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Biomet Microfixation Twist Drills are intended for drilling holes in large and small bone during orthopedic, spinal, neurosurgical, medial sternotomy, and oral and maxillofacial procedures.

Biomet Microfixation manufactures and distributes a variety of single use twist drills to aid in the implantation of Biomet Microfixation implants. Biomet Microfixation Twist Drills are intended for drilling holes in large and small bone during orthopedic, spinal, neurosurgical, medial sternotomy, and oral and maxillofacial procedures. The drills are manufactured from Stainless Steel. Some drills contain flutes along the majority of the drill length, while others contain a "stop" feature which prevents further drilling past a designated length. Additionally, some drills contain an "adjustable stop" feature which allows to surgeon to set the stop length intraoperatively. Twist Drills are distributed non-sterile and are intended for single-patient use. Cleaning should only be performed on new or uncompromised drills. The drills should be steam sterilized by the health-care facility prior to use.

This FDA 510(k) summary is for a medical device (Twist Drills), not an AI/ML algorithm. Therefore, many of the requested categories related to algorithm performance, training data, and expert review are not applicable.

Here's an analysis of the provided document based on the available information:

This document describes the FDA's decision to clear the Biomet Microfixation Twist Drills (K213208) as substantially equivalent to a predicate device (Twist Drills K062842).

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

The document states that "Design verification and validation testing were performed on the subject devices" and "The results from all design verification and validation tests confirmed that the subject devices met the predetermined acceptance criteria." However, the specific, quantitative acceptance criteria themselves are not provided in this summary document. The performance is reported as meeting these unspecified criteria.

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

This document discusses performance testing for a physical medical device, not a data-driven AI/ML algorithm. Therefore, terms like "test set" and "data provenance" in the context of data analysis are not directly applicable. The document refers to "design verification and validation testing," which would involve physical samples of the drill. The sample size for these physical tests is not specified in this summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This is not applicable as the document describes a physical medical device, not an AI/ML diagnostic or prognostic tool that requires expert-established ground truth.

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

This is not applicable for a physical medical device without a diagnostic component.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This is not applicable as the document describes a physical medical device, not an AI-assisted diagnostic tool.

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

This is not applicable as the document describes a physical medical device.

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

For a physical medical device like a drill, "ground truth" generally refers to objective physical and mechanical properties. The validation would typically involve comparing the device's performance against predefined engineering specifications and safety standards, rather than expert consensus on diagnostic images or pathology. The document generally refers to "predetermined acceptance criteria" and "design verification and validation tests."

8. The sample size for the training set

This is not applicable as the document describes a physical medical device, not an AI/ML algorithm that requires a training set.

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

This is not applicable as the document describes a physical medical device.

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The Smith & Nephew, Inc. SUTUREFIX Ultra Suture Anchor is intended for the secure fixation of soft tissue to bone for the following indications:

Hip
Hip capsule repair (Acetabular labrum repair/reconstruction)

Shoulder
Capsular stabilization (Bankart repair, Anterior shoulder instability, SLAP lesion repairs, Capsular shift or capsulolabral reconstructions), Acromioclavicular separation repairs, Deltoid repairs, Rotator cuff tear repairs, Biceps tenodesis

Foot and Ankle
Hallux valgus repairs, Medial or lateral instability repairs/reconstructions, Achilles tendon repairs/reconstructions, Midfoot reconstructions, Metatarsal ligament/tendon repair/reconstructions, Bunionectomy

Elbow, Wrist, and Hand
Biceps tendon reattachment, Ulnar or radial collateral ligament reconstructions, Lateral epicondylitis repair

Knee
Extra-capsular repairs (Medial collateral ligament, Lateral collateral ligament, Posterior oblique ligament), Patellar realignment and tendon repairs (Vastus medialis obliquous advancement), Illiotibial band tenodesis

The Smith & Nephew SUTUREFIX Ultra Suture Anchor is intended to provide secure . fixation of soft tissue to bone. The device consists of a soft suture anchor with an attached non-absorbable suture(s) preassembled onto an insertion device. The SUTUREFIX Ultra Suture Anchors are available pre-loaded with either one #2 suture or with two #1 sutures. This device is provided sterile, for single use only.

Here’s a breakdown of the acceptance criteria and study information for the SUTUREFIX Ultra Suture Anchor, based on the provided text:

Important Note: The provided text is a 510(k) premarket notification summary. This type of submission generally focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed clinical efficacy studies against acceptance criteria like you'd find for novel therapies or AI-driven diagnostic tools. Therefore, much of the requested information (especially regarding AI, human readers, sample sizes for training/test sets, and expert details for ground truth) is not applicable or not present in this document. The document primarily discusses mechanical performance data.

Acceptance Criteria and Reported Device Performance

Explanation: The document states, "Performance data demonstrates that the SUTUREFIX Ultra Suture Anchor has met performance specifications for insertion strength and pull-out strength and therefore, is considered substantially equivalent to the currently marketed predicate devices." This implies that the 'acceptance criteria' were the successful demonstration of adequate insertion and pull-out strength, and the ultimate acceptance criterion was deemed 'substantially equivalent' to the predicate devices.

Study Details

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

   • Sample Size: Not explicitly stated. The document refers to "Performance data" but does not quantify the number of devices or tests performed.
   • Data Provenance: Not specified, but generally, such biomechanical testing would be conducted in a laboratory setting (e.g., in-vitro or ex-vivo testing). No information on country of origin for the data is provided, nor whether it was retrospective or prospective in a clinical sense.

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

   • Not Applicable. For a mechanical device like a suture anchor, ground truth is typically established through direct physical measurement and engineering standards, not through "expert consensus" in the medical diagnostic sense. There are no "experts" establishing a diagnostic ground truth.

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

   • Not Applicable. Adjudication methods like 2+1 or 3+1 are used in studies where human interpretation of medical images or data is involved to establish a consensus ground truth. This is a biomechanical performance study, not an interpretative one.

4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • Not Applicable. This device is a surgical implant, not an AI-assisted diagnostic or imaging device. Therefore, no MRMC study, AI assistance, or human reader improvement data is relevant or provided.

5. 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 or AI.

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

   • Biomechanical Performance Metrics: Ground truth for this device would be based on empirically measured physical properties, such as the force required for insertion and the force required to pull out the anchor from a test material (e.g., bone surrogate or cadaveric bone). This is determined by engineering and biomechanical testing standards.

7. The sample size for the training set:

   • Not Applicable. This is not an AI/ML device that requires a "training set."

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

   • Not Applicable. As above, no training set for an AI/ML model.

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The Stryker® Twist Drills are intended to be used for drilling holes in large and small bone during orthopedic, spinal, neurosurgical, medial sternotomy, and oral and maxillofacial procedures.

Not Found

This document primarily concerns the 510(k) summary and FDA clearance letter for the Stryker® Twist Drills. It focuses on establishing substantial equivalence to predicate devices and detailing the intended use and regulatory classification.

Based on the provided text, there is no information available regarding acceptance criteria or a study proving device performance in the context of an AI/algorithm-driven device. The Stryker® Twist Drills are a physical medical device (drills), not an AI or software-based system that would typically have the acceptance criteria and study details you've outlined.

Therefore, I cannot provide the requested information for the following points as they are not applicable to the provided document:

1. A table of acceptance criteria and the reported device performance
2. Sample size used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
4. Adjudication method for the test set
5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done
7. The type of ground truth used
8. The sample size for the training set
9. How the ground truth for the training set was established

The document focuses on regulatory clearance for a physical medical tool, asserting its substantial equivalence to existing drills based on design and intended use, rather than demonstrating algorithm performance.

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The Lorenz Twist Drills are intended to be used for drilling holes in large and small bone during orthopedic, spinal, neurosurgical, medial sternotomy, and oral and maxillofacial procedures.

Lorenz Twist drills are drill bits which can either be attached to a manual instrument handle or attached to a powered handpiece/drill motor and used to drill holes in bone.

This document, K062842, is a 510(k) summary for the Lorenz Twist Drills. A 510(k) submission is a premarket submission made to the FDA to demonstrate that the device to be marketed is at least as safe and effective as a legally marketed predicate device and does not, therefore, require a Premarket Approval (PMA).

This document does not contain information regarding detailed acceptance criteria or a study that proves the device meets specific performance criteria beyond substantial equivalence. 510(k) submissions typically focus on demonstrating substantial equivalence to predicate devices through comparisons of technological characteristics, intended use, and performance data if relevant, rather than detailed clinical studies with specific performance benchmarks common for novel devices.

Therefore, many of the requested fields cannot be filled from the provided text because such information is not typically included in this type of FDA submission for devices like simple surgical drills.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

Explanation: The document does not describe specific numerical acceptance criteria (e.g., drill bit sharpness, durability over a certain number of uses, or specific force required for drilling) or quantitative performance data to meet such criteria. The 510(k) process for a device like a twist drill primarily relies on demonstrating substantial equivalence to legally marketed predicate devices, implying that the performance is similar and acceptable based on the predicate's established safety and effectiveness. The materials (Stainless Steel) are mentioned, which is a key characteristic for comparison.

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.
• Data Provenance: Not specified.

Explanation: This 510(k) summary does not mention any specific test sets, clinical studies, or data provenance to evaluate the device's performance in a quantitative manner. The evaluation is centered on a comparison to predicate devices.

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. No ground truth establishment for a test set is described in this 510(k) summary. Surgical drills, particularly those intended for general bone drilling, typically do not require expert-established ground truth in the same way an AI diagnostic device would.

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

Not applicable. No adjudication method is mentioned as there is no described test set requiring one.

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 manual/powered surgical drill, not an AI-assisted diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant or described.

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

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

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

Not applicable. As noted earlier, ground truth in the context of expert consensus or pathology is typically for diagnostic devices. For a surgical drill, the "ground truth" of its function would be its ability to drill holes in bone effectively and safely, traditionally assessed through engineering tests and comparison to established predicate devices, rather than a clinical ground truth established by experts in a diagnostic sense.

8. The sample size for the training set

Not applicable. There is no mention of a training set as this is not an AI/machine learning device.

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

Not applicable. There is no mention of a training set or ground truth establishment for such a set.

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