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Orthopantomograph® OP200 (film unit) and OP200 D (digital unit) devices are intended to be used for producing X-ray radiographs of dentition, TM-joints and other oral structures. The units are capable of taking panoramic, TM-joint and maxillary sinus radiographs from patients. When the units are equipped with cephalometric option Orthoceph® OC200 (film unit) or OC200 D (digital unit) units can be used for cephalometric radiography and examinations related thereto. OP200 or OC200 units can also be equipped with Ortho Trans (OT) option, which is capable of taking both cross and longitudinal slices of region of interest. Ortho Trans uses linear tomography imaging principle.

Panoramic X-ray devices Orthopantomograph® OP200, OP200 D and cephalometric options Orthoceph® OC200, OC200 D are the next generation in the Orthopantomograph® and Orthoceph® family. In the case of OP200 and OC200 devices, the image is captured to the film whilst OP200 D and OC200 D offer digital imaging. The units include patented V-shaped X-ray beam that adapts to the bone density and structure of the human anatomy. In the OP200 D and OC200 D the imaging geometry remains the same as in film-based imaging (OP200, OC200), thereby enabling comparison to earlier film-based studies. The patient positioning is easy and accurate thanks to motorized movements and three light lines for correct positioning of the patient's head. The patient's midsagittal view can be seen in a panoramic mirror and the electrically locked rigid forehead support is used to stabilize the head. Patient positioning can be performed on the left or right side. When OP200 or OC200 units are equipped with CR option they have bigger 24x30cm cassette holder in panoramic side. Normal cassette holder size is 15x30cm. With this bigger 24x30cm cassette holder CR imaging plates can be used. Optional Ortho ID film marking system can be used to store exposure parameters, patient and clinic information to films. Ortho ID is connected to OP200 or OC200 film units. Equipments are designed to be field upgradeable. This means that for example basic OP200 film unit can be field upgraded to OC200 (cephalometric imaging) or OP200 D digital or OC200 D digital. All different options like OT, CR, etc. can be field upgraded afterwards.

This 510(k) premarket notification for the Orthopantomograph® OP200, OP200D and Orthoceph® OC200, OC200D devices is for traditional X-ray equipment and does not contain information typically found in submissions for AI/ML-driven medical devices, such as performance criteria based on AI algorithm outputs, clinical study data comparing AI to human performance, or detailed data provenance for AI model training/testing.

Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment relevant to AI/ML device evaluations.

The document primarily focuses on demonstrating substantial equivalence to predicate devices based on design, composition, and function for conventional dental panoramic and cephalometric x-ray imaging.

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Performa Stereo is intended to be used for breast biopsy or lesion marking with the base mammographic system Performa with stereo adapter.

Performa Stereo is a breast biopsy and lesion marking system in connection with the Performa mammographic system (#K981641). The Performa stereo is especially developed for fine needle aspiration (FNA), core biopsy, vacuum assisted biopsy and lesion marking. The Performa Stereo system consists of a biopsy unit with a needle guide and a breast support table, an adapter unit for making ±15° angles, and a film marker unit. A mechanical docking interface is used for connecting the Performa Stereo's stereo adapter and the biopsy unit together. There are no electrical connections between the biopsy unit and Performa.

The adapter unit is identical to adapter used in the case of Alpha Stereo 4 and Delta 16. The needle guide is a Cytoguide biopsy unit which is the same than used in the case of Delta 32.

In an examination two X-ray images are taken at angles of +15° and -15° degree of the region of interest in the breast. The image capturing will be made by 18x24 cm film cassette and the needle targeting driving will be made with the motorized Cytoguide needle guide unit which are the main functions of the biopsy unit. After making two individual stereotactic X-ray exposures to one film, the corresponding two images are shown side by side on the film reader unit. The user then marks the target point with a cursor on each image. Based on the marking the xyzcoordinates of target are calculated by the film marker unit. The needle holder is then automatically positioned, taking into account the coordinate information and the needle length selected. The tip of the needle, which is then inserted into the holder with correct bushings can now be used to penetrate the lesion area.

The provided document is a 510(k) premarket notification for a medical device called "Performa Stereo." This document primarily focuses on establishing substantial equivalence to predicate devices and does not contain detailed information about a study proving specific acceptance criteria for the device itself.

Here's a breakdown of the information that can be extracted and what is missing:

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

Missing. The document does not provide a table of acceptance criteria or reported device performance metrics. It focuses on the function and design of the device and its equivalence to previously approved devices.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Missing. There is no mention of a test set, sample size, or data provenance. The submission describes the device's mechanism and its intended use, rather than presenting results from a clinical or performance study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Missing. Since no specific test set or study is described, there is no information about experts or ground truth establishment.

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

Missing. No test set or adjudication method is described.

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

Missing. The Performa Stereo is a mechanical system for breast biopsy and lesion marking, not an AI-powered diagnostic tool. Therefore, an MRMC study related to AI assistance is not applicable and not mentioned.

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

Missing. As the device is a physical, mechanical system, there is no "algorithm only" performance to evaluate in this context.

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

Missing. No study or ground truth is described.

8. The sample size for the training set

Missing. This device is a mechanical system, not an AI model, so there is no concept of a "training set" in the context of this submission.

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

Missing. Not applicable, as there is no training set for this type of device.

Summary of available information:

The document serves as a 510(k) summary for the "Performa Stereo" system, a breast biopsy and lesion marking system. Its purpose is to demonstrate substantial equivalence to previously marketed devices (Alpha Stereo 4, GE Stereotix 2, Siemens Mammomat 3000 Stereo). The submission describes the device's components and functionality, emphasizing its mechanical aspects and integration with the Performa mammographic system. It does not include performance data from a clinical study, acceptance criteria, or ground truth establishment as it's not a diagnostic AI device or a device requiring specific performance metrics beyond functional equivalence in this submission.

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Focus is intended to be used for producing diagnostic x-ray radiographs of dentition, jaws and other oral structures.

The FOCUS is a microprocessor controlled intra-oral x-ray unit with a Load Matching Frequency (LMF) DC generator, which produces dental images on digital and film media. For the digital images the FOCUS is connected to the Sigma USB terminal which is connected to a PC, which reads the image data from a sensor and displays the image on the PC monitor. In order to make installation and service faster and easier the electronics is integrated into the horizontal arm.

The provided text describes the 510(k) summary for the "Focus" intra-oral x-ray unit, which includes an AEC option. However, it does not contain detailed acceptance criteria, a specific study proving the device meets those criteria with performance metrics, or information about AI/algorithm performance.

The document focuses on demonstrating substantial equivalence to a predicate device (Focus K001729) and verifying the modified Focus functions as intended and provides images of equivalent diagnostic capability.

Therefore, many of the requested details cannot be extracted from this document. I will fill in the available information and explicitly state what is not present.

Acceptance Criteria and Device Performance

Detailed Study Information (Based on Available Text):

1. Sample size used for the test set and the data provenance: Not specified. The document only mentions "Verification and validation testing."
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not specified.
4. 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: Not applicable. This device is an x-ray unit, not an AI-based diagnostic tool. The document does not mention AI assistance or MRMC studies.
5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI algorithm. The performance evaluation is related to the imaging capabilities of the x-ray unit itself.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The document refers to "equivalent diagnostic capability to that of predicate device," implying a comparison based on image quality suitable for diagnosis. However, the specific method for establishing this "diagnostic capability" (e.g., by expert review, comparison to known clinical outcomes) is not detailed.
7. The sample size for the training set: Not applicable. This is not an AI algorithm requiring a training set.
8. How the ground truth for the training set was established: Not applicable.

Summary of what is known:

The submission focuses on demonstrating substantial equivalence to a previously cleared device (Focus K001729) and confirming that the modifications (primarily the AEC option) do not alter the diagnostic capability, safety, or effectiveness. The term "performance data" refers to verification and validation testing, but the specifics of these tests are not provided in this 510(k) summary. The comparison is against the predicate device's established performance, implying that the new device meets similar standards.

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Delta 32 and Delta 32 TACT® are intended to be used for diagnostic digital spot and 3D imaging, and optionally for digital stereotactic breast biopsy. Delta 32 and Delta 32 TACT® are intended to be used with the base mammographic system Diamond. However, a PC workstation of Delta 32 and Delta 32 TACT® can also be used as stand-alone for viewing images taken by Delta 32 and Delta 32 TACT®. The TACT® add-on provides means for digital 3D spot imaging using 2D projection images acquired with the system.

Delta 32 and Delta 32 TACT® is a mammographic diagnostic digital mammography spot and 3D imaging system, which can also be used for digital stereotactic breast biopsy. The base system is the Diamond mammographic system (#K955411), on which the Delta 32 and Delta 32 TACT® is installed. The images are acquired by a CCD camera identical to our Delta 32 (#K002472). The needle guiding system is the same than previously, Cytoguide biopsy unit (#K885020). A PC workstation receives images and computes the necessary needle coordinates for Cytoguide unit. The PC also performs the optional TACT® 3D reconstruction identically to the Delta 32 TACT® system described in (#K002472). The PC workstation can also be used as stand-alone for viewing digital mammography spot and 3D images taken by Delta 32 and Delta 32 TACT®.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Delta 32 with optional add-on TACT® device:

Acceptance Criteria and Device Performance Study for Delta 32 with optional add-on TACT®

The evaluation for the diagnostic use of the Delta 32 and Delta 32 TACT® was based on a clinical study comparing the subjective image quality of the digital system to screen and diagnostic film systems. The study used a Likert scale from +4 (digital image absolute better) to -4 (film image absolute better).

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria (e.g., "The average Likert score must be greater than X"). However, the performance indicated by the statistical significance (p

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Orthopantomograph® OP100D is intended to be used for producing diagnostic x-ray radiographs of dentition, TM-joints and other oral structures.

Not Found

The provided text does not contain detailed information regarding the acceptance criteria of device performance, the study design, or the specific metrics used to demonstrate the device meets those criteria. The document is an FDA 510(k) clearance letter for the Orthopantomograph® OP100D, indicating that the device has been deemed substantially equivalent to a legally marketed predicate device.

Therefore, I cannot provide the requested information about acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment based on the provided text.

The document primarily states that the device is intended for "producing diagnostic x-ray radiographs of dentition, TM-joints and other oral structures" and has received regulatory clearance based on substantial equivalence. This type of regulatory document does not typically include the technical details of performance studies as specific as those requested in your prompt.

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The mammographic X-ray unit model MGF101 and MGF110, is a mammographic imaging system for screening and diagnostic examinations. The unit can also be adapted for biopsy and spot mammographic examinations.

Mammography X-ray equipment models MGF101 and MGF110, Commercial names: Alpha III, Alpha ST, Alpha RT and Alpha IQ

The provided text is a 510(k) clearance letter from the FDA for mammography X-ray equipment (models MGF101 and MGF110, commercial names Alpha III, Alpha ST, Alpha RT, and Alpha IQ). This document is a regulatory approval and does not contain information about acceptance criteria or a study proving the device meets those criteria.

The letter confirms that the device is substantially equivalent to devices marketed before May 28, 1976, and outlines the regulatory class and general controls provisions of the Act. It mentions the "Indications For Use" which describes the intended purpose of the device (mammographic imaging system for screening, diagnostic, biopsy, and spot mammographic examinations), but it does not detail performance metrics or study results.

Therefore, I cannot provide the requested information based on the input text. The input only provides regulatory approval details, not technical performance or study data.

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The AS/3™ ESTPR module is intended to be used in the Datex AS/3" Anaeshesia Monitor or in the AS/3" Compact Monitor in anesthesia department, in recovery rooms, operation theatres etc.

The AS/300 ESTPR Module is a part of the modular anesthesia monitoring system AS/300. It provides ECG, SpO2, 2 invasive pressure and 2 temperature channels and impedance respiration measurements. The impedance respiration measurement hardware is in the ESTPR module. The ESTPR Module software measures the respiration signal is sent to the AS/3™ Anaesthesia or Compact Monitor central unit. The AS/3" monitor software receives the respiration signal from the ESTPR module, analyzes the respiration waveform, displays respiration rate and waveform, handles the alarms, trending and other general monitor features. The hardware and software of ECG, SpO2, pleth, invasive pressure and temperature measurements of M-ESTPR are same as in the M-ESTP.

I am sorry, but the provided text only details a 510(k) summary for a medical device called "AS/3™ M-ESTPR," an electrocardiographic device. It describes its function as part of a modular anesthesia monitoring system and lists the physiological parameters it measures (ECG, SpO2, invasive pressure, temperature, and impedance respiration).

However, the document does not contain any information regarding:

• Acceptance criteria or reported device performance for specific clinical outcomes.
• Details of any study that proves the device meets acceptance criteria, including sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods, or comparative effectiveness studies (MRMC, standalone).

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text.

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