(89 days)
The EchoMark and EchoMark LP are indicated for radiographic marking of sites in soft tissue. In addition, the EchoMark LP are indicated for situations where a soft tissue site needs to be marked for future medical procedures.
The EchoMark and EchoMark LP are implantable ultrasound-visible markers used to facilitate visualization of a soft tissue site. The EchoMark and EchoMark LP are comprised of 70:30 poly(L-lactide-co-caprolactone) (PLC) which resorbs completely in one year or more. The EchoMark LP (low profile) is identical but smaller in size than the EchoMark. Both have identical performance and technological characteristics. The EchoMark and EchoMark LP are provided sterile and are single use devices. The EchoMark material is entirely polymeric and therefore has no clinically relevant diamagnetic or ferromagnetic potential. This device is MR safe.
The provided text describes a 510(k) submission for the EchoMark and EchoMark LP devices. It details the device's characteristics, indications for use, comparison to predicate devices, and safety and performance data. However, it does not contain the specific acceptance criteria and detailed performance study results that typically prove a device meets those criteria, particularly for an AI/algorithm-based device. This submission is for an implantable radiographic marker, which is a physical medical device, not a software or AI-driven diagnostic tool.
Therefore, many of the requested items (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance) are not applicable to this type of device submission as described in the provided document. The document focuses on material biocompatibility, physical performance, and visibility characteristics.
Based on the provided text, here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance:
The document describes types of tests performed and their successful completion, but does not provide quantitative acceptance criteria or specific numerical performance results in a table format. It states that the device "met all specified criteria" and "did not raise new safety or performance questions."
- Safety Testing (ISO 10993 Biocompatibility):
- Acceptance Criteria Implied: Non-toxic, non-sensitizing, non-mutagenic, non-irritating, biocompatible.
- Reported Performance: "Results from the tests indicate that the device is non-toxic, non-sensitizing, non-mutagenic and non-irritating therefore biocompatible for its intended use."
- Performance Testing (Bench):
- Acceptance Criteria Implied: Risk controls properly implemented, design outputs meet design inputs, device suitable for intended use.
- Reported Performance: "Successful completion of the following tests confirmed that risk controls were properly implemented, and design outputs meet design inputs and device is suitable for its intended use." Specific tests include:
- ISO 11135 Sterility testing validated to SAL of 10-6
- ISO 11607-1 Packaging validation distribution simulation
- Bench Suturability and Suture Retention
- Labeling verification
- Geometric analysis of EchoMark and EchoMark LP
- In vitro EchoMark and EchoMark LP degradation study
- Performance Testing (Animal & Cadaver):
- Acceptance Criteria Implied: Met specified criteria for visibility, echogenicity, degradation, suturability, and non-migration.
- Reported Performance: "The EchoMark and EchoMark LP met all specified criteria and did not raise new safety or performance questions." Specific tests include:
- Ultrasound Visibility and Orientation Verification
- Ultrasound Echogenicity
- Ultrasound Accelerated Aging Echogenicity
- Suturability Timing Study
- Tissue Marker Migration Study
- Instructions for Use Validation in Cadaver
2. Sample sizes used for the test set and the data provenance:
- The document mentions "GLP Swine Testing" (for biocompatibility and performance) and "Cadaver" studies for performance validation. Specific sample sizes are not provided.
- Data Provenance: The studies were conducted as part of the regulatory submission process, implying they are prospective studies specifically designed for this purpose. The country of origin of the data is not specified, but given the FDA submission, it's likely U.S.-based or from a facility compliant with U.S. regulatory standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is not applicable for this type of device. The "ground truth" for a physical implantable marker is typically objectively measurable (e.g., material degradation, dimensions, visibility under imaging modalities, biological response in animal models) rather than expert interpretation of images or data.
4. Adjudication method for the test set:
- This is not applicable as there is no mention of subjective expert assessment 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:
- This is not applicable. This is a physical marker, not an AI-driven diagnostic or assistance tool. Therefore, no MRMC study or effect size on human readers is relevant or mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This is not applicable. This is a physical marker, not an algorithm.
7. The type of ground truth used:
- The "ground truth" for this device relies on:
- Objective material properties: Chemical analysis of degradation, mechanical testing (suturability, retention).
- Direct biological observation: Histologic evaluation in animal models (GLP Swine Testing) to confirm safety and bioabsorption.
- Imaging visibility: Verification using ultrasound in animal and cadaver models.
8. The sample size for the training set:
- This is not applicable as this is not an AI/machine learning device. There is no "training set."
9. How the ground truth for the training set was established:
- This is not applicable for the reason stated above.
In summary, the provided document details the regulatory submission for a physical implantable medical device, not a software or AI-driven diagnostic system. Therefore, many of the questions related to AI/algorithm performance are not addressed and are outside the scope of this specific device type.
§ 878.4300 Implantable clip.
(a)
Identification. An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.