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SCS 17-01 is a syntheic, biocompatible bone graft substitute material that hardens and converts to a poorly crystalline hydroxyapatite at body temperature. It is indicated for filling bone voids or defects of the skeletal system (i.e. extremites and pelvis) that are not intrinsic to the stability of bony structure. These defects may be surgically created osseous defects or defects created from traumatic injury to the bone. The device provides an injectable, self-setting, osteoconductive bone graft substitute that resorbs and is replaced by the growth of new bone during the healing process.

The SCS 17-01 product is a synthetic, injectable, settable osteoconductive calcium phosphate bone graft substitute material. SCS 17-01 is composed of a dry powder and an aqueous solution (supplied in separate sterile, preloaded syringes) that must be mixed intra-operatively to form a cohesive paste prior to implantation using the supplied mixing system. The dry powder is composed of the alpha phase of tricalcium phosphate (alphaTCP) [Ca3(PO4)2], calcium [CaCO3] carbonate phosphate [Ca(H2PO4)2]. The aqueous component is composed of water for injection, sodium phosphate dibasic [Na2HPO4], citric acid [C6H8O7] and hyaluronic acid (HA). Upon mixing the cement powder and the setting solution at body temperature, a dissolution and reprecipitation reaction occurs resulting in the precipitation of a poorly crystalline hydroxyapatite. During the healing process, the bone void filler resorbs and is replaced with new bone growth. SCS 17-01 is provided sterile for single use in volumes ranging from 1cc to 4cc.

I am sorry, but the provided text does not contain information about the acceptance criteria and a study proving a device meets these criteria in the context of an AI/ML powered medical device. The document is a 510(k) clearance letter for a bone void filler and describes its substantial equivalence to a predicate device based on bench tests, chemical and physical characterization, and an in vivo animal study. It does not refer to an AI device or any associated performance metrics or studies as described in your request.

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SCS 17-01 is a synthetic, biocompatible bone graft substitute material that hardens and converts to a poorly crystalline hydroxyapatite at body temperature. It is indicated for filling bone voids or defects of the sketal system (i.e. extremities and pelvis) that are not intrinsic to the stability of bony structure. These defects may be surgically created osseous defects or defects created from traumatic injury to the bone. The device provides an injectable, self-setting, osteoconductive bone graft substitute that resorbs and is replaced by the growth of new bone during the healing process.

SCS 17-01 is an injectable, settable osteoconductive calcium phosphate bone graft substitute material. It is provided to the end-user as two components (a dry powder and an aqueous solution) that must be mixed intra-operatively prior to implantation using the supplied mixing system to form a cohesive paste. The dry powder component is composed of the alpha phase of tricalcium phosphate [Ca3(PO4)2], calcium carbonate [CaCO3], and monocalcium phosphate [Ca(H2PQ4)2]. The liquid component is composed of sodium phosphate dibasic [Na2HPO4], citric acid [CoH30], hyaluronic acid (HA), and water for injection. SCS 17-01 is provided sterile for single use in volumes ranging from 1.5cc to 4cc and is provided in a kit containing the dry powder component and the liquid component in pre-loaded syringes.

The provided text describes a 510(k) premarket notification for a medical device called SCS 17-01, a resorbable calcium salt bone void filler. This submission focuses on demonstrating substantial equivalence to predicate devices, rather than establishing new performance criteria or conducting a clinical effectiveness study against a defined set of acceptance criteria in humans.

Therefore, many of the requested details, such as specific acceptance criteria for device performance in a clinical setting, human-in-the-loop studies (MRMC), or a comprehensive standalone algorithm performance, are not applicable to this type of submission. The study described is primarily pre-clinical (animal studies) and lab-based testing to show equivalence in properties and performance to existing devices.

Here's an attempt to answer the questions based only on the provided text, highlighting where information is absent or not relevant to this type of regulatory submission:

Acceptance Criteria and Study for SCS 17-01 (K173008)

This submission is a 510(k) Premarket Notification for a Class II medical device (SCS 17-01, Product Code MQV). The primary goal of a 510(k) is to demonstrate "substantial equivalence" to a legally marketed predicate device, not necessarily to meet new, standalone acceptance criteria for clinical performance that would typically be seen for novel devices or those undergoing PMA. The "acceptance criteria" here are implicitly tied to demonstrating equivalence through comparative testing.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a substantial equivalence submission based on pre-clinical data and comparison to predicate devices, the "acceptance criteria" are not framed as specific clinical outcome thresholds, but rather as demonstrating similar characteristics and performance in in-vitro and in-vivo (animal) models.

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

• Test Set (Animal Study): The text mentions a "rabbit distal femoral condyle critical-sized defect model" and that "The baseline (time 0) animals provided information on the initial amount of material implanted to fill the defects. Emptv (unfilled) defects (negative control) and defects filled with autograft (positive control) were evaluated at 6 weeks and 12 weeks."
  • Sample Size: The exact number of animals or defects per group (subject device, primary predicate, negative control, positive control, time points) is not specified in the provided text.
  • Data Provenance: This was an in vivo animal study. The country of origin is not specified. It is a prospective experimental study in an animal model.

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

• Not Applicable / Not Specified: For the animal study, the "ground truth" would be established by the measured outcomes (radiographic appearance, micro-CT, histology, histomorphometry, mechanical testing). While pathologists or radiologists would interpret the animal data, the number and qualifications of experts involved in analyzing the animal study endpoints are not specified in the provided text. This is not a human clinical study requiring human interpretation of medical images.

4. Adjudication Method for the Test Set

• Not Applicable / Not Specified: As this is primarily an animal study and laboratory testing, there is no mention of a human-based adjudication method (like 2+1 or 3+1 consensus) for establishing ground truth, as would be common in human diagnostic imaging studies. The data points (e.g., measurements from histology, mechanical tests) would be objective.

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

• No: The provided text explicitly states: "No clinical data are included in this submission." An MRMC study involves human readers interpreting clinical cases, which was not performed or submitted for this device.

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

• No: This device is a bone void filler material, not an AI algorithm or software. Therefore, there is no "standalone algorithm" performance to report.

7. The Type of Ground Truth Used

• For the animal study, the ground truth was established through a combination of:
  • Histology / Histomorphometry: Direct microscopic examination of tissue and quantitative analysis of bone formation/resorption within the defect.
  • Radiography and Micro-Computed Tomography (micro-CT): Imaging modalities to visualize the implanted material and surrounding bone.
  • Mechanical Testing: Objective measurement of the strength or mechanical properties of the treated bone.
  • Expert Review/Pathology: While not explicitly detailed, trained personnel/experts would be involved in interpreting the histologic slides and radiographic images.
• This is an in vivo biological response and physical measurement ground truth in an animal model, not expert consensus on human images, pathology from human biopsies, or human clinical outcomes data.

8. The Sample Size for the Training Set

• Not Applicable: This device is a physical product (bone void filler), not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning.

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

• Not Applicable: As above, there is no training set for an AI/ML algorithm for this physical device.

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