "All materials used in the fabrication," implying material-level tests, not a clinical test set with a specific number of patients/cases.
• Data Provenance: Not specified. The tests were performed on the materials of the device.
• Retrospective or Prospective: 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. Ground truth as typically understood for clinical performance studies (e.g., disease presence) is not established here. The "truth" is whether the materials meet specified safety standards. The document doesn't detail the personnel conducting these material tests.

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

• Not applicable. Adjudication methods are relevant for expert review of images or clinical data, which is not the nature of this submission.

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 physical medical device (surgical drape), not an AI/software device. No MRMC study was conducted.

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)

• The "ground truth" for this device's acceptance is based on adherence to established material safety standards for medical devices (biocompatibility, flammability, lint), which are typically defined by regulatory bodies (e.g., ISO) and demonstrated through standardized laboratory tests.

8. The sample size for the training set

• Not applicable. This is a physical medical device, not an AI/software device that requires a training set.

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

• Not applicable. See #8.

Ask a specific question about this device

The Busse Surgical Drape is intended to be used as a protective patient covering, such as to isolate a site of surgical incisions from microbial and other contamination. They are provided sterile using Ethylene Oxide. This is the same intended use as a previously cleared for the Busse Surgical Drape II, K083424.

The Laminated Non-Woven Surgical drapes described in this submission are one piece, single use, designed to provide an absorbent sterile barrier & protection from microbial and other contamination. There are various sizes, with & without fenestration, and with & without adhesive strip/patch.

The provided text describes a 510(k) submission for "Busse Surgical Drapes III." The primary focus of this document is to demonstrate substantial equivalence to a predicate device, "Busse Surgical Drapes II (K083424)," not to provide a detailed study proving the device meets new, objective performance criteria in the way AI/ML medical devices often do.

Therefore, many of the requested categories related to AI/ML device studies (such as sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth types) are not applicable to this 510(k) submission for a traditional medical device (surgical drapes).

However, I can extract the relevant information regarding acceptance criteria and the "study" that demonstrates compliance based on the document's content.

Here's a breakdown:

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)

• Sample Size: Not specified in the provided document. Biocompatibility tests typically use a small number of animal subjects or cell cultures, but the exact count is not given.
• Data Provenance: Not specified. The tests are standard biological qualification safety tests, generally performed in specialized labs. Whether these were conducted in the US or elsewhere is not stated. The data would be prospective for these specific tests on the device materials.

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 is a traditional medical device (surgical drape), not an AI/ML device requiring expert ground truth for image interpretation or diagnosis. The "ground truth" for the material tests would be the established safety thresholds and methodologies for biocompatibility, as defined by international standards (e.g., ISO 10993). The interpretation of these results is done by qualified toxicologists/biocompatibility specialists, but specific numbers and qualifications are not provided in this summary.

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

Not applicable. As this is not an AI/ML device involving human interpretation of results, there is no adjudication method in the context 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 is a traditional medical device; therefore, no MRMC study, human readers, or AI assistance is involved.

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

Not applicable. This is a traditional medical device; therefore, no algorithm or "standalone" performance is relevant.

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

The "ground truth" for the reported tests is established through pre-defined scientific methods and acceptance criteria for biocompatibility testing. These criteria are based on established toxicology and material science principles, typically referenced in standards like ISO 10993. The test results (e.g., cell viability, irritation response) are compared against these predetermined thresholds.

8. The sample size for the training set

Not applicable. This is a traditional medical device; there is no "training set" in the context of an AI/ML algorithm.

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

Not applicable. As there is no training set, this question is not relevant.

Ask a specific question about this device

The Busse Surgical Drape is intended for external use only and is used is as a protective patient covering, such as to isolate a site of surgical incisions from it a vacu is a a provided steries using ethylene oxide.

Surgical drapes are intended to provide protection from microbial and other contamination. There are various sizes, with & without fenestration, and with & without adhesive strip/patch.

The document describes a 510(k) premarket notification for the Busse Surgical Drape. The stated goal is to demonstrate substantial equivalence to a predicate device (3M Company, Drapes, K031287). The acceptance criteria and the study performed are focused on the safety and material compatibility of the new device.

There is no mention of an algorithm or AI in this document, as it pertains to a physical medical device (surgical drapes). Therefore, many of the requested points related to AI performance metrics (e.g., effect size of human readers with AI, standalone algorithm performance, training set details) are not applicable.

Here's an analysis of the provided information concerning acceptance criteria and the supporting study:

1. Table of Acceptance Criteria and Reported Device Performance

• Kligman Maximization Test
• Intracutaneous Injection Test
• Systemic Injection Test
• Rabbit Pyrogen Test |

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

The document specifies biocompatibility tests were performed on the materials used in the surgical drapes. Regarding "sample size used for the test set," this would refer to the number of samples of the material tested in each biological assay, or the number of animals used for the in vivo tests. However, the document does not explicitly state the number of samples or animals for these tests.

The data provenance is internal to Busse Hospital Disposables, as they commissioned or performed these tests. It is a prospective evaluation of their device materials. The country of origin of the data is not specified but is implicitly the United States given the FDA submission.

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

Not applicable in the context of biocompatibility testing for a physical device. Ground truth for these types of tests is established by standardized laboratory protocols and scientific interpretation of results (e.g., observation of reactions in animal models, or cell culture changes), not by expert consensus in the way medical image analysis or clinical diagnosis might be.

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

Not applicable. Biocompatibility tests have predefined endpoints and interpretation criteria, and do not typically involve an adjudication process by multiple experts for 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 is a medical device (surgical drape), not an AI/CAD system for interpretation by human readers.

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

Not applicable. This is a medical device (surgical drape), not an algorithm.

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

For biocompatibility testing, the "ground truth" is derived from standardized biological testing protocols and laboratory observations/measurements. For example:

• Kligman Maximization Test: Assesses skin sensitization. Ground truth would be the presence/absence and severity of allergic reactions in test subjects.
• Intracutaneous Injection Test: Assesses local tissue reaction. Ground truth would be the presence/absence and severity of erythema/edema.
• Systemic Injection Test: Assesses systemic toxicity. Ground truth would be observations of general toxicity signs/symptoms.
• Rabbit Pyrogen Test: Detects pyrogens. Ground truth would be the presence or absence of a fever response in rabbits.

These are objective, biologically defined endpoints.

8. The sample size for the training set

Not applicable. There is no training set mentioned, as this is not an AI/machine learning device.

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

Not applicable. There is no training set.

Ask a specific question about this device

specialty needles - Spinal Needle, Pencil Point Needle, and Epidural Needle - are intended for the transient delivery of anesthetics to provide regional anesthesia or to facilitate placement of an epidural catheter.

Anesthesia conduction needles consist of different styles. All the needles consist of a plastic or K-Resin hub connected to a stainless steel cannula. Some of the needles have stylets made of the same steel whereas others have stylets made of plastic. Some of the needles have wings, which can be attached to the hub for more stability depending on user procedure. The needles have been categorized as following: 1. Spinal Needles (Quincke) 2. Pencil Point Spinal Needle (Whitacre) 3. Epidural Needles (Tuohy & Hustead) The differences between the styles of needles are the tip of the needle, which is pencilpoint-tip (Whitacre), curved and sharp needle (Toulty) or sharp needle tin (Quincke)

The provided text describes a 510(k) premarket notification for "Specialty Needles" by Busse Hospital Disposables. This document primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove acceptance criteria in the context of device performance as one might expect for a diagnostic or AI-based medical device.

Therefore, many of the requested fields are not applicable or cannot be extracted from this type of regulatory submission. The submission strategy is to show the new device is as safe and effective as a device already on the market, not to establish new performance metrics through clinical trials.

Here's an attempt to populate the table and answer the questions based on the provided text, indicating where information is not available or not applicable for this type of submission.

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

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

• Sample Size for Test Set: Not specified. The document refers to "biological qualification safety tests" and "tests performed to prove the substantial equivalence," but does not provide numbers of devices or subjects tested.
• Data Provenance: Not specified. This would typically be internal laboratory testing results, not clinical data from a specific country.
• Retrospective or Prospective: Not applicable in this context. These are engineering and biocompatibility tests, not clinical studies.

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)

• Number of Experts: Not applicable. The "ground truth" for these types of tests is typically established by laboratory standards and established test methodologies, not expert consensus on interpretations.
• Qualifications of Experts: Not applicable.

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

• Adjudication method: Not applicable. This concept is relevant for studies involving human interpretation or clinical outcomes, not for material or mechanical performance 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

• MRMC study: No, this is not an AI-based device or a diagnostic imaging device. An MRMC study was not performed.
• Effect size: Not applicable.

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

• Standalone performance: Not applicable. This is a physical medical device (anesthesia needle), not an algorithm.

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

• Type of Ground Truth: For the biocompatibility tests (Elution Test, Systemic Injection Test, Rabbit Pyrogen Test, Intracutaneous Injection Test, Kligman Maximization Test), the "ground truth" is adherence to established biological safety standards and pass/fail criteria for these specific tests. For the functional characteristics (flow rate, bonding strength), the ground truth is likely measured values compared against specifications or the predicate device's performance.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. This is not an AI/machine learning device that requires a training set.

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

• Ground Truth for Training Set: Not applicable.

Ask a specific question about this device

The Epidural Catheter is intended for administration of local anesthetics into the epidural space. Busse recommends the removal and/or replacement of the catheter every 72 hours.

The Busse Epidural Catheter is a single use device, which is sold as sterile individually packaged and sterile packaged inside a kit/procedure tray. The Catheter will also be sold as a non-sterile product to kit packers, who then may sterilize the catheter as part of a kit.

The provided document is a 510(k) summary for the Busse Epidural Catheter, which primarily focuses on demonstrating substantial equivalence to a predicate device. It does not contain information about a study with acceptance criteria for device performance in the way a clinical trial or algorithm performance study would. Instead, it details biocompatibility testing for the materials used in the catheter.

Here's an breakdown based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states "These materials have met the testing requirements and were found to be acceptable for the intended use" for all listed tests, implying that meeting the standard for each test constitutes the acceptance criteria.

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

This document describes biocompatibility testing of materials, not a test set of data for an AI/algorithm. Therefore, concepts like sample size for a test set, and data provenance (country of origin, retrospective/prospective) are not applicable in this context. The tests listed are laboratory-based assessments of material interaction with biological systems.

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

Not Applicable. Ground truth, in the context of expert review, is not relevant for the biocompatibility tests described. These tests have established scientific methods and pass/fail criteria.

4. Adjudication Method for the Test Set

Not Applicable. Adjudication methods are typically used when there's subjective interpretation, like in a clinical image review. Biocompatibility tests have objective results.

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

No, an MRMC study was not done. This document is for a physical medical device (epidural catheter), not an AI/algorithm where human reader performance would be evaluated.

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

No, this is not an AI/algorithm device, so standalone performance is not applicable.

7. The Type of Ground Truth Used

The "ground truth" for the biocompatibility tests is the established scientific methodology and criteria for each specific test (e.g., cell viability in L929, skin reaction scores in Kligman, hemolytic index in rabbit blood). Pathology would be relevant if the study involved tissue analysis from implantation, which is part of the Intramuscular Implantation Test. Outcomes data is not mentioned in these specific tests.

8. The Sample Size for the Training Set

Not Applicable. This is not an AI/algorithm, so there is no training set.

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

Not Applicable. As there's no training set, this question is not relevant.

Ask a specific question about this device

The Glass Loss of Resistance Syringe is intended for use in conjunction with an epidural needle, to verify the needle tip placement in the epidural space by the loss of Resistance technique; it will be filled with air and/or saline during use. The loss of Resistance Syringe is not intended for injection or aspiration. The Syringe will be sold sterile individually packaged, and as part of a sterile kit.

The Glass Loss of Resistance Syringe is a single use device, which is sold as sterile individually packaged and sterile packaged inside a kit/procedure tray. The syringe will be available in luer lock and luer slip tip.

The provided 510(k) summary for the "Glass Loss of Resistance Syringe" (K063018) does not contain information about acceptance criteria or a study proving the device meets specific performance criteria in the way that an AI/algorithm-based medical device would.

This submission is for a physical medical device (a syringe) and the safety and effectiveness are established primarily through biocompatibility testing and substantial equivalence to a pre-amendment predicate device. There is no "algorithm" or "AI" involved, so many of the requested fields are not applicable.

Here's an analysis based on the provided text, highlighting what is present and what is absent:

Acceptance Criteria and Device Performance (Not Applicable for this type of device/submission)

Study Details

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

   • Test Set Sample Size: Not applicable. The "tests" were biological qualification safety tests on the materials, not a performance study on a 'test set' of data.
   • Data Provenance: Not applicable in the context of clinical data. The summary mentions "All materials used in the fabrication... were evaluated through biological qualification safety tests." The origin of these tests (e.g., country) is not specified.

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

   • Not applicable. There is no concept of "ground truth" or "experts" establishing it for this type of physical device's initial regulatory submission. The assessment is based on standardized biological safety tests.

3. Adjudication method for the test set:

   • Not applicable. No expert adjudication process is described or implied.

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 device is a physical syringe, not an AI/algorithm-based diagnostic tool. No MRMC study was conducted or is relevant.

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

   • Not applicable. There is no algorithm.

6. The type of ground truth used:

   • Not applicable. The "truth" in this context is the pass/fail result of standardized biological safety tests for materials: L929 Men Elution Test, Intracutaneous Injection Test, Systemic Injection Test, Salmonella Typhimurium and Escherichia Coil Reverse Mutation Assay, Hemolysis - Rabbit Blood Test, and Kligman Maximization Test.

7. The sample size for the training set:

   • Not applicable. There is no training set for an AI/algorithm.

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

   • Not applicable. There is no training set or ground truth in the AI sense.

Summary of the K063018 Submission:

The Busse Hospital Disposables Glass Loss of Resistance Syringe (K063018) received FDA clearance primarily based on:

• Substantial Equivalence: The device was found substantially equivalent to a pre-amendment predicate device (BD Glass Loss of Resistance Syringe). This implies that its design, materials, and intended use are sufficiently similar to a device that was legally marketed before May 28, 1976 (the enactment date of the Medical Device Amendments).
• Biocompatibility Testing: The materials used in the syringe's fabrication underwent several biological qualification safety tests. The summary explicitly states: "These materials have met the testing requirements and were found to be acceptable for the intended use." The tests listed are standard biocompatibility assays to ensure the materials are not toxic or harmful when in contact with the human body.

In essence, this submission focuses on the safety of the materials and the functional similarity to an existing device, rather than performance metrics for an intelligent system.

Ask a specific question about this device