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The indications for use of the Osteo BOS" System bone plates and Kirschner wire, in keeping with those of other legally marketed bone plates and Kirschner wires, are as follows.

The indications for each of the Osteo BOS" System product line extension bone plates are:

• . Internal fracture fixation of long and small bones.
  The indications for the Kirschner wires with a trocar point are:

• For use as guide wires in hip pinning procedures.

• . For use in aligning and reducing long bone fractures.

• For use in securing non-long bone fractures such as olecranon fractures, patella fractures, . tibial plateau fractures, small hand and foot bone fractures, humeral, and humeral, radial and ulnar fractures, etc.

• . For use with cerclage wire/cable in treating greater trochanter fractures.

The Osteo BOS" System product line extension components are used for fracture fixation on various small and long bones. All Osteo BOS" System product line extension components are manufactured from Titanium alloy and include the following:

• Oblique T-Plate, ø4.0/03.5
• One-Third Tubular Plate, 04.0/03.5
• Kirschner wire with trocar point

This document is a 510(k) Premarket Notification for the "Osteo BOS" System Product Line Extension," a set of bone plates and Kirschner wires used for fracture fixation. The submission aims to demonstrate substantial equivalence to predicate devices, primarily those offered by Synthes.

Based on the provided text, the following information can be extracted regarding acceptance criteria and the "study" that proves the device meets them:

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

The document does not outline specific, quantifiable acceptance criteria or report device performance in terms of metrics like accuracy, sensitivity, specificity, or precision. Instead, it focuses on demonstrating substantial equivalence to predicate devices. The "performance" being assessed is primarily technological and intended use equivalence, rather than a clinical outcome or diagnostic accuracy.

Acceptance Criteria (Implied by Substantial Equivalence):

• Plates: Both subject and predicate plates are for internal fracture fixation.
• Kirschner wires: Both subject and predicate are for skeletal traction, guide wires, and fracture fixation. |
  | Intended Use Equivalence: The device's intended use should be the same as legally marketed predicate devices. | The Osteo BOS™ System product line extension bone plates are intended for internal fracture fixation of various long and small bones. The Kirschner wires are intended for use in skeletal traction, as guide wires, and for fracture fixation. These indications are in keeping with those of other legally marketed bone plates and Kirschner wires (including the Synthes predicate). |
  | Technological Characteristics Equivalence: The materials and fundamental technological principles should be similar to legally marketed predicate devices. | Plates: Subject plates are manufactured from Titanium alloy. Predicate plates are manufactured from CP Titanium. The document implies this is equivalent for the intended use.
  Kirschner wires: Both subject and predicate Kirschner wires are manufactured from Titanium alloy. |

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

There is no mention of a "test set" or any experimental data being collected from patients or subjects. This is a premarket notification for a medical device that relies on demonstrating substantial equivalence to existing devices, not on proving clinical efficacy via a clinical trial with a test set. Therefore, there's no information on sample size or data provenance.

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. As no "test set" or clinical study was conducted, there were no experts establishing ground truth in that context. The "ground truth" for this submission is implicitly the established safety and effectiveness of the legally marketed predicate devices.

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

Not applicable. No "test set" or clinical study was conducted, so no adjudication method 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 is a submission for bone plates and Kirschner wires, which are mechanical fixation devices, not an AI or diagnostic imaging device. 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-based device.

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

The "ground truth" for this 510(k) submission is the established safety and efficacy of the predicate devices (Synthes bone plates and Kirschner wires) that are already legally marketed. The submission's goal is to show the new device is "substantially equivalent" to these known safe and effective products. There is no mention of pathology, outcomes data, or expert consensus relating to a new clinical study.

8. The sample size for the training set

Not applicable. This type of submission does not involve a "training set" in the context of an algorithm or machine learning.

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

Not applicable. No training set was used.

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The Osteo BOS" System in Stainless Steel components are intended for fracture fixation of long and small bones.

The Osteo BOS" System in Stainless Steel components are used for fracture fixation of long and small bones. All Osteo BOS" System components are manufactured from ASTM F-138-92 Stainless Steel and include the following:

• Plate Wide (06.5mm/04.5mm)
• Plate - Narrow (06.5mm/04.5mm)
• Plate Wide (04.0mm/03.5mm)
• One-Third Tubular Plate (e4.0mm/03.5mm)
• Plate (@2.7mm)

This document describes a 510(k) Premarket Notification for the Osteo BOS™ System in Stainless Steel, a bone plating system. It does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the manner typically seen for performance evaluation studies of medical devices generating quantitative performance metrics (e.g., diagnostic devices).

Instead, this submission is focused on demonstrating substantial equivalence to a predicate device, which is a different type of regulatory pathway. Substantial equivalence is established by comparing the subject device's technological characteristics and intended use to a legally marketed predicate device. The "proof" is the argument and documentation that the new device is as safe and effective as the predicate.

Here's a breakdown of why many of your requested points cannot be directly answered from the provided text, and what information is available:

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

• Not applicable in the provided context for performance metrics. This document is a 510(k) summary, which for this type of device (bone plate), focuses on showing it's "substantially equivalent" to an existing device rather than presenting acceptance criteria for a performance study (like sensitivity/specificity for a diagnostic tool). The "performance" in this context refers to its ability to perform the intended function as a bone fixation device, which is inferred by its similarity to the predicate device and manufacturing materials.

  Instead, the "acceptance criteria" here is the FDA's determination of substantial equivalence. The "reported device performance" is implicitly understood to be equivalent to the predicate device.

  Acceptance Criteria (for 510(k) pathway)	Reported Device Performance (as demonstrated for 510(k))
  Substantial Equivalence to Predicate Device (Synthes bone plates) in terms of:
  - Intended Use	- Intended Use: Fracture fixation of long and small bones. (Matches predicate)
  - Technological Characteristics	- Material: ASTM F-138-92 Stainless Steel. (Matches predicate type)
  	- Design: Various plate sizes/types (Wide, Narrow, One-Third Tubular, etc.). (Comparable to predicate)
  - Performance (Safety and Effectiveness)	- Implied safety and effectiveness are equivalent due to similar materials, design, and intended use as the predicate device. No new safety/effectiveness concerns raised.

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

• Not applicable. This submission does not describe a clinical performance study with a "test set" of patients or data samples. The "testing" discussed is primarily related to material composition and design comparison against a predicate, not clinical outcomes in a sample population.

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

• Not applicable. There is no "ground truth" derived from expert review for a test set in this 510(k) submission. The "ground truth" for regulatory assessment is the established performance and safety of the predicate device.

4. Adjudication method for the test set

• Not applicable. No test set requiring adjudication is described.

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 passive, implantable bone plate, not an AI-powered diagnostic or assistive tool. MRMC studies are irrelevant here.

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

• Not applicable. This device is a physical medical implant, not an algorithm.

7. The type of ground truth used

• The "ground truth" in the context of this 510(k) is the established safety and effectiveness profile of the legally marketed predicate device (Synthes bone plates). The Osteo BOS™ System in Stainless Steel demonstrates substantial equivalence to this predicate.

8. The sample size for the training set

• Not applicable. There is no "training set" as this is not a machine learning or AI-driven device.

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

• Not applicable. As above, no training set or its associated ground truth establishment method is relevant here.

Summary of the Study/Evidence Provided in the Document:

The "study" in this context is a comparison to a predicate device to demonstrate substantial equivalence, required for a 510(k) premarket notification.

• Device Name: Osteo BOS™ System in Stainless Steel
• Predicate Device: Similar bone plates offered by Synthes.
• Basis for Equivalence:
  • Intended Use: Both the subject device and the predicate are intended for "fracture fixation of long and small bones."
  • Technological Characteristics: Both are manufactured from stainless steel (Osteo BOS™ uses ASTM F-138-92 Stainless Steel). They both comprise various plate designs (wide, narrow, one-third tubular, etc.).
• Conclusion: The FDA reviewed the 510(k) submission and determined the device is substantially equivalent to devices marketed prior to May 28, 1976, and therefore may be marketed. This decision essentially "proves" that the device meets the regulatory acceptance criteria for substantial equivalence.

This type of regulatory submission relies on comparison to existing, proven technologies rather than generating new clinical performance data for every single new iteration of a well-understood device type.

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The Osteo BOS™ System components are intended for long and small bone fracture fixation.

The Osteo BOS" System components are used for internal fracture fixation of long and small bones. All Osteo BOS" System components are manufactured from Titanium alloy and include the following:

• Plate - Wide (06.5mm/04.5mm)
• Plate Narrow (06.5mm/04.5mm) .
• . T-Plate (06.5mm/04.5mm)
• T-Buttress Plate (06.5mm/04.5mm) .
• L-Plate (Ø6.5mm/Ø4.5mm) .
• Plate Wide (@4.0mm/03.5mm)
• Plate Narrow (e4.0mm/03.5mm) & Osteo Plate (04.0mm/03.5mm)
• Small T-Plate (04.0mm/03.5mm) ◆
• Plate (@2.7mm)
• Cortex Screw (02.7mm) .
• . Cortex Screw (03.5mm)
• t Cortex Screw (03.5mm with shaft)
• Cortex Screw (04.5mm) .
• Cortex Screw (04.5mm with shaft) .
• Nut for @4.5mm cortex screw .
• Ø8mm Washer for Ø4.0mm cancellous screws & . @3.5mm cortex screws
• 06.5mm Washer for 02.7mm cortex screws
• Cancellous Screw (ø4.0mm) ↓
• Cancellous Screw ($4.0mm with short thread) .
• Cancellous Screw (06.5mm) ♥
• Cancellous Screw (06.5mm, thread lengths 16mm & 32mm) .
• 013.0mm Washer for cancellous screws 26.5mm & . cortex screws 04.5mm

This document describes the Osteo BOS™ System, a bone plate and screw system for fracture fixation. However, the provided text is a 510(k) premarket notification summary and an FDA clearance letter from 1997. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting extensive clinical study data with detailed acceptance criteria and performance metrics typically found in more recent device submissions or clinical trial reports for AI/software as a medical device (SaMD).

Therefore, the information requested about acceptance criteria, detailed study design, sample sizes, ground truth establishment, expert qualifications, and MRMC studies is largely not present in the provided text. The document primarily confirms the device's substantial equivalence in design and intended use to existing bone plates and screws.

Here's an analysis based on the available information:

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

No explicit acceptance criteria or performance metrics (like sensitivity, specificity, accuracy) are reported in this 510(k) submission summary. The demonstration of "substantial equivalence" is the primary acceptance criterion for a 510(k). Performance is implied to be equivalent to the predicate device.

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

Not applicable. This 510(k) summary does not describe a test set or clinical study involving patient data with sample sizes. Substantial equivalence was primarily based on comparing the design, materials, and intended use to a predicate 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)

Not applicable. No ground truth establishment by experts is described for this type of device submission.

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

Not applicable. No test set or human interpretation requiring adjudication is described.

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. The Osteo BOS™ System is a physical medical device (bone plates and screws), not an AI/software device. Therefore, no MRMC study or AI assistance evaluation was conducted.

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

Not applicable. This is not an algorithm or software device.

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

Not applicable. Ground truth, in the context of device performance, as typically understood for diagnostic or AI devices, is not a concept applied in this 510(k) submission for mechanical equivalence. The "ground truth" for demonstrating substantial equivalence for a bone plate system would be its material properties, mechanical testing (which is not detailed here but would have been part of the full submission), and clinical history of similar predicate devices.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device; hence, no training set is relevant.

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

Not applicable. No training set is relevant.

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