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The Spectra, "GLASS LOR SYRINGE" [Loss of Resistance Syringe] is intended for use, in conjunction with an epidural needle, to verify the needle tip placement in the cpidural space by the Loss of Resistance technique as explained in standard medical textbooks. These syringes are not intended for injection or aspiration.

Spectra, GLASS LOR SYRINGE

This document is a 510(k) clearance letter from the FDA for a medical device called "Spectra, GLASS LOR SYRINGE". This type of letter generally does not include detailed study results, acceptance criteria, or performance data beyond stating that the device is substantially equivalent to a predicate. The letter confirms the device can be marketed based on its equivalence.

Therefore, many of the requested items (e.g., acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) will not be available in the provided text.

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

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

• Cannot be provided. This document is an FDA clearance letter based on substantial equivalence, not a detailed study report. It does not contain specific acceptance criteria or performance metrics beyond the general statement of substantial equivalence to a predicate device.

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

• Cannot be provided. The 510(k) letter does not include details about specific test set sample sizes or data provenance.

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)

• Cannot be provided. Information on expert involvement for ground truth establishment for a test set is not present in this regulatory clearance letter.

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

• Cannot be provided. Details on adjudication methods are not included in this document.

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

• Cannot be provided. This device is a "GLASS LOR SYRINGE" (Loss of Resistance Syringe), a physical medical device. It is not an AI algorithm, and therefore, an MRMC comparative effectiveness study involving AI assistance would not be applicable or performed for this product.

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

• Cannot be provided. As a physical syringe, the concept of "standalone algorithm performance" is not relevant.

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

• Cannot be provided. This information is not part of an FDA clearance letter for a physical device. For a device like a syringe, performance is typically assessed through physical and mechanical testing against recognized standards or direct comparison to a predicate, rather than through complex ground truth establishment methods relevant to diagnostic algorithms.

8. The sample size for the training set

• Cannot be provided. As this is a physical device and not an AI algorithm, there would be no "training set" in the computational sense.

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

• Cannot be provided. This is not applicable to a physical device.

Summary based on the provided text:

The provided document is an FDA 510(k) clearance letter for the "Spectra, GLASS LOR SYRINGE." This letter indicates that the device has been deemed substantially equivalent to legally marketed predicate devices. The basis for this determination is typically a comparison of the device's technological characteristics and performance to those of the predicate.

While the letter confirms the device meets the regulatory requirements for market entry, it does not contain the detailed study data, acceptance criteria, or performance reports that would include information on sample sizes, expert involvement, ground truth establishment, or specific metrics like sensitivity, specificity, or effect sizes. Such detailed information would typically be found in the manufacturer's 510(k) submission itself, which is not provided here.

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The SPECTRA-LOR, Loss of Resistance Syringe is intended for use, in conjunction with an epidural needle, to verify the needle tip placement is in the epidural space by use of the Loss of Resistance Technique as detailed in medical textbooks and medical journal articles. The LOR Syringe is not intended for injection or aspiration.

The construction of the SPECTRA-LOR, Loss of Resistance Syringe is similar to that of a standard piston syringe; it has a barrel, a plunger and a bung. The barrel has graduations which correspond to a capacity of 10 ml and is available in a Luer Lock or Luer Slip tip.

The provided text is a 510(k) summary for the SPECTRA-LOR, Loss of Resistance Syringe. It describes the device, its intended use, and its equivalence to a predicate device. However, it does not contain any information about acceptance criteria, device performance metrics, or any studies conducted to prove the device meets specific acceptance criteria.

The document explicitly states: "The SPECTRA-LOR, Loss of Resistance Syringe is equivalent to the predicate device, AVID-NIT Loss of Resistance Syringe in materials of construction, intended use, capacity and bench testing." This indicates that the regulatory clearance was based on substantial equivalence to a predicate device, rather than new studies proving pre-defined acceptance criteria for the SPECTRA-LOR syringe's performance.

Therefore, I cannot provide the requested information from the text.

If this were a typical AI device submission, the response would look like this (but based on the actual information provided, such details are absent):

1. Table of Acceptance Criteria and Reported Device Performance
(No specific acceptance criteria or performance metrics were provided in the document for the SPECTRA-LOR syringe. Its approval is based on substantial equivalence to a predicate device.)

2. Sample Size Used for the Test Set and Data Provenance
(Not applicable, as no dedicated study with a test set was described to prove specific performance metrics for the SPECTRA-LOR syringe.)

3. Number of Experts Used to Establish Ground Truth and Qualifications
(Not applicable, as no specific study involving expert-established ground truth was described.)

4. Adjudication Method for the Test Set
(Not applicable.)

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
(Not applicable. This device is a physical syringe, not an AI-assisted diagnostic tool.)

6. Standalone (Algorithm Only) Performance Study
(Not applicable. This device is a physical syringe, not an algorithm.)

7. Type of Ground Truth Used
(Not applicable, as no ground truth was established for performance metrics in a study for this device.)

8. Sample Size for the Training Set
(Not applicable. This device is a physical syringe, not a machine learning model requiring a training set.)

9. How the Ground Truth for the Training Set Was Established
(Not applicable.)

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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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The Busse 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 Busse 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.

This document is a 510(k) summary for the Busse Loss of Resistance Syringe, which is a medical device. The information provided heavily focuses on the regulatory submission and equivalency to a predicate device, rather than detailed performance study results that would typically be associated with software or AI-driven medical devices.

Based on the provided text, the device is a physical syringe, not an AI or software-driven product, so many of the questions related to acceptance criteria for software performance, sample sizes for test sets, ground truth establishment, MRMC studies, or training data are not applicable.

Here's an analysis based on the available information:

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

The document does not explicitly state quantitative "acceptance criteria" for performance in the way one might expect for a diagnostic device (e.g., sensitivity, specificity). Instead, the acceptance criteria for this physical medical device are related to its biocompatibility and functional equivalence to a predicate device.

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 "tests" performed are described as biological qualification safety tests on materials, not clinical performance studies with a test set of patient data from a specific provenance.

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 is not applicable as the device is a physical syringe, not a diagnostic or AI-based device requiring expert ground truth establishment for a test set. The evaluation is based on material testing and comparison to a predicate device. The FDA's review and determination of substantial equivalence are conducted by regulatory experts.

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

Not applicable. There is no test set in the context of diagnostic performance that would require an adjudication method.

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 (syringe), not an AI-assisted diagnostic 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, not an algorithm.

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

For this type of device, "ground truth" would be established through scientific testing standards and regulatory compliance. For biocompatibility, the ground truth is adherence to established biological qualification safety test protocols and their passing criteria. For technological characteristics, the ground truth is direct comparison and equivalence to a legally marketed predicate device in terms of design, materials, and function for the stated intended use.

8. The sample size for the training set

Not applicable. This is a physical medical device. There is no concept of a "training set" in the context of AI/machine learning for this product.

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

Not applicable. There is no training set for this physical medical device.

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THE LOSS OF RESISTANCE SYRINGE IS INTENDED TO BE USED FOR THE DETECTION AND CONFIRMATION OF THE PLACEMENT OF THE EPIDURAL NEEDLE INTO THE EPIDURAL SPACE PRIOR TO EPIDURAL ANESTHESIA. THIS SYRINGE IS INTENDED FOR THE LOSS OF RESISTANCE TECHNIQUE ONLY. IT IS NOT INTENDED FOR ASPIRATION OR INJECTION.

Not Found

The provided documents are a 510(k) premarket notification approval letter and the "Indications For Use" statement for the TE ME NA Loss of Resistance Syringe, 10CC. These documents do not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies.

The letter explicitly states that the device is "substantially equivalent" to devices marketed prior to May 28, 1976. This means that the FDA determined the new device is as safe and effective as a legally marketed predicate device, without requiring extensive clinical trials or performance studies that would typically be detailed in a Device Performance section.

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

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