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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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 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 either pencil-point-tip (Whitacre), curved and sharp needle (Touhy), sharp needle tip (Quincke).
   These needles will be provided as sterile, single use, disposable devices. They will be packaged individually or included in regional anesthesia trays.

The provided text describes a 510(k) premarket notification for "Specialty Needles." This document focuses on demonstrating substantial equivalence to a predicate device rather than defining acceptance criteria and presenting results from a standalone performance study with a test set, expert adjudication, or MRMC studies for AI devices.

Therefore, many of the requested categories (2, 3, 4, 5, 6, 7, 8, 9) are not applicable or cannot be extracted from this type of regulatory submission. The information provided is primarily related to product description, intended use, and a summary of tests performed to establish substantial equivalence based on material properties and functional comparisons.

Here's an attempt to answer the questions based only on the provided text, indicating where information is not available for an AI device study:

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

For a traditional medical device like these needles, "acceptance criteria" are implied by demonstrating substantial equivalence to a legally marketed predicate device. The performance is reported in terms of matching key characteristics of the predicate.

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. This is a traditional medical device (needles), not an AI device undergoing a performance study with a test set. The document refers to "testing requirements" for materials and functional characteristics for comparison to a predicate, not a clinical test set.

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 requiring expert ground truth for an AI device is described.

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

Not applicable. No test set requiring adjudication in the context of AI device performance 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 is a physical medical device (needles), not an AI-assisted diagnostic or therapeutic tool.

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

Not applicable. This is a physical medical device.

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

For the "Specialty Needles," the "ground truth" for demonstrating substantial equivalence is based on:

• Predicate Device Characteristics: The established and accepted characteristics and performance of the predicate device (Exel Spinal Needle - K895771).
• Standardized Material Testing: The results of the specified biocompatibility tests (L929 Men Elution Test, Kligman Maximization Test, Intracutaneous Injection Test, Systemic Injection Test, Salmonella Typhimurium and Escherichia Coli Reverse Mutation Assay).
• Functional Comparisons: Direct measurement and comparison of properties like flow rate and bonding strength to the predicate device.

8. The sample size for the training set

Not applicable. This is a traditional medical device, not an AI device requiring a training set.

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

Not applicable. This is a traditional medical device.

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The I-Style Bone Marrow Aspiration Needle is to be used for the aspiration of bone marrow.
The I-Style Bone Marrow Aspiration Needle is intended for Aspiration of Bone Marrow.

The I-Style Bone Marrow Aspiration Needle consists of an 8ga - 15ga needle and a triple sharpened atraumatic tip stylet of corresponding size. The needle is manufactured in lengths upto 2" with an adjustable depth stopper and graduated scale which allow for the adjustment of the penetration length of the needle. A luer lock connection is provided in the molded needle handle to allow aspiration of bone marrow or blood by use of a standard surgical syringe. The needle will be provided as sterile, single use, disposable device. They will be packaged individually or included in Bone Marrow Biopsy Tray.

The provided document describes the K061570 submission for the I-Style Bone Marrow Aspiration Needle. This is a 510(k) summary, which generally involves demonstrating substantial equivalence to a predicate device rather than undergoing extensive clinical trials with acceptance criteria and a device performance study as one might see for novel high-risk devices or software as a medical device (SaMD).

Here's an analysis based on the provided text, addressing your points where information is available:

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Device Meets Acceptance Criteria:

The study proving the device meets the acceptance criteria is a "Summary of Tests performed to prove the substantial equivalence of the Aspiration Needles with the predicate device." This is a comparison-based assessment rather than a performance study against predefined numerical benchmarks.

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

• Sample Size for Test Set: Not explicitly stated. The document refers to "testing requirements" and "materials ... evaluated through biological qualification safety tests" and tests done to prove substantial equivalence. These are likely bench tests and material characterization, not patient-based clinical studies with a 'test set' of clinical data in the traditional sense.
• Data Provenance: Not explicitly stated. Given the nature of the device (a bone marrow aspiration needle) and the types of tests mentioned (biocompatibility, flow rate, bonding strength), the "data" would be generated from laboratory and bench testing, not clinical data from a specific country or collected retrospectively/prospectively from patients.

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

• Number of Experts: Not applicable. For this type of device and submission, there is no mention or requirement for experts to establish a "ground truth" for a test set in the context of clinical data interpretation (e.g., from images). The evaluation is based on engineering and material performance specifications.
• Qualifications of Experts: N/A

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. There is no clinical test set requiring adjudication in the context of medical image interpretation or clinical outcome assessment.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for AI-powered diagnostic devices where human readers interpret medical images or data. The I-Style Bone Marrow Aspiration Needle is a mechanical device, not an AI or diagnostic tool.
• Effect Size of Human Readers Improvement: Not applicable.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Standalone Study: No, a standalone performance study in the context of an algorithm or AI was not done. The device is a physical medical instrument. The "tests" performed were for material safety and equivalence to a predicate device's mechanical characteristics.

7. Type of Ground Truth Used

• Type of Ground Truth: For the "tests" performed, the ground truth would be based on established material specifications, engineering requirements, and performance data of the predicate device. For biocompatibility, established biological safety standards serve as the ground truth. For flow rate and bonding strength, the measured values are compared directly to the predicate device's characteristics. There's no "expert consensus," "pathology," or "outcomes data" ground truth in this context.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This device does not involve machine learning or AI, and therefore does not have a "training set" in the context of algorithm development.

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

• Ground Truth for Training Set: Not applicable, as there is no training set mentioned or relevant for this device.

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The Needle Stick Block is a single needle holder to be used after the needle is removed from the patient and until it can be properly disposed, therefore, aiding in the prevention of needle stick injuries. The Needle Stick Block is a safety device designed to help the health care facilities to minimize the risk of needle sticks. Busse Hospital Disposable intent to sell this device individually and as part of safety trays in which needle is involved. The intended use will remain the same whether is sold individually or as part of a tray.

Sterile/ Latex Free/ Needle Stick Block. The proposed Needle Stick Block was created to help prevent needle sticks by providing a means of moving used sharps from procedure and hold it temporarily until procedure is completed to then be disposed off in a sharps container.

This document describes the regulatory submission for the "Needle Stick Block" device and the testing performed to demonstrate its substantial equivalence to a predicate device, the "SharpsAway Disposal Cup."

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

1. Table of Acceptance Criteria and Reported Device Performance

1. Same intended use
2. Same features | Implicitly, the simulated use study demonstrated that the Needle Stick Block has the same intended use and features as the predicate device when used by experienced medical experts. (The document states "D) Simulate use study by experienced medical experts (at least 1 year experience with handling needles using the predicate instrument)"). Specific qualitative or quantitative results are not provided beyond the general statement of substantial equivalence. |

Note: The document provided is a 510(k) summary, which often provides high-level statements about tests performed but often omits detailed quantitative results. The "reported device performance" is inferred from the statement that these tests were performed "to prove the substantial equivalence."

Study Details:

The overall goal of the study was to demonstrate substantial equivalence of the "Needle Stick Block" to the "SharpsAway Disposal Cup" predicate device.

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

• Sample Size (Test Set): Not explicitly stated for any of the tests (A, B, C, D).
• Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). However, the company, Busse Hospital Disposables, is located in Hauppauge, NY, United States, suggesting the tests would likely have been conducted in the US. The nature of the tests (material properties and simulated use) suggests they were conducted prospectively.

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

• Number of Experts: Not explicitly stated for the "simulate use study" (Test D). It refers to "experienced medical experts."
• Qualifications of Experts: "at least 1 year experience with handling needles using the predicate instrument."

4. Adjudication Method for the Test Set:

• Not applicable as the tests described are primarily engineering/material property tests and a simulated use study, not diagnostic performance evaluations requiring adjudication of expert interpretations.

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

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. The study involves material property testing and a simulated use study, not a comparative effectiveness study of human readers' performance with and without AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

• This question is not applicable as the device is a physical medical device (a needle holder), not an algorithm or AI software. Therefore, there is no "standalone performance" of an algorithm. The device's performance is inherently physical and involves human interaction for its intended use.

7. The Type of Ground Truth Used:

• For tests A, B, and C (puncture resistance, needle retention), the "ground truth" would be established by the physical measurement and engineering standards used to quantify these properties.
• For test D (simulated use study), the "ground truth" was established by the observation and assessment of "experienced medical experts" confirming the device's equivalent intended use and features.

8. The Sample Size for the Training Set:

• This question is not applicable as the device is a physical medical device, not an AI/ML algorithm that requires a training set.

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

• This question is not applicable as the device is a physical medical device, not an AI/ML algorithm that requires a training set.

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