(42 days)
The piXarray 100 Digital Specimen Radiography (DSR) System is a cabinet digital Xray imaging system intended to generate and control X-rays for examination of various anatomical regions, and to provide rapid verification that the correct tissue has been excised during excisional or percutaneous biopsy.
Performing the verification directly in the same biopsy procedure room enables cases to be completed faster, thus limiting the time the patient needs to be under examination. Specimen radiography can potentially limit the number of patient recalls. This device is intended to be operated wherever the medical professionals deem appropriate, including a surgical suite or a room adjacent to a surgical suite.
The piXarray 100 Digital Specimen Radiography (DSR) System is a standalone cabinet digital X-rav imaging system to provide rapid verification that the correct tissue has been excised during excisional or percutaneous biopsy.
Performing the verification directly in the same biopsy procedure room enables cases to be completed faster, thus limiting the time the patient needs to be under examination. Specimen radiography can potentially limit the number of patient recalls.
The piXarray 100 Digital Specimen Radiography (DSR) System employs the use of Biopix image acquisition software. The Biopix software handles the digital X-ray image acquisition, calibration, image display, image analysis and manipulation, patient database, image archiving, and transmittal. Biopix software is the central part of this system. Biopix software is Digital Imaging and Communications in Medicine (DICOM) 3.0 compliant and comes with DICOM Print, Store and Modality Work List (MWL).
Here's an analysis of the provided text regarding the piXarray 100 Digital Specimen Radiography (DSR) System, focusing on acceptance criteria and study details.
Based on the provided document, the submission for the piXarray 100 Digital Specimen Radiography (DSR) System (K052433) is a 510(k) premarket notification. This type of submission primarily relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than extensive clinical studies proving new acceptance criteria.
The acceptance criteria are therefore focused on meeting regulatory standards and demonstrating equivalence to the predicate, the Mammopath™ cabinet X-ray system (K021113).
Here's the breakdown of the information requested, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Implied/Stated) | Reported Device Performance |
|---|---|---|
| Regulatory Compliance | - Compliance with 21 CFR 1020.40 (Cabinet X-ray systems) |
- Radiation emission not exceeding 0.5 milliroentgen in one hour at any point five centimeters outside the external surface.
- Compliance with FDA's performance standards for ionizing radiation emitting products (Part 1020).
- Compliance with applicable general controls (annual registration, listing, good manufacturing practice, labeling, prohibitions against misbranding and adulteration).
- Software Level of Concern: "moderate". | - "The piXarray 100 Digital Specimen Radiography (DSR) System conforms to 21 CFR 1020.40."
- "Evidence of the compliance is provided throughout this submission and is referenced in the appropriate exhibits."
- "The radiation emitted from the piXarray 100 Digital Specimen Radiography (DSR) System cabinet x-ray system does not exceed an exposure of 0.5 milliroentgen in one hour at any point five centimeters outside the external surface. See Radiographic Control Certificate. Document # 1240 is included in this exhibit."
- "Bioptics has determined that the submitted device has a 'moderate' software Level of Concern and has provided that documented record as part of this submission." |
| Substantial Equivalence to Predicate Device (Mammopath) | - Same Indications for Use as predicate. - Same technological characteristics as predicate (X-ray technology, power source, digital imaging, computer interface, hardware, OS, functionality).
- Performance as well as the predicate. | - "The piXarray 100 Digital Specimen Radiography (DSR) System has the same indications for use as the Mammopath cabinet X-ray system."
- "The piXarray 100 Digital Specimen Radiography (DSR) System has the same technological characteristics as the Mammopath cabinet X-ray system."
- "The submitter concludes that the piXarray 100 Digital Specimen Radiography (DSR) System employs the same type of technological characteristics..."
- "The results of this testing substantiates that the piXarray 100 Digital Specimen Radiography (DSR) System performs as well as the predicate, the Mammopath cabinet X-ray system."
- Differences noted but deemed not significant or evolutionary: Energy Range (5-45 kV vs 10-35 kV), Tube Current (0.5 mA vs 0.1 mA), X-ray Coverage (19.0 cm vs 14.6 cm), Window Filtration (0.2 mm Beryllium vs 0.8 mm Beryllium), Footprint (38cm w x 41cm d x 66cm h vs 36cm w x 34cm d x 39cm h). |
| Design Control & Verification/Validation | - Robust quality system. - Detailed design inputs and outputs.
- Verification and Validation activities.
- Risk assessment and management for software.
- Software coding verification.
- Alpha validation testing of all functionality and hazard addressing.
- System software and operating software performance and environmental testing. | - "Additionally, the submitted device has been designed in a device design and manufacturing environment with a robust quality system."
- "Extremely controlled and detailed design inputs and outputs define all of Bioptics product development activities."
- "The submitter believes and claims that the submitted device was developed, tested and validated to perform in a manner that accurately portrays the submitted systems intended use, functionality, safety features, user interface, operation, and documentation."
- "The submitted device's software controls were subjected to significant verification and validation testing."
- "Verification testing was performed during software coding and results were recorded as 'comments' in the software code."
- "Alpha validation testing included testing of all functionality and confirmation that all identified hazards have been adequately addressed by software functionality, the user interface or documentation."
- "Alpha validation activities included specified system software and operating software performance and environmental testing within the specified environment. Refer to 'Software Revision History'. Document # 1239, included in Exhibit 9." |
| Intended Use & Functionality | - Rapid verification of correct tissue excision. - X-ray image creation.
- Operation in biopsy procedure room/surgical suite.
- Compact and portable design.
- One-button operation with automatic exposure control.
- High-resolution digital imaging.
- DICOM 3.0 compliance. | - "Performing the verification directly in the same biopsy procedure room enables cases to be completed faster..."
- "The piXarray 100 Digital Specimen Radiography (DSR) System employs the use of Biopix image acquisition software. The Biopix software handles the digital X-ray image acquisition, calibration, image display, image analysis and manipulation, patient database, image archiving, and transmittal."
- "Biopix software is Digital Imaging and Communications in Medicine (DICOM) 3.0 compliant and comes with DICOM Print, Store and Modality Work List (MWL)."
- "The piXarray 100 Digital Specimen Radiography (DSR) System is of compact and portable design plugs into any A/C outlet and requires no external X-ray shielding."
- "The piXarray 100 DSR System offers one-button operation utilizing automatic exposure control for optimal X-ray exposure. High resolution digital imaging with large area formats is available." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a sample size for a test set in the context of clinical or performance data for image interpretation. The testing described is primarily for engineering, software, and regulatory compliance.
- Sample Size (Test Set): Not specified for image-based performance evaluation. The "Alpha validation testing" implies internal software and system functionality testing, but not a dataset of medical images for diagnostic performance.
- Data Provenance: Not applicable in the context of image data. The testing mentioned is internal to the manufacturer (Bioptics, Inc.) for system and software validation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The submission does not describe a study involving expert readers establishing ground truth for a test set of medical images for diagnostic purposes. The "ground truth" for the engineering and software validation would be the design specifications and expected system behavior.
4. Adjudication Method for the Test Set
Not applicable, as no external test set requiring expert adjudication is described in the document.
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. The document explicitly states: "To the submitter's knowledge, the predicate device, Mammopath cabinet X-ray system, did not provide or reference any clinical tests submitted in compliance with 807.92(b)(2), therefore the submitter believes such clinical testing is not appropriate or required by FDA and has not made or provided any summary of such testing."
This indicates that no clinical comparative effectiveness study, including an MRMC study with or without AI assistance, was performed or presented as part of this 510(k) submission. The device is for "Digital Specimen Radiography," which typically involves immediate visual verification by a clinician, not necessarily a complex AI-assisted diagnostic workflow with multiple readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
No specific standalone algorithm performance study is described as part of this submission. The device is a "system" (piXarray 100 DSR System) that includes the Biopix software, which "handles the digital X-ray image acquisition, calibration, image display, image analysis and manipulation, patient database, image archiving, and transmittal." This is an integrated system for image generation and display for human interpretation, not an AI algorithm intended for standalone diagnostic output.
7. The Type of Ground Truth Used
The primary "ground truth" for this submission revolves around:
- Regulatory Standards: Compliance with 21 CFR 1020.40 and general performance standards for X-ray emitting products.
- Predicate Device Characteristics: The functional and technological characteristics of the Mammopath cabinet X-ray system.
- Design Specifications: For the internal verification and validation of the piXarray system's own design, software, and hardware.
There is no mention of ground truth established from pathology, expert consensus on image findings, or patient outcomes data for clinical diagnostic performance.
8. The Sample Size for the Training Set
No training set is mentioned or applicable, as this device primarily relies on traditional X-ray imaging principles and software for image acquisition, processing, and display for human interpretation, rather than a machine learning or AI model that requires a training set of images.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no mention of a training set.
§ 892.1680 Stationary x-ray system.
(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.