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The M-CORE disposable biopsy needle is intended for use with the Bard® Magnum® biopsy instrument in obtaining biopsies from soft tissues such as liver, kidney, prostate, breast, spleen, lymph nodes and various soft tissue tumors. The M-CORE needle is not intended for use in bone.

The M-CORE disposable core biopsy needle is a sterile, disposable biopsy needle featuring stainless steel cutting cannula and stylet, with sample is a lotenio, disposable biopsy needle leading stames steaturing statiness steat themoplastic removable spacer is provided to allow easy insection of both hubs into a Bard@ Magnum® reusable biopsy instrument. An LDP of the county the neder in both huss in a Barde Magnum® reuseble available in gauges from 14 - 18 and lengths from 10 - 25 centimeters.

The provided 510(k) summary for the M-CORE disposable core biopsy needle does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and a study proving those criteria are met. The document focuses on demonstrating substantial equivalence to predicate devices based on design and materials, and mentions "Performance testing summary" but does not elaborate on the specific tests or their results within this summary.

Here's a breakdown of what can be extracted and what is missing, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary does not explicitly state acceptance criteria in terms of specific performance metrics (e.g., biopsy sample quality scores, tensile strength, or cutting efficiency thresholds). Instead, it relies on demonstrating that the device is "substantially equivalent" to predicate devices, implying similar performance.

The summary states: "Performance testing confirms that the quality of the samples obtained with the M-CORE disposable core biopsy needle is substantially equivalent to the predicate device(s)." This is a general statement of performance, not a quantified measurement against an acceptance criterion.

The table provided in the document compares device characteristics, not performance metrics:

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

The 510(k) summary does not provide any information regarding the sample size used for performance testing (e.g., number of biopsies performed, number of needles tested). It also does not specify the data provenance (e.g., country of origin, retrospective or prospective).

3. Number of Experts and Qualifications for Ground Truth

No information is provided about experts used to establish ground truth. The summary mentions "the quality of the samples obtained," suggesting an evaluation of biopsy specimens, but does not detail how this quality was assessed or by whom.

4. Adjudication Method for the Test Set

No information is provided regarding any adjudication method for performance testing.

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

No MRMC study is mentioned or implied. This device is a biopsy needle, not an imaging or diagnostic algorithm that would typically involve human readers.

6. Standalone (Algorithm Only) Performance Study

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

7. Type of Ground Truth Used

While not explicitly called "ground truth," the performance testing likely involved assessing the "quality of samples obtained." This would typically be evaluated through:
* Histopathology/Pathology: Examination of the tissue samples by a pathologist to determine adequacy for diagnosis.
* Visual Inspection/Gross Examination: Assessment of the sample size, integrity, and appearance.
The document does not specify which of these, or any other method, was used.

8. Sample Size for the Training Set

Not applicable. This device is a physical medical instrument, not a machine learning algorithm that requires a training set.

9. How Ground Truth for the Training Set Was Established

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

In summary, the provided 510(k) notification primarily focuses on demonstrating substantial equivalence through a comparison of design and materials with predicate devices, and a general statement about performance testing confirming sample quality. It lacks the specific details about acceptance criteria, study sizes, methodologies, and expert involvement that your detailed questions request. This level of detail is often found in the full test reports referenced (e.g., "See Section 18" for Performance Testing Summary), but not typically within the concise 510(k) summary itself.

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The RP Cutting Needle is intended to be used by medical professionals with the Bard® Magnum® reusable biopsy instrument for biopsies of soft tissues, such as the liver, lung, kidney or prostate. The RP Cutting Needle is not intended for use in bone. The RP Cutting Needle is provided sterile as a single use device.

The RP Cutting Needle is a sterile, disposable biopsy instrument composed of a stainless steel cannula with a molded plastic hub, and a stainless steel stylet with a notch removed for specimen collection and a molded plastic hub. The cannula and stylet hubs are provided with a spacer attached which is designed to allow for easy insertion of both hubs into a Bard® Magnum® reusable biopsy instrument. The needle is covered with a LDPE sheath for safety. Needles are available in 14-20 gauge, with lengths between 10 and 25 cm. The predicate devices listed contain identical or substantially equivalent materials and characteristics as described above.

The provided text details the submission of a 510(k) premarket notification for the "RP Cutting Needle" and states its substantial equivalence to predicate devices. However, it does not contain the specific information requested regarding acceptance criteria, a study proving device performance against those criteria, sample sizes, expert involvement, adjudication methods, or MRMC/standalone study results.

Here's an analysis of what can be extracted and what is missing based on your request:

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

• Missing. The document states: "The RP Cutting needle is designed and manufactured to be substantially equivalent to the predicate devices listed below for safety and effectiveness." and "Dimensional and quality verifications, along with material certification has confirmed that the RP Cutting Needle is substantially equivalent to the predicate devices in size, shape, and function."
• This indicates that the acceptance criteria are based on substantial equivalence to predicate devices regarding general shape, size, method of function, and material properties. However, specific numerical acceptance criteria (e.g., minimum tensile strength, maximum bend angle, biopsy core length) and the reported performance against those numerical criteria are not provided.

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

• Missing. No information on sample sizes for any testing (e.g., dimensional, quality verifications) is provided.
• Missing. No information on data provenance is provided.

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)

• Missing. No information about experts or ground truth establishment for a test set is provided, as no clinical or comparative performance study is detailed. The device is deemed substantially equivalent based on engineering/material comparisons to predicate devices.

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

• Missing. Not applicable, as no test set requiring ground truth adjudication is 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

• Missing. Not applicable. This document is for a biopsy needle, not an AI-powered diagnostic device, so an MRMC study with human readers and AI assistance would not be relevant.

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

• Missing. Not applicable. This is a physical medical device (biopsy needle), not an algorithm.

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

• Missing. Not applicable. The "ground truth" here seems to be engineering specifications and material properties of existing predicate devices for establishing substantial equivalence, rather than clinical outcomes or diagnostic accuracy.

8. The sample size for the training set

• Missing. Not applicable. This is not an AI/machine learning device that would have a training set.

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

• Missing. Not applicable.

Summary of available relevant information from the document related to substantial equivalence:

• Device Description: "The RP Cutting Needle is a sterile, disposable biopsy instrument composed of a stainless steel cannula with a molded plastic hub, and a stainless steel stylet with a notch removed for specimen collection and a molded plastic hub. The cannula and stylet hubs are provided with a spacer attached which is designed to allow for easy insertion of both hubs into a Bard® Magnum® reusable biopsy instrument. The needle is covered with a LDPE sheath for safety. Needles are available in 14-20 gauge, with lengths between 10 and 25 cm."
• Equivalence Claim: "The RP Cutting needle is designed and manufactured to be substantially equivalent to the predicate devices listed below for safety and effectiveness."
• Evidence for Equivalence: "All materials used were selected based on known biocompatibility and established histories of use in the medical device industry for non-implantable devices, and are identical or substantially equivalent to the materials used in the predicate devices listed. The RP Cutting Needle has been designed to have the same general shape, size and method of function as the predicate devices. Dimensional and quality verifications, along with material certification has confirmed that the RP Cutting Needle is substantially equivalent to the predicate devices in size, shape, and function."
• Predicate Devices:
  • C.R. Bard®: Biopty-Cut® Needle; Magnum® Needle
  • Remington Medical: MLL Needle; M-Needle
  • Cook® Medical: Cook Biopsy Needle

Based on the provided text, the device's acceptance criteria are implicit in its claim of "substantial equivalence" to existing predicate devices regarding materials, general shape, size, and method of function. The "study" proving this substantial equivalence consists of "dimensional and quality verifications, along with material certification." Specific quantitative results or detailed study protocols are not included in this 510(k) summary.

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