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The LATERA Absorbable Nasal Implant System is indicated for supporting upper and lower lateral nasal cartilage.

The LATERA Absorbable Nasal Implant System is intended to support upper and lower lateral cartilage in the nose. The system consists of the LATERA Absorbable Nasal Implant) and Delivery Device (Delivery Device). An Implant Positioning Guide is provided to serve as an external visual planning aid prior to Implant placement. The Implant is composed of a PLLA-PDLA copolymer that is predominantly cylindrical in shape with an approximate diameter of 1mm and lengths of 20mm and 24mm. The distal end of the Implant is forked to facilitate anchoring during implantation and the proximal end is narrower for increased flexibility. The disposable Delivery Device is comprised of a non-patient contacting handle assembly and a medical grade stainless steel 16-gauge delivery cannula. The Delivery Device enables placement of the Implant in a minimally invasive manner. Each Implant length (20mm, 24mm) is compatible with the Delivery Device packaged with the Implant. The LATERA Absorbable Nasal Implant System is provided sterile and is intended for single-use only.

Here's a breakdown of the acceptance criteria and study information based on the provided document:

This document is a 510(k) summary for the Stryker ENT LATERA Absorbable Nasal Implant System. A 510(k) clearance is based on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving independent performance against specific acceptance criteria for a novel device. Therefore, the "acceptance criteria" here refer to the design specifications and performance standards met to demonstrate equivalence, and the "study" is the performance testing conducted for that purpose. There is no AI/ML component to this device or its evaluation presented in this document.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify sample sizes for individual tests (e.g., number of implants tested for tensile strength, number of sterilization cycles validated). The testing is generally referred to as "design verification testing and distribution testing to support the additional implant size."

• Test Set Size: Not specified.
• Data Provenance: Not specified, but generally, such testing is conducted internally by the manufacturer or by contract labs in the country of origin of the manufacturer (USA, given the address). The testing is prospective in nature, as it is performed to validate the device's design and manufacturing processes prior to marketing.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

• Not Applicable. This device is a physical implant, not an AI/ML diagnostic or predictive tool that requires expert-established ground truth for its performance evaluation in the context of this 510(k) summary. Performance is evaluated through engineering and biocompatibility testing against predefined specifications.

4. Adjudication Method for the Test Set

• Not Applicable. As mentioned above, this is basic engineering and biocompatibility testing, not a clinical trial or AI evaluation requiring expert adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No. This is a physical medical device (nasal implant), not an imaging or diagnostic AI tool. An MRMC study is not relevant to its clearance.

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

• No. This is a physical medical device. There is no algorithm or AI component involved in its function or evaluation as described in this document.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is based on:

• Engineering Specifications: Pre-defined design parameters, material properties, and functional requirements.
• Established Test Standards: Adherence to recognized biocompatibility standards, sterilization validation methods, and shelf-life determination protocols.
• Predicate Device Characteristics: The LATERA Absorbable Nasal Implant [K161191] serves as the benchmark for demonstrating "substantial equivalence" in terms of safety and effectiveness, meaning features and performance are shown to be equivalent to an already cleared device.

8. The Sample Size for the Training Set

• Not Applicable. There is no AI/ML component; therefore, no "training set."

9. How the Ground Truth for the Training Set was Established

• Not Applicable. As there is no training set.

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The Spirox Latera Absorbable Nasal Implant is indicated for supporting nasal upper and lower lateral cartilage.

The Spirox Latera Absorbable Nasal Implant System is intended to support cartilage in the nasal lateral wall. The System consists of the Latera Absorbable Nasal Implant) and Accessory Delivery Device (Delivery Device). The Implant is composed of a PLLA-PDLA copolymer that is predominantly cylindrical in shape with an approximate diameter of 1mm and overall length of 24mm. The distal end of the Implant is forked to facilitate anchoring during implantation and the proximal end is narrower for increased flexibility. The disposable Delivery Device is comprised of a non-patient contacting handle assembly and a medical grade stainless steel 16 gauge delivery cannula. The Delivery Device enables placement of the Implant in a minimally invasive manner. The Latera Absorbable Nasal Implant and Accessory Delivery Device are provided sterile and are intended for single-use only.

This document, K161191, describes the Spirox Latera Absorbable Nasal Implant, a medical device intended to support nasal upper and lower lateral cartilage. It is a Special 510(k) submission, meaning it describes modifications to an already cleared predicate device (INEX Absorbable Nasal Implant K152958), and therefore focuses on demonstrating that the modified device remains substantially equivalent to the predicate.

Given this context, the document does not describe a study to prove the device meets specific acceptance criteria in the traditional sense of a clinical trial or performance study against quantitative metrics for efficacy or diagnostic accuracy. Instead, the acceptance criteria are related to validating the changes made to the device and demonstrating that these changes do not alter the safety and effectiveness profile such that it is no longer substantially equivalent to the predicate.

Therefore, many of the requested items (e.g., effect size of human readers with AI, standalone algorithm performance, ground truth establishment for training set) are not applicable as this is not an AI/ML device or a device requiring a new clinical efficacy study under this 510(k) pathway.

Here's the breakdown of the information that is available in the document related to acceptance criteria and validation:

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

The document does not present a formal table of quantitative acceptance criteria and reported device performance in the way one would see for a diagnostic device (e.g., sensitivity, specificity thresholds). Instead, the "acceptance criteria" are implied by the verification and validation tests undertaken to confirm that the modifications do not negatively impact the device's safety or functionality and that it remains substantially equivalent to the predicate.

I will formulate a table based on the described design control activities and their implied "acceptance criteria" (i.e., successful completion of the tests).

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify sample sizes for any of the verification and validation tests. It states that the "methods used for the verification and validation tests for the modified device are the same as those submitted in the original 510(k) application for the predicate device," but does not provide details on those methods or sample sizes in this submission. The provenance of any data (e.g., country of origin, retrospective/prospective) is also not mentioned.

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 is not applicable as this is a physical implant and delivery system, not an interpretive diagnostic device requiring expert-established ground truth on a test set of medical images or patient data. The "ground truth" for this device relates to engineering specifications, material properties, sterility, and usability, which are validated through laboratory and simulated use testing, not expert adjudication of clinical cases.

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

This is not applicable for the same reasons as #3. There is no clinical imaging or diagnostic test set requiring human 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 device is not an AI-assisted diagnostic tool, so no MRMC study or AI assistance effect size is relevant or reported.

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

This is not applicable. This is a physical medical implant, not a standalone algorithm.

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

For a physical device like this, "ground truth" refers to established engineering standards, material specifications, biocompatibility requirements, and performance characteristics (e.g., mechanical strength, ease of delivery, sterility). The validation tests (e.g., sterilization validation, packaging tests, biocompatibility tests) establish that the device meets these pre-defined engineering and material "truths" or standards. There is no biological or diagnostic "ground truth" as might be found in clinical studies of diagnostic tools.

8. The sample size for the training set

This is not applicable. This is a physical medical device; there is no "training set" in the context of machine learning or AI.

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

This is not applicable for the same reasons as #8.

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