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BioHorizons Tapered Pro Conical dental implants are intended for use in the mandible or maxilla for use as an artificial root structure for single tooth replacement or for fixed bridgework and dental implants may be restored immediately (1) with a temporary prosthesis that is not in functional occlusion or (2) when splinted together for multiple tooth replacement or when stabilized with an overdenture supported by multiple implants.

BioHorizons Tapered Short Conical dental implants are intended for use in the mandible or maxilla as an artificial root structure for single tooth replacement or fixed bridgework and dental retention. These dental implants must be restored using delayed loading, for single tooth replacement, or may be used with a terminal or intermediate abutment for fixed or removable bridgework or for overdentures. Tapered Short Conical implants should be used only when there is not enough space for a longer implant. If the ratio of crown length is unfavorable, the biomechanical risk factors have to be considered and appropriate measures have to be taken by the dental professional.

BioHorizons conical dental prosthetic components connected to the endosseous dental implants are intended for use as an aid in prosthetic rehabilitations of the maxillary or mandibular arch to provide support for prosthetic restorations.

All digitally designed abutments for use with Conical CAD/CAM Ti Blanks and Ti Bases are to be sent to a BioHorizons validated milling center for manufacture.

The purpose of this submission is to obtain marketing clearance for an endosseous dental implant and abutment system, Tapered Pro Conical Implant System, from BioHorizons Implant Systems Inc. The Tapered Pro Conical Implant System includes a range of ental implants and prosthetic components, BioHorizons Tapered Pro Conical implants feature a tapered screw-shaped design with a reverse buttress thread. Cutting flutes are incorporated into the thread to be self-tapping when placed into the prepared surgical site. The outer surface of the implant has been roughened with resorbable blast texturing (RBT) using a hydroxyapatite blast media. Internally, the implant features a deep conical prosthetic connection between implants and abutments with six anti-rotation cams at the base of the connection, intended to interface with the three cams of the prosthetic components. It is available with or without Laser-Lok treatment applied to the collar of the implant.

Tapered Pro Conical Implants are available in a range of implant diameters and lengths with two prosthetic platform (implant/abutment connection) sizes, as shown below. Internal surfaces of the Tapered Pro Conical Regular platform implants are anodized yellow to distinguish them from Narrow platform implants.

Abutments are available in multiple designs, including straight and angled abutments intended for single tooth and multi-unit restorations. The Conical Ti-Base abutments are a two-piece abutment composed of a pre-manufactured Ti Base component and a CAD/CAM patient-matched mesostructure (superstructure) composed of sagemax® NexxZr zirconia (K130991).

The provided text is a 510(k) premarket notification summary for a dental implant system. It does not describe a study to prove the device meets acceptance criteria related to an AI/ML-driven medical device, nor does it contain information on the performance data, sample sizes, expert ground truth establishment, or multi-reader multi-case studies typically associated with such devices.

The document focuses on demonstrating substantial equivalence to predicate dental implants and their components. The "PERFORMANCE DATA" section (page 7 of the PDF, starting on page 8 of the transcription) lists non-clinical data such as validation of sterilization, bacterial endotoxin testing, shelf-life testing, biocompatibility, MRI compatibility, and mechanical testing, which are standard for dental implants.

Therefore, I cannot fulfill the request as the provided text does not contain the necessary information about acceptance criteria and a study proving the device meets those criteria, specifically for an AI/ML medical device.

To be explicit, the document states:

• "No clinical data were included in this submission." (Page 7)
• The performance data discussed are entirely non-clinical and relate to the physical and material properties of the dental implants, not an AI or software component assessing images or providing diagnostic assistance.

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The TAP Lancet is a single-use blood lancing device intended for producing microliter capillary whole blood samples. It does not collect or transport such samples.

The TAP Lancet is a single-use blood lancing device with an integral sharps injury prevention feature intended for producing microliter capillary whole blood samples. The TAP Lancet comprises a lancing module and a vacuum creation module which operate in an entirely mechanical fashion. The device uses a lancet and vacuum to initiate blood flow from the capillary bed in the upper arm. To use the device, the user removes that TAP Lancet from a sterile barrier package. Next, the user removes a protective liner from the bottom of the device to expose a layer of medical adhesive and places the device onto the

Let's break down the information regarding the acceptance criteria and the study proving the device meets them for the TAP Lancet.

The provided text is a 510(k) Summary for the TAP Lancet, a blood lancing device. The summary focuses on demonstrating substantial equivalence to a predicate device and includes details about non-clinical and clinical performance testing.

Here's the breakdown of the acceptance criteria and study as presented in the document:

1. Acceptance Criteria and Reported Device Performance

The document describes the performance of the device in a clinical study primarily under the "Non-Clinical and/or Clinical Tests Summary & Conclusions" section. The key metric reported related to the device's functional performance in producing blood samples.

Note: The document doesn't explicitly state quantitative 'acceptance criteria' in a table format for the clinical study results, but rather presents the study outcome as meeting the overall performance goals.

2. Sample Size and Data Provenance

• Test Set (Clinical Study):

  • Sample Size: Not explicitly stated as a number of subjects. The text mentions "human subjects" and "The devices had a total success rate of 95.0%". From the information on the training set (380 samples), this seems to be a separate smaller study for usability.
  • Data Provenance: Not specified regarding country of origin. The study was an "actual-use study" where "Subjects produced their blood samples following the TAP Lancet instructions for use," indicating a prospective study design.

• Training Set (Usability Study, from context of "clinical testing" section related to usability):

  • Sample Size: 380 samples (This is the only specific number of "samples" mentioned in relation to a study that isn't device/material testing).
  • Data Provenance: Not specified regarding country of origin. The study was a "human use study" that also seems prospective, as subjects were producing blood samples using the device.

3. Number of Experts and Qualifications for Ground Truth

The document does not indicate the use of experts to establish ground truth for the clinical performance. The "ground truth" for the clinical study appears to be the successful production of microliter capillary whole blood samples by the device itself when used by human subjects according to instructions. This implies a direct observational assessment of the device's primary function rather than interpretation by human experts.

4. Adjudication Method for the Test Set

No adjudication method is mentioned. The success of blood sample production is likely a direct, measurable outcome, not requiring interpretation or adjudication by multiple reviewers.

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

No MRMC study was performed or described. The study focused on the performance of the device itself (ability to produce blood samples) and its usability, not on comparing human readers with and without AI assistance. This device is a physical lancing device, not an AI/imaging diagnostic tool.

6. Standalone Performance (Algorithm Only)

Not applicable. This is a physical medical device (lancet), not an algorithm or software. Its performance is inherent to its mechanical function.

7. Type of Ground Truth Used

The ground truth for the clinical performance assessment was outcomes data related to the device's primary function: the successful production of microliter capillary whole blood samples. This was a direct, observable outcome of the device's use.

8. Sample Size for the Training Set

As mentioned above, if we interpret "training set" as the data used for the usability study which informed product improvements or finalized the design:

• Sample Size: 380 samples.

9. How Ground Truth for the Training Set Was Established

The "training set" (presumably the samples from the usability study) ground truth was established by direct observation and assessment of the device's ability to produce blood samples and its usability when used by human subjects. The phrase "Subjects produced their blood samples following the TAP Lancet instructions for use" and "The devices had a total success rate of 95.0% and demonstrated that they performed as intended" suggests that success was a direct observation of whether a sample was obtained as specified. The usability portion would have involved feedback or evaluation based on the instructions for use.

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TAPESTRY® Biointegrative Implant is indicated for the management and protection of tendon injuries in which there has been no substantial loss of tendon tissue.

The TAPESTRY® Biointegrative Implant is composed of collagen and poly(D,L-lactide). It is designed to function as a non-constricting, protective layer between the tendon and surrounding tissues. The implant is provided sterile for single use only. It is supplied as a standalone implant, in an insertion sleeve, or on an introducer assists in delivering the implant to the surgical site during arthroscopic procedures. The device is provided in a dual pouch configuration.

This document is an FDA 510(k) summary for the TAPESTRY® Biointegrative Implant. It outlines the device, its intended use, and compares it to a predicate device. However, it does not describe acceptance criteria, nor does it present a study that proves the device meets specific performance criteria related to AI/algorithm performance.

The performance data section explicitly states: "The testing in this submission was directly applicable to the new introducer and no additional performance testing was required for the implant based on the modification." This indicates that the reported performance data focuses on the mechanical aspects of the introducer instrument, rather than clinical efficacy or AI/algorithm performance.

Therefore, I cannot provide the requested information about acceptance criteria and a study proving device performance for an AI/algorithm, as the provided document does not contain such details. It pertains to a physical medical device (an implant and its introducer) and its regulatory clearance based on substantial equivalence to a predicate device.

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TAPESTRY® Biointegrative Implant is indicated for the management and protection of tendon injuries in which there has been no substantial loss of tendon tissue.

The TAPESTRY® Biointegrative Implant (TAPESTRY) is composed of collagen and poly(D,Llactide). It is designed to function as a non-constricting, protective layer between the tendon and surrounding tissues. TAPESTRY is conformable and designed for easy placement between the tendon and surrounding tissue and may be secured in place using standard fixation techniques. TAPESTRY is provided sterile, non-pyrogenic, for single-use only, in a variety of sizes, ranging from 20mm x 25mm to 70mm x 50mm. TAPESTRY is available with or without a co-packaged polyethylene Insertion Sleeve, which is used to maintain the implant's orientation and to facilitate easy application onto the tendon. The Insertion Sleeve is discarded after use and not implanted. TAPESTRY is designed for stand-alone use. At the discretion of the surgeon. TAPESTRY may be hydrated with sterile isotonic solution.

Preclinical studies of TAPESTRY showed dense collagenous fibrous connective tissue ingrowth into and around the scaffolding.

This document describes a 510(k) premarket notification for the Tapestry Biointegrative Implant. The notification, K212306, seeks to demonstrate substantial equivalence to its predicate device, Tapestry (K201572).

Crucially, the provided text states that the Tapestry Biointegrative Implant (the subject device) is "the same device as its TAPESTRY predicate" with "the same indications for use, design, materials, and technological characteristics." The primary change leading to this 510(k) submission is the addition of validation methods for establishing collagen stability throughout the device's shelf life, and the introduction of two new product sizes within the already cleared size range.

Given this context, the acceptance criteria and the study proving the device meets these criteria are not based on new clinical performance data for the device itself. Instead, the submission relies on the established performance of the predicate device and additional bench testing for the new shelf-life validation.

Therefore, many of the requested details regarding clinical studies (such as sample size for test sets, expert adjudication methods, MRMC studies, standalone algorithm performance, and ground truth establishment for clinical data) are not applicable to this 510(k) submission for the Tapestry Biointegrative Implant, as no new clinical performance claims or studies are presented.

Here's a breakdown based on the provided text:

Acceptance Criteria and Device Performance for Tapestry Biointegrative Implant (K212306)

The acceptance criteria for this 510(k) submission are primarily focused on demonstrating that the subject device, despite minor changes (shelf-life validation and new sizes), maintains substantial equivalence to its predicate device. This means ensuring that the changes do not raise new questions of safety or effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not applicable for a clinical test set as no new clinical performance studies were conducted for this 510(k) submission.
• Data Provenance: The reliance is on existing data from the predicate device (K201572) and new bench test data for collagen stability. The document does not specify the country of origin for the predicate's data. The collagen stability testing would have been done in a laboratory, but specific details on its provenance (e.g., specific country, specific lab) are not provided. The study design is retrospective in the sense that it relies on performance data of the previously cleared predicate device, supplemented by prospective bench testing for the new shelf-life validation.

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

• Not applicable. There was no clinical test set requiring expert ground truth establishment for this 510(k). The evaluation of substantial equivalence is based on engineering, material, and bench test data, as well as the prior clearance of the predicate.

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

• Not applicable. No clinical test set requiring adjudication was used.

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 surgical implant, not an AI-assisted diagnostic or imaging device. Therefore, MRMC studies are irrelevant.

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

• Not applicable. This is not an algorithmic device.

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

• The "ground truth" for this 510(k) is the established safety and performance of the legally marketed predicate device (K201572) for its intended use, combined with analytical and material testing data (Hydroxyproline analysis, FTIR analysis) to confirm the new aspects (collagen stability) do not alter the inherent properties or introduce new risks. Preclinical animal studies of the predicate showed "dense collagenous fibrous connective tissue ingrowth into and around the scaffolding," which would likely have been part of the initial "ground truth" for the predicate's safety and effectiveness.

8. The sample size for the training set:

• Not applicable. No training set for an AI/algorithm was used. The device is a physical implant.

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

• Not applicable. No training set for an AI/algorithm was used.

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The Taperloc® Complete Hip Stems are intended for hip joint arthroplasty.

1. Non-Inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
2. Rheumatoid arthritis.
3. Correction of functional deformity.
4. Treatment of non-union. Femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques.
5. Revision procedures where other treatment or devices have failed
   Porous coated components are intended for uncemented biological fixation.

Taperloc® Complete Hip Stems are an implant device, a porous coated femoral stem intended for uncemented biological fixation. The Taperloc® Complete is a series of hip stems with a bi-planar wedge design, titanium substrate, and proximally circumferential titanium porous plasma sprayed design.

The document provided is a 510(k) premarket notification for the Taperloc® Complete Hip Stems. It describes the device, its intended use, and provides a summary of performance data to demonstrate substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and study information based on the provided text, focusing on what is stated and explicitly noting what is not present:

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

The document does not explicitly present acceptance criteria in a formal table with pass/fail thresholds for the tests conducted. Instead, it states that "All testing passed and met the specifications or comparison testing (as applicable) to the predicate devices." This implies that the acceptance criteria were either established by the referenced ASTM standards or through direct comparison to the performance of the predicate device.

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

• Sample Size for Test Set: The document mentions "samples" for the porous plasma spray coating testing and "samples" for the one-step forging distal pot up/down fatigue testing. However, specific numerical sample sizes are not provided for any of these non-clinical tests.
• Data Provenance: The document states these are "Non-Clinical Tests" performed to support the 510(k) submission. It does not specify the country of origin where the testing was conducted. It is inherently prospective in the sense that the tests were performed specifically for this regulatory submission to evaluate the cumulative changes to the device.

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 a medical device, specifically an orthopedic implant (hip stem), and the performance data is entirely non-clinical (mechanical and material testing). Therefore, there were no human experts involved in establishing ground truth in the traditional sense of clinical or diagnostic studies. The "ground truth" for these engineering tests would be established by the testing protocols and the objective measurements themselves, adhering to the specified ASTM standards.

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

Not applicable. As stated above, these are non-clinical, objective engineering tests, not clinical evaluations requiring expert 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 document describes a medical device (hip implant), not an AI/software as a medical device (SaMD) that would involve human readers or AI assistance. No MRMC study was performed.

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

Not applicable. This document describes a physical medical device, not an algorithm or AI.

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

For the non-clinical tests, the "ground truth" is defined by the objective measurements obtained through adherence to the specified ASTM standards and direct comparison to the predicate device's performance. There is no expert consensus, pathology, or outcomes data used as ground truth for these non-clinical mechanical tests.

8. The sample size for the training set

Not applicable. There is no "training set" as this is a physical medical device and the studies refer to non-clinical material and manufacturing process changes, not machine learning or AI.

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

Not applicable. As above, there is no training set mentioned or implied.

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TAPESTRY® Biointegrative Implant is indicated for the management and protection of tendon injuries in which there has been no substantial loss of tendon tissue .

The TAPESTRY® Biointegrative Implant device is composed of collagen and poly(D,L-lactide). It is designed to function as a non-constricting, protective layer between the tendon and surrounding tissues. TAPESTRY® is conformable and designed for easy placement between the tendon and surrounding tissue and may be secured in place using standard fixation techniques. TAPESTRY® is provided sterile, non-pyrogenic, for single-use only, in a variety of sizes, ranging from 20mm x 25mm to 70mm x 50mm. TAPESTRY® is available with or without a co-packaged polyethylene Insertion Sleeve, which is used to maintain the implant's orientation and to facilitate easy application onto the tendon. The Insertion Sleeve is discarded after use and not implanted. TAPESTRY® is designed for stand-alone use. At the discretion of the surgeon, TAPESTRY® may be hydrated with sterile isotonic solution.

The provided text describes a 510(k) premarket notification for the TAPESTRY® Biointegrative Implant, a Class II surgical mesh. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study for an AI-powered diagnostic device with specific acceptance criteria and performance metrics typically associated with AI.

Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria and a study proving a device meets these criteria for an AI/diagnostic device.

The text discusses:

• The device (TAPESTRY® Biointegrative Implant) and its intended use (management and protection of tendon injuries).
• Comparison of technological characteristics with a predicate device (Rotation Medical Inc. Collagen Tendon Sheet).
• Preclinical studies (in vivo animal study) to evaluate tissue response, systemic toxicity, and device resorption, not performance metrics of an AI diagnostic tool.
• Biocompatibility testing against ISO 10993-1 standards.

It is a submission for a surgical implant, not an AI-powered diagnostic tool. Hence, the concepts of "acceptance criteria" and "study proving the device meets the acceptance criteria" as they apply to diagnostic accuracy (e.g., sensitivity, specificity, AUC) for an AI model are not present in this document. There's no mention of:

• A table of acceptance criteria with reported device performance for an AI/diagnostic task.
• Sample sizes for test sets in an AI context.
• Number of experts or their qualifications for ground truth.
• Adjudication methods for test sets.
• MRMC studies or effect sizes for human reader improvement.
• Standalone AI performance.
• Type of ground truth (e.g., pathology, outcomes data in an AI context).
• Sample size for a training set or how its ground truth was established.

In summary, this document is entirely unrelated to the type of AI/diagnostic device evaluation you are asking about.

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The TAP Blood Collection® Device is a lithium heparin coated single use device intended to collect capillary blood from the upper arm of adults (21 years of age or older). The TAP Blood Collection® Device is for measurement of HbAlc on blood specimens which can be collected by self-administration of the TAP Device by a layperson or by a healthcare worker in a healthcare setting. The collected sample is then transported for analysis in a clinical laboratory for determination of Hemoglobin Alc (HbA1c) using tests intended for monitoring glycemic control.

The TAP Blood Collection® Device (herein “TAP Device”) is a single-use, sterilized whole blood specimen collection and transportation device that uses a combination of two mechanisms, capillary action and vacuum extraction, to obtain a capillary blood sample from the upper arm. The device contains lithium heparin as an anticoagulant. The device is intended for self-administration by a layperson or by a healthcare worker. When the TAP Device is actuated, it collects the sample in an integrated reservoir and provides a visual indicator (fill indicator window) to the end user to confirm that the collection is complete and sufficient blood has been collected to conduct HbA1c testing. The sample collection time is 7 minutes or less and typically takes 2-3 minutes. The TAP Device is then sent to the laboratory for testing. The sample must be tested within 6 hours from time of collection or as indicated in the HbA1c test system package insert (whichever is less).

The provided text describes the TAP Blood Collection® Device, focusing on its re-submission for an expanded indication of use, specifically for self-administration by laypersons for HbA1c testing. The device itself (K161521) was previously cleared, and this submission (K190225) aims to add layperson use.

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA 510(k) summary does not explicitly list "acceptance criteria" in a table format with specific numerical targets. Instead, it describes general performance goals for the additional testing supporting the layperson use indication. The reported device performance is presented as conclusions from these studies.

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

The provided text does not specify the sample size for either the usability study or the analytical performance study. It also does not mention the country of origin of the data or whether the studies were retrospective or prospective.

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

This information is not provided in the given text.

4. Adjudication Method for the Test Set

This information is not provided in the given text.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

This device is a blood collection device, not an AI-powered diagnostic tool requiring human reader interpretation. Therefore, an MRMC comparative effectiveness study regarding human readers and AI assistance is not applicable and not mentioned.

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

This device is a blood collection device. Its primary function is to collect a blood sample. The "performance" being evaluated here is the ability to collect a suitable sample for laboratory analysis and the comparability of the collected sample to a standard collection method. There is no "algorithm only" performance that would be applicable to this type of device.

7. The Type of Ground Truth Used

• For the usability study, the "ground truth" was likely defined by successful completion of specified tasks by laypersons according to instructions. This would be assessed through observation and potentially questionnaires.
• For the analytical performance testing, the "ground truth" for HbA1c values was established by venous blood samples collected by a healthcare worker, considered the reference standard for HbA1c measurement.

8. The Sample Size for the Training Set

This information is not provided in the given text. The studies described are performance validation studies, not AI model training.

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

As this is not an AI algorithm, there is no "training set" in the context of machine learning. The studies are evaluating the device's ability to facilitate sample collection and the quality of those samples.

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The TAP Blood Collection® Device is a lithium heparin coated single intended to be used to collect capillary blood from the upper arm of adults (21 years of age or older) by a healthcare worker. The collected sample is then transported for analysis in a clinical laboratory for determination of Hemoglobin A1c (HbA1c) using tests intended for monitoring glycemic control.

The TAP Blood Collection® Device (herein "TAP Device") is a single-use, sterilized whole blood specimen collection and transportation device that uses a combination of two mechanisms, capillary action and vacuum extraction, to obtain a capillary blood sample from the upper arm. The device contains lithium heparin as an anticoagulant.

The device is intended for use by a healthcare worker. When the TAP Device is actuated, it collects the sample in an integrated reservoir and provides a visual indicator (fill indicator window) to the end user to confirm that the collection is complete and sufficient blood has been collected to conduct HbA1c testing. The sample collection time is 7 minutes or less and typically takes 2-3 minutes. The TAP Device is then sent to the laboratory for testing. The sample must be tested within 6 hours from time of collection or as indicated in the HbA1c test system package insert (whichever is less).

The provided document describes the TAP Blood Collection® Device, its indications for use, and the studies conducted to demonstrate its safety and effectiveness.

Here’s a breakdown of the acceptance criteria and study details based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly list "acceptance criteria" in a separate table with pass/fail thresholds. However, it presents various performance metrics and concludes that the device is "equivalent" or "no significant differences" exist compared to established methods. We can infer the de-facto acceptance criteria from the reported performance which demonstrates equivalence to venipuncture blood samples for HbA1c testing.

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

• Pivotal Study: 143 participants.
  • Data Provenance: Prospective study conducted at multiple hospital clinic sites by healthcare workers. The country of origin is not explicitly stated but implied to be the USA given the FDA submission. Participants spanned representative age, gender, ethnicity, race, and health status (healthy and diabetic).
• Analyte Stability Study: "multiple TAP Device samples were collected" and "A total of two or three samples were tested from each participant." The exact number of participants is not given.
  • Data Provenance: Prospective study. Country of origin not explicitly stated.
• Usability Study: The number of participants is not explicitly stated, but it assessed "intended users of the product."
  • Data Provenance: Prospective study. Country of origin not explicitly stated.
• Sample Quality Studies (Collection time, volume, clotting, hemolysis):
  • Collection time, volume, clotting: 209 TAP Devices.
  • Hemolysis: 69 TAP Device blood samples.
  • Data Provenance: Not explicitly stated whether these were distinct studies or part of the pivotal study, but implied to be prospective. Country of origin not explicitly stated.

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

The ground truth for the HbA1c levels was established by venipuncture blood samples analyzed in a clinical laboratory using "HbA1c analyzers." The document does not specify the number of experts or their qualifications for interpreting these venipuncture samples, as it relies on standard clinical laboratory procedures and FDA-cleared analyzers. The "healthcare workers" collected samples, but the analysis establishing the "ground truth" (the comparator) was performed by laboratory instruments.

4. Adjudication Method for the Test Set:

Not applicable in the typical sense of expert adjudication for diagnostic imaging or clinical endpoints. The primary comparison in the pivotal study was between HbA1c levels derived from the TAP Device and those from venipuncture, both analyzed by standard laboratory methods. Discrepancies would be handled by statistical methods (bias, correlation).

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 blood collection system, not an AI-assisted diagnostic tool that requires human interpretation of outputs. The studies focused on device performance (e.g., sample equivalence, variability between lots/operators) and usability by healthcare workers, not on improving human reader performance.

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

Not applicable. The device is a physical blood collection tool. Its "performance" is measured by the quality and accuracy of the sample it collects when analyzed by an external laboratory process, not by an internal algorithm's standalone output.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):

The ground truth for the primary effectiveness evaluation (HbA1c levels) was established using venipuncture blood samples analyzed by FDA-cleared HbA1c analyzers in a clinical laboratory. This represents a recognized standard method for measuring HbA1c.

8. The Sample Size for the Training Set:

Not applicable. This device is a physical blood collection device, not an algorithm that requires a "training set."

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

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

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Taps are nonpowered hand-held devices intended for bone cutting and drilling on a patient's skull during fracture repair and reconstructive procedures of the cranium. The taps may be used to prepare cranial bone to insert bone fixation screws.

Taps are used to drill a hole and simultaneously create threads in order to accommodate a Rapid Resorbable Fixation System bone screw. The self-drilling fixed-stop taps are manufactured from Stainless Steel 440A which conforms to ASTM F899 Standard Specification for Stainless Steel for Surgical Instruments and ASTM A276 Specification for Stainless Steel Bars and Shapes. The adjustable-length taps (final assembly) are assembled from three components; the adjustable tap (Stainless Steel 440A), the locking collar (Makrolon Rx2530 W/1118 Tint), and the stop collar (Stainless Steel 316L with an aluminum titanium nitride coating).

The provided document describes the Synthes Taps for Resorbable Screws (K153587) and the performance testing conducted to support its substantial equivalence to predicate devices. Here's a breakdown of the requested information based on the document:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Simulated Use/Bioskills Lab:
  • Sample Size: 5 individual participants (users) and 4 cadaveric cephaluses (heads).
  • Data Provenance: Prospective, from cadaveric cephaluses. Likely from the US, given the submission to the FDA.
• Saw Bones Lab:
  • Sample Size: 4 users and an unspecified number of "saw bones" (synthetic bone models). The test involved 36 total insertions (implying 3 subject taps x 3 tapped holes x 4 users).
  • Data Provenance: Prospective, using synthetic bone models (Sawbones).
• Mechanical Tests (Torsional, Axial Load, Hex Coupling Validation):
  • Sample Size: For Torsional Testing, all three sizes of RapidSorb Self-Drilling Taps (1.5, 2.0, and 2.5 mm) were tested. For Axial Load, adjustable length taps (311.100, 311.101, 311.102, 311.110, 311.111, 311.112) of 1.5, 2.0, and 2.5mm were compared. For Hex Coupling Validation, 12 taps were driven by "all participants" (number not specified but implied to be multiple, likely the same 5 as the simulated use or similar).
  • Data Provenance: In-vitro / bench testing. No specific country of origin or retrospective/prospective distinction is given for the collected data, but it is implied to be newly generated for this submission.
• Biocompatibility Testing:
  • Sample Size: Not specified for the extract, but presumably standard in-vitro cell culture methods.
  • Data Provenance: In-vitro lab testing.

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

The concept of "experts" establish ground truth in the traditional sense (e.g., radiologists interpreting images) is not directly applicable here as this is a medical device for surgical procedures (taps).

• Simulated Use/Bioskills Lab: "The users are independent from the design of the subject device." No specific qualification (e.g., surgeon, resident) or experience level is mentioned for the 5 participants.
• Saw Bones Lab: 4 users. No specific qualifications mentioned.

For mechanical and biocompatibility testing, the "ground truth" is established by the physical and biological properties being measured against established engineering and biological standards.

4. Adjudication Method for the Test Set

No formal adjudication method (like 2+1 or 3+1 consensus) is described for any of the performance tests. The tests appear to involve direct measurement (mechanical tests) or observed outcomes (simulated use, Sawbones lab), with success defined by meeting the specified acceptance criteria. For the "Simulated Use/Bioskills Lab," "The results indicated full validation... All acceptance criteria were met," suggesting a pass/fail outcome rather than a consensus on a specific finding.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a manual surgical instrument, not an AI or imaging diagnostic tool where MRMC studies are typically performed.

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

This question is not applicable. The device is a physical, manual surgical instrument. There is no "algorithm" or AI component to this device.

7. The Type of Ground Truth Used

The "ground truth" primarily relies on:

• Performance against engineering specifications: For mechanical tests (torsional, axial load, hex coupling), the ground truth is defined by the device's ability to withstand forces, prevent stripping, and couple correctly according to established engineering benchmarks and statistical comparisons with null hypotheses.
• Direct observation of functional performance: For the Simulated Use and Saw Bones labs, the ground truth is observed successful drilling/tapping and accommodation of screws by human users, as per the defined acceptance criteria.
• Biological standards: For biocompatibility, the ground truth is the absence of cytotoxicity, evaluated against ISO 10993-5 guidelines.

8. The Sample Size for the Training Set

No training set is mentioned as this device is not an AI/ML algorithm. The performance data presented are for validation/verification testing.

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 submission.

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