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

The Spirox INEX Absorbable Nasal Implant System is intended to support cartilage in the nasal lateral wall. The System consists of the INEX Absorbable Nasal Implant and accessory Delivery Tool. The implant is composed of a PLLA-PDLA copolymer that is predominantly cylindrical in shape with an approximate diameter of 1mm and an 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 Tool is comprised of a non-patient contacting handle assembly and a medical grade stainless steel 16 gauge delivery cannula. The Delivery Tool enables placement of the implant in a minimally invasive manner. The INEX Absorbable Nasal Implant and accessory Delivery Tool are provided sterile and are intended for single-use only.

The provided document details the 510(k) summary for the Spirox INEX Absorbable Nasal Implant, focusing on its substantial equivalence to a predicate device. The information primarily addresses device performance and safety rather than AI algorithm performance.

Therefore, many of the requested categories related to AI-specific study design (e.g., number of experts for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, AI training set details) are not applicable to this document as it describes a physical medical device.

However, I can extract the relevant information regarding the device's acceptance criteria and the study that proves it meets those criteria based on the provided text.

Acceptance Criteria and Reported Device Performance

• Mean NOSE Score reduction of 64.8% (n=30) at 1 month.
• Mean NOSE Score reduction of 63.4% (n=29) at 3 months.
• Mean NOSE Score reduction of 56.4% (n=22) at 6 months.
  These reductions were comparable to those reported for more invasive surgical procedures. External physical exam findings were normal with no evidence of implant migration. An independent physician review of photographs showed 1 adverse cosmetic effect at 3 months, which was resolved or not observed at 6 months. |
  | Bench Testing: Verification tests for implant (Dimensional Inspections, Implant Migration, Flexural Rigidity, Bend Radius, Degradation Testing) and Delivery Tool (Dimensional Inspections, Plunger Force, System Functionality, Handle Joint Strength, Cannula Joint Strength, Plunger Bond Verification) must yield "passing results" at baseline and up to 6 months aged. | Met. "Passing results were obtained for all design verification tests." |
  | Biocompatibility Testing: Conducted according to AAMI/ANSI/ISO 10993-1 and FDA guidance for "tissue/bone" implant devices with "permanent" duration of contact (>30 days). Tests include Cytotoxicity, Sensitization, Irritation, Systemic Toxicity, Genotoxicity, and Implantation for the implant, and Cytotoxicity for the Delivery Tool cannula. Must obtain "acceptable results." | Met. Biocompatibility testing was conducted on the predicate device and leveraged for the subject device due to shared material and manufacturing. The Delivery Tool cannula underwent cytotoxicity testing with acceptable results. The material has a long history of use and demonstrated adequate biocompatibility. |
  | Sterilization Data: Compliance with ISO 11137-1:2006 and ISO 11137-2:2006, supporting an SAL of 10^-6 for both gamma (implant) and e-beam (Delivery Tool) radiation. | Met. Validation results support an SAL of 10^-6 for gamma radiation of the implant and a minimum radiation dose of 25kGy and SAL of 10^-6 for e-beam radiation of the Delivery Tool. |
  | Packaging and Shipping Validation: Compliance with ASTM F88, ASTM F2096, ASTM F1929, ISO 11607-1 for packaging integrity (seal peel, bubble emission, dye migration) and ISTA 3A for simulated transport conditions. Must meet "acceptance criteria." | Met. "All tests results met the acceptance criteria demonstrating that the packaging process and the packaging materials maintained their integrity throughout the shelf-life." ISTA 3A standard also met acceptance criteria. An equivalency analysis confirmed applicability of predicate device's packaging tests, and comparable testing was done for the accessory Delivery Tool, supporting its shelf-life. |

Study Details

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

   • Sample Size (Clinical Performance Data): 30 subjects for safety and effectiveness analysis.
     • Follow-up: 30 at 1 month, 29 at 3 months, 22 at 6 months, and 10 at 12 months.
     • A total of 56 implants were placed (26 bilateral, 4 unilateral).
   • Data Provenance:
     • Country of Origin: Germany (3 investigational sites).
     • Study Design: Prospective, multi-center, non-randomized, single-arm study.

2. 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 for a physical device. Ground truth for clinical performance was established through patient outcomes (NOSE scores, reported adverse events) and clinical evaluations by study investigators, and an independent physician review of photographs. Qualifications of these clinical investigators are not specified beyond "independent physician."

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

   • Not applicable for a physical device. Clinical outcomes were measured directly based on patient reports (e.g., NOSE score) and investigator observations. The only mention of external review is "an independent physician review of the collected photographs," but no adjudication process is described.

4. 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

   • Not applicable. This document describes a physical medical implant, not an AI device or a comparative effectiveness study involving human readers with or without AI assistance.

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

   • Not applicable. This document describes a physical medical implant, not an AI algorithm.

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

   • Clinical Performance Ground Truth: Patient-reported outcomes (validated NOSE scores), clinician observations of physical exams, reported adverse events, and an independent physician review of photographs.
   • Bench Testing Ground Truth: Predetermined engineering and material science specifications, applicable ASTM and ISO standards.
   • Biocompatibility Ground Truth: Standards from AAMI/ANSI/ISO 10993-1 and FDA guidance documents.
   • Sterilization Ground Truth: ISO 11137-1:2006 and ISO 11137-2:2006 standards.
   • Packaging Ground Truth: ASTM and ISO standards for packaging integrity and transport simulation.

7. The sample size for the training set

   • Not applicable. This document describes a physical medical implant, not an AI device requiring a training set. The device's design and performance were developed through engineering processes, bench testing, and clinical studies, not machine learning training.

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

   • Not applicable. As above, no AI training set is involved.

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The Spirox INEX absorbable implant is indicated for supporting nasal septal cartilage.

The Spirox INEX implantable sheet is an absorbable device comprised of a poly (L-lactide) 70:30. The product is provided as a perforated sheet comprised of multiple "rod" like elements. The sheet is nominally 24.5 x 20.0 mm with a thickness of 1.1 mm. The bridge sections are nominally 3.0 x 1.9 mm and the voids are nominally 2.4 x 1.9 mm. The implant can be trimmed and shaped to dimensions suitable for the surgical need. The device is implanted using standard surgical tools and techniques The Spirox INEX implantable sheet is a sterile, single use device.

The manufacturer, Spirox, Inc., did not conduct a study to prove the device met acceptance criteria in the traditional sense of a clinical trial or comparative effectiveness study with specific performance metrics. Instead, the submission focuses on demonstrating substantial equivalence to predicate devices through non-clinical performance data.

Here's an analysis of the provided text in direct reference to your questions:

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

The document does not provide a table of acceptance criteria with specific quantitative performance metrics (e.g., sensitivity, specificity, accuracy) or a direct comparison to acceptance thresholds. The "reported device performance" is described qualitatively as:

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 mentions "Design verification testing," "comparative testing with the cited predicate devices," and a "GLP animal study." However, it does not specify the sample sizes for any of these tests. The provenance of the data (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 information is not applicable as the device is an absorbable implant for nasal septal cartilage support, not an AI/diagnostic device requiring expert ground truth establishment for a test set. The validation relies on physical and biological testing.

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

This information is not applicable for the same reasons as #3.

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. This type of study is relevant for diagnostic or AI-powered devices where human interpretation is involved. The Spirox INEX Device is a physical implant.

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

This question is not applicable. The device is an implant, not an algorithm.

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

The "ground truth" for the non-clinical performance tests was based on established engineering specifications, regulatory standards (ISO 10993, ISO 11137, ISO/ISTA 3A), and the outcomes of the GLP animal study. For the biocompatibility and sterilization, the "ground truth" aligns with the requirements outlined in the respective ISO standards and FDA guidance.

8. The sample size for the training set

This information is not applicable as there is no mention of a "training set" in the context of this device's evaluation. The device is not learning-based.

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

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

In summary:

The approval of the Spirox INEX Device was based on demonstrating substantial equivalence to existing predicate devices through non-clinical performance data. This included mechanical and functional testing against product specifications, biocompatibility testing according to ISO standards and FDA guidance, sterilization validation, and packaging/shipping validation. A GLP animal study was also conducted to verify device safety, biocompatibility, and use. There was no mention of specific acceptance criteria with quantitative thresholds nor a study involving human readers or AI algorithms.

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