FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

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.

AI/ML Overview

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

Acceptance Criteria	Reported Device Performance (Summary)
Primary Safety Endpoint: Adverse event rate comparable to published studies for similar alloplastic materials and expected types of adverse events. Specifically, a per-subject device-related adverse event rate of 13% for 3 months with expected types of events.	Met. The per-subject device-related adverse event rate was 13% (5 events in 4 subjects) at 3 months. Events included hematoma (1), inflammation (1), and extrusions (3). These were deemed comparable to published studies for other alloplastic materials and were expected. Extrusions were internal nasal cavity extrusions related to implantation technique or patient manipulation, resolved without surgical intervention or clinical sequelae.
Primary Efficacy Endpoint: Mean NOSE Score reduction comparable to published literature for more invasive surgical procedures, normal external physical exam findings with no implant migration, and no adverse cosmetic effects (or resolved).	Met.

Acceptance Criteria

Reported Device Performance (Summary)

Primary Safety Endpoint: Adverse event rate comparable to published studies for similar alloplastic materials and expected types of adverse events. Specifically, a per-subject device-related adverse event rate of 13% for 3 months with expected types of events.

Met. The per-subject device-related adverse event rate was 13% (5 events in 4 subjects) at 3 months. Events included hematoma (1), inflammation (1), and extrusions (3). These were deemed comparable to published studies for other alloplastic materials and were expected. Extrusions were internal nasal cavity extrusions related to implantation technique or patient manipulation, resolved without surgical intervention or clinical sequelae.

Primary Efficacy Endpoint: Mean NOSE Score reduction comparable to published literature for more invasive surgical procedures, normal external physical exam findings with no implant migration, and no adverse cosmetic effects (or resolved).

Met.

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

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.
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."
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.
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.
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.
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.
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.
How the ground truth for the training set was established
- Not applicable. As above, no AI training set is involved.

Summary

Regulation Number and Section

§ 874.3620 Ear, nose, and throat synthetic polymer material.

(a)
Identification. Ear, nose, and throat synthetic polymer material is a device material that is intended to be implanted for use as a space-occupying substance in the reconstructive surgery of the head and neck. The device is used, for example, in augmentation rhinoplasty and in tissue defect closures in the esophagus. The device is shaped and formed by the suregon to conform to the patient's needs. This generic type of device is made of material such as polyamide mesh or foil and porous polyethylene.(b)
Classification. Class II.