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510(k) Data Aggregation
(107 days)
STARCHMARK BIOPSY SITE MARKER, MODEL STMKEC-10GSS, STMKEC-10GTR, STMKMT-11GS
The StarchMark Biopsy Site Marker is intended to radiographically mark breast tissue during a percutaneous breast biopsy procedure.
The StarchMark Biopsy Site Marker is a sterile, disposable applicator containing 4 resorbable polysaccharide (starch) pellets and a polylactic/polyglycolic acid-based co-polymer (PLA/PGA) pellet with an embedded radiopaque wireform.
The provided text describes a 510(k) summary for the StarchMark Biopsy Site Marker. It details the device's characteristics, indications for use, and a comparison to a predicate device to establish substantial equivalence. However, it does not contain specific acceptance criteria or the details of a study structured to prove the device meets such criteria in terms of performance metrics like sensitivity, specificity, or accuracy, which would typically be found in performance studies for diagnostic devices.
Instead, the submission focuses on preclinical studies and biocompatibility testing to demonstrate safety and functional aspects under simulated use conditions and to meet ISO 10993-1 requirements. The "study" mentioned is primarily a comparison to a predicate device for substantial equivalence.
Based on the provided text, here's what can be extracted and what information is missing:
1. A table of acceptance criteria and the reported device performance
No explicit acceptance criteria with specific quantitative thresholds (e.g., sensitivity, specificity, accuracy) are provided in the document for the StarchMark Biopsy Site Marker in terms of diagnostic performance. The document focuses on demonstrating substantial equivalence to an existing predicate device (K031938; Gel Mark III Biopsy Site Marker).
The "performance" is reported in terms of:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Performance as intended under simulated use conditions (in vitro) | In vitro laboratory studies demonstrated intended performance. |
| Biocompatibility (ISO 10993-1) | Biocompatibility testing performed and met ISO 10993-1 requirements. |
| Control of bleeding (in vivo) | Demonstrated superiority over the control group in cessation of bleeding time in a porcine study. |
| Substantial Equivalence to Predicate Device | Found substantially equivalent based on: |
| • Same indications for use | |
| • Same intended use | |
| • Same intended treatment site | |
| • Same operating principle | |
| • Same technological characteristics | |
| • Same packaging | |
| • Same sterilization method |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set:
- For in vitro laboratory studies: Not specified.
- For biocompatibility testing: Not specified.
- For the porcine study: Not specified.
- Data Provenance: Not specified. The document does not mention the country of origin of data or whether studies were retrospective or prospective.
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)
This information is not provided in the document. The studies mentioned (in vitro, biocompatibility, porcine bleeding control) do not involve human expert interpretation for establishing a "ground truth" in the diagnostic sense.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided. As the studies described do not involve human diagnostic interpretation for a test set, adjudication methods are not applicable here.
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, an MRMC comparative effectiveness study was not conducted or reported.
- Effect Size of AI assistance: Not applicable, as this device is a biopsy site marker and not an AI-powered diagnostic tool. The document describes a medical device, not an AI algorithm.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Study: This question is not applicable as the StarchMark Biopsy Site Marker is a physical medical device, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The concept of "ground truth" as typically applied to diagnostic performance studies (e.g., against pathology for cancer detection) is not directly applicable to the reported studies.
- For in vitro studies: Performance "as intended" under simulated use implies comparison against pre-defined functional specifications.
- For biocompatibility: ISO 10993-1 standards serve as the "ground truth" or benchmark.
- For the porcine study: "Cessation of bleeding time" in the control group served as a comparative "ground truth" for evaluating superiority.
8. The sample size for the training set
This information is not applicable as the described studies are not for training an algorithm.
9. How the ground truth for the training set was established
This information is not applicable as the described studies are not for training an algorithm.
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