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SonoMSK anesthesia conduction needles enhanced for ultrasound visibility are intended for the transient delivery of anesthetics to provide regional anesthesia and analgesia.

The subject device, the SonoMSK needle is a single-use anesthesia conducting needle intended for for the transient delivery of anesthetics to provide regional anesthesia and analgesia.

The SonoMSK needle is intended for use under ultrasound guidance. Visibility under ultrasound is enhanced by CornerStone reflectors as cleared by FDA in several Premarket Notification Submissions.

The SonoMSK needle is equipped with an injection tube. The distal connection of the tube is equipped with a LUER Connector according to ISO 80369-7.

The device in focus is a single use device and has an intended time of use up to 24 hours acc. EO-residuals acc. DIN EN ISO 10993-7. The standard time of use is less than 60 minutes.

The SonoMSK cannulas are not for intrathecal use.

The SonoMSK cannulas are produced at PAJUNK® GmbH Medizintechnologie in Geisingen, Germany.

Based on the provided FDA 510(k) Clearance Letter for SonoMSK, here's a detailed description of the acceptance criteria and the study proving the device meets them:

Disclaimer: This document is a 510(k) Summary, not the full submission. Therefore, it focuses on demonstrating "substantial equivalence" to a predicate device, rather than proving novel performance claims directly against established acceptance criteria for a new type of device. The acceptance criteria described below are primarily related to meeting established international standards for similar devices and ensuring equivalence to the predicate. The "study" largely consists of performance testing against these standards and validation of manufacturing processes (sterilization, packaging, shelf life).

Acceptance Criteria and Device Performance for SonoMSK

The SonoMSK device, as per this 510(k) submission, demonstrates substantial equivalence to its predicate device (SonoTAP) by meeting a series of performance and safety standards, particularly concerning its materials, manufacturing processes (sterilization, packaging), and device characteristics.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily defined by compliance with specific sections of recognized international standards for hypodermic needles and connectors. The reported device performance is a "Passed" status for each tested section, indicating compliance with the respective standard's requirements.

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

The document does not explicitly state the numerical sample sizes for each specific test (e.g., "n=X needles for cleanliness testing"). However, it indicates that testing was performed "on a regular basis as well as type tests performed after design transfer" and "using process most challenging worst case devices."

• Test Set Sample Size: Not explicitly stated for each test, but implied to be sufficient for compliance with the referenced ISO standards. For shelf-life testing, "process most challenging worst case devices" were used.
• Data Provenance: The device is manufactured in Geisingen, Germany by PAJUNK GmbH Medizintechnologie. Sterilization is performed at Sterigenics Germany GmbH (Wiesbaden, Germany) and HA2 Medizintechnik GmbH (Halberstadt, Germany). The testing itself would have been conducted by the manufacturer or accredited labs in support of the submission, likely within Germany. The data is retrospective, as it covers tests completed before the 510(k) submission.

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

This submission does not involve clinical data or "ground truth" established by expert review in the sense of image interpretation or diagnostic accuracy. The "ground truth" here is adherence to engineering and safety standards (e.g., ISO, component specifications). Compliance is determined by objective measurements against these standards, not subjective expert consensus.

4. Adjudication Method for the Test Set

Not applicable. As noted above, the basis for "ground truth" is objective measurement against specified international standards, not subjective assessment requiring adjudication.

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

No, an MRMC comparative effectiveness study was not done. The device is an anesthesia conduction needle, not an AI-powered diagnostic imaging tool. The submission focuses on demonstrating substantial equivalence in physical characteristics, biocompatibility, sterilization, and basic performance parameters to a predicate device.

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

Not applicable. SonoMSK is a physical medical device (anesthesia needle), not a software algorithm.

7. The Type of Ground Truth Used

The "ground truth" used is defined by the objective requirements and test methods outlined in the cited international standards:

• ISO 7864 (Sterile hypodermic needles for single use)
• ISO 9626 (Stainless steel needle tubing)
• ISO 80369-7 (Small-bore connectors for intravascular or hypodermic applications)
• ISO 10993-series (Biological evaluation of medical devices)
• ISO 11135-1 (Sterilization of health care products - Ethylene oxide)

These standards specify measurable parameters (e.g., dimensions, force, pH limits, sterility levels, residual limits) that the device must meet.

8. The Sample Size for the Training Set

Not applicable. SonoMSK is a physical medical device, not an AI algorithm requiring a training set.

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

Not applicable, as there is no training set for a physical device.

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SonoPlex STIM and SonoPlex II Needles equipped with Cornerstone reflectors are used to puncture the tissue in order to gain entry and inject local anesthetics to induce regional anesthesia. An electrical stimulus may be applied to the needle via a cable and connector to assist the physician pinpoint the area of application.

The subject device, the SonoPlex STIM and SonoPlex II nerve block needle is a single-use anesthesia conducting needle intended to gain entry or puncture the tissue and inject anesthetics to induce regional anesthesia. The SonoPlex STIM and SonoPlex II needle is intended for use under ultrasound guidance. Visibility under ultrasound is enhanced by CornerStone reflectors as cleared by FDA in several Premarket Notification Submissions. The SonoPlex STIM and SonoPlex II needle is equipped with an connecting cable, injection tube and NanoLine® coating (Parylene, no nanomaterials incorporated). The distal connection of the tube is either equipped with a LUER Connector according to ISO 80369-7 or a NRFit-Connector according to ISO 80369-6. The device in focus is a single use device and has an intended time of use up to 24 hours acc. EO-residuals acc. DIN EN ISO 10993-7. The standard time of use is less than 60 minutes. The SonoPlex STIM and SonoPlex II cannulas are not for intrathecal use. The SonoPlex STIM and SonoPlex II cannulas are produced at PAJUNK® GmbH Medizintechnologie in Geisingen, Germany.

The provided FDA 510(k) clearance letter and associated summary pertain to the SonoPlex STIM and SonoPlex II anesthesia conduction needles. This document focuses on demonstrating substantial equivalence to a predicate device (SonoBlock/SonoBlock II) and primarily addresses changes related to sterilization and packaging, rather than the performance of an AI/ML-driven device.

Therefore, the requested information regarding AI/ML device performance (e.g., acceptance criteria for AI, sample sizes for test/training sets, expert adjudication, MRMC studies, standalone algorithm performance, ground truth definitions for AI models) cannot be extracted from this document, as it describes a traditional medical device and not an AI-powered one.

The "study" described in the document is a series of performance tests and validations for the physical properties, sterilization, and biocompatibility of the needles, and not a study validating an AI/ML diagnostic or assistive tool.

However, I can provide a summary of the acceptance criteria and the studies that prove the device (SonoPlex STIM and SonoPlex II needles) meets its acceptance criteria based on the information provided:

Acceptance Criteria and Device Performance (SonoPlex STIM and SonoPlex II Needles)

The acceptance criteria for the SonoPlex STIM and SonoPlex II needles are primarily based on established international standards for medical devices, specifically for anesthesia conduction needles. The studies performed were performance testing, sterilization validation, and shelf-life testing, demonstrating that the device meets these criteria.

1. Table of Acceptance Criteria and Reported Device Performance

The core acceptance criteria are compliance with various ISO standards, ensuring the physical and biological safety and efficacy of the needles.

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

• Sample Size: The document repeatedly mentions that tests were conducted, but does not specify the exact sample sizes for each of the performance tests (e.g., how many needles were tested for patency, stiffness, etc.). It mentions "process most challenging worst case devices" were used for shelf life and sterility tests.
• Data Provenance: The devices are manufactured by PAJUNK GmbH Medizintechnologie in Geisingen, Germany. The contract sterilizers are Sterigenics Germany GmbH (Wiesbaden, Germany) and HA2 Medizintechnik GmbH (Halberstadt, Germany). The tests appear to be prospective (conducted specifically for this submission) in a laboratory/manufacturing setting.

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

This section is not applicable as the device is a physical medical needle, not an AI/ML diagnostic or assistive device that would require expert-established ground truth from medical images or clinical data. The acceptance criteria are based on engineering specifications and international standards.

4. Adjudication Method for the Test Set

This section is not applicable for the same reasons as above. The tests performed are objective, quantitative measurements against defined standard specifications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

This section is not applicable. This is a physical medical device, not an imaging or diagnostic AI/ML tool that would be subject to MRMC studies. The document specifies that the new devices are "substantially equivalent" to predicate devices, and the dual guidance (ultrasound + electrical stimulus) for localization is considered "state of the art" and "safe and effective."

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

This section is not applicable. The device is a needle used by a human physician, possibly with assistance from an ultrasound machine and/or an electrical stimulator. There is no AI algorithm component.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is defined by the specifications within the cited ISO standards (e.g., acceptable limits for fluid leakage, minimum breaking strength, chemical residue limits) and validated manufacturing processes (e.g., sterilization parameters, biocompatibility testing). It is not derived from patient outcomes, expert consensus on clinical findings, or pathology reports in the context of an AI/ML algorithm.

8. The Sample Size for the Training Set

This section is not applicable. There is no AI/ML component; therefore, no training set is relevant to this device submission.

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

This section is not applicable for the same reason as above.

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The SPROTTE® STANDARD (LUER/ NRFit®) lumbar puncture needles are intended to gain entry into or puncture the spinal cavity permitting injection/ withdrawal of fluids for purposes of diagnostic lumbar puncture, myelography/ discography.

The subject device, the SPROTTE® STANDARD (LUER/ NRFit®) anaesthesia conduction needle is a single-use anaesthesia conducting intended for administer anesthetic agent to the spinal space.

The SPROTTE® cannulas are equipped with a stylet as well as optional with an Introducer. It is available with a LUER respectively with a NRFit® hub. The LUER is either a standard hub, a magnifying hub or a 2.G hub. The cannula tube is straight. The distal connection of the hub is either equipped with a LUER Connector according to ISO 80369-7 or a NRFit-Connector according to ISO 80369-6.

This document, an FDA 510(k) clearance letter and associated summary, pertains to a lumbar puncture needle – a physical medical device. The information provided heavily details the material composition, dimensions, and manufacturing processes (including sterilization and packaging) of the needle, and compares these characteristics to previously cleared predicate and reference devices.

Crucially, this document does NOT describe the acceptance criteria and study that proves a software algorithm or AI/ML device meets those criteria. It is about a physical medical device, not a digital health product that uses algorithms to process data or make predictions.

Therefore, I cannot extract the information required by your prompt, as it is designed for a different type of medical device (software/AI/ML).

To directly answer your numbered points based on the provided text:

• 1. A table of acceptance criteria and the reported device performance: Not applicable for an AI/ML device. The document lists performance testing against physical standards (ISO 7864, ISO 9626, ISO 80369-6, ISO 80369-7) for the needle's physical properties (e.g., cleanliness, dimensions, bond strength, fluid/air leakage, stress cracking), with all sections reported as "Passed."
• 2. Sample sizes used for the test set and the data provenance: Not applicable for an AI/ML device. For the physical device, testing appears to be based on compliance with ISO standards, implying a certain number of units were tested to demonstrate conformity. Data provenance specific to an AI/ML context (e.g., country of origin, retrospective/prospective) is not present.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable for an AI/ML device. This document does not describe a process of establishing "ground truth" by experts reviewing medical images or data.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for an AI/ML device.
• 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 for an AI/ML device. This type of study is for evaluating AI assistance to human interpretation, which is not relevant for a physical needle.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable for an AI/ML device.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable for an AI/ML device. The "ground truth" for a physical needle's performance is its adherence to mechanical, material, and sterility standards.
• 8. The sample size for the training set: Not applicable for an AI/ML device. There is no AI model being trained.
• 9. How the ground truth for the training set was established: Not applicable for an AI/ML device.

In summary: The provided text describes the regulatory clearance for a traditional, physical medical device (a lumbar puncture needle) based on its material properties, manufacturing processes, and adherence to established physical performance standards. It does not contain any information relevant to the testing and validation of an AI/ML-based medical device.

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The SonoTAP and SonoTAP II anaesthesia conduction needles enhanced for ultrasound visibility are intended for the transient delivery of anesthetics to provide regional anesthesia and analgesia.

The subject device, the SonoTAP II needles are single-use anaesthesia conducting needles intended for the transient delivery of anesthetics to provide regional anesthesia and analgesia. The SonoTAP and SonoTAP II needles are intended for use under ultrasound guidance. Visibility under ultrasound is enhanced by CornerStone reflectors as cleared by FDA in several Premarket Notification Submissions. The SonoTAP and SonoTAP II needles is equipped with an injection tube. The distal connection of the tube is either equipped with a LUER Connector according to ISO 80369-7 or a NRFit-Connector according to ISO 80369-6. The device in focus is a single use device and has an intended time of use up to 24 hours acc. EO-residuals acc. DIN EN ISO 10993-7. The standard time of use is less than 60 minutes. The SonoTAP and SonoTAP II cannulas are not for intrathecal use.

The provided text is a 510(k) Summary for the SonoTAP and SonoTAP II anesthesia conduction needles. It focuses on demonstrating substantial equivalence to a predicate device (SonoTAP, K113207) primarily by addressing changes related to sterilization facilities and packaging materials.

The document does not describe a study involving an AI/human reader comparative effectiveness study, nor does it provide a standalone algorithm performance study data, nor does it typically include details on ground truth establishment for a diagnostic AI study. This submission is for a medical device (anesthesia conduction needles), not an AI-powered diagnostic device. Therefore, the questions related to AI performance, ground truth, expert adjudication, and training/test set sample sizes in the context of AI are not applicable to the scope of this regulatory submission.

The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to engineering and biocompatibility tests for the needle itself, validating manufacturing processes and material changes, rather than a clinical performance study involving human interpretation of diagnostic images or AI output.

Here's an analysis based on the provided text, addressing the applicable points:

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

The document lists various sections of ISO standards as "sections tested" and reports "Pass / Fail" for them. This indicates that the tests successfully met the acceptance criteria defined by those standards. However, specific numerical performance results against acceptance thresholds are only given for one specific test:

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

• Sample Size: The document does not specify the exact sample sizes for each mechanical and sterility test, only that "worst case needles" were subjected to testing for hub-to-needle bonding strength and that "sample size" for ISO 9626 was "Passed," implying it met the standard's requirements. For sterility validation, ISO 11135 dictates specific sample sizes based on the method (e.g., overkill, half-cycle approach), which would have been followed but are not explicitly reported in quantitative terms in this summary.
• Data Provenance: The tests were conducted internally by PAJUNK GmbH Medizintechnologie (Germany) or by their contract sterilizers (Sterigenics Germany GmbH and HA2 MEDIZINTECHNIK GMBH, Germany). The data is generated from prospective testing of manufactured devices and packaging.

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

Not applicable. This is not a diagnostic AI device requiring expert ground truth for image interpretation. The "ground truth" here is the physical measurement results from standardized tests.

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

Not applicable. This is not a study assessing subjective interpretation (e.g., radiological reads). Quality control and engineering tests have defined pass/fail criteria.

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, not an AI-powered diagnostic tool.

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

Not applicable.

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

The ground truth used for these tests are objective, measurable physical and chemical properties and performance characteristics defined by international standards (e.g., force in Newtons for bonding strength, presence/absence of leakage, sterility assurance level).

8. The sample size for the training set:

Not applicable. As this is not an AI/ML device, there are no training sets.

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

Not applicable.

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The SPROTTE® STANDARD (LUER/ NRFit®) needles are anesthesia conduction needles which are used to administer anesthetic agent to the subarachnoid space.

The subject device, the SPROTTE® STANDARD (LUER/ NRFit®) anaesthesia conduction needle is a single-use anaesthesia conducting intended for administer anesthetic agent to the subarachnoid space. The SPROTTE® cannulas are equipped with a stylet as well as optional with an Introducer. It is available with a LUER respectively with a NRFit® hub. The LUER is either a standard hub, a magnifying hub or a 2.G hub. The cannula tube is straight. The distal connection of the hub is either equipped with a LUER Connector according to ISO 80369-7 or a NRFit-Connector according to ISO 80369-6.

The provided text describes a 510(k) premarket notification for a medical device, specifically SPROTTE® STANDARD (LUER/ NRFit®) Anesthesiology needles. The submission aims to demonstrate substantial equivalence to a legally marketed predicate device (SPROTTE NRFit™, Quincke NRFit™) by validating the addition of an alternative sterilization service provider and an alternative packaging material.

The document does not detail acceptance criteria or study results for AI performance or diagnostic accuracy. Instead, it focuses on the physical and biological characteristics of the needle itself, and the validation of manufacturing processes (sterilization and packaging) to ensure sterility and shelf life.

Therefore, many of the requested items (e.g., AI performance, expert ground truth, MRMC studies, training set details) are not applicable to this type of device submission. This is a traditional medical device submission, not an AI/ML-based device.

However, based on the provided text, we can address the applicable criteria:

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

The acceptance criteria are generally implied by adherence to relevant ISO standards and maintaining the same performance characteristics as the predicate device. The "reported device performance" is essentially a "Pass/Fail" determination against these standards.

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: The document indicates that for ISO 9626, "5.7 Sample size" was "Passed", implying a specific sample size was used as per the standard, but the exact number is not provided. For sterility and shelf-life testing, "process most challenging worst case devices" were used, but specific numbers are not given.
• Data Provenance: The manufacturing and testing are stated to occur at PAJUNK GmbH Medizintechnologie in Geisingen, Germany, and the contract sterilizers are in Wiesbaden, Germany (Sterigenics) and Halberstadt, Germany (HA2 Medizintechnik). The data is derived from prospective testing conducted to validate the manufacturing and sterilization processes.

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

This is not applicable. This submission concerns the physical and biological characteristics of a medical device (anesthesia needle) and the validation of its manufacturing and sterilization processes, not the performance of an AI/ML algorithm or diagnostic accuracy involving expert review.

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

This is not applicable. No adjudication method for expert reviews or ground truth establishment is mentioned as this is not an AI/ML or diagnostic performance study. Performance is measured against specific ISO standards and validated processes.

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 is not applicable. This is not an AI-assisted device; it is a physical medical device.

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

This is not applicable. This is not an AI/ML algorithm.

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

The "ground truth" in this context is the adherence to established international standards (ISO series) for medical device design, manufacturing, sterilization, and biocompatibility. For instance, sterility is validated to an SAL of 10^-6 (a defined standard), and material properties are tested against specified values in the ISO standards. The performance characteristics of the new device are directly compared to existing predicate devices and their proven specifications, and confirmed by testing against the same engineering and safety standards.

8. The sample size for the training set:

This is not applicable. This is not an AI/ML device that requires a training set.

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

This is not applicable.

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SonoBlock and SonoBlock II Needles equipped with Cornerstone reflectors are used to puncture the tissue in order to gam entry and inject local anaesthetics to induce regional anaesthesia.
Warning:
SonoBlock and SonoBlock II Needles are not intended for RF ablation or any other type of ablation procedure.

The subject device, the SonoBlock II nerve block needle is a single-use anaesthesia conducting nerve block needle intended for performing peripheral nerve blocks.
The SonoBlock and SonoBlock II nerve block needle is intended for use under ultrasound guidance. Visibility under ultrasound is enhanced by CornerStone reflectors as cleared by FDA in several Premarket Notification Submissions.

The provided document is a 510(k) Summary for the SonoBlock and SonoBlock II needles. It focuses on demonstrating substantial equivalence to a predicate device (SonoPlex II) and primarily addresses changes in manufacturing processes (hub-to-needle bonding), sterilization providers, and packaging materials.

The document does not contain information related to software performance, AI assistance, or human reader effectiveness studies. Therefore, I cannot provide details for criteria 5, 8, and 9, and some parts of other criteria will be marked as "Not Applicable" or "Not Provided."

Here's the breakdown based on the information available:

Acceptance Criteria and Reported Device Performance

The document does not present a formal table of "acceptance criteria" against "reported device performance" in the context of device function/efficacy. Instead, it discusses compliance with international standards and the results of various performance tests. The focus is on ensuring that changes to manufacturing and sterilization do not negatively impact the device's physical and material properties.

Here's a compilation of the relevant performance tests and their outcomes:

Study Details

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

   • Bending Rigidity & Bonding to Hub: Specific item codes are listed with individual deflection or force values. However, the number of units tested for each item code is not explicitly stated in the summary, nor is the total sample size for these tests.
   • Breakage: The number of complete cycles (20) is mentioned, but the number of needles tested is not specified.
   • Penetration Force: Not specified.
   • Hub/Connection Performance: Not specified.
   • Sterilization Validation: Refers to "process most challenging worst case devices" and "1 sublethal cycle, 1 full cycle" for the Overkill Approach, but the specific number of devices tested is not provided.
   • Shelf Life: Refers to "process most challenging worst case devices" and "similar characteristics made from the same material," but the specific number of devices tested is not provided.
   • Data Provenance: The manufacturing site is PAJUNK GmbH Medizintechnologie, Geisingen, Germany. The sterilization facilities are Sterigenics in Wiesbaden, Germany, and HA2 Medizintechnik in Halberstadt, Germany. The tests appear to be conducted internally or by contract labs associated with the manufacturer, rather than clinical studies with patient data. The studies are prospective in the sense that they are validations performed for regulatory submission, but they are not clinical studies in the traditional sense.

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

   • Not Applicable. This document describes engineering performance tests and sterilization/biocompatibility validations, not studies requiring expert review for ground truth in clinical image interpretation or similar contexts.

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

   • Not Applicable. The tests are governed by international standards (e.g., ISO, EN) which define the test procedures and acceptance criteria objectively.

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:

   • No. This device is an anesthesia conduction needle and does not involve AI assistance or human readers.

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

   • No. This device is a medical instrument, not an algorithm. The "standalone" performance refers to the device's physical and material characteristics as tested against international standards.

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

   • The "ground truth" for the performance tests in this document is defined by the acceptance criteria specified in the referenced international standards (e.g., ISO 9626, ISO 7864, ISO 80369 series, ISO 11135-1, ISO 10993-7). These standards provide objective and measurable criteria for physical properties, material strength, sterility, and biocompatibility.

7. The sample size for the training set:

   • Not Applicable. This device does not use machine learning or AI that requires a "training set."

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

   • Not Applicable. As there is no training set mentioned, the method for establishing its ground truth is irrelevant.

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The Reach Needle is used for in injecting local anesthetics into a patient to provide regional anesthesia.

The Reach Needle is a sterile, single use, 4-inch-long needle used for administering anesthetic solutions for regional anesthesia. The Reach Needle is 27-qauge needle that is reinforced to reduce needle flex during administration of anesthesia solutions. The needle tip is a short bevel quincke style tip that extends approximately 2mm past the reinforcing shaft, providing a distal stop for consistent injection depth. The distal end of the needle has a slight bend to help access difficult to reach areas such as nasal anatomy. The needle hub is compatible with luer lock connectors. The Reach Needle is intended for use in adults (≥ 22 years).

The provided text is a U.S. FDA 510(k) summary for the "Reach Needle," an anesthesia conduction needle. It outlines the device's characteristics, intended use, and comparison to a predicate device.

Crucially, the document explicitly states under the section "Summary of clinical test": "Clinical testing was not necessary for this device."

This means that the device's acceptance was based on non-clinical testing (e.g., in vitro or bench testing) and a demonstration of substantial equivalence to a legally marketed predicate device, rather than a clinical study involving human patients or complex AI algorithms requiring extensive ground truth establishment and expert adjudication.

Therefore, I cannot provide the information requested in your prompt regarding acceptance criteria and a study proving the device meets those criteria, as the nature of the device (a medical needle, not an AI or imaging device) and the regulatory pathway chosen (510(k) based on substantial equivalence and non-clinical data) did not involve such a study.

The questions you asked are highly relevant for AI/ML-enabled medical devices or devices where performance needs to be validated against complex human assessment or outcomes, but they do not apply to this specific medical needle as per the provided FDA documentation.

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Spinal Needle (Quincke Bevel and Pencil Point) is intended for injection of local anesthetics into the subarachnoid space to provide spinal anesthesia for pain management. The device is intended to be used in a professional healthcare environment and not tested for MRI safety.

Spinal Needles are long, flexible needles of small gauge (typically 18G to 27G) which are available with different types of tips: Pencil point and Quincke bevel. The Spinal Needles are available in a series of combination of needle size and length. The smaller size needles of Pencil point tip are provided with introducer needles to provide support for accessing the tough tissues. Spinal needles have a removable stylet that completely occludes the lumen to avoid block. The stylet is withdrawn after the spinal anesthesia needle has penetrated into the subarachnoid space for injecting anesthetic. The needle hub is luer connector (6% luer taper).

The provided text is a 510(k) premarket notification for a medical device (Spinal Needle). It primarily focuses on demonstrating substantial equivalence to a predicate device rather than describing an AI/ML algorithm's performance. As such, it does not contain the information required to answer the prompt regarding acceptance criteria and performance studies for an AI/ML device.

Specifically, the document states: "No clinical data was included in this premarket application submission." and the detailed sections relate to physical and chemical properties, sterilization, and material compatibility, not AI system performance.

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

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BD Perisafe™ Tuohy Epidural Needle and BD Perisafe™ Weiss Epidural Needle are indicated for the administration of anesthesia or analgesia into the epidural space, or to introduce a dedicated catheter for continuous administration of anesthesia or analgesia into the epidural space. They can also be used to introduce a spinal needle to perform a combined spinal and epidural procedure.

These devices are intended for adult and pediatric patients.

BD Perisafe™ Tuohy Epidural Needle and BD Perisafe™ Weiss Epidural Needle are single use, sterile needles which incorporate an ISO 594-1/-2 compliant connector. The needles are also available in bulk, non-sterile configurations (to be sterilized prior to use). Each type of needle consists of a hollow, stainless steel cannula, a translucent, polypropylene hub and a polypropylene shield over the needle. The cannula is bonded to the hub at one end. The BD Perisafe™ Epidural needles also contain a plastic stylet handle and are available in various needle lengths. The needle hubs are ISO 594-1 and ISO 594-2 compliant connectors. The stylet handle for the BD Perisafe™ Epidural needles is color coded and correlate to the gauge size per ISO 6009:2016.

The provided text is a 510(k) summary for the BD Perisafe™ Tuohy Epidural Needle and BD Perisafe™ Weiss Epidural Needle. It describes the subject device, its indications for use, and compares it to a predicate device to demonstrate substantial equivalence.

Based on the information provided, this document deals with the regulatory clearance of a medical device (epidural needles) and not an AI/ML-driven device. Therefore, many of the requested criteria related to AI/ML model performance, such as sample size for test/training sets, ground truth establishment by experts, adjudication methods, MRMC studies, and effect sizes, are not applicable to this submission.

The acceptance criteria and performance data provided are for physical and biological characteristics of the medical device, not for an AI algorithm's diagnostic or predictive performance.

Here's an attempt to answer the questions based only on the provided document, highlighting when the information is not applicable or not present for AI/ML-specific inquiries:

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

The document provides a comparison table between the subject device and the predicate device across various aspects, including functional testing and biocompatibility testing. The "Substantially Equivalent" column indicates that the subject device met the acceptance criteria by demonstrating equivalence or acceptable performance based on established standards or internal requirements.

Notes:

• The asterisks (*) indicate that for "Stylet Pull Force," "Handle/Hub Separation Force," and "Needle Shield/Hub Separation Force," the subject device had internal requirements and performed additional testing because the predicate device did not specify these tests, and there were design differences that necessitated these tests to ensure safety and effectiveness.
• "N/A" in the "Substantial Equivalence" column for some biocompatibility and additional tests indicates that these specific tests were performed by the subject device's manufacturer but were not explicitly specified for the predicate device in the comparison table. This implies the subject device met these criteria, contributing to substantial equivalence based on a broader assessment including materials equivalence.

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 applicable as this is not an AI/ML-enabled device. The testing described focuses on physical and biological performance of the device itself (e.g., fluid leakage, material strength, biocompatibility), not on data-driven performance. The sample sizes for the functional and biocompatibility tests are not explicitly stated in this summary.

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 not an AI/ML-enabled device and no ground truth from expert readers/reviewers was established for its performance. The "ground truth" for this device's performance is based on established engineering standards (ISO standards, USP standards) and internal testing protocols.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not an AI/ML-enabled device and no human adjudication process for performance was involved.

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 not an AI/ML-enabled device. No MRMC study or assessment of human reader improvement with AI assistance was performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML-enabled device. There is no algorithm to test in a standalone manner.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the device's performance is derived from:

• International Standards: ISO (International Organization for Standardization) standards (e.g., ISO 594, ISO 9626, ISO 10993, ISO 7864) for functional, mechanical, and biocompatibility properties.
• United States Pharmacopeia (USP) Standards: (e.g., USP, USP, USP) for specific biological and purity tests.
• Internal Requirements: For tests not explicitly covered by external standards but deemed critical by the manufacturer (e.g., Stylet Pull Force, Handle/Hub Separation Force, Needle Shield/Hub Separation Force). The rationale for these internal tests is provided, linking them to specific risks (e.g., user inconvenience, inability to use product, needle-stick injury).

8. The sample size for the training set
Not applicable. This is a physical medical device, not an AI/ML algorithm. There is no concept of a "training set" in this context.

9. How the ground truth for the training set was established
Not applicable. As there is no training set for an AI/ML algorithm, no ground truth was established for it.

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The BD™ Spinal Needles are intended to gain entry into or puncher the spinal cavity permitting injection (including anesthesia)/withdrawal of fluids for purposes of diagnostic lumbar puncture and myelography procedures.

This device is intended for adult and pediatric patients.

The BD™ Spinal Introducer Needle is intended for placement or introduction of spinal needles.

This device is intended for adult and pediatric patients.

The BD Quincke Spinal Needle, BD Whitacre Spinal Needle are available in various gauges and needle lengths. The needle consists of a hollow needle (cannula) bonded to a clear hub at one end and a specific needle-point type (Quincke or Whitacre) at the other end. The stylet has a handle, which is color-coded and correlates to the gauge size.

The BD Spinal Needle Introducer consists of a needle, needle hub and needle shield and is available in various gauges. The needle consists of a hollow needle (cannula) bonded to a translucent colored hub (per gauge) at one end and a specific needle-point type at the other end. The introducer needle is optional aid through which a spinal needle can be inserted.

The BD Quincke Spinal Needle, BD Whitacre Spinal Needle and BD Spinal Needle Introducer devices are single use, sterile needles which, incorporate the ISO 594-1 and ISO 594-2 compliant connector. The needles are also available in bulk, non-sterile configurations (to be sterilized prior to use).

The document is a 510(k) summary for the BD Quincke Spinal Needle, BD Whitacre Spinal Needle, and BD Spinal Introducer Needle. It describes the acceptance criteria and the studies performed to demonstrate substantial equivalence to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for Test Set and Data Provenance

The document does not explicitly state the specific sample sizes used for each of the functional and biocompatibility tests. It indicates that the tests were performed according to specified ISO standards and internal requirements. Data provenance is not specified beyond the fact that these are non-clinical/design verification tests performed by BD. There is no indication of country of origin for any data or whether it is retrospective or prospective.

3. Number of Experts and Qualifications for Ground Truth

Not applicable. The tests performed are engineering and biocompatibility evaluations of physical device properties, not assessments requiring expert interpretation of clinical data in the same way an AI/ML device would.

4. Adjudication Method

Not applicable. This is not a study requiring adjudication of interpretations.

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

Not applicable. This is a 510(k) submission for conventional medical devices (needles), not an AI-assisted device.

6. Standalone (Algorithm Only) Performance Study

Not applicable. This is not an algorithm-based device.

7. Type of Ground Truth Used

The "ground truth" for the performance criteria in this submission is based on established engineering standards (e.g., ISO 594, ISO 7864, ISO 10993, USP) and internal company requirements for device functionality and safety. The performance is measured against these objective, predefined criteria rather than a subjective "ground truth" established by experts or clinical outcomes in the context of diagnostic accuracy.

8. Sample Size for Training Set

Not applicable. This is not an AI/ML device, therefore, there is no training set.

9. How Ground Truth for Training Set Was Established

Not applicable. There is no training set.

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