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SPECBOARD JR is intended to be used as an accessory to a mammographic x-ray system. The SPECBOARD JR is used to contain the mammographic specimen from the patient when transported to the x-ray device and then accompany the x-ray image to the pathology laboratory.

The SPECBOARD is a medical device that allows for accurate localization of suspect lesions in breast tissue. The SPECBOARD JR is comprised of a foam core base coupled with a tape hinge along one edge to a thick cardboard cover. On the base foam core piece there is a centrally located piece of absorbent blotter paper. Along two joining edges of the blotter are two radio-opaque nickel stencils, one marked with alpha characters and the other with numerical characters. The SPECBOARD JR is used in the operating room where the surgeon will remove a suspect portion of the breast tissue and place it on the blotter portion of the SPECBOARD JR. The cover is then closed, sandwiching the breast specimen between the cover and the base. The cover is then secured with the Velcro latch and an x-ray is taken of the specimen inside the SPECBOARD JR. The resulting x-ray image will show the perpendicular stencils along the border of the blotter paper and the specimen on the blotter paper. Any lesions will show up within the specimen and the pathologist then has a reference of where to cut into the specimen to withdrawal a piece for analysis.

The provided text is a 510(k) summary for the SPECBOARD JR, which is a specimen transport and identification device used as an accessory to a mammographic x-ray system. The filing asserts substantial equivalence to a predicate device, the SPECBOARD (K891090).

Based on the provided information, there is no detailed study described that establishes acceptance criteria for device performance or provides data from such a study. The 510(k) summary focuses entirely on demonstrating substantial equivalence to the predicate device, not on proving clinical performance or meeting specific acceptance criteria through a performance study.

Here's an analysis based on the structure of your request and the information available:

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

• Acceptance Criteria: Not explicitly stated or provided in the document.
• Reported Device Performance: Not explicitly stated or provided in the document in terms of quantitative performance metrics. The filing claims the device "is expected to have the same safety record as the predicate SPECBOARD product, no failures reports." This is a statement of expectation rather than reported performance from a specific study.

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

• Sample Size: Not applicable. No test set or performance study data is described.
• Data Provenance: Not applicable.

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)

• Number of Experts: Not applicable. No performance study requiring expert adjudication is described.
• Qualifications of Experts: Not applicable.

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

• Adjudication Method: Not applicable. No performance study requiring adjudication 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

• MRMC Study: No. This device is a passive accessory and does not involve AI or human readers for diagnostic interpretation in the way an AI-driven imaging CAD system would. Its function is to hold a specimen for X-ray and provide reference markers.

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

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

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

• Ground Truth: Not applicable. No performance study is described that would require a ground truth for evaluation. The device's primary function is to aid in localization for pathology, not to diagnose.

8. The sample size for the training set

• Training Set Sample Size: Not applicable. This is a physical device, not an AI algorithm requiring a training set.

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

• Ground Truth for Training Set: Not applicable.

Summary of the 510(k) Approach for SPECBOARD JR:

The 510(k) for SPECBOARD JR is a design modification submission, leveraging the substantial equivalence pathway based on predicate device K891090 (SPECBOARD). The core argument for safety and effectiveness is that:

• The SPECBOARD JR is smaller than the predicate SPECBOARD.
• It uses the same materials as the predicate.
• It has the same design elements and packages them into a smaller form factor.
• It performs the same function (containing specimens for X-ray and providing reference markers for pathology).
• The predicate device has a long history of safe use ("in worldwide use since 1989" with "no failures reports").

Because the changes are minimal and do not alter the fundamental technological characteristics or intended use, a dedicated performance study with acceptance criteria was not deemed necessary by the FDA. The FDA's decision summary explicitly states, "The information in the 510(k) is complete and supports a substantial equivalence (SE) determination." This indicates that the comparison to the predicate, demonstrating that the device is "the difference being in size," was sufficient for clearance.

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