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The Blom-Singer® Septal Perforation Prosthesis is indicated for use for non-surgical closure of nasal septum perforations.

The Blom-Singer® Septal Perforation Prosthesis is a bi-flanged elastomeric device, each prosthesis are comprised of two (2) pieces which are attached to one another using a set of 2 enclosed magnets at the center of the flanges. The center post is either an oval or circular silicone stem that will fill most of the nasal septal perforation. The overlapping thin section or flange will extend beyond perforation to help with the closure of the perforation and the retention of the device.

The flanges will be offered is various sizes and shapes to accommodate the individual's septal shape. In addition, the clinician may trim the flanges to fit.

The device is intended to be used up to 29 days.

Here is the information about the acceptance criteria and study for the Blom-Singer® Septal Perforation Prosthesis, based on the provided 510(k) summary:

Acceptance Criteria and Device Performance Study

The Blom-Singer® Septal Perforation Prosthesis received 510(k) clearance based on demonstrating substantial equivalence to predicate devices, K013686 (Silmed Nasal Septal Button) and K810738 (Xomed-Treace - Goode-Magne nasal splint). The primary method of demonstrating this equivalence was through non-clinical bench testing and a comparison of key features.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are not explicitly quantified performance metrics in the way a diagnostic algorithm's sensitivity/specificity would be. Instead, the "acceptance criteria" are implied by demonstrating that the proposed device performs functionally as intended and is safe, similar to the predicate devices, across various non-clinical tests. The reported device performance is that these tests were successfully passed, meeting the "requirements for the intended and environment of use."

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

• Sample Size for Test Set: Not applicable as this was a premarket notification (510(k)) that relied on non-clinical bench testing and comparison to predicates for substantial equivalence. There was no "test set" of patient data in the context of clinical trials. The bench tests would have used an unspecified number of device prototypes or components.
• Data Provenance: Not applicable. The data is from internal bench testing performed by the manufacturer, Helix Medical, LLC.

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

Not applicable. There was no clinical ground truth established by experts for a test set of patient data. The "ground truth" for the non-clinical tests was likely established by engineering specifications and industry standards for mechanical and material performance.

4. Adjudication Method for the Test Set

Not applicable. There was no test set involving human interpretation requiring adjudication.

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

No, an MRMC comparative effectiveness study was not done. This device is a physical medical device (prosthesis), not an AI algorithm or a diagnostic tool that would typically undergo such a study. The substantial equivalence was based on physical and material characteristics and bench testing.

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

Not applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this submission was primarily:

• Engineering specifications and performance requirements for the device's mechanical integrity (e.g., magnet strength, aging, environmental resilience).
• Biocompatibility standards and certifications for materials in prolonged mucosal contact.
• The established safety and effectiveness profile of the predicate devices.

8. The Sample Size for the Training Set

Not applicable. There was no "training set" in the context of AI or machine learning for this physical medical device.

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

Not applicable, as there was no training set.

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Silmed Nasal Septal Button is indicated for use for non-surgical closure of nasal septum perforations.

Silmed, Inc. Nasal Septal Button is indicated for use for non-surgical closure of nasal perforations. The Silmed Nasal Septal Button is designed in three sizes: small, medium and large. The Silmed Nasal Septal Button features two circular flanges centrally comected by a post. The circular flanges come in varying diaments depending on the size of the button. The central post is elliptical in shape and can also be explained as an elongated circular section. The post dimensions vary with size and with the circular flange diameter based on the size of the nasal perforation and can be trimmed at the time of placement.

The provided text is a 510(k) pre-market notification for a medical device called the "Silmed Nasal Septal Button." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than performing de novo studies with specific acceptance criteria and detailed performance results for the novel device.

Therefore, the document does not contain the information requested regarding:

• A table of acceptance criteria and reported device performance.
• Sample size used for the test set or its provenance.
• Number of experts used to establish ground truth or their qualifications.
• Adjudication method for the test set.
• Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done or its effect size.
• Whether standalone performance (algorithm only) was done.
• The type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

The document primarily focuses on establishing "substantial equivalence" of the Silmed Nasal Septal Button to existing predicate devices (Nasal Septal Buttons from Boston Medical Products, Micromedics Inc., and Hood Laboratories Inc.) based on:

• Design concept
• Indications for use: "non-surgical closure of nasal septum perforations."
• Use of standard materials
• Feature comparisons
• Method of manufacture, cleaning, and device packaging

The FDA's decision to clear the device is based on this demonstration of substantial equivalence, not on independent performance testing against specific acceptance criteria for the new device outlined in the request.

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Non-surgical closure of nasal septum perforation

Not Found

This document is a 510(k) clearance letter from the FDA for a device called "Nasal Septal Button" by Micromedics, Inc. It states that the device is substantially equivalent to a pre-amendment device and can be marketed.

Crucially, this document does NOT contain any information regarding acceptance criteria or the results of a study to prove device performance.

The letter is a regulatory clearance document, not a performance study report. It indicates that the device is cleared for non-surgical closure of nasal septum perforation based on substantial equivalence to devices marketed prior to May 28, 1976. This substantial equivalence determination means the FDA did not require a new clinical study to establish safety and effectiveness for this type of device.

Therefore, I cannot provide the requested information because it is not present in the provided text.

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To be used for non-surgical closure of nasal perforations.

The Nasal Septal Button is designed for non-surgical closure of septal perforations. The device is manufactured using soft medical grade silicone and can be trimmed at the time of placement. Studies have shown that use of a nasal septal button has decreased symptoms of nasal perforations including epistaxis and crusting. The button features two 3.2cm diameter flanges connected by a central 7mm diameter post.

The provided document is a 510(k) summary for the Boston Medical Products Nasal Septal Button. This type of regulatory submission is not typically accompanied by detailed studies proving acceptance criteria in the way a new, innovative device might require. Instead, it focuses on demonstrating "substantial equivalence" to a legally marketed predicate device.

Therefore, the specific information requested, such as a table of acceptance criteria with reported device performance metrics, sample sizes for test sets, data provenance, number and qualifications of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and details on training sets, are not present in this document.

Here's an explanation based on the available information:

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

• Not present. The document states: "Studies have shown that use of a nasal septal button has decreased symptoms of nasal perforations including epistaxis and crusting." However, it does not present specific acceptance criteria (e.g., "epistaxis decrease by X%") or quantitative performance data from a specific study.

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

• Not present. No information about a specific test set, its sample size, or data provenance is provided. The document refers generally to "Studies" that have shown decreased symptoms.

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):

• Not present. No details on expert involvement for ground truth establishment.

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

• Not present. No information about adjudication methods.

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/Not present. This device is a physical medical implant (nasal septal button), not an AI-driven diagnostic or image analysis tool. Therefore, MRMC studies involving human readers and AI assistance are not relevant to this product.

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

• Not applicable/Not present. As this is a physical device, not an algorithm, standalone performance as described for AI is not relevant.

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

• Not explicitly stated, but implied by 'substantial equivalence'. For a 510(k), the "ground truth" for demonstrating safety and effectiveness often comes from the established clinical use and performance of the predicate device. The general statement "Studies have shown that use of a nasal septal button has decreased symptoms of nasal perforations including epistaxis and crusting" suggests that clinical outcomes (symptom reduction) served as a basis for understanding effectiveness, likely derived from clinical observations or existing literature on such devices.

8. The sample size for the training set:

• Not applicable/Not present. This product is a physical device and does not involve a "training set" in the context of machine learning or AI models.

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

• Not applicable/Not present. As above, no training set is relevant.

Summary of the document's core message regarding "testing":

The primary "testing" mentioned in this 510(k) summary is:

• Material Compatibility: "Device is constructed using medical grade silicone, a well-established material for this application." This implies that the safety and biocompatibility of the material itself are well-understood and accepted, negating the need for novel material studies.
• Clinical Effectiveness (Historical/Literature-based): "Studies have shown that use of a nasal septal button has decreased symptoms of nasal perforations including epistaxis and crusting." This statement refers to the general clinical experience and evidence supporting the class of device, rather than specific performance data for this particular device model in a controlled study presented in the submission. The substantial equivalence argument relies on this existing evidence for similar devices and the fact that this device shares similar design and materials with its predicate.

In conclusion, this 510(k) document establishes "substantial equivalence" based on similar materials, design, and intended use as a predicate device, relying on the generally accepted clinical outcomes for this type of device, rather than presenting a detailed study with specific acceptance criteria and performance data for this new device.

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