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510(k) Data Aggregation
(229 days)
The Mammotome elite® Biopsy System is indicated to obtain tissue samples from the breast or axillary lymph nodes for diagnostic analysis of breast abnormalities.
• The Mammotome elite® Biopsy System is intended to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality.
· The Mammotome elite® Biopsy System is intended to provide breast tissue for histologic examination with partial removal of a palpable abnormality.
The extent of a histologic abnormality cannot always be readily determined from the palpation or imaged appearance. Therefore, the extent of removal of the palpated or imaged evidence of an abnormality does not predict the extent of removal of a histologic abnormality, e.g., malignancy. When the sampled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal using standard surgical procedures.
In instances when a patient presents with a palpable abnormality that has been classified as benign through clinical and/or radiological criteria (e.g., fibroadenoma, fibrocystic lesion), the Mammotome elite® Biopsy System may also be used to partially remove such palpable lesions. Whenever breast tissue is removed, histological evaluation of the tissue is the standard of care. When the sampled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal using standard surgical procedures.
The Mammotome elite® Biopsy System consists of a reusable Holster (MEH1) and a single-patient use, sterile Probe (MEP10 and MEP13) that is used with ultrasound imaging guidance to excise and collect diagnostic samples with a single insertion of the Probe. Introducer Stylets (MEI10 and MEI13) are also available as optional accessories that can be used with the Mammotome elite® Biopsy System. The components of the System are designed to operate safely when used together for diagnostic sampling of tissue during a biopsy procedure.
The Holster is a self-contained, handheld, reusable electro-mechanical vacuum-assisted biopsy device that consists of a rechargeable lithium-polymer battery and includes a charging base with AC power adapter. The Probe consists of an outer trocar shaft, a telescoping inner hollow coaxial cutter and an integrated coaxial cannula. The Probe incorporates a distal needle aperture and a proximal specimen collection cup with a tissue sample basket and specimen collection cap. The Holster contains one alignment tab that inserts into the holster notch located on the body of the Probe. The Probe body also contains two locking tabs to secure the Probe into the Holster. The Holster creates vacuum inside the device to assist in pulling tissue into the aperture while the sharpened inner cutter rotates at high speeds and extends across the aperture to acquire targeted tissue. The tissue sample is transported by vacuum to the specimen collection cup at the proximal end of the Probe. The integrated coaxial cannula may be detached either after the biopsy and remain in the breast to retain a track to the biopsy site when placing a biopsy site identifier or prior to the procedure when used in conjunction with the Introducer Stylet. The Introducer Stylet/integrated coaxial cannula combination is an option that is available for those physicians who are trained in percutaneous needle techniques for tissue collection.
The provided FDA 510(k) summary for the Mammotome elite® Biopsy System details its performance testing. However, it does not explicitly state numerical acceptance criteria for many of the tests, nor does it provide detailed quantitative results for the device performance against those criteria. Instead, it generally states that the device is "comparable to the predicate," or "complies with" certain standards.
Below is an attempt to extract the available information and structure it as requested, acknowledging the limitations of the provided document.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Criteria (Implicit or Explicit in Document) | Reported Device Performance |
|---|---|---|
| Biocompatibility | - Cytotoxicity: Acceptable | Complies with ISO 10993-1. |
| - Sensitization: Acceptable | Complies with ISO 10993-1. | |
| - Irritation: Acceptable | Complies with ISO 10993-1. | |
| - Systemic toxicity: Acceptable | Complies with ISO 10993-1. | |
| Electrical Safety & EMC | - Compliance with specified standards (e.g., IEC 60601-1, AAMI ES 60601-1, IEC 60601-1-2) | Complies with applicable portions of listed electrical/electromagnetic standards. |
| Software V&V | - Mitigated hazards such that failure of device software does not result in minor injury to patient or user. | Software verification and validation testing conducted, documentation provided as recommended by FDA guidance. Considered "moderate" level of concern. |
| Animal Testing | ||
| - Tissue Sample Weight | Acquire tissue sample weights comparable to the predicate device. | Performed comparable to the identified predicate device. |
| - Tissue Transport Efficiency | Deliver similar performance as the predicate system in terms of the percent of samples acquired to the number of samples attempted. | Performed comparable to the identified predicate device. |
| - Sample Quality | Not alter the characteristics of the acquired tissue in such a way as to affect the ability to achieve optimal histological assessment and is comparable to the predicate device. | Performed comparable to the identified predicate device; comparable to predicate. |
| Bench Testing | Force to penetrate comparable to the predicate system. | Bench testing confirmed comparable performance to the predicate device. |
2. Sample size used for the test set and the data provenance
The document explicitly mentions "In these studies, acquisition of tissue samples from a single insertion site was evaluated..." but does not provide specific numerical sample sizes for the animal testing. It also does not provide details on the data provenance (e.g., country of origin, retrospective/prospective). It only states an "in vivo porcine animal model was used."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not provide information on the number of experts used or their qualifications for establishing ground truth, particularly for the histological assessment of sample quality. It states, "When the sampled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal using standard surgical procedures" and "Whenever breast tissue is removed, histological evaluation of the tissue is the standard of care," implying histological assessment is handled by standard professional practice, but not specifying details for this particular study.
4. Adjudication method for the test set
The document does not describe any specific adjudication method for the test set.
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 MRMC comparative effectiveness study was done, nor does the device involve AI. The device is a biopsy system and the testing involved evaluating its physical performance (e.g., tissue acquisition, transport, quality) compared to a predicate device, not diagnostic effectiveness with human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device is a physical biopsy system, not a software algorithm. Therefore, a standalone algorithm-only performance study is not applicable and was not conducted.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the tissue sample quality evaluation in animal testing, the ground truth was histological assessment (implied by "optimal histological assessment"). For other performance aspects like sample weight and transport efficiency, the "ground truth" was direct measurement and comparison to the predicate device's measured performance.
8. The sample size for the training set
No training set is mentioned or applicable as this is a physical medical device, not an AI or machine learning algorithm.
9. How the ground truth for the training set was established
Not applicable as there is no training set for this physical device.
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