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The Nylon flexTAP is intended to reduce or alleviate nighttime snoring and mild to moderate obstructive sleep apnea, OSA for adults, 18 years of age and older.

The Nylon flexTAP is a custom-fit oral device intended to reduce or alleviate nighttime snoring and mild to moderate obstructive sleep apnea (OSA). The Nylon flexTAP device consists of 3 components:

1. Upper Tray that fits on the upper teeth
2. Lower Tray that fits on the lower teeth.
3. An Adjustment Mechanism attached to the lower tray that fits into an Adjustment Post on the upper tray.

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Aurolab nonabsorbable, synthetic polyamide suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.

This nonabsorbable suture is composed of mono or multi filament nylon yarns, type 66, which is polymerized hexamethylene diamine and adipic acid. The yarns may be in monofilament form or braided in suitable construction for the intended size to meet current USP specifications. Those dyed black are dyed with Hematein (logwood) black and the logwood extract conforms with 21 CFR 73.1410 and does not exceed 1.0% (W/W) of Suture. The braided suture may be uncoated or have a silicone coating, or a paraffin wax coating. The mono nylon suture is uncoated. The suture thread has a needle attached to it.

The provided text describes a 510(k) summary for a Nylon Suture manufactured by Aurolab. The study focuses on demonstrating substantial equivalence to predicate devices rather than establishing specific performance metrics against pre-defined acceptance criteria for a new AI/software device. Therefore, much of the requested information regarding AI-specific studies (e.g., sample size for test set, number of experts, MRMC studies, training set details) is not applicable or cannot be extracted from this document.

However, I can extract the acceptance criteria and the performance results related to the device itself (the suture), even though it's not an AI device.

Here's the information based on the provided text, with clarifications where AI-specific details are not applicable:

Acceptance Criteria and Device Performance for Aurolab Nylon Suture

1. Table of Acceptance Criteria and the Reported Device Performance

2. Sample size used for the test set and the data provenance

The document does not explicitly state the sample size used for the testing of diameter, tensile strength, and suture-needle attachment. It mentions that tests were conducted "according to methods presented in United States Pharmacopoeia (U.S.P)".

Data Provenance: Not explicitly stated beyond "tests according to methods presented in United States Pharmacopoeia (U.S.P)". The manufacturer is Aurolab, located in India. The studies were likely performed internally or by a contracted lab. The study appears to be a bench study to assess physical properties, not a clinical study on patient data.

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

Not applicable. This device is a physical medical device (suture), and its performance was assessed against established physical standards (USP) through laboratory testing, not through expert review of data.

4. Adjudication method for the test set

Not applicable. The assessment was based on objective measurements against USP standards, not subjective interpretation requiring 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

Not applicable. This is not an AI device.

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

Not applicable. This is not an AI device.

7. The type of ground truth used

The ground truth used was United States Pharmacopoeia (U.S.P) standards for physical properties of sutures, specifically:

• Diameter
• Tensile Strength
• Suture-Needle Attachment

8. The sample size for the training set

Not applicable. This is a physical device, not an AI/ML algorithm requiring a training set.

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

Not applicable. This is a physical device, not an AI/ML algorithm. The "ground truth" for the performance evaluation was established by the USP standards themselves.

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NYLON is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.

NYLON is a nonabsorbable sterile surgical suture composed of the long-chain aliphatic polymers Nylon 6 and/or Nylon 6,6. NYLON meets all requirements established by the United States Pharmacopeia (USP) for Nonabsorbable Surgical Suture. Offered as monofilament in form, it maybe offered coated or uncoated, undyed and dyed with an appropriate FDA listed color additive, D&C Blue No. 2. (21CFR74.3102) or Logwood extract, C.I. Natural Black 1. (21CFR74.1410). NYLON will be offered with or without standard needles attached.

Acceptance Criteria and Device Performance Study for NYLON Surgical Suture

This analysis focuses on the acceptance criteria and the study performed for the T.CAD International NYLON surgical suture, as presented in the provided 510(k) submission.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample size used for the non-clinical testing. The provenance of the data is not specified beyond being "non-clinical testing" conducted to prove conformance to U.S.P. standards. It is implied the testing was performed by or for T.CAD International. The nature of the testing (physical properties and functionality) suggests it was retrospective in the sense that the suture material was already manufactured and then tested.

3. Number of Experts Used to Establish Ground Truth and Qualifications

The document does not mention the number or qualifications of experts used to establish ground truth for the test set. The ground truth for the non-clinical tests appears to be the United States Pharmacopeia (U.S.P.) standards themselves.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method for the test set. The testing was against pre-defined U.S.P. standards, implying a pass/fail outcome based on direct measurement compared to the standard, rather than subjective expert opinion requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

There was no MRMC comparative effectiveness study performed. Surgical sutures are not typically evaluated using MRMC studies, as their effectiveness is primarily gauged by their physical and biological performance rather than interpretative tasks. Clinical testing was explicitly stated as "Not available at the present time."

6. Standalone Performance Study (Algorithm Only)

This question is not applicable as the device is a physical surgical suture, not an algorithm or software. Therefore, there was no "algorithm only" performance study.

7. Type of Ground Truth Used

The primary ground truth used for the device's acceptance was United States Pharmacopeia (U.S.P.) Standards. This represents established regulatory and performance benchmarks for surgical sutures. The comparison to predicate devices also implies a ground truth established by the long-standing safe and effective use of those predicate devices.

8. Sample Size for the Training Set

This question is not applicable. Surgical sutures, being physical devices, do not typically involve "training sets" in the context of machine learning or algorithms. The manufacturing process is controlled to produce sutures that consistently meet specifications.

9. How Ground Truth for the Training Set Was Established

This question is not applicable for the same reason as point 8. The production of surgical sutures relies on established manufacturing processes and quality control to ensure consistency, rather than a "training set" with established ground truth in the AI sense.

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The provided text is a 510(k) clearance letter from the FDA for "Nylon Coated Specula (Vaginal)". It is not a study report or a technical document detailing acceptance criteria and performance data for a medical device.

Therefore, I cannot extract the requested information (acceptance criteria, device performance, study details, sample sizes, expert qualifications, etc.) from this document. This letter merely states that the device is substantially equivalent to previously marketed devices and can be marketed, subject to general controls. It does not contain any of the technical or clinical performance data you've asked for.

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The nylon nonabsorbable sutures, USP are indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurologica1 procedures.

Nylon nonabsorbable surgical sutures, USP, manufactured by R. K. Medical L. L. C. are equivalent to nylon nonabsorbable surgical sutures manufactured by Davis + Geck. The nylon sutures manufactured by R. K. Medica1 and D+G can be monofilament or braided, coated with silicone, or wax, or uncoated, dyed black or blue or undyed.

This document is a 510(k) summary for R. K. Medical L. L. C.'s Nylon Nonabsorbable Surgical Sutures. It's a regulatory submission, not a research study report, so it doesn't contain detailed information about acceptance criteria and a study in the way one would typically describe for an AI/CAD device.

However, I can extract the relevant information and structure it to answer your questions to the best of what's provided, interpreting "acceptance criteria" as meeting USP specifications and "study" as the testing performed.

Context: This device is a surgical suture, not an AI or diagnostic imaging device. Therefore, many of your questions (e.g., MRMC studies, ground truth for AI, training sets) are not applicable. I will indicate where this is the case.

Here's the breakdown of the information based on your request:

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

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

• Sample Size: Not specified in the document.
• Data Provenance: Not specified, but implied to be from testing conducted during the manufacturing process by R. K. Medical L. L. C. in Danbury, CT, USA. The testing is likely prospective, as it's a part of demonstrating compliance for a new product.

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 Applicable. For a surgical suture, "ground truth" is established by adherence to defined physical specifications (USP XXIII), not by expert interpretation in a clinical context. The "ground truth" is the USP standard itself.

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

• Not Applicable. Adjudication methods are typically for subjective assessments or disagreements in clinical interpretations (e.g., in reading medical images). Here, objective physical measurements against established standards are performed.

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. This is a surgical product, not an AI or diagnostic imaging device.

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

• Not Applicable. This is a surgical product, not an AI algorithm. The "standalone performance" is the suture's physical properties when tested.

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

• Type of Ground Truth: USP XXIII (United States Pharmacopeia) specifications for nylon nonabsorbable surgical sutures. These are objective, quantitative standards for physical properties.

8. The sample size for the training set

• Not Applicable. This refers to machine learning. No training set is used for this type of device.

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

• Not Applicable. As no training set is used, this question is irrelevant. The "ground truth" (USP standards) is established by a pharmacopeia, based on scientific testing and consensus for medical devices.

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