Search Results

SeptAlign is used to support and straighten minor deviations in septal cartilage when sufficient healthy cartilage exists, and the cartilage is appropriately mobilized utilizing standard septoplasty techniques.

The Spirair SeptAlign implant is a bioabsorbable, polydioxanone ribbon that is intended to be used in nasal surgery. SeptAlign is 190 mm long and 0.65 mm thick with barbed features ("anchors") which enable attachment to and support of nasal septal cartilage. SeptAlign is trimmed to size by the physician to suit the anatomical conditions and clinical use case. The device includes a surgical needle to enable attachment to the tissue which is trimmed off affer use. SeptAlignis provided sterile as a single use device and when permanently implanted, is resorbed within a 6-month period.

The SeptAlign implantis provided preloaded into a disposable delivery tool comprised of a non-patient contacting handle assembly and a medical grade stainless steel delivery cannula and trocar. The delivery tool enables placement of the distal portion of the implant in a minimally invasive manner. The SeptAlign implant and accessory delivery tool are provided sterile and are intended for single-use only.

I am sorry, but the provided text from the FDA 510(k) notification for the SeptAlign device does not specify acceptance criteria for device performance or describe a study that proves the device meets such criteria in terms of accuracy, sensitivity, or specificity for any diagnostic or prognostic task.

The document primarily focuses on the device's mechanical and material performance, biocompatibility, packaging, and shelf-life. It states that "No animal or clinical performance testing was required to support substantial equivalence." This indicates that the substantial equivalence determination for this device (SeptAlign) was not based on clinical performance studies measuring diagnostic accuracy or reader improvement.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance related to diagnostic/prognostic metrics.
2. Sample size, data provenance, expert ground truth establishment, adjudication, MRMC studies, standalone performance, or ground truth types. These are typically associated with studies evaluating AI/diagnostic device performance, which were not required or reported for this submission.

The "Performance Data" section (Pages 4-5) lists the following performance elements:

• Biocompatibility Testing: Confirms materials do not pose a risk of negative interaction. This is about safety, not diagnostic performance.
• Distribution, Packaging and Shelf-Life Testing: Demonstrates integrity of sterile barrier and preservation of performance, related to product stability and safety.
• Performance Testing – Bench: Focuses on the accessory delivery tool's functionality, mechanical integrity, and cannula joint strength. This is about the physical device and its delivery mechanism working as intended, not its ability to detect or diagnose anything.

The acceptance criteria implicitly met are related to these physical and material properties (e.g., passing biocompatibility tests, maintaining sterility, successful mechanical deployment).

In summary, the provided document does not contain the type of information needed to answer your questions regarding acceptance criteria for diagnostic performance or studies proving such performance, as the device is a physical implant (a bioabsorbable ribbon) rather than a diagnostic or AI-powered device.

Ask a specific question about this device

The Spirair Nasal Septal Strap is used to support and straighten in septal cartilage when sufficient healthy cartilage exists, and the cartilage is appropriately mobilized utilizing standard septoplasty techniques.

The Spirair Nasal Septal Strap is a bioabsorbable, polydioxanone ribbon that is intended to be used in nasal surgery. The Nasal Septal Strap is 190 mm long and 0.65 mm thick with barbed features ("anchors") which enable attachment to and support of nasal septal cartilage. The Nasal Septal Strap is trimmed to size by the physician to suit the anatomical conditions and clinical use case. The device includes a surgical needle attachment to the tissue which is trimmed off after use. The Nasal Septal Strap is provided sterile as a single use device and when permanently implanted, is resorbed within a 6-month period.

This document is a 510(k) summary for the Spirair Nasal Septal Strap, detailing its regulatory review and substantial equivalence to a predicate device. It primarily focuses on the device's technological characteristics, indications for use, and performance data required for regulatory clearance. It does not describe a study that proves a device meets specific acceptance criteria in the context of an AI/ML medical device, as the Spirair Nasal Septal Strap is a physical medical device.

Therefore, I cannot provide the requested information about acceptance criteria and a study proving device performance as it pertains to an AI/ML medical device, because the provided text is for a physical medical device and lacks any mention of AI, algorithms, or complex performance metrics typical of AI/ML systems.

The document discusses performance data related to:

• Biocompatibility Testing: According to ISO 10993-1 and FDA Guidance, assessing cytotoxicity, sensitization, irritation, implantation, and chemical characterization.
• Distribution, Packaging, and Shelf-Life Testing: Successful completion of accelerated aging and integrity of sterile barrier.
• Performance Testing - Bench: Demonstrating physical and functional requirements, including mechanical properties, material properties, migration of implant, and in vitro degradation.
• Performance Testing - Animal: A GLP animal study for safety, degradation, and biocompatibility.
• Performance Testing - Clinical: Interim safety data from a prospective, multi-center, multi-cohort, early feasibility clinical study in the US.

These tests are designed to demonstrate the safety and effectiveness of a physical implantable device, not an AI/ML algorithm.

Ask a specific question about this device

PosiSep® EAR Fragmentable Ear Dressing is indicated for use in patients undergoing outer ear surgery:
As a space occupying stent to separate and prevent adhesions between mucosal surfaces; and
To help control minimal bleeding following surgery or trauma by tamponade effect, blood absorption and platelet aggregation.
PosiSep® Ear is intended for use under the direction of a licensed healthcare provider.

The Hemostasis PosiSep® EAR Fragmentable Ear Dressing is a sterile dressing comprised of modified Chitosan particles and polysaccharide binder. Chitosan has well known hemostasis properties and when combined with hydroxyethyl cellulose binder, forms a foam-type dressing that has an affinity to absorb and hold water. PosiSep® EAR Fragmentable Ear Dressing is used in patients undergoing outer ear surgery as a space occupying stent and to help control minimal bleeding. The dressing quickly dehydrates blood, thereby causing rapid hemoconcentration of platelets, serum proteins and fibrinogen, leading to clotting that limits and controls bleeding and edema.
PosiSep® EAR is fragmentable and eliminated from the site of application by natural excretion via the ear canal.

This document describes the PosiSep® EAR Fragmentable Ear Dressing, a medical device, and its acceptance criteria as demonstrated through a substantial equivalence submission to the FDA. The information provided focuses on comparing the device to a predicate device (NasoPore® Ear) and reference devices (PosiSep/PosiSep X) rather than detailing a specific clinical study with granular data on acceptance criteria and performance metrics.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly provide a table of acceptance criteria with numerical targets and corresponding reported device performance. Instead, substantial equivalence is claimed based on comparable characteristics to predicate devices. The key "acceptance criteria" are implied through the comparison parameters.

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

The document primarily relies on non-clinical performance data, specifically biocompatibility testing and performance bench testing. It does not mention a "test set" in the context of clinical data or patient samples for evaluating device performance against the specified indications. The evaluation appears to be based on:

• Biocompatibility testing: Performed internally, demonstrating compliance with ISO 10993 and FDA guidelines.
• Performance bench testing: Performed internally to demonstrate physical and functional requirements were met.
• Comparison to predicate devices: The primary data provenance is the established safety and effectiveness of the legally marketed predicate devices (NasoPore® Ear, PosiSep/PosiSep X).

The document does not specify a sample size for these non-clinical tests. As it's a 510(k) submission, the focus is on demonstrating "substantial equivalence" rather than conducting a de novo clinical trial with a large patient sample.

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

This information is not provided because the submission primarily relies on non-clinical data and comparisons to predicate devices for demonstrating substantial equivalence, not on a clinical test set with human expert-adjudicated ground truth.

4. Adjudication Method for the Test Set

Not applicable, as no clinical test set with expert adjudication is described.

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

Not applicable. The device described is a physical ear dressing, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant to this submission.

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

Not applicable, as the device is a physical medical dressing, not an algorithm.

7. The Type of Ground Truth Used

For biocompatibility, the ground truth is established by standardized biological tests (e.g., cytotoxicity, irritation, sensitization) following ISO 10993 guidelines, where "ground truth" means the objective results of these tests (e.g., non-cytotoxic). For performance, the "ground truth" relates to the physical and functional properties of the device meeting predetermined engineering specifications during bench testing.

8. The Sample Size for the Training Set

Not applicable. The device is not an AI/ML algorithm requiring a training set.

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

Not applicable, as the device is not an AI/ML algorithm.

Ask a specific question about this device

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.

Ask a specific question about this device

PuraSinus® is a space occupying gel stent intended to separate and prevent adhesions between mucosal surfaces, help to control minimal bleeding following surgery or nasal trauma, and act as an adjunct to aid in the natural healing process.

PuraSinus® is indicated following nasal/sinus surgery or trauma to prevent lateralization of the middle turbinate and formation of nasal adhesions during the post-operative period.

PuraSinus® is a sterile gel composed of a synthetic peptide and sterile water for injection. It is provided as a prefilled syringe (2.5% peptide content) ready for use as a wound dressing with or without the optional sterile application nozzle. PuraSinus® forms a moist wound environment that is supportive of the healing process and allows non-traumatic removal of the secondary dressing without damaging newly formed tissue.

PuraSinus® is completely non-animal and non-plant derived and contains no preservatives that might present a risk of allergic reaction or skin irritation.

Exposure to physiological fluids such as blood causes the peptide solution to quickly form a transparent gel without expansion in volume. PuraSinus® can be easily rinsed away by gently flushing the wound with sterile saline, without causing trauma to the underlying wound.

This document ("510(k) Summary for PuraSinus®") does not describe an AI/ML device, nor does it present the acceptance criteria and study proving a device meets those criteria in a format applicable to AI/ML device performance. This is a 510(k) submission for a medical device (a bioresorbable nasal dressing and sinus stent) where the key demonstration of substantial equivalence relies on comparison to a predicate device through bench testing and a small retrospective case series, rather than formal performance goals met by an AI/ML algorithm.

Therefore, many of the requested categories for defining acceptance criteria and study details for an AI/ML device cannot be extracted from the provided text. However, I can still interpret the information regarding the "performance data" that was presented to support the device.

Here's an analysis based on the provided text, interpreted as much as possible in the context of your request for device performance, but noting the relevant limitations due to the nature of the device:

Device Name: PuraSinus®

Type of Device: Bioresorbable nasal dressing and sinus stent (not an AI/ML device)

Acceptance Criteria and Reported Device Performance (as far as applicable to this non-AI device):

Study Details (as derived from the text):

1. Sample Size used for the test set and the data provenance:

   • Test Set Sample Size: 19 sequential patients.
   • Data Provenance: Retrospective case series. The country of origin is not explicitly stated but implied to be where the clinical institution(s) conducting the FESS procedures are located (no specific country mentioned).

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable in the AI/ML sense. The "ground truth" for the clinical performance (re-bleeding, adhesion formation, adverse events) would have been established by the treating physicians/surgeons during post-operative patient follow-up. The document does not specify the number or qualifications of these clinical evaluators.

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

   • Not explicitly described. Clinical outcomes (adhesions, re-bleeding, adverse events) were reported, presumably as direct observations during patient follow-up, not through a formal adjudication process like one used for AI/ML image review.

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 is not an AI/ML device. The "comparison" was PuraSinus® performance to literature reported performance of a predicate device (MeroGel®).
   • Comparison: PuraSinus® showed an adhesion rate of 16% compared to a literature-reported adhesion rate of 27% for MeroGel® in similar procedures. This is a comparison of device outcome, not human reader performance.

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

   • Not applicable as this is not an AI/ML device.

6. The type of ground truth used:

   • Clinical Outcomes/Observations: Directly observed post-operative clinical outcomes (adhesion formation, re-bleeding, adverse events) by treating physicians.
   • Bench Test Results: Quantitative measurements from laboratory tests (Complex Modulus, Viscosity, Injection Force).
   • Rabbit Model: In vivo animal study data for material comparison.

7. The sample size for the training set:

   • Not applicable, as this is not an AI/ML device that requires a "training set."

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

   • Not applicable, as this is not an AI/ML device.

Summary of Device Performance Evidence (based on the provided text):

The primary evidence presented to demonstrate the substantial equivalence and performance of PuraSinus® focused on:

• Bench Testing: Comparative physical and mechanical properties of PuraSinus® and the predicate device (MeroGel®).
• Animal Model: A side-by-side comparison in a rabbit model to address material differences between PuraSinus® and MeroGel®, concluding no impact on safety or effectiveness.
• Retrospective Case Series (Human Data): A small series (19 patients) showing favorable clinical outcomes (no re-bleeding, low and mild adhesion rates) compared to literature data for the predicate device.

The document emphasizes that PuraSinus® is the "identical product" to the previously cleared PuraDerm Gel (K140358), leveraging its biocompatibility and product characterization studies.

The acceptance of this device by the FDA (as indicated by the clearance letter K183015) was based on the provided data demonstrating substantial equivalence to the predicate device, not on meeting specific, pre-defined performance thresholds for an AI/ML algorithm.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device

MeroGel Injectable Bioresorbable Nasal Dressing and Sinus Stent and Otologic Gel is a space occupying gel stent intended to separate and prevent adhesions between mucosal surfaces, help control minimal bleeding following surgery or nasal trauma, and act as an adjunct to aid in the natural healing process.

MeroGel Injectable Bioresorbable Nasal Dressing and Sinus Stent and Otologic Gel is indicated for use in the middle ear and external ear canal following canalplasty, myringoplasty, tympanoplasty, and stapes and mastoid surgery. The device is indicated following nasal / sinus surgery or trauma to prevent lateralization of the middle turbinate and nasal adhesions during the post operative period.

MeroGel is a sterile, transparent, viscoelactic, bioresorbable gel composed of cross-linked polymers of hyaluronic acid. The MeroGel device fills ENT cavities following surgery or trauma to keep tissues or structures separate during the healing process. During this time, the tamponade effect helps control minimal bleeding normally associated with routine ENT surgery. MeroGel leaves the site of placement by natural elimination, or it may be aspirated from the cavity earlier at the discretion of the physician.

This is a 510(k) premarket notification for a medical device (MeroGel Injectable Bioresorbable Nasal Dressing and Sinus Stent and Otologic Gel), not an AI/ML-driven diagnostic device. Therefore, the information typically found in a study proving the device meets AI/ML acceptance criteria (such as sample size for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance) is not applicable here.

The "study" in this context refers to the testing performed to demonstrate substantial equivalence to a predicate device.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a quantitative performance metric sense (e.g., sensitivity, specificity). Instead, it focuses on demonstrating substantial equivalence to a predicate device (K070886) by showing that the proposed device performs identically or similarly across key characteristics. The "performance" is implicitly deemed acceptable if it matches the predicate or meets established standards for safety and effectiveness for such a device.

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

This information is not provided in the document. The document describes tests performed on the device itself and its manufacturing processes, not a "test set" of patient data for evaluating an AI algorithm.

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

This information is not provided and is not applicable to this type of device submission. Ground truth, in the context of AI/ML, refers to labels for data, which wasn't established for this device.

4. Adjudication Method for the Test Set

This information is not provided and is not applicable.

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 information is not provided and is not applicable. This device is a physical medical implant/dressing, not an AI-assisted diagnostic tool.

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

This information is not provided and is not applicable. This device is not an algorithm.

7. The Type of Ground Truth Used

This information is not provided and is not applicable. The assessment is based on physical and chemical properties and functional equivalence, not on a "ground truth" derived from patient outcomes or pathology.

8. The Sample Size for the Training Set

This information is not provided and is not applicable. This device is a manufactured product, not an AI model requiring a training set.

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

This information is not provided and is not applicable.

Ask a specific question about this device

Indicated for:

• Nasal soft-tissue and cartilage reconstruction
  The Ethicon Inc. PDS Flexible Plates are indicated for:
  – Nasal soft-tissue and cartilage reconstruction

PDS Flexible Plate are made of poly-p-dioxanone, an aliphatic polyester which is manufactured by polymerisation of the monomer p-dioxanone. PDS Flexible Plate are dyed with D+C violet # 2 (Color index Number 60725). PDS Flexible Plate are available in various film thicknesses, some of which are also perforated. PDS Flexible Plate can be trimmed to suit the anatomical conditions. The PDS Flexible Plate is a sterile, single use device.

This 510(k) premarket notification describes a medical device, the PDS Flexible Plate, which is a synthetic absorbable polymer indicated for nasal soft-tissue and cartilage reconstruction. The submission focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed clinical study results with specific acceptance criteria and performance metrics typically found for novel AI/ML-driven diagnostics.

Therefore, many of the requested sections regarding AI/ML study design, reader studies, and detailed performance metrics are not applicable to this 510(k) submission. This document primarily reports on bench-top and preclinical evaluations to support substantial equivalence.

Here's the information that can be extracted and a clear statement of what is not applicable:

Acceptance Criteria and Device Performance (Based on Substantial Equivalence)

The acceptance criteria for this 510(k) submission are not explicitly stated in terms of quantitative performance metrics for a diagnostic or AI device. Instead, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence to predicate devices. This means the device must show comparable characteristics in relevant areas and raise no new issues of safety or effectiveness.

The following sections are NOT APPLICABLE as this is a 510(k) submission for a non-AI/ML implantable medical device, not a diagnostic or AI-powered system.

2. Sample size used for the test set and the data provenance: Not applicable. Performance testing was "bench top" and "preclinical evaluations" and not based on a test set of patient data as for an AI/ML diagnostic.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI/ML diagnostic test set is not relevant for this device.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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: Not applicable.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to an AI/ML diagnostic. For this device, "ground truth" relates to the physical and biological performance in preclinical models or bench tests demonstrating its ability to function as intended and comparably to predicates.
8. The sample size for the training set: Not applicable. There is no training set for an AI/ML model for this device.
9. How the ground truth for the training set was established: Not applicable.

Summary of Relevant Information:

• Device Name: PDS Flexible Plate
• Intended Use: Nasal soft-tissue and cartilage reconstruction.
• Study Type: Bench top testing and preclinical evaluations to support substantial equivalence.
• Primary Objective of Study: To demonstrate that the PDS Flexible Plate fulfills device requirements, functions as intended, and is substantially equivalent to predicate devices (Orthosorb Pin, PDS Suture, MACROPORE ENT Reconstruction Film, LactoSorb Sheets, Silmax Sheeting).
• Key Findings: The device demonstrated comparable characteristics to predicate devices in thickness, tensile properties, and flexibility. Preclinical evaluations showed the device's ability to achieve intended use.

Ask a specific question about this device