(248 days)
The Biopsy Digit S and SL are intended to be used for mammographic procedures requiring stereotactic guidance, such as fine needle aspiration, needle biopsy and guide wire placement.
The Biopsy Digit S and Biopsy Digit SL are modifications to the Biopsy Digit AM needle guidance system. previously cleared as #K062039. and supplied as an accessory to the Giotto Image 3D/DL mammography system. The CMOS digital camera used on the Biopsy Digit AM is not used on the Biopsy Digit S/SL. Rather a 65mm (high) X 80mm (wide) portion of the full field amorphous selenium detector of the Giotto Image 3D/DL is used to acquire the mammographic, targeting, image data. The mechanics, cleanable surfaces, on-board electronics, and user interface software are all the same as on the biopsy Digit AM. The Biopsy Digit S/SL receives power from the Giotto Image 3D/DL. The Biopsy Digit S/SL in conjunction with the Giotto Image 3D/DL, take two exposures at separate angles ± 22.6° from the perpendicular of the digital detector centerline. The x-ray tube is driven first to one side of center and then to the other by an electro-mechanical mechanism, which is an integral part of the Giotto Image 3D/3DL, so that a stereo pair of images can be acquired. The two views provide two separate 2dimensional projections of the subject anatomy. The two views are stored in the computer system, and can be retrieved and viewed on the computer monitor. The operator, using a mouse, identifies the region of interest on the monitor. The computer then calculates of the region of interest in three dimensions, using trigonometry, and then transfers the coordinates to the needle-positioning unit. The software algorithm used for the calculation is identical to that used by the Biopsy Digit AM (#K062039). The needle-positioning unit then drives the needle holder to the required location so that the operator can insert the needle or locating wire into the exact coordinates necessary.
The provided 510(k) summary for the Giotto Biopsy Digit S/SL does not contain explicit acceptance criteria or a detailed study description with specific performance metrics and statistical analyses typically associated with proving a device meets acceptance criteria.
The document describes the device as a modification of a previously cleared device (Biopsy Digit AM) and focuses on demonstrating substantial equivalence through non-clinical testing. It highlights changes in the detector technology (from CMOS to an amorphous selenium detector) and confirms that the mechanics and software algorithms remain the same.
However, based on the information provided, here's what can be inferred and what is explicitly missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred from testing description) | Reported Device Performance (Inferred/Stated) |
|---|---|
| Equivalent image parameters between new aSe detector and old CMOS detector | Comparative image parameter testing performed. (No specific quantitative results provided) |
| Stereotactic accuracy in compliance with IEC Standard 60601-2-45 | Stereotactic accuracy testing performed for both biopsy systems. (No specific quantitative results provided) |
| User validation of the Biopsy Digit S/SL system | End user validation testing performed. (No specific quantitative results or success criteria provided) |
| Compliance with International Standards: IEC 60601-1-2, 60601-1-3, 62304 | Testing performed to demonstrate compliance. (No detailed report of compliance provided, only a statement) |
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the document. There is no mention of the number of images, cases, or subjects used in any of the described tests. The provenance of any data (e.g., country of origin, retrospective/prospective) is also not stated.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided. The document mentions "end user validation testing," but does not specify how many users participated, their qualifications, or how any "ground truth" for this validation was established. For stereotactic accuracy testing, the "ground truth" would likely be derived from physical measurements against a known standard, not expert consensus.
4. Adjudication Method for the Test Set
This information is not provided. Given the nature of the testing described (comparative image parameters, stereotactic accuracy, end-user validation), an adjudication method (like 2+1 or 3+1 expert consensus) is unlikely to be directly applicable in the way it would be for diagnostic AI performance. For end-user validation, feedback mechanisms would be used, but the specific method is not detailed.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed or described in this 510(k) submission. The device is a needle guidance system, not a diagnostic AI intended to assist human readers in interpretation. Therefore, assessing how human readers improve with or without AI assistance is not relevant to this device's function as described.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Standalone performance, especially for the "software algorithm used for the calculation" of the region of interest in three dimensions, was implicitly tested. The document states:
- "Stereotactic accuracy testing for both biopsy systems in compliance with IEC Standard 60601-2-45"
This testing would assess the accuracy of the system (including the algorithm) in guiding the needle, independent of a specific human operator's interpretation. However, specific results of this standalone accuracy are not provided. The document emphasizes that "The software algorithm used for the calculation is identical to that used by the Biopsy Digit AM (#K062039)," relying on the previous clearance for the algorithm's validation.
7. The Type of Ground Truth Used
- For Image Parameter Testing: Likely objective measures derived from test phantoms or calibrated imaging standards.
- For Stereotactic Accuracy Testing: Established through physical measurements against known targets or a gold standard measurement device, as per IEC Standard 60601-2-45.
- For End User Validation: Likely user feedback and possibly a demonstration of successful task completion based on the device's intended use.
- For Compliance with Standards: Objective verification against the requirements of the specified IEC standards.
The document does not explicitly state the exact nature of the ground truth for each test, but it can be inferred from the type of testing.
8. The Sample Size for the Training Set
This information is not applicable / not provided. The device is an accessory for stereotactic guidance, not a machine learning or AI algorithm that requires a training set in the conventional sense. The "software algorithm" for coordinate calculation is stated to be "identical" to the predicate device, implying it was developed and validated previously, not "trained" in this submission.
9. How the Ground Truth for the Training Set was Established
This information is not applicable / not provided for the same reasons as #8. If the "software algorithm" for coordinate calculation was developed using any form of historical data or training, those details are not within this 510(k) submission. The submission relies on the previous clearance (K062039) for the validation of this specific algorithm.
§ 892.1710 Mammographic x-ray system.
(a)
Identification. A mammographic x-ray system is a device intended to be used to produce radiographs of the breast. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.