Search Results

The iSR'obot Biopsy Kit (consisting of a needle guide, a probe sheath and a drape) is intended to be used with the iSR'obot Mona Lisa (K130944) for performing image guided transperineal biopsies of the prostate.

The iSR'obot Biopsy Kit is a consumables pack consisting of three (3) separate singleuse items designed to be used with the iSR'obot Mona Lisa (K130944).
Contents of the Biopsy Kit:
Probe Sheath: Non-active invasive device made of medical grade TPX (polymethylpentene). The open end of the sheath is intended to be connected to the end of the probe platform of Mona Lisa and its closed end is to be inserted into the patient's rectum for transient use (

The provided text describes the 510(k) submission for the iSR'obot Biopsy Kit, which consists of a needle guide, a probe sheath, and a drape. It establishes substantial equivalence to predicate devices rather than presenting a study proving performance against acceptance criteria for an AI-powered device. Therefore, a direct answer to the request regarding acceptance criteria and a study proving an AI device meets them cannot be fully provided from the given text.

However, I can extract the information related to the device itself and its testing, and then explain why a full answer to your prompt is not possible with the provided document.

Based on the provided document, here's what can be extracted regarding acceptance criteria and device testing:

This document is a 510(k) premarket notification, which seeks to demonstrate "substantial equivalence" to existing legally marketed predicate devices, rather than proving performance against specific acceptance criteria for a novel AI device through a clinical study with detailed statistical outcomes.

The testing described is primarily for the physical components of the iSR'obot Biopsy Kit (probe sheath, needle guide, drape) and their functionality, biocompatibility, and sterility, which are typical for consumable medical devices. It does not describe an AI device, an AI-powered component, or an MRMC study.

Here's a breakdown of the requested information, adapted to what is (and isn't) available in the text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" in the format typically seen for AI device performance (e.g., sensitivity, specificity, AUC thresholds). Instead, it discusses the functional and safety requirements for a physical medical device kit and reports on non-clinical tests to meet these.

• Effective ultrasound imaging through the sheath
• Biocompatibility (ISO 10993-01)
• Environmental, packaging, shipping, shelf-life, and sterilization requirements | - Laboratory stress tests demonstrated mechanical safety.
• Performance testing showed effective ultrasound imaging of the prostate gland through the probe sheath using a phantom.
• Reviewed images obtained during the clinical trial of the main device (iSR'obot Mona Lisa, K130944) for imaging effectiveness.
• Met biocompatibility requirements specified by ISO 10993-01.
• Environmental, packaging, shipping, shelf-life, and sterilization requirements were met through validations performed by a certified laboratory. |
  | Needle Guide | - Allow 18-gauge needle passage
• Needle deflection within specified tolerance
• Biocompatibility (ISO 10993-01)
• Environmental, packaging, shipping, shelf-life, and sterilization requirements | - Physical dimensions were verified to ensure an 18-gauge needle can pass through.
• Any deflection of the needle was within the specified tolerance.
• Met biocompatibility requirements specified by ISO 10993-01.
• Environmental, packaging, shipping, shelf-life, and sterilization requirements were met through validations performed by a certified laboratory. |
  | Drape | - Sterility maintenance over shelf-life | - Microbial barrier test on the Tyvek film pouch showed it can maintain sterility for the 3-year shelf-life if packaging integrity is not compromised. |
  | Overall Kit| - Designed and manufactured under Quality System Regulations (21 CFR 820 and ISO 13485) | - Risk Analysis conducted
• Requirements Reviews completed
• Design Reviews completed
• Usability Analysis performed
• Performance testing (Verification) completed |

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

• Test Set: The document does not specify a "test set" in the context of an AI algorithm's performance validation.
  • For the probe sheath, testing involved a phantom and a "review of images obtained during the clinical trial conducted for the main device - iSR'obot Mona Lisa (K130944)". The sample size for this review is not specified.
  • For the needle guide, "physical dimensions were verified," implying a small sample or inspection.
• Data Provenance: Not applicable as this is not a study on a data-driven AI device. The images reviewed for the probe sheath came from the clinical trial of the associated Mona Lisa device, but no further details on origin (e.g., country) or retrospective/prospective nature are provided for those images.

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

• Not applicable. This is a submission for a physical medical device kit, not an AI device requiring expert-established ground truth for a diagnostic task.

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

• Not applicable. No such adjudication method is mentioned or relevant for this type of device submission.

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, an MRMC study was NOT done. This document pertains to a physical medical device kit, not an AI-powered diagnostic or assistive tool.

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

• Not applicable. This is not an AI algorithm.

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

• Not applicable in the context of AI device ground truth. The "ground truth" for this device's performance relates to its physical properties:
  • Mechanical safety: Direct observation against stress.
  • Imaging effectiveness: Comparison of ultrasound images (with and without the sheath) using a phantom and potentially clinical images from the associated device's trial.
  • Sterility: Microbial barrier tests.
  • Biocompatibility: Adherence to ISO 10993-01 standards.

8. The sample size for the training set:

• Not applicable. This is not an AI device.

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

• Not applicable. This is not an AI device.

In summary: The provided document is a 510(k) premarket notification for a physical medical device kit. It focuses on demonstrating substantial equivalence to predicate devices through functional and safety testing of its components (probe sheath, needle guide, drape), rather than detailing the performance metrics or clinical study results of an AI-powered diagnostic system. Therefore, most of the questions pertaining to AI device validation (e.g., acceptance criteria for AI, training/test set details, expert ground truth, MRMC studies) are not addressed in this document.

Ask a specific question about this device