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MEDONE ULTRA Soft tissue programmable automatic biopsy system: biopsy system has been designed to be used for histological biopsy of soft tissues (such as breast, kidney, liver, prostate and various soft tissue masses). It is not intended for use in bone biopsy.

MEDEXTRA lymph node biopsy system with rectangular shaped cannula and adjustable penetration depth: is intended for use in obtaining biopsies from lymph nodes and other superficial non-vascular lumps. It is not intended for use in bone, deep visceral structures and breast biopsy.

Medax Soft Tissue Biopsy System portfolio is composed by single use devices intended to obtain biopsy samples from soft tissue for histological examinations.

MEDONE ULTRA Devices are available in different gauge dimensions (identified by different colors) and needle length.

Disposable programmable automatic spring-loaded guillotine style biopsy system for histological biopsy on soft tissue.

Disposable semi-automatic spring-loaded guillotine style biopsy system with adjustable penetration depth and rectangular shaped cannula for histological biopsy on lymph nodes and other superficial non-vascular lumps.

The Medax Soft Tissue Biopsy System (MEDONE ULTRA and MEDEXTRA) has been deemed substantially equivalent to its predicate devices based on non-clinical performance testing. Here's a breakdown of the acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA 510(k) summary does not explicitly list distinct "acceptance criteria" values in the traditional sense (e.g., a specific sensitivity or specificity percentage). Instead, it states that the devices met the acceptance criteria defined in the product specification and performed comparably to the predicate devices. The overall acceptance criterion for this submission is demonstrating substantial equivalence to legally marketed predicate devices.

The reported device performance is based on the results of the non-clinical bench tests demonstrating that the devices designed and tested to assure conformance to the requirements for its intended use and perform comparably to the existing predicate devices.

The tests demonstrated that the Medax Soft Tissue Biopsy System devices met the acceptance criteria defined in the product specification and performed comparably to the predicate device. Differences in needle range for MEDONE ULTRA (14G-20G vs 12G-20G for predicate) and MEDEXTRA (single length 100mm vs 80mm-300mm for predicate) were considered to fall within the predicate's range or not affect safety and effectiveness. |
| Biocompatibility | Biocompatible according to ISO 10993 applicable parts. |
| Sterilization effectiveness | Sterilized by Ethylene Oxide (EO), validated according to ISO 11135-1. Demonstrates compliance with bioburden and sterility tests, and EtO Residual, Ethylene Chlorohydrin and Ethylene Glycol according to EN ISO 10993-7. |
| Packaging integrity | Packaging validation performed according to ISO 11607-1.2006. |
| Labeling compliance | Labeling evaluation performed. |

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

The document details in vitro bench tests for performance evaluation. It does not mention a "test set" in the context of clinical studies with patients or human data.

• Sample Size for Test Set: Not applicable as it was an in vitro bench testing for physical and functional characteristics, biocompatibility, and sterility validation, not a clinical trial with a patient test set.
• Data Provenance: The testing was "in vitro bench testing," indicating laboratory-based tests. The country of origin for the data (where the tests were conducted) is not explicitly stated, but the submitter is MEDAX S.R.L. UNIPERSONALE based in Mantova, Italy. The tests were done as part of a 510(k) submission to the FDA. The data provenance is effectively non-clinical, laboratory-based, and retrospective (done to support current submission).

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

Not applicable. This was a non-clinical, bench testing study. The "ground truth" was established by engineering specifications, regulatory standards (e.g. ISO, ASTM), and the validated performance of the predicate devices. Experts involved would be engineers, quality assurance personnel, and regulatory affairs specialists, not clinical experts establishing a medical "ground truth."

4. Adjudication Method for the Test Set

Not applicable. There was no clinical test set requiring adjudication from medical experts.

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

No. This device is a biopsy instrument, not an AI-powered diagnostic tool, and therefore, an MRMC study related to AI assistance for human readers is not relevant or applicable to this submission.

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

No. This device is a manual biopsy instrument and does not involve any algorithms or AI for standalone performance evaluation.

7. The Type of Ground Truth Used

The "ground truth" for this submission is based on adherence to:

• Engineering and product specifications for the biopsy devices.
• International and national standards (e.g., ISO 9626, ASTM F899-12b, ISO 10993 series, ISO 11607-1, ISO 11737, ISO 11135-1, EN ISO 10993-7).
• Functional performance comparable to the legally marketed predicate devices.

Essentially, the ground truth is compliance with established regulatory standards and verifiable performance metrics for medical devices of this type, as demonstrated through bench testing.

8. The Sample Size for the Training Set

Not applicable. This device does not involve a "training set" in the context of machine learning or AI.

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

Not applicable. There is no training set for this device.

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