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The LAP DISC Hand Access Device is intended to provide extracorporeal extension of pneumoperitoneum and abdominal access for the surgeon during laparoscopic surgery. The LAP DISC is indicated for use in laparoscopic procedures, where entry of the surgeon's hand may facilitate the procedure, and for extraction of large specimens. The LAP DISC has application in colorectal, urological, gynecologic and general surgical procedures. This indication for use includes the specific procedures which fall under these broad categories.

The LAP DISC is a sterile, single-use disposable device. The LAP DISC is an abdominal wall closure unit consisting of three overlaid plastic rings that are interconnected by means of a silicone rubber membrane. The two lower rings hold the abdominal wall to maintain peritoneal gas pressure. The bottom ring is a flexible ring made with a shapememory alloy. The top ring has a structure similar to the aperture in a camera (an Iris Valve). Because the aperture of the Iris Valve can be adjusted continuously, the system can maintain constant peritoneal gas pressure while allowing the insertion of the surgeon's hand and alternatively, it can be used as an insertion site.

This submission, K030824, is for a medical device (LAP DISC Hand Access Device), not an AI/ML device. Therefore, the concepts of acceptance criteria, study data, sample sizes, ground truth establishment, expert adjudication, or comparative effectiveness studies (MRMC, standalone algorithm) typically associated with AI/ML device evaluations are not applicable in this context.

The 510(k) summary provided indicates that this submission is for a device identical in technological characteristics to a previously cleared predicate device (K010870 and K020307), with the only differences being an expanded intended use statement and the addition of a measuring tape accessory.

The FDA's review for this type of submission focuses on demonstrating substantial equivalence to a predicate device, primarily through technological characteristics and intended use. There is no mention of a study to prove acceptance criteria in the provided text because it is not relevant for this type of device submission.

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The BioSuc Fine Aspiration Cytology Needle is indicated for the biopsy of tumors in the Thyroid, Breast or Lymph node.

Needle size: 20G: 50mm to 100mm, 21G: 50mm, 22G: 50mm Needle tip: Bayonet point (Lancet point) Suction syringe: 7 ml Plunger slide: 35 mm Side Hole 20G: φ 0.35 to φ 0.5 n=0 to 3; 21G: φ 0.35 to φ 0.5 n=0 to 3; 22G: φ 0.35 n=0 to 2

This submission (K013108) is for the BioSuc Fine Aspiration Cytology Needle. The provided documents focus on establishing substantial equivalence to predicate devices and do not contain detailed information about performance studies or acceptance criteria beyond stating the device's intended use and physical characteristics.

Therefore, I cannot provide a complete answer to your request regarding acceptance criteria and the study that proves the device meets them based solely on the provided text. The document is a 510(k) premarket notification for a medical device, which primarily establishes substantial equivalence to predicate devices rather than providing detailed performance study results in the way a clinical trial report might.

However, I can extract the information that is present and explain why other sections are not available in this document:

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

• Acceptance Criteria: Not explicitly stated in terms of performance metrics (e.g., success rate of aspiration, tissue yield). The acceptance criteria for this type of submission generally revolve around demonstrating that the device is as safe and effective as its predicate devices. This is typically done by comparing technological characteristics and intended use.
• Reported Device Performance: Not reported in terms of quantitative performance metrics from a study. The document lists physical specifications of the needle (size, tip, syringe, side holes) which are inherent to the device design rather than performance outcomes.

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 available in the provided 510(k) submission. A 510(k) generally focuses on demonstrating substantial equivalence to existing devices through comparison of design, materials, and intended use, rather than requiring extensive new clinical trial data for devices like this aspiration needle. If any testing was done, it would likely be non-clinical (e.g., mechanical testing, biocompatibility) but details are not provided here.

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 available. Ground truth establishment and expert review are typically part of clinical performance studies, which are not detailed in this 510(k) submission.

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

• This information is not available.

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 question is not applicable to this device. The BioSuc Fine Aspiration Cytology Needle is a physical biopsy instrument, not an AI-assisted diagnostic tool or imaging device that would involve human readers or MRMC studies.

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

• This question is not applicable to this device. It is a physical medical instrument, not an algorithm.

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

• As no clinical performance study data is provided, the type of ground truth used is not applicable/not available. For a device like this, ground truth in a clinical study would typically involve pathological confirmation of biopsies.

8. The sample size for the training set

• This information is not applicable/not available as there is no mention of a training set, usually associated with machine learning or AI models, which this device is not.

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

• This information is not applicable/not available.

Summary of available information related to "acceptance criteria" and "study":

The core "study" proving the device meets "acceptance criteria" in a 510(k) for a device like this is the demonstration of substantial equivalence to predicate devices. The "acceptance criteria" for such a submission are met if the FDA agrees that the new device is as safe and effective as a legally marketed predicate device.

The provided document states:

• "The BioSuc Fine Aspiration Cytology Needle is substantially equivalent to the referenced predicated devices in that it is similar with respect to technological characteristics and intended use."

The FDA's letter further confirms:

• "We have reviewed your Section 510(k) premarket notification of intent to market the device... and have determined that the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..."

Therefore, the "study" is the 510(k) review process itself, which concluded that based on comparison of intended use and technological characteristics (listed in the tables for needle size, tip, syringe, side holes), the BioSuc needle is substantially equivalent to existing, legally marketed predicate devices (Manan Medical Products, Inc. Westcott Aspiration Needle K943651; Allegiance Aspiration Needle K831392; Travenol Lab. Daum Aspiration Biopsy Needle K974575). The "acceptance criteria" were met by successfully demonstrating this substantial equivalence to the FDA.

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The Sonopsy aspiration needle is intended to percutaneously obtain abdominal tissue including the liver, prostate, kidney, breast, lymph node, and other soft tissues using ultrasonic visualization.

Needle size: 14G to 21G, 80 to 200mm Needle tip: Biopsy point Inner needle tip: pencil point or trocar point Suction syringe: 7 ml Plunger slide: 35 mm Guide needle size: L=50 to 80 mm or without Guide needle tip: Lancet point or blunt end Filter paper: size 20x35mm, 3 pieces

The provided text describes a 510(k) submission for a medical device, the "Sonopsy Aspiration Biopsy Needle." This type of submission establishes substantial equivalence to legally marketed predicate devices, rather than proving performance against specific acceptance criteria through a clinical study in the way a novel AI or diagnostic device might.

Therefore, the information requested regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth for training/test sets is not applicable to this type of regulatory submission.

Here's why:

• 510(k) for Substantial Equivalence: A 510(k) premarket notification demonstrates that a new device is "substantially equivalent" to a predicate device already legally marketed. This process primarily focuses on comparing the new device's technological characteristics and intended use to the predicate, rather than conducting new clinical trials to establish performance against pre-defined clinical acceptance criteria.
• Device Type: The Sonopsy Aspiration Biopsy Needle is a Class II gastroenterology-urology biopsy instrument. These are typically mechanical devices where performance is assessed through bench testing (e.g., needle sharpness, strength, material compatibility) and comparison of specifications to predicate devices. Clinical studies with human subjects to determine performance metrics like sensitivity, specificity, or accuracy (as would be relevant for an AI diagnostic tool) are generally not required for this type of device to obtain 510(k) clearance.

The key takeaway from the provided text is that the device was deemed substantially equivalent to the predicate devices listed (INRAD/MANAM Accucore Biopsy Needle, E-Z-EM, INC. Lufkin Aspiration Needle, DAUM Corp. DAUM Aspiration Needle) based on its technological characteristics and intended use, which is sufficient for 510(k) clearance.

If this were an AI-powered diagnostic device, a much more comprehensive study section detailing the points you've listed would be present.

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