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The Portex® Lancet Point Spinal Needles with NRFit™ connectors are indicated for the injection of local anesthetics or narcotics to provide regional anesthesia or withdrawal of cerebrospinal fluid when used with compatible components. The intended target population is pediatrics and adults.

The Portex® Pencil Point Spinal Needles with NRFit™ connectors are indicated for the injection of local anesthetics or narcotics to provide regional anesthesia or withdrawal of cerebrospinal fluid when used with compatible components. The intended target population is pediatrics and adults.

The PORTEX® Lancet Point Spinal Needle with NRFit™ connectors and PORTEX® Pencil Point Spinal Needles with NRFit™ connectors are indicated for the injection of local anesthetics or narcotics to provide regional anesthesia or withdrawal of cerebrospinal fluid when used with compatible components. The intended target population is pediatrics and adults.

The NRFit ™ connectors conform to ISO 80369-6, Small bore connectors for liquids and gases in healthcare applications -- Part 6: Connectors for neuraxial applications. The connectors are not compatible with standard luer connectors which is intended to reduce the risk of misconnection that may result in the infusion of medications not intended for neuraxial or regional anesthetic use.

The PORTEX® NRFit™ Spinal Needles are color-coded yellow to indicate medication intended for neuraxial or regional anesthetic delivery.

This Premarket Notification Traditional 510(k) includes various configurations of PORTEX® Lancet Point with NRFit TM connectors and PORTEX® Pencil Point Spinal with NRFit TM connectors.

The provided text details the non-clinical testing performed to demonstrate substantial equivalence for the Portex® Lancet Point Spinal Needles and Portex® Pencil Point Spinal Needles with NRFit™ connectors to their predicate devices. This is a premarket notification (510(k)) to the FDA, which focuses on demonstrating substantial equivalence rather than proving device efficacy from scratch.

Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for functional performance tests are primarily based on ISO 80369-6: Small bore connectors for liquids and gases in healthcare applications - Part 6: Connectors for neuraxial applications. While specific numerical acceptance criteria are not explicitly detailed in the summary, the document states that "All testing met pre-established specifications," implying adherence to the pass/fail criteria outlined in the referenced ISO standards.

Study Proving Acceptance Criteria:

The study that proves the device meets the acceptance criteria is a series of non-clinical performance tests as summarized in "Table 2: Summary of Non-Clinical Testing" and described in Section 7 of the document. These tests evaluated the functional performance of the NRFit™ connectors, packaging integrity, sterilization effectiveness, and biocompatibility of the materials.

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

The document does not specify the exact sample sizes used for each of the non-clinical tests. It states that "various configurations" of the spinal needles were included. The data provenance is also not explicitly stated in terms of country of origin, nor whether it was retrospective or prospective. Given it's non-clinical testing (bench testing, lab tests), these details are typically less relevant than for clinical trials. The tests were performed in a controlled laboratory environment.

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

This information is not applicable to this type of submission. The ground truth for non-clinical performance and biocompatibility tests is established by adherence to recognized international and national standards (e.g., ISO, ANSI/AAMI, USP). There are no "experts" in the sense of clinicians establishing a "ground truth" on patient data for this kind of engineering and laboratory testing.

4. Adjudication Method for the Test Set

This information is not applicable as the evaluation relies on objective measurements against pre-defined engineering and biological standards, not subjective assessments requiring adjudication.

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 done. This type of study is relevant for imaging devices or diagnostic tools where human readers interpret results, and the AI's impact on their performance is being evaluated. This submission concerns spinal needles, which are physical medical devices, not an AI or diagnostic algorithm, so an MRMC study is not relevant here.

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

This question is not applicable as the device is a physical medical instrument (spinal needle), not a software algorithm or an AI.

7. The Type of Ground Truth Used

For this submission, the "ground truth" is defined by established international and national standards (e.g., ISO 80369-6, ISO 11607, ISO 11135, ISO 10993 series, ANSI/AAMI ST72, USP 788). The device's performance is compared against the requirements and specifications outlined in these standards.

8. The Sample Size for the Training Set

This question is not applicable. There is no "training set" in the context of this device and its non-clinical testing. Training sets are used in machine learning and AI development, which is not relevant here.

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

This question is not applicable for the same reason as point 8.

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The Flexible Introducer Cannula is intended for the epidural placement, directly The Flexible Introducer cannuid is Inventour of the opents to elicit regional anesthesia.

The Flexible Introducer Cannula consists of a plastic cannula with a molded plastic hub. The device is also packaged with a stainless steel introducer needle which is removed after the device has been placed.

This document is a 510(k) summary for a medical device called the "Flexible Introducer Cannula." It details the device's characteristics, its intended use, and its comparison to a predicate device to establish substantial equivalence.

Based on the provided text, there is no information available about acceptance criteria for performance metrics (e.g., sensitivity, specificity, accuracy) for a study involving the device's performance, nor a study proving such criteria are met.

The document is a regulatory submission focused on establishing substantial equivalence for a physical medical device (anesthesia conduction needle), not a software or AI/ML-driven device that would typically have performance metrics and acceptance criteria for classification or detection tasks.

Here's a breakdown of why this information is not present and what is discussed instead:

• Acceptance Criteria and Reported Device Performance: This device is a physical instrument. The "acceptance criteria" here are related to physical and technical characteristics and safety/effectiveness as compared to a predicate device, rather than statistical performance metrics for a diagnostic or AI system. The document states:

  • "The Flexible Introducer Cannula has similar physical and technical characteristics to the predicate device and a similar intended use to the predicate device."
  • "The testing performed and comparison to the predicate device demonstrates that the Flexible Introducer Cannula is safe and effective and is substantially equivalent to the predicate device."
  • No specific quantitative performance metrics (e.g., sensitivity, specificity, accuracy) are reported.

• Sample size for the test set and data provenance: Not applicable. There is no mention of a "test set" in the context of diagnostic performance data. The "testing performed" would likely refer to engineering validation and verification tests (e.g., materials testing, sterility, functionality) and comparison of physical attributes to the predicate.

• Number of experts and their qualifications for ground truth: Not applicable. Ground truth as typically defined for AI/ML performance studies is not relevant here. The "ground truth" for this device would be its physical conformance to specifications and its biological safety, established through standard engineering and biocompatibility testing.

• Adjudication method: Not applicable.

• MRMC comparative effectiveness study: Not applicable. There is no mention of human readers or AI assistance.

• Standalone performance study: Not applicable in the context of AI/ML. All the documentation describes the device's standalone characteristics and function.

• Type of ground truth used: For a physical medical device like this, "ground truth" means demonstrating the device meets design specifications, material properties, biocompatibility, and functional requirements. This is typically established through engineering tests, material science analysis, and preclinical studies where relevant. The summary provided does not detail these specific tests, but rather states that "testing was performed."

• Sample size for the training set: Not applicable. This is not an AI/ML device.

• How ground truth for the training set was established: Not applicable.

In summary, the provided document is a 510(k) summary for a traditional medical device (anesthesia conduction needle). It establishes substantial equivalence to a predicate device through comparison of physical and technical characteristics and intended use, rather than through performance metrics typically associated with AI/ML or diagnostic devices. Therefore, the specific questions regarding acceptance criteria, study details, and ground truth establishment in the context of AI/ML or diagnostic performance are not addressed by this document.

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Spinal needles are indicated for the injection of local anesthetics into a patient to provide regional anesthesia.

A spinal needle is an instrument used for the injection of local anesthetics into a patient to provide regional anesthesia. The needle consists of a luer hub, a stainless steel cannula, and a stainless steel stylete. The needles are provided as sterile, single use, disposable devices. They may be packaged individually or included in our regional anesthesia trays. The spinal needles are provided in three styles; Lancet Point (Quincke), Pencil Point (Whitacre), and European Style (Sprotte). The introducer needle is a simple hypodermic needle, either 18g or 20g, to make the initial puncture through the skin to aid in the placement of the spinal needle.

The provided document is a 510(k) Summary for Spinal Anesthesia Needles. It describes the device, its intended use, technical characteristics, and non-clinical data. It does not present acceptance criteria or a study designed to prove the device meets specific acceptance criteria as would be typical for an AI/ML medical device.

Instead, this document focuses on demonstrating substantial equivalence to predicate devices through comparison testing of physical characteristics and performance attributes (like flow rate and penetration force). This is a regulatory pathway for traditional medical devices, not for AI/ML algorithms.

Therefore, for your request, I must state that the information you are asking for (acceptance criteria, specific study design, performance metrics, ground truth, expert involvement, MRMC studies, standalone performance, training set details) is not available in this document because it pertains to a different type of device evaluation (traditional medical device vs. AI/ML medical device).

The document's "study" is a comparison test, not a performance study against predefined acceptance criteria in the context of an AI/ML algorithm.

Here's a breakdown of why each specific point you asked for cannot be extracted from this document:

1. A table of acceptance criteria and the reported device performance: This document does not establish explicit "acceptance criteria" for the device in the way an AI/ML device would, nor does it report performance against such criteria. Instead, it compares characteristics like "increased inside diameter" and "reduced outside diameter" to predicate devices, stating that the proposed device "compared well" and that the differences are "not significant."

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): The document mentions "comparison testing between the proposed device and the predicate devices" and "unisis needles tested." However, it does not specify sample sizes for this testing, nor does it provide details on data provenance (e.g., country of origin, retrospective or prospective nature of the test data).

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): Since this is a physical medical device and not an AI/ML system, the concept of "ground truth" established by experts for a test set is not applicable in the way it would be for an AI/ML device. The "truth" here is based on physical measurements and mechanical performance.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for a physical medical device comparison test.

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 document is about spinal needles, not an AI system.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): The "ground truth" in this context would be the physical properties and performance characteristics of the needles themselves (e.g., measured flow rates, penetration force), rather than clinical outcomes or expert consensus on interpretations.

8. The sample size for the training set: Not applicable. This device is not an AI/ML algorithm that requires a training set.

9. How the ground truth for the training set was established: Not applicable, as there is no training set for this type of device.

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The Clear Hub Spinal Needle is a device which is intended for patients requiring aspiration and or injection of fluids during regional spinal anesthesia and parenteral diagnostic procedure, specifically lumbar puncture, myelogram and amniocentesis.

The Clear Hub Spinal Needle is a blue tinted transparent polycarbonate or acrylic hub, connected to the stainless steel cannula and hub assembly. The cannula/hub assembly provides wings and finger holds for proper control, stability and grip.

This document describes the 510(k) submission for the Allegiance Clear Hub Spinal Needle (K982269). The submission focuses on demonstrating substantial equivalence to a predicate device, the Baxter Pharmaseal Clear Hub Spinal Needle, rather than establishing de novo acceptance criteria through clinical trials and performance studies with novel metrics.

Here's a breakdown based on the provided text, addressing your questions where possible:

1. Table of Acceptance Criteria and Reported Device Performance

This 510(k) summary does not define specific numerical acceptance criteria (e.g., sensitivity, specificity, accuracy) for device performance as a diagnostic or analytical tool. Instead, the acceptance criteria are framed in terms of biocompatibility and functional equivalence to the predicate device.

Note: This is a Class II medical device (Spinal Needle, product code 73 MIA). For such devices seeking 510(k) clearance, the primary "study" is often a demonstration of substantial equivalence to a legally marketed predicate device, rather than extensive clinical efficacy trials. The "performance" is largely around material safety and functional similarity.

2. Sample Size for the Test Set and Data Provenance

The document does not describe a "test set" in the context of diagnostic performance (e.g., images for an AI algorithm). The "testing" referred to is related to the biocompatibility of the materials.

• Sample Size: Not explicitly stated as a number of devices or units tested. Biocompatibility testing is typically performed on material samples rather than a large batch of finished products for each test.
• Data Provenance: The biocompatibility tests were "performed" on the materials. The document does not specify where these tests were conducted (e.g., an independent lab, manufacturer's own lab) or the country of origin of the data beyond the manufacturer being US-based. These tests are inherently prospective in nature, as they were conducted specifically for this submission.

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

This question is not applicable to this 510(k) submission.

• There is no "test set" requiring ground truth established by experts in the context of diagnostic interpretation (e.g., radiologists interpreting images).
• The "ground truth" for biocompatibility is based on established scientific protocols and standards for biological safety testing (e.g., ISO 10993 series), which are interpreted by qualified toxicologists or material scientists. Their specific number or qualifications are not detailed in this summary.

4. Adjudication Method for the Test Set

Not applicable. As there's no diagnostic test set requiring human interpretation, no adjudication method (like 2+1 or 3+1 consensus) was used.

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

Not applicable. This device is a physical medical instrument (spinal needle), not an AI-assisted diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers improving with AI assistance is not relevant.

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

Not applicable. This device is a physical medical instrument, not an algorithm.

7. Type of Ground Truth Used

The "ground truth" for this device's safety and effectiveness is established through:

• Predicate device comparison: The primary "ground truth" for substantial equivalence is the legally marketed Baxter Pharmaseal Clear Hub Spinal Needle. The performance attributes and intended use of the new device are compared directly to those of the predicate.
• Biocompatibility standards: The "ground truth" for material safety is based on established scientific protocols and regulatory standards for biocompatibility testing (e.g., tests for cytotoxicity, sensitization, irritation/intracutaneous reactivity, systemic toxicity). Satisfactory results against these standards indicate biological safety.

8. Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device; therefore, there is no "training set" in the context of algorithm development.

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

Not applicable, as there is no training set for an algorithm.

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A single use, disposable, lumbar puncture kit for collection and sampling of spinal fluid from Neonatal patients.

Not Found

The provided document is a 510(k) clearance letter from the FDA for the Neo-Care Lumbar Puncture Kit. It is not a study report or a summary of a study that establishes acceptance criteria and reports device performance against those criteria. Therefore, most of the requested information cannot be extracted from this document.

The letter explicitly states: "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976..."

This indicates that the device's clearance is based on substantial equivalence to a predicate device, rather than a standalone study demonstrating performance against predefined acceptance criteria. The FDA reviews the provided information to ensure the new device is as safe and effective as a legally marketed predicate device.

Therefore, the following information cannot be provided based on the given text:

• A table of acceptance criteria and the reported device performance
• Sample sizes used for the test set and the data provenance
• Number of experts used to establish the ground truth for the test set and their qualifications
• Adjudication method for the test set
• Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size
• Whether a standalone (algorithm only) performance study was done
• The type of ground truth used
• The sample size for the training set
• How the ground truth for the training set was established

The only piece of relevant information provided is the Indications for Use:

Indications for Use: A single use, disposable, lumbar puncture kit for collection and sampling of spinal fluid from Neonatal patients.

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