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This device, Polymer OBL SB Series and Cinch Series Anchor/Suture Combination is intended for use only for the fixation of non-absorbable synthetic sutures for the following indications.

The Polymer Cinch SB Anchor/Suture Combination is intended only for the fixation of surgical suture material to the pelvis for the purpose of bladder neck suspensions for female urinary incontinence due to urethral hypermobility of intrinsic sphincter deficiency.

Shoulder:

• Bankhart Repair
• SLAP Lesion Repair
• Acromio-clavicular separation
• Rotator Cuff Repair
• Capsule and Capsulolabral Reconstruction
• Biceps Tenodesis
• Deltoid Repair

Hand, Wrist, Elbow:

• Scapholunate ligament reconstruction
• Ulnar Collateral Ligament Reconstruction
• Lateral Collateral Ligament Reconstruction
• Biceps Tendon Reattachment
• Elbow Medial/Lateral Repair of Tendons in the Elbow

Foot:

• Hallux Valgus Reconstruction
• Mid and Forefoot Reconstruction

Knee:

• medial collateral ligament
• lateral collateral ligament
• posterior oblique ligament
• Joint capsule closure
• Illiotibial band tendonesis
• VMO Advancement

Urinary: Bladder Neck Suspension

The Polymer OBL SB Anchor is a simple modified polyacetal cylinder designed to be pushed through a hole in bone chosen by the surgeon as a site for anchoring soft tissue to bone. Each anchor is preloaded with suture and includes an insertion device.. These components are packaged together sterile in double mylar/tyvek pouches or formed trays. The device is single use. The device can be used for open and arthroscopic procedures.

The anchor is a modified cylinder made of polyacetal. From the end, the anchor is round with two grooves milled 180° apart. From the side, the anchor is a parallelogram with a hole through it. The anchors will be referred to by the diameter and the overall length, for example 2x8 means the diameter is 2.0 mm and the length is 8 mm. Refer to the drawing on page 12 for the dimensions "C" and "A".

The largest anticipated size of the anchor is 3 mm in diameter and 15 mm in length (3x15). The smallest anticipated size of the anchor is 2 mm in diameter and 8 mm in length (2x8). The purpose of the hole through the device is to hold suture. The smooth longitudinal grooves on each side of the device allow the suture to pass into the bone hole without pinching the suture. The ends of the device are designed to initiate rotation of the device as it is pushed and subsequently pulled into place. The ends are tapered at angles that range from 30° to 60°. The anchor is symmetric, allowing it to be inserted with regard to which end enters first. The shape of the device distributes the load over a large bone surface reducing the risk of bone breakage or pullout.

The Insertion Device is a manual surgical instrument comprised of a handle, sleeve, and piston. The handle is constructed from polypropylene and serves the functions of holding all pieces together and to interface between the surgeon's hand and the device. The sleeve houses the piston and the Anchor. The sleeve keeps the Anchor and piston in-line to allow the piston to push the Anchor into the implantation site.

The Suture is Braided Polyester Suture from Surgical Specialties (See Appendix 3 for Approval Letters. N80950). The largest anticipated diameter of the suture USP #2. The smallest anticipated diameter of suture is USP #2-0. The suture is preloaded in the anchor eyelet.

Materials
Anchor: Polyacetal Inserter: Piston and Sleeve: Stainless Steel, Handle: Polypropylene Suture: Braided Polyester from Surgical Specialties, See Appendix 3.

Use
To implant the Anchor, the surgeon must first create an implantation site in bone. OBL supplies accessory drills and awls to prepare these sites.

Once the implantation site is prepared, the surgeon simply aligns the Anchor to the hole, pushes the handle toward the bone, retracts, and disconnects the Suture from the Inserter. The Suture will be retained by the Anchor. Pulling back on the Suture further engages the Anchor into the walls of the hole. The surgeon is then left with an Anchor in the bone and Suture to attach to the soft tissue.

This is a 510(k) premarket notification for a medical device, not an AI/ML device. Therefore, the requested information about AI/ML specific acceptance criteria, study designs, and performance metrics (e.g., sample sizes for training/test sets, expert adjudication, MRMC studies, standalone performance, ground truth establishment) is not applicable.

The document describes the device, its intended use, a comparison to predicate devices, and performance data related to its physical characteristics.

Here’s the available information presented in a format that aligns with the requested table, as much as possible for a non-AI/ML device:

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information (Not applicable for this type of device submission):

The following points are specific to AI/ML device evaluations and are not present in this 510(k) submission for a non-AI surgical anchor:

• Sample sizes used for the test set and the data provenance
• Number of experts used to establish the ground truth for the test set and their qualifications
• Adjudication method for the test set
• Multi-reader multi-case (MRMC) comparative effectiveness study or effect size
• Standalone (algorithm only) performance
• Type of ground truth used (e.g., expert consensus, pathology, outcomes data)
• Sample size for the training set
• How the ground truth for the training set was established

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This device (Polymer Threaded Anchor and Cinch Polymer Threaded Anchor) is intended for use only for the fixation of non-absorbable synthetic sutures.

The Polymer Threaded Series Anchor is intended for the fixation of surgical suture material for the following indications:

Shoulder:

• し、 Bankhart Repair
• SLAP Lesion Repair vi
• Acromio-clavicular separation 3.
• Rotator Cuff Repair 4.
• Capsule and Capsulolabral Reconstruction ર.
• 6. Biceps Tenodesis
• 7. Deltoid Repair

Hand, Wrist, Elbow:

• Scapholunate ligament reconstruction し、
• 2. Ulnar Collateral Ligament Reconstruction
• 3. Lateral Collateral Ligament Reconstruction
• 4. Biceps Tendon Reattachment
• Elbow Medial/Lateral Repair of Tendons in the Elbow న్.

Foot:

• 1. Hallux Valgus Reconstruction
• Mid and Forefoot Reconstruction 2.

Knee:

• medial collateral ligament l .
• lateral collateral ligament 2.
• posterior oblique ligament 3.
• 4. Joint capsule closure
• Illiotibial band tendonesis
• VMO Advancement 6.

The Cinch Polymer Threaded Anchor is intended only for the fixation of surgical material to the pelvis for the purpose of bladder neck suspensions for female urinary incontinence due to urethral hypermobility of intrinsic sphincter deficiency.

The proposed device, Polymer Threaded Anchor, is a pre-packaged, sterile polyacetal implant. The device is used to secure soft tissue to bone. The device is to be used with reusable insertion devices including a drill, tap, drill/tap combination, and inserter. Surgeons may loop suture of his/her choice through the eyelet of the anchor for the attachment of soft tissue. The device is single use. The device can be used for open and arthroscopic procedures. The anchor is packaged sterile in double mylar/tyvek pouches or formed trays.

The Polymer Threaded Anchor is a polyacetal screw designed to be screwed into a hole in bone chosen by the surgeon as a site for anchoring soft tissue to bone. The anchor constists of a threaded portion to engage bone, an eyelet to retain suture, and a drive means to couple the device to the inserter. The anchor is referred to by it's major diameter of the largest thread). The sizes included in this submission are 2.8 mm, 4.0 mm, 5.0 mm, and 6.5 mm. Please see the drawings on page 9 for shape and dimensions of the device.

The Insertion Device is a manual surgical instrument comprised of a handle and shaft. The handle is constructed from polypropylene and serves as the interface between the surgeon's hand and the device. The shaft serves the functions of transferring the torque from the surgeon's hand to the anchor.

Materials Polyacetal

Use

To implant the Anchor, the surgeon must first create an implantation site in bone. OBL supplies accessory drills, taps and drill/tap combinations to prepare these sites. The inserter is used to screw the anchor into the implantation site. After the anchor is fully seated, the inserter is removed from the implantation site, leaving the anchor in the bone and suture through the anchor. The suture can then be used to attach soft tissue.

The Polymer Threaded Anchor is a medical device designed to secure soft tissue to bone. The acceptance criteria and the study proving the device meets these criteria are detailed below:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• The document does not specify the exact sample size for either the pullout strength or anchor/suture interface tests. It refers to "All four of the proposed devices" for pullout strength (2.8 mm, 4.0 mm, 5.0 mm, and 6.5 mm anchors) and the "2.8 mm anchor" for interface testing, implying multiple units of each size were tested.
• Data Provenance: The tests were conducted using a "cancellous bone model made from polyurethane foam." This is an in vitro (laboratory) test, not originating from a country in terms of patient data. The study is prospective in nature, as it involves testing the device under controlled conditions to gather performance data.

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

• This information is not applicable to this type of performance study. The "ground truth" here is the physical measurement of pullout strength and suture break strength, determined by mechanical testing, not by expert interpretation.

4. Adjudication Method for the Test Set:

• Not applicable. As the ground truth is established through objective mechanical testing, there is no need for expert adjudication. The results are quantitative measurements.

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

• No. This is a performance study of a physical medical device (an anchor) measuring its mechanical properties. MRMC studies are typically used for diagnostic or imaging devices where human readers interpret results, and the effectiveness of AI assistance for these readers is being evaluated. This device's function does not involve human interpretation in a diagnostic context.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

• Yes, in essence. The performance tests described (pullout strength and anchor/suture interface) assess the inherent mechanical properties of the device itself, without any human interaction or algorithm involvement during the measurement of these properties. The device's "performance" is its intrinsic mechanical behavior.

7. Type of Ground Truth Used:

• Objective Mechanical Measurements: The ground truth for pullout strength was the force required to liberate the anchor from the foam model, and for the anchor/suture interface, it was the force at which the suture failed. These are direct, quantifiable physical measurements.

8. Sample Size for the Training Set:

• Not applicable. This study does not involve a "training set" in the context of machine learning or AI. The device's performance is evaluated based on its physical and mechanical properties, not on learned patterns from a dataset.

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

• Not applicable. No training set was used.

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This device (PeBA Series and Cinch Series Anchor/Suture Combination) is intended for use only for the fixation of non-absorbable synthetic sutures.

The PeBA Series Anchor/Suture Combination is intended for the fixation of surgical suture material for the following indications:

Shoulder:

• 1. Bankart lesion repairs
• 2. SLAP lesion repairs
• Acromio-clavicular separation repairs 3.
• Rotator cuff tear repairs 4.
• Capsular shift or capsulolabral reconstructions 5.
• Biceps tenodesis 6.
• Deltoid repairs 7.

Foot and Ankle:

• 1. Hallux Valgus repairs
• Medial or lateral instability repairs/reconstructions 2.
• Achilles tendon repairs/reconstructions 3.
• Midfoot reconstructions 4.
• Metatarsal ligament/tendon repairs/reconstructions 5.

Elbow, Wrist, and Hand:

• Scapholunate ligament reconstructions 1.
• Ulnar or radial collateral ligament reconstructions 2.
• Tennis elbow repair 3.
• Biceps tendon reattachment 4.

Knee:
1.

• Extra-capsular repairs:
  • a. medial collateral ligament
  • lateral collateral ligament b.
  • c. posterior oblique ligament
• Iliotibial band tenodesis 2.
• Patellar realignment and tendon repairs, including vastus medialis 3. oblivious advancement

The Cinch Threaded Anchor/Suture Combination is intended only for the fixation of surgical suture material to the pelvis for the purpose of bladder neck suspensions for female urinary incontinence due to urethral hypermobility of intrinsic sphincter deficiency. The Cinch Threaded Anchor/Suture Combination is intended for the fixation of surgical suture material for the following indication:

Urinary: Bladder Neck Suspension

The proposed device, Polymer Threaded Anchor/Suture Combination, is a pre-packaged, sterile device composed of a suture anchor, anchor inserter, and non-absorbable sutures. The device is used to secure soft tissue to bone. The device is pre-packaged so that the suture is looped through the anchor eyelet and the anchor/suture is installed in the inserter. The device is single use. The device can be used for open and arthroscopic procedures. These components are packaged together sterile in double mylar/tyvek pouches or formed trays.

The Polymer Threaded Anchor is a polyacetal screw designed to be screwed into a hole in bone chosen by the surgeon as a site for anchoring soft tissue to bone. The anchor consists of a threaded portion to engage bone, an eyelet to retain suture, and a drive means to couple the device to the inserter. The anchor is referred to by its major diameter of the largest thread). The sizes included in this submission are 2.8 mm, 4.0 mm, 5.0 mm, and 6.5 mm.

The suture used in the proposed device is a braided polyester suture. The suture is multifilament, braided, non-absorbable poly(ethylene terephthalate) surgical suture meeting USP requirements.

The Insertion Device is a manual surgical instrument comprised of a handle and shaft. The handle is constructed from polypropylene and serves as the interface between the surgeon's hand and the device. The shaft serves the functions of transferring the torque from the surgeon's hand to the anchor.

Materials:
Anchor: Polyacetal
Inserter: Piston and Sleeve: Stainless Steel, Handle: Polypropylene
Suture: multifilament, braided, non-absorbable poly(ethylene terephthalate) surgical suture from Surgical Specialties

Here's a breakdown of the acceptance criteria and study information for the Polymer Threaded Anchor / Suture Combination, based on the provided text:

Acceptance Criteria and Device Performance

The provided document focuses on demonstrating substantial equivalence to predicate devices, primarily through mechanical testing. The acceptance criteria are implicitly defined by showing superior or equivalent performance to the predicate devices and meeting general design objectives.

Study Details

2. Sample Size and Data Provenance

• Sample Size for Test Set: Not explicitly stated. The text mentions "All four of the proposed devices" for pullout strength testing and "the 2.8 anchor" for suture interface testing, implying multiple tests were performed for each, but the exact number of samples per device/test is not provided.
• Data Provenance: The studies were conducted internally by Orthopaedic Biosystems Ltd., Inc. (OBL) as part of their 510(k) submission. The data is retrospective in the sense that the testing was performed specifically to support the regulatory submission. The country of origin for the testing would presumably be the US, where OBL is located.

3. Number of Experts and Qualifications for Ground Truth (Test Set)

Not applicable. This is a medical device (implantable anchor/suture system, not an AI/diagnostic software) submission, and the "ground truth" for mechanical performance is established through physical testing against defined material properties and biomechanical measures (e.g., load to failure, USP standards). Expert opinion is typically not used to establish "ground truth" for such mechanical tests, though engineering expertise would be involved in designing and interpreting the tests.

4. Adjudication Method (Test Set)

Not applicable. As described above, the "ground truth" is based on direct physical measurements and comparison to established standards or predicate device performance, not on expert adjudication of diagnostic findings.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices or AI systems where human readers interpret medical images or data. The Polymer Threaded Anchor / Suture Combination is a physical implantable device, and its effectiveness is determined by mechanical properties and clinical outcomes post-implantation, not by physician interpretation of its 'output' in a diagnostic sense.

6. Standalone Performance Study (Algorithm Only)

No, a standalone (algorithm only) performance study was not done. This is not an AI/software device. The performance refers to the biomechanical integrity of the physical device.

7. Type of Ground Truth Used

• For Pullout Strength: The ground truth is the force (in lbs or another force unit) at which the anchor is liberated from the foam model. This is a direct physical measurement. The "worst case" cancellous bone model (polyurethane foam with a density of 8 lbs/cft) serves as a standardized, uniform, and challenging environment for comparison.
• For Anchor/Suture Interface Strength: The ground truth is the force at which the suture breaks when tensioned through the anchor eyelet. This is a direct physical measurement. Comparison is made against USP listed Knot Break Strength, which serves as a recognized standard for suture performance.

8. Sample Size for Training Set

Not applicable. This is a physical medical device, not an AI or machine learning model that requires a training set.

9. How Ground Truth for Training Set was Established

Not applicable for the reason stated above.

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This device (PeBA Series and Cinch Series Anchor/Suture Combination) is intended for use only for the fixation of non-absorbable synthetic sutures.

The Cinch Series Anchor/Suture Combination is intended only for the fixation of surgical suture material to the pelvis for the purpose of bladder neck suspensions for female urinary incontinence due to urethral hypermobility of intrinsic sphincter deficiency.

The PeBA Series Anchor/Suture Combination is intended for the fixation of surgical suture material for the following indications:

Shoulder:

1. Bankart lesion repairs
2. SLAP lesion repairs
3. Acromio-clavicular separation repairs
4. Rotator cuff tear repairs
5. Capsular shift or capsulolabral reconstructions
6. Biceps tenodesis
7. Deltoid repairs

Foot and Ankle:

1. Hallux Valgus repairs
2. Medial or lateral instability repairs/reconstructions
3. Achilles tendon repairs/reconstructions
4. Midfoot reconstructions
5. Metatarsal ligament/tendon repairs/reconstructions

Elbow, Wrist, and Hand:

1. Scapholunate ligament reconstructions
2. Ulnar or radial collateral ligament reconstructions
3. Tennis elbow repair
4. Biceps tendon reattachment

Knee:

1. Extra-capsular repairs:
   a. medial collateral ligament
   b. lateral collateral ligament
   c. posterior oblique ligament
2. Iliotiband tenodesis
3. Patellar realignment and tendon repairs, including vastus medialis obliquous advancement

The proposed device, Anchor/Suture Combination is a pre-packaged, sterile device composed of a suture anchor, anchor inserter, and non-absorbable sutures. The device shall be used to secure soft tissue to bone. The device is pre-packaged so that the suture is looped through the anchor eyelet and the anchor/suture is installed in the inserter. The anchor implant site shall be prepared with an appropriate OBL drill. The inserter is used to screw the anchor into the implant site. After the anchor is fully seated, the inserter is removed from the implant site, leaving the anchor in the bone and suture looped through the anchor.

The proposed device is constructed from the following materials. The anchor is made of titanium alloy TI6Al4VELI. The suture is multifilament, braided, non-absorbable poly(ethylene terephthalate) surgical suture meeting USP requirements. The inserter shaft is a 300 series, 400 series, 17Cr-4Ni, or other alloy stainless steel.

The provided text is a 510(k) summary for the PeBA Anchor/Suture Combination. This document outlines the device's characteristics, its intended use, and a comparison to predicate devices for substantial equivalence. It is a regulatory submission for a physical medical device, not a software-as-a-medical-device (SaMD) or an AI algorithm.

Therefore, the requested information pertaining to AI/ML device studies (acceptance criteria, device performance, sample size for test/training sets, data provenance, number/qualification of experts, adjudication methods, MRMC studies, standalone performance, and ground truth establishment) is not applicable to this submission. The 510(k) describes a traditional hardware medical device.

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The Cancellous Screw Washers designed for use in conjunction with cancellous bone screws. These implants are intended for fracture fixation of the metatarsals, and tarsal bones.

The proposed device, the Cancellous Screw Washer claims substantial equivalence to a currently marketed device, Synthes Screw Washer. The Synthes Screw Washer and the proposed device are available in either Titanium or Stainless Steel. Both function as added support under bone screw head and have no significant design differences.

Based on the provided K9634 Cancellous Screw Washer 510(k) Summary, it is not possible to describe acceptance criteria and a study proving the device meets them in the way typically expected for an AI/CAD medical device.

The provided document describes a Class II surgical instrument (Cancellous Screw Washer) and its 510(k) submission for market clearance. This type of device does not involve algorithmic performance, image interpretation, or human-in-the-loop interaction in the same way an AI/CAD system would.

Therefore, many of the requested categories are not applicable to this specific device and document.

Here's a breakdown of why and what information can be inferred:

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

• Not Applicable in the AI/CAD context. For a surgical washer, "acceptance criteria" typically relate to manufacturing specifications (material strength, dimensions, sterilization compatibility, biocompatibility) rather than diagnostic performance metrics like sensitivity, specificity, or AUC.
• The document states "no significant design differences" to a predicate device (Synthes Screw Washer) and claims substantial equivalence. This is the primary "acceptance criteria" for a 510(k) for this type of device: demonstrating equivalence to a legally marketed predicate.
• Reported Device Performance: The document doesn't explicitly list performance data beyond functional claims (added support under bone screw head). Equivalence is demonstrated by similarity in materials, design, and intended use.

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

• Not Applicable. There is no "test set" in the context of diagnostic data for a surgical washer. Performance is typically assessed through engineering bench testing, biocompatibility studies, and documented manufacturing controls. Such details are not provided 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)

• Not Applicable. "Ground truth" in the diagnostic sense is not relevant for this device. Ground truth for a surgical washer would be established through engineering standards, clinical consensus on a safe and effective design, and regulatory requirements.

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

• Not Applicable. No test set for diagnostic performance exists.

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 passive surgical implant, not an AI/CAD diagnostic tool.

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

• Not Applicable. No algorithm is involved.

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

• Ground Truth (in a very loose sense for a medical device): The "ground truth" for a surgical washer's safety and effectiveness is established by:
  • Engineering Standards: Meeting material specifications, mechanical strength, and dimensional tolerances.
  • Biocompatibility Standards: Demonstrating the material (Titanium or Stainless Steel) is suitable for implantation.
  • Clinical Efficacy/Safety of Predicate: The fact that the substantially equivalent predicate device (Synthes Screw Washer) is already legally marketed and presumed safe and effective.
  • Intended Use Compatibility: The device is designed for use with cancellous bone screws, implying its form and function align with established surgical practices for fracture fixation.

8. The sample size for the training set

• Not Applicable. No training set for an algorithm exists.

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

• Not Applicable. No training set exists.

In summary, the provided document describes a 510(k) submission for a conventional medical device (surgical washer) based on substantial equivalence to an existing predicate device. The framework of acceptance criteria and study design requested is specifically tailored for AI/CAD systems and is not relevant to this type of product.

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function with a cannuiated bone screw used as internal fixation for the carpel, tarsal, metacarpal, and phalanges of the hand and foot.

The proposed device, the guidewires for cannulated screws claims substantial equivalence to a currently marketed device, Synthes guidewires. The Synthes guidew res and the proposed device are available in either stainless steel or Titanium alloy. Both function with a cannuiated bone screw used as internal fixation for the carpel, tarsal, metacarpal, and phalanges of the hand and foot. There are no significant design differences. The tips of the guidewires are pointed with either a trocar or diamond point for starting into the bone. The wires are normally used as temporary fixation of a fracture or osteotomy site until a bone screw can be driven over the wire and the wire removed

This document describes acceptance criteria and a study for "Guide Wires for Cannulated Screws." However, the provided text does not contain any information about acceptance criteria, device performance metrics, or any study design details related to demonstrating the device meets performance criteria.

The provided text only constitutes a 510(k) summary for the "Guide Wires for Cannulated Screws," focusing on demonstrating substantial equivalence to a predicate device (Synthes guidewires). It describes the devices' materials, function, and design, but not their performance in a medical setting or any testing conducted beyond basic design equivalence.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them based on the provided input. The input lacks all the necessary information.

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Not Found

Threaded Fixation Pin

The provided text is a 510(k) summary for a medical device (Threaded Fixation Pin) from 1996. This document is a regulatory submission focused on demonstrating substantial equivalence to a predicate device, not a study report detailing performance data against acceptance criteria.

Therefore, the input does not contain the information necessary to describe acceptance criteria and a study proving a device meets them in the way requested by your prompt.

Here's why and what's missing:

• Acceptance Criteria & Reported Device Performance (1): The document doesn't define any specific performance metrics (e.g., sensitivity, specificity, accuracy, mechanical strength, displacement limits) nor does it report any numerical performance results for the Threaded Fixation Pin. It only states its intended use and material.
• Sample Size (Test Set) & Data Provenance (2): There is no mention of a test set, sample sizes, or data provenance as no performance study is described.
• Number/Qualifications of Experts (3): No experts are mentioned in the context of establishing ground truth for a test set.
• Adjudication Method (4): Not applicable as no ground truth establishment process is described.
• MRMC Comparative Effectiveness Study (5): This type of study is not mentioned or implied. The document focuses on material and intended use equivalence.
• Standalone Performance (6): No standalone performance data is presented.
• Type of Ground Truth (7): Not applicable as no ground truth is established for device performance.
• Sample Size (Training Set) (8): No training set is mentioned as no learning algorithm or AI is involved.
• Ground Truth (Training Set) (9): Not applicable.

In summary, the provided text is an equivalence claim for a rudimentary medical device from 1996 and does not contain the kind of detailed study information (especially concerning AI/algorithm performance) that your prompt is looking for.

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Not Found

The proposed device, the small bone screw claims substantial equivalence to a currently marketed device, the Synthes mini-fragment bone screw. The Synthes screws and the proposed device are both available in Titanium and Stainless Steel. Both function as internal fixation for bones and have no significant design differences.

The provided text does not contain information about an AI/ML powered device, its acceptance criteria, or a study proving its performance. Instead, it describes a 510(k) summary for a small bone screw claiming substantial equivalence to a predicate device.

Therefore, I cannot answer your request regarding acceptance criteria and a study for an AI/ML device, as the provided input is irrelevant to that topic.

The input describes a medical device, a small bone screw, and its claim of substantial equivalence to a predicate device (Synthes mini-fragment bone screw) based on material (Titanium and Stainless Steel) and function (internal fixation for bones) with no significant design differences. This is a common process for regulatory clearance of traditional medical devices, not AI/ML driven ones.

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