(22 days)
The Rubicor EnCapsule™ Breast Biopsy Device is intended for diagnostic sampling of breast tissue during breast biopsy procedure. The Rubicor EnCapsule™ Breast Biopsy Device is to be used for diagnostic purposes only and is not intended for therapeutic uses.
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The provided text describes a 510(k) submission for the Rubicor EnCapsule™ Breast Biopsy Device. This device is classified as an electrosurgical device and accessories (21 CFR 870.4400) and is intended for diagnostic sampling of breast tissue during breast biopsy procedures. The submission is for a device in 2002, and at that time, 510(k) submissions were primarily focused on demonstrating substantial equivalence to a predicate device rather than extensive clinical efficacy studies with specific acceptance criteria and performance metrics as might be seen in later regulations or for higher-risk devices.
Based on the provided text, there is no detailed acceptance criteria or a study proving specific performance metrics in the way modern AI/software device submissions might include. The focus of this 510(k) is on safety and substantial equivalence.
Here's an analysis of the available information against your requested points:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated as quantifiable metrics. The implied acceptance criteria for a 510(k) in 2002 revolve around demonstrating: |
- Safety and effectiveness
- Substantial equivalence to a predicate device | Performance: "Results of in-vitro testing demonstrate that Rubicor EnCapsule™ Breast Biopsy Device is safe and effective for its intended function."
Biocompatibility: "The materials used in the Rubicor EnCapsule™ Breast Biopsy Device have been shown to be biocompatible." |
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: Not specified. The document only mentions "in-vitro testing."
- Data Provenance: Not specified.
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)
- Not applicable. The submission focuses on in-vitro testing for a physical biopsy device, not on diagnostic performance where expert ground truth would typically be established for image interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This is not a study assessing diagnostic accuracy requiring adjudication.
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. This is a physical biopsy device, not an AI or imaging diagnostic aid.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is a physical biopsy device, not an AI or software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the "in-vitro testing" and "biocompatibility" mentioned, the ground truth would be based on engineering specifications, laboratory standards, and material science principles rather than clinical outcomes or pathology for diagnostic accuracy. Specific details are not provided.
8. The sample size for the training set
- Not applicable. This is a physical device, not an AI/ML algorithm.
9. How the ground truth for the training set was established
- Not applicable.
Summary of Study (as described in the 510(k)):
The study described is not a clinical study in the sense of evaluating diagnostic performance against a ground truth. Instead, it's a submission demonstrating the safety and effectiveness of a physical medical device (a breast biopsy device) primarily through in-vitro testing and biocompatibility assessments. The core of the 510(k) process is to show substantial equivalence to a predicate device (Rubicor Breast Biopsy Device, K020047). The text only states that the in-vitro testing demonstrated the device is "safe and effective for its intended function" and that its materials are "biocompatible." No specific quantifiable acceptance criteria or detailed study results are provided in this summary.
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.