Search Results

IMD's Lumbar Puncture Needle, a single patient use needle; it is intended to gain entry into or puncture the spinal cavity permitting injecting (including anesthesia) / withdrawl of fluids for purpose of diagnostic lumbar puncture, myelography discography procedures.

The device is intended for adult and pediatric patients.

It is to be used only under the direction of a licensed clinician.

The IMD Inc. Lumbar Puncture Needle shares major similarities with the predicate device(s), in as much as the configuration, materials, area of use, and are identical to the IMD reference devices.

It consists of an introducer, stylet, and pencil-point needle, with plastic hubs, and stainless steel cannula. Offered in 18-27 gauges, and 3.5 in. (90 mm) and 5.0 in (124 mm) lengths.

The provided text is a 510(k) summary for a medical device called IMD's Lumbar Puncture Needle. This document focuses on demonstrating substantial equivalence to existing predicate devices, rather than presenting a study that establishes acceptance criteria and proves the device meets them from scratch.

Therefore, the information typically found in a clinical study report regarding acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, and MRMC studies is not present in this document.

The document primarily relies on the equivalency of its design, materials, manufacturing processes, and sterilization methods to previously cleared devices. The "performance" mentioned refers to the device's functional integrity as a medical instrument, rather than clinical efficacy measured through a traditional study.

Here's an attempt to answer your questions based on the available information, noting where information is not provided:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not define specific clinical acceptance criteria in terms of accuracy, sensitivity, specificity, or other performance metrics typically associated with AI/diagnostic device studies. Instead, it relies on demonstrating that the device is manufactured to established standards and is functionally equivalent to already-cleared devices.

The "performance" referred to here relates to product integrity and manufacturing quality, not clinical outcome or diagnostic accuracy.

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

Not applicable. This is not a study involving a "test set" in the context of diagnostic performance evaluation (e.g., AI algorithms). The document does not describe a clinical study with a patient test set for the device's performance. The "testing" mentioned refers to manufacturing quality control (e.g., sterility, biocompatibility).

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

Not applicable. No "ground truth" establishment in a diagnostic sense is described. The assessment is mechanical and material equivalency.

4. Adjudication method for the test set

Not applicable. There is no test set or adjudication process described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a physical medical instrument (lumbar puncture needle), not an AI algorithm or an imaging device requiring human reader interpretation, hence an MRMC study is irrelevant for this product.

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

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

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

Not applicable. Ground truth for diagnostic accuracy is not relevant here. The ground truth for the "performance" described relates to adherence to manufacturing specifications, material composition, and proven sterilization effectiveness, which are established by standardized laboratory tests and regulatory compliance (e.g., ISO 10993 for biocompatibility, USP/AAMI/ISO standards for sterility).

8. The sample size for the training set

Not applicable. This isn't an AI device requiring a training set.

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

Not applicable. This isn't an AI device requiring a training set.

Ask a specific question about this device

Anesthesia conduction needles are intended for the transient delivery of anesthetics to provide regional anesthesia or to facilitate placement of an epidural catheter.

needles, including Epidural Needle for Single Use(AN-E), Spinal Needle for Single Use(AN-S), AN-SII), consist of needle tube, hub, stylet and jacket The product is mainly used for epidural and/or spinal block (also called as epidural and/or spinal anesthesia) in human bodies.
The needles have been categorized as following in detail:

1. AN-SI Spinal Needles (same to IMD's Quincke needle)
2. AN-SII Spinal Needle (same to IMD's Pencil point needle)
3. AN-E Epidural Needles (same to IMD's Tuchy needle)
   These needles are provided as sterile, single use devices. They may be packaged individually or included in regional anesthesia trays (kits). Anesthesia conduction needle. This is a simple hypodernic regional allestilesia trays (Mis). Anoonball concession of the aresthesia onduction needle. The later needie to hake the intral punction and election of local and the end anesthelics into the epidural space for longer pain relief.
   The Shanghai SA's anesthesia conduction needles – AN-SI, AN-SII, AN-SII, AN-E – are single use, sterile madical devices for like The Shanghal SA s anesulesia conductions. The cannula is stabilized during puncture with use of an Inner thanslent delively of ancollobo acting regioned its reached its analogical site for regional style. This stylet is within atter the ansociety (i.e., within minutes) by the professional ansether and the possible. The altestiesia. Then the arestheses our as opplied below the anesthesia conduction needle. The needle is Allondavely of dealer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

The provided document is a 510(k) summary for Anesthesia Conduction Needles (K120475). It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not include information about a study proving the device meets specific acceptance criteria in the way typically expected for a medical device performance study, especially one involving AI or detailed clinical outcomes.

Instead, the document focuses on demonstrating substantial equivalence to an existing predicate device (IMD's Tuohy needle, Quincke needle, Pencil Point needle K070354) through non-clinical performance and biocompatibility testing against recognized international standards.

Therefore, many of the requested fields regarding acceptance criteria, study design, expert involvement, and AI performance cannot be directly extracted from this document. I will fill in what is available and indicate when information is not present.

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

The document does not explicitly state "acceptance criteria" in a quantitative, measurable table format for device performance in a clinical setting with associated outcomes. Instead, it refers to conformity with international standards for device components and materials as the basis for performance.

Acceptance Criteria (Implicit from Standards Conformity) and Reported Device Performance:

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

This information is not provided in the document. The document refers to "Performance testing was conducted to verify that the proposed device met all design specifications," but does not detail the sample sizes, origin, or retrospective/prospective nature of this testing. This implies bench testing or material conformance rather than a clinical human subject study.

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 information is not applicable/provided. The device is an anesthesia conduction needle, and the testing described is non-clinical (material and structural compliance with standards, biocompatibility). There is no "ground truth" established by human experts in the context of diagnostic or interpretive performance for such a device in this document.

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

This information is not applicable/provided. As above, there is no diagnostic or interpretive test set 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

This information is not applicable. The device is an anesthesia conduction needle (a physical medical instrument), not an AI-powered diagnostic or decision-support system. Therefore, an MRMC study or AI assistance is not relevant to this submission.

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

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

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

This information is not applicable. The device is a physical medical instrument, and the testing focuses on its physical and material properties, and sterility, against engineering standards.

8. The sample size for the training set

This information is not applicable/provided. There is no "training set" in the context of an AI algorithm described for this device. For the non-clinical testing, sample sizes are not explicitly stated in this summary.

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

This information is not applicable/provided. As there is no training set for an AI algorithm, this question is not relevant. For the non-clinical tests, the "ground truth" is adherence to the specified international standards.

Ask a specific question about this device