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SHOULDER: Acromio-clavicular; Bankart repair; Biceps tenodesis; Capsule shift/capsulolabral reconstruction; Deltoid repair; Rotator cuff repair; SLAP lesion repair. ANKLE: Achilles tendon repair/reconstruction; Lateral instability; Medial instability; Midfoot reconstructions. FOOT: Hallux valgus reconstruction. WRIST: Scapholunate ligament reconstruction. HAND: Ulnar or lateral collateral ligament reconstruction. ELBOW: Biceps tendon reattachment; Tennis elbow repair. KNEE: Extra capsular reconstruction, ITB tenodesis; Lateral ligament; Patellar ligament and tendon avulsion repairs; Posterior oblique ligament or joint capsule to tibia; Joint capsule closure to anterior proximal tibia; Medial collateral ligament. BNS: Fixation in pubic bone for bladder neck suspension using USP #2 Class I nonabsorbable synthetic suture (e.g. polypropylene). A minimum of 2 Anchors should be used in this procedure.

The only proposition of this 510(k) submission is to add a "MR-Conditional" statement and symbol to all applicable product package-insert and labels of GII™ Anchor devices. Technological characteristics including indications, product design, material, and packaging are the same as the predicate devices.

The provided text describes a 510(k) submission for the DePuy Mitek GII™ Anchor, focusing on adding an "MR-Conditional" statement and symbol to the product. This submission is for a modification to an already marketed device, not for a new medical device that performs a diagnostic or predictive function.

Therefore, the document does not contain the information requested in the prompt regarding acceptance criteria, device performance metrics (like sensitivity, specificity, AUC), sample sizes for test/training sets, expert qualifications, or adjudication methods typically associated with studies proving the performance of AI/analytic devices.

The "Nonclinical Testing" section mentions "MRI Testing using a scanner operating with a static magnetic field was performed on the DePuy Mitek metal implant devices." and "Results of 'Evaluation of Magnetic Field Interactions, Heating, and Artifacts' have demonstrated that the currently marketed DePuy Mitek GII™ Anchors are 'MR-conditional'." This refers to physical testing to ensure safety in an MRI environment, not a study evaluating an algorithm's performance.

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THE IMPLANT(S) IS DESIGNED FOR USE IN THE EDENTULOUS SITES IN THE MANDIBLE OR MAXILLA FOR SUPPORT OF A COMPLETE DENTURE PROSTHESIS, A TERMINAL OR INTERMEDIATE ABUTMENT FOR FIXED OR PARTIAL DENTURES, OR A SINGLE TOOTH REPLACEMENT. THE 8,25MM LONG IMPLANT CAN NOT BE USED AS A SINGLE TOOTH REPLACEMENT.

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The provided document is an FDA 510(k) clearance letter for a dental implant. It states that the device is substantially equivalent to legally marketed predicate devices and therefore does not require a premarket approval application (PMA).

However, this document *does not contain any information regarding:

• Acceptance criteria and reported device performance (in terms of specific metrics like sensitivity, specificity, accuracy)
• Details of any specific study (clinical or analytical) that would prove the device meets acceptance criteria.
• Sample sizes used for test sets or training sets.
• Data provenance, number or qualifications of experts, adjudication methods, multi-reader multi-case studies, standalone performance, or types of ground truth.

This document is a regulatory clearance and not a study report. It confirms that the device can be legally marketed based on its equivalence to existing products, but it does not provide the technical performance data that would typically be found in a study proving acceptance criteria.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance, nor the other requested details about a study, because this information is not present in the provided text.

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The Brånemark System implants are for single-stage or two-stage surgical procedures and cement or screw retained restorations. The Branemark System implants are intended for immediate placement and function on single tooth and/or multiple tooth applications recognizing sufficient bone stability (type I or II bone) and appropriate occlusal loading, to restore chewing function. Multiple tooth applications may be splinted with a bar.

The Brånemark System implant products that are the subject of this 510(k) are threaded, root-form implants fabricated from commercially pure titanium, either machined or modified (TiUnite) surface, and are already commercially available.

The provided text describes a 510(k) summary for various Brånemark System Dental Implant Products, specifically regarding an expanded indication for immediate function. It does not contain information about acceptance criteria or a study proving that a device meets those criteria, as typically seen in submissions for AI/ML-enabled devices.

The submission is for a medical device (dental implants) where the technological characteristics are stated to remain "substantially unchanged" and "no design modifications were made that effect safety and effectiveness." The "Performance Data" section merely states: "Clinical results show that the expanded Indications for Use are as safe and effective as the original Indications for Use." This is a general statement and does not provide specific acceptance criteria or detailed study results.

Therefore, for your request, I must report that the provided text does not contain the requested information regarding acceptance criteria and a study proving a device meets those criteria.

The document is a 510(k) summary focusing on the equivalence of an expanded indication for use for dental implants, not a detailed performance study for a new or modified device with specific acceptance metrics. The questions you've asked are typically relevant for AI/ML-driven devices or those with quantifiable performance metrics that need to be demonstrated against pre-defined acceptance criteria. This document doesn't fall into that category.

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Surgical Drapes are single use and shall be used by medical professionals in an operating room or healthcare setting for patient protective covering.

Various Sterile and Non-Sterile Surgical Drapes, DISPOSABLES MINOR PROCEDURE DRAPES, LARGE APERTURE DRAPE, ABSORBANT ANG'IO GRAPHY SHEET, CEGEAREAN BIRTH SHEET AND POLY-U-DRAPE

This document is a 510(k) clearance letter from the FDA for various sterile and non-sterile surgical drapes. It does not contain information about acceptance criteria or a study proving the device meets those criteria.

Therefore, I cannot provide the requested information. The document does not describe:

• A table of acceptance criteria or reported device performance.
• Sample sizes, data provenance, or details of a test set.
• Number or qualifications of experts for ground truth.
• Adjudication method.
• A multi-reader multi-case (MRMC) comparative effectiveness study.
• A standalone algorithm performance study.
• The type of ground truth used.
• The sample size or ground truth establishment for a training set.

This document is solely an FDA clearance stating that the device is substantially equivalent to legally marketed predicate devices, allowing it to proceed to market. It does not elaborate on the specific performance studies that might have been conducted by the manufacturer to support their submission.

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The Ansell or private label black condom is a male contraceptive device, fabricated of latex, which is designed to completely cover the penis during sexual intercourse. This condom is intended to be used for contraceptive and prophylactic purposes. If used properly, this condom will help reduce the risk of transmission of HIV infection (AIDS) and many other sexually transmitted diseases including chlamydia, genital herpes, genital warts, gonorrhea, hepatitis B, and syphilis. In addition, this condom will help reduce the risk of pregnancy without the serious side effects sometimes associated with other methods. However, no contraceptive can guarantee 100% effectiveness. Failure to use as directed may further result in loss of protection. Furthermore, sexually transmitted diseases can be transmitted through lesions and various body fluids during intimate contact. Therefore, the condom should be applied before any such contact.

This condom is a male contraceptive and prophylactic device which is fabricated of a natural rubber latex. The condom is designed as a fitted sheath with an integral ring at the open end and a reservoir at the closed end to contain semen. This condom is designed to conform to established national and international voluntary standards including ASTM D3492, ISO 4074, and EN 600.

The provided document is a 510(k) Pre-market Notification for a latex condom, and as such, it focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study of its effectiveness against a set of acceptance criteria in the way medical diagnostic or AI-driven devices typically would.

Therefore, the information requested in your prompt regarding acceptance criteria, device performance, sample sizes for test/training sets, experts, adjudication methods, multi-reader studies, and ground truth types is not explicitly detailed within this regulatory submission.

However, I can extract the information related to conformance with required specifications and physical testing which implies a form of acceptance criteria and performance evaluation.

Here's an attempt to answer your request based on the available information, noting the absence of detail for many of your points:

1. Table of Acceptance Criteria and Reported Device Performance

   Acceptance Criteria (Implied)	Reported Device Performance
   Conformance to ASTM D3492 standards	"revealed results in conformance with required specifications"
   Conformance to ISO 4074 standards	"revealed results in conformance with required specifications"
   Conformance to EN 600 standards	"revealed results in conformance with required specifications"
   Biocompatibility: Not toxic (local or systemic)	"The condom is not toxic (local or systemic)"
   Biocompatibility: Not sensitizing	"not sensitizing"
   Biocompatibility: Not locally irritating	"not locally irritating"
   Biocompatibility: Not otherwise harmful	"not otherwise harmful"
   Colorfastness	"revealed results in conformance with required specifications"
   Air inflation testing	"revealed results in conformance with required specifications"
   Other in-process and final release testing (physical properties)	"revealed results in conformance with required specifications"

2. Sample sizes used for the test set and the data provenance: Not explicitly stated. The document mentions "All physical testing, air inflation testing, colorfastness testing, including other in-process and final release testing." The provenance would be from manufacturing batches of the device, likely from India where the manufacturer is located. It is an intrinsic part of the manufacturing quality control process, not a separate clinical "test set" in the sense of a diagnostic device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The "ground truth" for condom performance in this context refers to adherence to international and national standards for physical properties and biocompatibility. This is assessed through laboratory testing, not expert interpretation of results.

4. Adjudication method for the test set: Not applicable. Laboratory testing against predefined standards does not typically involve adjudication in the expert consensus sense.

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 device is a physical product (condom), not an AI-driven diagnostic tool or imaging system.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable for a physical device like a condom.

7. The type of ground truth used:

   • External Standards: ASTM D3492, ISO 4074, and EN 600 for physical properties.
   • Biocompatibility Standards: Methods of ISO 10993 Biological Evaluation of Medical Devices and ODE Guidance Memorandum G95-1 (for 24 hours or less contact with skin/mucosal membrane).

8. The sample size for the training set: Not applicable. There is no "training set" in the context of a physical product's regulatory submission for demonstrating substantial equivalence. All testing mentioned relates to quality control and final product verification against established standards.

9. How the ground truth for the training set was established: Not applicable.

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The implant(s) is designed for use in the edentulous sites in the mandible or maxilla for support of a complete denture prosthesis, a terminal or intermediate abutment for fixed or partial dentures, or a single tooth replacement.

Various Dental Implants with Various abutments

I am sorry, but the document provided does not contain information about acceptance criteria or a study proving device performance. The document is an FDA 510(k) substantial equivalence letter for "Various Dental Implants with Various Abutments." It confirms that the device is substantially equivalent to legally marketed predicate devices and outlines regulatory requirements. It does not include details on specific device performance metrics, study designs, sample sizes, expert qualifications, or ground truth establishment.

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Paragon Trade Brands Digital tampons are menstrual tampons that are inserted into the vagina and used to absorb menstrual fluid.
As a Class II device, the menstrual tampon is defined as follows: (21 CFR 884.5460 and 21 CFR 884.5470)
Paragon Trade Brands Digital Tampons are made of a plug of cellulosic or synthetic material that is inserted into the vagina and used to absorb menstrual or other vaginal discharge.

Paragon Trade Brands Digital Tampons are menstrual tampons used to absorb menstrual fluid. These Tampons will be provided with 3 absorbencies, regular, super and super plus.
These Paragon Trade Brands Tampons are made from rayon and cotton and cotton cord.
The material used in Paragon Trade Brand tampons are similar to those used in other legally marketed tampons.

The provided text describes the 510(k) summary for "Paragon Trade Brand Digital Tampons." However, the device is not an AI/ML device, but rather a traditional medical device (menstrual tampons). Therefore, many of the requested categories related to AI/ML device studies (such as sample sizes for test sets, expert ground truth, MRMC studies, standalone performance, training set details) are not applicable to this submission.

Here's the relevant information that can be extracted from the provided text, structured according to your request, with "Not Applicable" for AI/ML specific criteria:

Acceptance Criteria and Device Performance for Paragon Trade Brand Digital Tampons

This submission describes a traditional medical device (menstrual tampons), not an AI/ML device. Therefore, the acceptance criteria and study details are focused on traditional medical device safety and performance, primarily demonstrating substantial equivalence to legally marketed predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

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

Not Applicable (N/A) for AI/ML test sets. The non-clinical testing involved material characterization and absorbency testing (Syngyna testing). The text does not specify the sample sizes for these tests, nor the "country of origin of the data" in a way relevant to clinical data. The studies performed were non-clinical bench tests.

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

N/A for AI/ML-style ground truth. The "ground truth" here is based on chemical and physical testing standards for biocompatibility and absorbency, not expert human interpretation of images or other data.

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

N/A. This concept applies to expert consensus in AI/ML performance evaluation, which is not relevant here.

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

N/A. This device is a tampon, not an AI diagnostic or assistance tool.

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

N/A. This device is a tampon, not an algorithm.

7. The type of ground truth used

The "ground truth" for this device's performance is established through standardized non-clinical laboratory testing (e.g., biocompatibility assays, Syngyna absorbency testing) and comparison to the known safety and performance of legally marketed predicate devices (Tampax tampons).

8. The sample size for the training set

N/A. This device is not an AI/ML model and does not have a "training set."

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

N/A. This device is not an AI/ML model and does not have a "training set" with associated ground truth.

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The implant(s) is designed for use in the edentulous sites in the mandible or maxilla for support of a complete denture prosthesis, a terminal or intermediate abutment for fixed or partial dentures, or a single tooth replacement.

Various Dental Implants

I am sorry, but the provided text does not contain the detailed information necessary to answer your request about acceptance criteria and the study proving the device meets them. The document is a 510(k) clearance letter from the FDA for "Various Dental Implants," confirming their substantial equivalence to previously marketed devices.

This type of document typically focuses on regulatory clearance based on substantial equivalence, rather than detailing the specific performance studies and acceptance criteria that would have been submitted by the manufacturer as part of their 510(k) application.

Therefore, I cannot provide:

1. A table of acceptance criteria and reported device performance.
2. Sample size for the test set or data provenance.
3. Number and qualifications of experts for ground truth.
4. Adjudication method.
5. Information about an MRMC comparative effectiveness study or effect size.
6. Whether a standalone performance study was done.
7. The type of ground truth used.
8. Sample size for the training set.
9. How the ground truth for the training set was established.

The letter only states that the FDA "reviewed your Section 510(k) notification of intent to market the device... and we have determined the device is substantially equivalent... to legally marketed predicate devices." It also lists the "Indications For Use."

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Paragon Menstrual Tampons are a plug made of cellulosic or synthetic material that is inserted into the vaginal and used to absorb menstrual or other vaginal discharge.

Paragon Trade Brands Tampons are menstrual tampons used to absorb menstrual fluid. These Tampons will be provided with 3 absorbencies, regular, super and super plus. These Paragon Trade Brands Tampons are made from rayon and cotton and cotton cord. The material used in Paragon Trade Brand tampons are similar to those used in other legally marketed tampons.

The provided text describes a 510(k) summary for "Paragon Trade Brand Tampons" (K981953), which are menstrual tampons used to absorb menstrual fluid. The submission focuses on demonstrating substantial equivalence to legally marketed Tampax tampons with applicators rather than establishing novel acceptance criteria through a specific clinical study with a device performance table.

Therefore, many of the requested elements for describing a study proving the device meets acceptance criteria are not directly applicable or explicitly stated in the provided text. However, I can extract the relevant information and indicate where data is not available from the text.

Here's an analysis based on the provided documents:

Acceptance Criteria and Device Performance

The core of this submission is substantial equivalence to a predicate device (Tampax tampons with applicators), not a new set of numerical performance acceptance criteria. The "acceptance criteria" are implicitly met if the device is found to be substantially equivalent in terms of safety and effectiveness to the predicate.

Study Details (Based on available information in the 510(k) Summary)

The "study" described is a non-clinical testing program to support substantial equivalence.

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

   • Sample Size: Not specified for individual tests. The text mentions "Biocompatibility testing of the Paragon Trade Brands Tampons components" and "Standard Syngyna testing confirmed the absorbency of these Tampons." The number of samples or items tested for each specific biocompatability assay (irritation, sensitization, etc.) or Syngyna absorbency is not provided.
   • Data Provenance: Not explicitly stated, but typically non-clinical testing like this would be conducted in a laboratory setting, likely within the US or by a contracted lab. It is retrospective in the sense that the testing was performed on the completed device design.

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

   • This question is not applicable in the context of this 510(k) submission. The "ground truth" for non-clinical testing like biocompatibility or absorbency is established by the standardized test methods themselves and the quantitative or qualitative results obtained from those tests, not by expert consensus on interpretations of complex data like medical images. For instance, Syngyna testing has a defined protocol for measuring absorbency.

3. Adjudication method for the test set:

   • Not applicable. Adjudication methods (like 2+1, 3+1) are typically used for clinical studies involving multiple expert readers interpreting subjective data (like medical images) to establish a consensus ground truth. This submission describes non-clinical laboratory testing. The results of tests like biocompatibility or absorbency are typically numerical or based on predefined pass/fail criteria, not subjective expert judgment requiring adjudication.

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:

   • This is not applicable. This device is a menstrual tampon, not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study and AI performance metrics are irrelevant to this submission.

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

   • This is not applicable. As stated above, this device is not an algorithm or AI system.

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

   • For biocompatibility tests (irritation, sensitization, toxicity, cytotoxicity, dioxins/furans), the "ground truth" is established by the standardized test methodologies and their direct results (e.g., specific cellular reactions, chemical levels, lack of observed adverse effects). These results are then compared to established safety profiles for similar materials or predicate devices.
   • For absorbency, the "ground truth" is established by the quantitative measurement obtained through standard Syngyna testing.

7. The sample size for the training set:

   • This is not applicable. This is a physical medical device, not a machine learning model. There is no concept of a "training set" in this context.

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

   • This is not applicable as there is no training set for this device.

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The various surgical or patient drapes manufactured by DEKA Medical, Inc., consist of natural or synthetic materials intended to be used as a protective patient covering during surgical procedures. The primary purpose of the drapes is to isolate a site of surgical incision from microbial or other contamination.

DEKA Medical, Inc., will market Surgical Drapes composed of nonwoven fabric or polyethylene film and are of various configurations appropriate for Otological, Ophthalmic, Heart & Neurological, Peri/OB, Arthroscopic, and Specialty Procedures. These devices use nonwoven and film materials as a protective patient covering during surgical procedures. These barrier materials are essentially impervious to fluid transfer across them, thus function to isolate the operative site from the surrounding area. Drapes may feature tape adhesive to temporarily bind the drape to the periphery of the operative site. Fluid collection pouches are attached to the drape for collection of operative wound solid and liquid effluents. The DEKA Medical Surgical Drapes will be subjected to a sterilizing dose of gamma radiation sufficient to achieve a Sterility Assurance Level (SAL) of 10-6.

The provided text describes a 510(k) submission for a Patient Drape product, not an AI-powered device. Therefore, a direct comparison using typical AI/ML acceptance criteria and study methodologies (like those that assess algorithm performance, MRMC studies, or multi-reader, multi-case studies) is not applicable.

The document focuses on demonstrating substantial equivalence to a predicate device (Invotec International, Inc. Ear Drape K911039) for a medical device (surgical drape) that is not an AI-driven product. The study described is a nonclinical test data analysis, primarily evaluating the physical properties and biocompatibility of the materials used in the drapes.

However, I can extract the relevant information about the acceptance criteria and the "study" (nonclinical testing) as presented in the document for the Patient Drape:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: Not explicitly stated as a "sample size" in the context of clinical trials. The performance data is derived from material supplier data and specific laboratory tests on the drape materials and a "Composite Patient Drape." The exact number of material samples or drapes tested is not specified.
• Data Provenance: The data is "Physical properties data obtained from suppliers of DEKA Medical Surgical Drape nonwoven fabric, polyethylene films, and skin contacting adhesives." It also includes "Biocompatibility testing... of a gamma sterilized Composite Patient Drape." This is primarily retrospective (data from suppliers) and prospective (specific biocompatibility testing). The country of origin is not specified, but the submission is to the U.S. FDA, implying compliance with U.S. standards.

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

• This is not applicable as the "ground truth" for this medical device is based on objective physical and chemical properties testing against established standards (e.g., ISO for sterility and biocompatibility, 16 CFR for flammability), not expert interpretation of outputs.

4. Adjudication method for the test set

• Not applicable as the "test set" involves objective laboratory measurements against predefined specifications, not subjective reviewer performance.

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, and therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed or is relevant.

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

• Not applicable. This is not an algorithm or AI device.

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

• The "ground truth" here is based on objective measurements and adherence to established industry standards and regulations for material properties and performance. Examples include:
  • Material specifications confirming impermeability, tensile strength, and puncture resistance (from suppliers).
  • Regulatory standards like 16 CFR Part 1610 for flammability.
  • International Standards like ISO 11137 for sterility assurance and ISO 10993-10 for biocompatibility.

8. The sample size for the training set

• Not applicable. This is not an AI/ML device that requires a training set. The performance is based on the inherent properties of the manufactured materials and products.

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

• Not applicable, as there is no training set for this type of medical device.

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