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Automatic Biopsy Needles are intended in obtaining biopsy samples from soft tissues such as liver, kidney, prostate, breast, lymph nodes and various soft tissue tumors. It is not intended for use in bone.

Co-Axial Biopsy Device is mainly used to guide the insertion of biopsy needle into the soft tissue under imaging control (ultrasound, X-ray, CT, etc.). It is not intended for use in bone.

Semi-automatic Biopsy Needles are intended in obtaining biopsy samples from soft tissues such as liver, kidney, prostate, breast, lymph nodes and various soft tissue tumors. It is not intended for use in bone.

When used for breast biopsy, the product is for diagnosis only. The extent of histological abnormality cannot be reliably determined from its mammographic appearance. Therefore, the extent of removal of the imaged evidence of an abnormality does not predict the extent of removal of a histological abnormality; e.g., malignancy. When sampled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal of using standard surgical procedures.

Promisemed Automatic Biopsy Needles, Semi-automatic Biopsy Needles and Co-axial Biopsy Devices are hand-operated, non-electronic, surgical instruments.

Promisemed Automatic Biopsy Needles is designed for the automatic extraction of a specimen from soft tissues, while causing minimal surrounding tissue damage, for tissue pathological examination/ testing. Push the outer needle backward to expose the sampling slot of the inner needle by compression spring, then the spring's resilience realizes the movement of the outer needle and the excitation function.

Promisemed Semi-automatic Biopsy Needles is designed for the extraction of a specimen from soft tissues, while causing minimal surrounding tissue damage, for tissue pathological examination/testing. The semi-automated biopsy needle requires manual advancement of the inner needle to expose the specimen notch. With pressure on its plunger, a spring action rapidly advances the outer needle (cutting cannula) over the specimen notch of the inner needle.

Promisemed Co-Axial Biopsy Device is used with biopsy needles to guide the insertion of biopsy needle into the soft tissue under imaging control (ultrasound, X-ray, CT, etc.). It is supplied with trocar tip stylet with or without blunt tip stylet.

Promisemed biopsy device and accessories are sterile with a Sterility Assurance Level (SAL) of 106, non-pyrogenic and single-use devices.

The ultrasound, X-ray, CT and other equipments are used to guide the puncture and sampling. These products can't be used under MRI.

This document describes a 510(k) premarket notification for Promisemed Automatic Biopsy Needles, Promisemed Co-Axial Biopsy Devices, and Promisemed Semi-automatic Biopsy Needles. It does not present a study proving the device meets acceptance criteria in the way an AI/ML device would, but rather demonstrates substantial equivalence to predicate devices through comparisons of intended use, technological characteristics, and performance testing.

Therefore, many of the requested criteria for an AI/ML device's performance study (such as expert reads, MRMC studies, training/test set details, and ground truth establishment methods) are not applicable to this type of medical device submission.

Here's how to interpret the provided information in the context of the prompt, focusing on what is available and explaining why certain information is absent:

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

The document doesn't define "acceptance criteria" in terms of clinical performance metrics (like sensitivity/specificity for a diagnostic AI). Instead, for a medical device like a biopsy needle, "performance" is demonstrated through bench testing and adherence to recognized standards, showing that the device functions as intended and is safe and effective compared to similar devices already on the market.

The comparison tables for each device vs. its predicate device serve as the primary "performance" demonstration in this submission. The "Comments" column often highlights where the subject device either matches or has minor, acceptable differences from the predicate.

For example, from Table 1 (Promisemed Automatic Biopsy Needle vs. K192101):

The "Performance Testing Summary" on page 10 reiterates that "The bench testing performed verifies that the performance of the subject device is substantially equivalent in terms of critical performance characteristics to the predicate device." This is the core "proof" point for this type of submission.

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

• Sample Size for Test Set: Not applicable. This is not a study involving a test set of patient data for an algorithm. The "testing" refers to mechanical and material property bench tests of the physical device. The documents do not specify sample sizes (e.g., number of needles tested) for the bench tests, as this is typically reported in standard engineering reports.
• Data Provenance (country of origin, retrospective/prospective): Not applicable, as no patient data is used in this type of submission for performance evaluation.

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

• Number of Experts/Qualifications: Not applicable. This device is a physical instrument, not an AI that interprets images or data requiring expert-established ground truth. The "ground truth" for a biopsy needle's performance is its physical characteristics (e.g., strength, sharpness, sterility) and its ability to procure tissue, as validated through engineering and biocompatibility testing against established standards (e.g., ISO standards).

4. Adjudication method for the test set

• Adjudication Method: Not applicable. There is no human interpretation of a "test set" in the context of this device's performance validation.

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

• MRMC Study: Not applicable. This is not an AI/ML device and therefore no MRMC studies are performed.

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

• Standalone Performance: Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used

• Type of Ground Truth: For this type of device, the "ground truth" is established by engineering specifications, material standards (e.g., stainless steel properties), and biological safety standards (e.g., ISO 10993 for biocompatibility, sterility assurance levels). The device's performance is compared against these industry-recognized benchmarks and the performance of legally marketed predicate devices.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. There is no training set as this is not an AI/ML device.

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

• Ground Truth for Training Set Establishment: Not applicable. There is no training set.

Summary regarding the study:

The provided document, a 510(k) Premarket Notification, demonstrates the substantial equivalence of Promisemed's biopsy devices to legally marketed predicate devices. The "study" proving the device meets acceptance criteria in this context consists of:

• Bench Testing: Verifying critical performance characteristics (e.g., mechanical properties, material composition, sterile attributes) against recognized international standards (e.g., ISO 9626:2016 for needle tubing, ISO 10993 for biocompatibility, USP42-NF37 for pyrogenicity).
• Comparison Tables (Tables 1-3): Detailed comparisons of crucial technical specifications (e.g., gauge, needle length, materials, sterilization method, intended use) between the subject devices and their respective predicate devices. Any differences are explicitly noted and deemed not to affect the device's safety or effectiveness.

This approach is standard for demonstrating substantial equivalence for general medical devices, which differs significantly from the performance validation required for AI/ML-based medical devices.

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