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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.

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The Nerve Capping Device is indicated to protect a peripheral nerve end and to separate the nerve from surrounding environment to reduce the development of a symptomatic neuroma.

The Nerve Capping Device is a sterile biodegradable nerve cuff composed of the bioresorbable copolyester poly(DL-lactide-s-caprolactone). It is a tubular device with one open end and one sealed end which functions as a cap, isolating the nerve end. The capping device prevents dislocation of the stump by pulling the nerve end into the tube and suturing in the nerve within the cap. Consequently, the end of the cap will be sutured to surrounding tissue. One hole at the sealed end of the tube allows easy fixation with a suture to the surrounding tissue. The size of the product is 3cm in length, and is available in different diameters for different sized nerves. The Nerve Capping Device is sterilized in a pouch package. The device is single-use, cannot be re-sterilized, and is a prescription product.

The provided text describes a 510(k) premarket notification for a medical device called the "Nerve Capping Device." This FDA document focuses on establishing substantial equivalence to previously cleared devices rather than a standalone clinical study demonstrating the device's absolute effectiveness or performance against specific acceptance criteria in a clinical setting.

Therefore, the information requested in your prompt regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, adjudication methods, and MRMC studies generally does not apply to this type of regulatory submission in the way you've outlined for algorithms or diagnostic tools.

However, I can extract and present the performance data provided in the document, which primarily consists of biocompatibility and other physical/mechanical testing, and reframe it to best fit your request.

Here's an attempt to answer your questions based on the provided text, with clear indications where the requested information is not available:

Description of Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

The Nerve Capping Device's substantial equivalence was established through non-clinical performance data, primarily focusing on biocompatibility, physical degradation, usability, and mechanical strength, comparing it to predicate devices. The "acceptance criteria" in this context are implicitly met if the device demonstrates comparable biocompatibility and functional characteristics to existing, legally marketed predicate devices.

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

Since this is a 510(k) submission seeking substantial equivalence, specific numerical acceptance criteria (e.g., "sensitivity > 90%") for clinical performance are not present. Instead, the "acceptance criteria" are implied by demonstrating that the device meets safety and performance standards generally, and is comparable to predicate devices. The reported "performance" are the results of these non-clinical tests.

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: Specific sample sizes for each individual test (e.g., number of devices tested for suture retention or in vitro degradation) are not provided in this summary. The biocompatibility tests for cytotoxicity, pyrogenicity, and EO residues were conducted for the Nerve Capping Device. Other biocompatibility tests (sensitization, irritation, acute systemic toxicity, hemocompatibility, implantation, degradation, subchronic toxicity, genotoxicity, carcinogenicity) were leveraged from predicate NEUROLAC® data due to identical materials and similar manufacturing processes.
• Data Provenance: Not explicitly stated, but common for medical device testing to be conducted in accredited laboratories. The device developer is Polyganics Innovations BV, located in The Netherlands. The referenced FDA Blue Book Memorandum and ISO standards are international.
• Retrospective/Prospective: These are laboratory and engineering tests, not clinical studies, so the terms retrospective/prospective do not directly apply.

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 question is not applicable. The "ground truth" in this context refers to established scientific methods and standards for biocompatibility, material properties, and physical performance testing (e.g., ISO standards, ASTM methods). These tests yield objective measurements rather than subjective interpretations requiring expert consensus on "ground truth" in the way a diagnostic algorithm might.

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

• This question is not applicable. Adjudication methods are typically used in clinical trials or studies where subjective interpretations or ambiguous results require resolution by multiple experts to establish a definitive outcome or "ground truth." The tests reported here are largely objective physical and biological assays.

5. If a multi-reader multicase (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 question is not applicable. An MRMC study is designed for diagnostic tools or AI systems to evaluate their impact on human reader performance. The Nerve Capping Device is a physical implantable medical device, not a diagnostic or AI-powered system.

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

• This question is not applicable. The Nerve Capping Device is a physical medical device, not an algorithm or AI system.

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

• The "ground truth" for the non-clinical performance evaluation is based on established scientific and engineering principles, standardized test methods (e.g., those described in ISO 10993), and comparisons to characteristics of legally marketed predicate devices. This includes objective measurements (e.g., chemical residue levels, degradation rates, force measurements) and observations of biological responses in accordance with validated protocols.

8. The sample size for the training set

• This question is not applicable. There is no "training set" as this is not an AI/machine learning device. The biocompatibility data from the existing NEUROLAC® devices served as a "leveraged" dataset for comparison, but it's not a training set in the AI sense.

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

• This question is not applicable for the reasons stated above (no training set for an AI device). The "ground truth" for the leveraged predicate data would have been established through similar standardized non-clinical testing performed at the time of their original 510(k) clearances.

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