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The Uniever Disposable Epidural Anesthesia Needle is intended to injection into the epidural space / or placing the epidural catheter into the epidural space.

Uniever Disposable Nerve Blockade Needle is intended to be used for injection of local anesthetic agent near the nerve for temporary pain control.

The UNIEVER Disposable Epidural Anesthesia Needles and UNIEVER Disposable Nerve Blockade Needles are available in an array of sizes, lengths, and bevel and tip designs. Both have a tightly fitting removable stylet.

The UNIEVER Disposable Epidural Anesthesia Needles are available with Huber, Hustead, or Crawford tips. Available sizes are 14G to 25G (Huber), 16G to 19G (Hustead), and 16G to 22G (Crawford) for lengths of 30-160mm.

The UNIEVER Disposable Nerve Blockade Needles are available with Back-Cut, K-3, or Huber tips. Available sizes are 18G, 20G to 26G for lengths of 25-260mm (Back Cut and K-3), and 20G, 22G and 25G for lengths of 30-160mm (Huber).

The provided document is a 510(k) premarket notification for two medical devices: the Uniever Disposable Epidural Anesthesia Needle and the Uniever Disposable Nerve Blockade Needle. This document focuses on demonstrating substantial equivalence to predicate devices, rather than establishing acceptance criteria and conducting a study to prove a device meets those criteria from scratch, which is typical for novel devices or PMAs (Premarket Approval Applications).

Therefore, the information for acceptance criteria and a detailed study proving performance against those criteria in the way one might expect for a new diagnostic or AI-based device is not explicitly present in this document. The document describes performance testing to ensure compliance with voluntary safety standards and internal functional specifications.

Here's an analysis based on the information available:

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

The document doesn't present a formal table of acceptance criteria and reported device performance in the way requested for a new device. Instead, it describes performance testing conducted to demonstrate compliance with recognized international standards and internal specifications, implying that meeting these standards constitutes "acceptance."

Implicit Acceptance Criteria (based on compliance with standards):

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

The document does not specify the sample size used for any of the performance tests (e.g., how many needles were tested for biocompatibility, sterility, or functional aspects). It also does not mention the data provenance (e.g., country of origin, retrospective/prospective). This information is typically detailed in the underlying test reports, which are not included in this summary.

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

This type of information (experts, ground truth for a test set) is typically relevant for diagnostic devices or AI algorithms where a "truth" needs to be established (e.g., presence/absence of a disease). For a physical medical device like an anesthesia needle, "ground truth" is established by adherence to engineering performance standards and biological safety standards. Therefore, this information is not applicable in the context of this 510(k) summary. Quality engineers, material scientists, and microbiologists would have conducted and reviewed the tests, but they wouldn't be referred to as "experts establishing ground truth" in this manner.

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

As mentioned above, adjudication methods like 2+1 or 3+1 are used for interpreting ambiguous cases or establishing consensus in diagnostic studies. This is not applicable to the performance testing of a physical medical device like an anesthesia needle, where test results are typically objective measurements against a standard.

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 explicitly for AI-assisted diagnostic devices. This 510(k) is for a physical epidural and nerve block needle, so an MRMC study is not applicable and was not done.

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

This is also explicitly for AI-driven algorithms. This 510(k) is for a physical medical device, so a standalone algorithm performance evaluation is not applicable and was not done.

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

For this device, "ground truth" is defined by compliance with established international consensus standards (ISO standards) and verified internal functional specifications for physical and biological properties. It is not expert consensus on diagnostic images, pathology results, or patient outcomes data.

8. The sample size for the training set:

There is no "training set" in the context of this 510(k) for a physical medical device. Training sets are applicable to machine learning algorithms.

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

Again, no training set exists for this type of device.

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UNIEVER Disposable Spinal Anesthesia Needle is intended to be used for injection of local anesthetic agent into the subarachnoid cavity for pain management.

The UNIEVER Disposable Spinal Anesthesia Needles are available in an array of sizes, lengths, and bevel and tip designs. The UNIEVER Disposable Spinal Anesthesia Needle has a tightly fitting removable stylet that completely occludes the lumen to avoid tracking epithelial cells into the subarachnoid space. The needles are available with a sharp (cutting)-tip or a blunt-tip. UNIEVER Disposable Spinal Anesthesia Needles are also available with an introducer. Available sizes are 18G to 29G (K-3), and 22G to 29G (Pencil Point) for lengths of 30-150mm. The introducers are available in sizes of 18G-22G with needle lengths of 25-50mm.

This document is a 510(k) summary for the UNIEVER Disposable Spinal Anesthesia Needle. It focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance, rather than a clinical study evaluating diagnostic or prognostic accuracy. Therefore, many of the requested elements for describing a study proving the device meets acceptance criteria are not directly applicable or available in this type of submission.

Based on the provided text, here's what can be extracted and inferred regarding acceptance criteria and performance, with limitations acknowledged:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation of Limitations:

• The acceptance criteria are largely based on adherence to established international standards (ISO) and common practices for medical devices of this type, rather than specific performance metrics like sensitivity, specificity, or accuracy (which would be relevant for diagnostic AI devices).
• "Reported Device Performance" here refers to the direct statements of compliance or characteristics mentioned in the summary, not quantitative results from detailed performance studies. The document states "Tests were performed...demonstrated that the device is safe and effective" but does not provide the raw data or specific outcomes of these tests beyond affirming compliance with standards.

The following points address the remaining questions, but it's crucial to understand that a 510(k) summary for a spinal needle (a physical medical device, not an AI or diagnostic algorithm) does not typically involve the kind of performance studies common for AI/ML or diagnostic devices. Therefore, most of these fields will be marked "Not Applicable" or "Not Provided" in this context.

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

• Not Applicable/Not Provided: This type of information is not relevant for a physical device like a spinal needle, which undergoes bench testing and compliance verification rather than "test sets" of patient data for diagnostic accuracy. The testing mentioned (ISO standards, biocompatibility) would involve material samples or device prototypes in controlled environments.

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/Not Provided: Ground truth, in the sense of expert consensus on diagnostic interpretations, is not part of the evaluation for a spinal needle. Compliance with standards and biocompatibility are typically assessed by laboratory technicians, engineers, and toxicologists, rather than medical experts forming a "ground truth" on patient outcomes for a test set.

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

• Not Applicable/Not Provided: Adjudication methods are used to resolve disagreements among experts in establishing ground truth for diagnostic studies. This is not relevant for the type of testing described in this 510(k) summary.

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/ML algorithm. Therefore, an MRMC comparative effectiveness study involving human readers or AI assistance is entirely irrelevant.

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. Standalone performance as described is not relevant.

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

• Not Applicable/Inferred: While "ground truth" in the diagnostic sense is not used, the "truth" for this device's performance would be established by:
  • Compliance with International Standards: Adherence to physical, mechanical, and safety specifications outlined in ISO 594-1, 7864, and 9626.
  • Biocompatibility Testing: Results from validated laboratory tests (e.g., in vitro or in vivo) demonstrating absence of cytotoxicity, sensitization, irritation, pyrogenicity, and acceptable endotoxin/particulate levels.
  • Material Characterization: Verification that materials are as specified and commonly used in medical devices.

8. The sample size for the training set

• Not Applicable/Not Provided: There is no "training set" in the context of a physical medical device's 510(k) submission. This concept applies to AI/ML algorithms.

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

• Not Applicable/Not Provided: As there is no training set, this question is not applicable.

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